Zernicka-Goetz Receives Honors from the NOMIS Foundation – Caltech

Magdalena Zernicka-Goetz, Bren Professor of Biology and Biological Engineering and affiliated faculty member with Caltech'sTianqiao and Chrissy Chen Institute for Neuroscience, has been awarded the 2022 NOMIS Distinguished Scientist and Scholar Award. Established in 2016, the award is presented to "pioneering scientists and scholars who, through their innovative, groundbreaking research, have made a significant contribution to their respective fields and who inspire the world around them," according to the NOMIS Foundation.

Zernicka-Goetz's research addresses fundamental questions about how life begins, such as: What drives a fertilized egg to divide and grow until it becomes 40 trillion cells, and how do these cells know how to make a person? To address these questions, she has developed methods for tracking living embryos to determine how stem cells are first created, establish their fates, and work together to shape the body. She also pioneered methods to grow embryos beyond implantation, techniques that won the "People's Choice Scientific Breakthrough of the Year" in 2016 inSciencemagazine. Her team used these methods to createthe first complete embryo models from stem cells that develop like natural embryos.

In 2021, the team determined the molecular signals involved in how an embryo becomesasymmetrical and polarizedand how the embryo forms itshead-to-tail body axis.

Zernicka-Goetz received her PhD from Warsaw University and joined the Caltech faculty in 2019. Prior to Caltech, she was professor of mammalian development and stem cell biology at the University of Cambridge, England. She is a fellow of the British Academy of Medical Science, the Polish Academy of Sciences, and a recipient of anNIH Director's Pioneer Award and the 2022 Edwin G. Conklin Medal from the Society for Developmental Biology.

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Zernicka-Goetz Receives Honors from the NOMIS Foundation - Caltech

Lokken to retire as vice chancellor for government and community relations – The Source – Washington University in St. Louis

Pamela Lokken, vice chancellor for government and community relations at Washington University in St. Louis, will retire from the university this fall after more than 30 years of service.

We celebrate Pam for her substantial contributions to the Washington University community, both measurable and immeasurable, Chancellor Andrew D. Martin said. She has been instrumental in positioning the university to advance its mission at the national, state and local levels. She has served in this role during several critical junctures in the universitys history collaborating closely with Chancellors Danforth, Wrighton and myself and has done so with her characteristic humility, warmth, humor and common sense. I join with countless others across the university in stating, simply, that we will miss Pam and that we deeply appreciate all she has done to make Washington University a leader in higher education.

Lokken joined Washington University in 1991 and has served in senior leadership roles for over three decades. As vice chancellor, she has led a team that oversees the universitys federal, state and local governmental and community affairs initiatives. Her experience includes extensive engagement at all levels of government and associated legislative bodies, executive branch departments and regulatory agencies. Among her specific areas of public policy expertise are scientific research, health care, higher education and tax policy.

Earlier this year, Lokken was honored by the Association of American Universities (AAU) whose membership is composed of Americas leading research universities with the 2022 Legacy Award, which recognizes career excellence, distinguished contributions to the community and national leadership in the higher education community. An excerpt from the award citation states: By all measures Pam is one of the great leaders in higher education in building trust and alliances with the federal government as well as taking it on, when needed. Pam knows that our work is not about who is in or out in D.C., but about students, teaching, research and patient care and promoting, protecting and providing for Washington University and the St. Louis region.

As a trusted leader, Lokken developed critical relationships to advance meaningful change.Her accomplishments include establishing the National Institute for Food and Agricultural Research at the U.S. Department of Agriculture; transferring federal property to make Washington University the sole owner of the Tyson Research Center; preserving the universitys ROTC program from elimination; protecting stem cell research; and expanding the Missouri Medicaid program. She also was instrumental in the vision and early development of the Danforth Plant Science Center, the expansion of St. Louis public transit system and university-supported development in surrounding communities.

Lokken helped spearhead the creation of several national and statewide advocacy coalitions to protect and advance research being conducted at Washington University and other institutions, including The Science Coalition, the Coalition for the Advancement of Medical Research, Supporters of Agricultural Research, United for Medical Research, Missouri Biotechnology Association and Missouri Cures. She has chaired key committees for the AAU, the American Association of Medical Colleges and the Consortium on Financing Higher Education and has served as a board member of the National Association of Independent Colleges and Universities, Tuition Plan Consortium and the Stowers Institute for Medical Research.

Im immensely proud of the progress the university has made as an engaged partner in community and government affairs over the past three decades. Weve elevated our research profile, expanded our student financial aid, and enhanced our economic and community impact in the St. Louis region, Lokken said. Im honored to have been part of these efforts and I credit so much of the progress to the talented and dedicated team in the Office of Government & Community Relations, with whom Ive had the enormous privilege to work.

Lokkens last day at the university will be Sept. 2. A search for her successor will be announced in coming weeks.

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Lokken to retire as vice chancellor for government and community relations - The Source - Washington University in St. Louis

Updated Data for Janssen’s Bispecific Teclistamab Suggest Continued Deep and Durable Responses in the Treatment of Patients with Relapsed or…

New teclistamab data presented at the 2022 ASCO Annual Meeting report longer follow-up from Phase 1/2 MajesTEC-1 study evaluating the BCMAxCD3 bispecific antibody, including progression-free survival and subgroup analyses

Data from MajesTEC-1 study published in The New England Journal of Medicine

June 5, 2022, CHICAGO /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced updated efficacy and safety results from the teclistamab Phase 1/2 MajesTEC-1 study. Teclistamab is an investigational, off-the-shelf, T-cell redirecting bispecific antibody targeting B-cell maturation antigen (BCMA), which is being studied in patients with relapsed or refractory multiple myeloma (RRMM) who have received three or more prior lines of therapy.1The data were featured as part of an oral session during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. Additional poster presentations featured data on teclistamab as a monotherapy, as well as in combination with DARZALEX FASPRO (daratumumab and hyaluronidase-fihj). Applications seeking approval of teclistamab are currently under health authority review in the U.S. and Europe.

The multicohort, open-label, Phase 1/2 MajesTEC-1 study is investigating the safety and efficacy of teclistamab in patients with RRMM who received at least three prior lines of therapy. As of March 2022, 165 patients were treated with teclistamab at the recommended subcutaneous (SC) Phase 2 dose (RP2D) of 1.5 mg/kg preceded by step-up doses of 0.06 and 0.3 mg/kg across both Phase 1 (NCT03145181) and Phase 2 (NCT04557098)of the study.

Longer Follow-up from MajesTEC-1 Study in Patients with Triple Class Exposed Multiple Myeloma (Abstract #8007)

At a median follow-up of 14.1 months (0.2624.4), an overall response rate (ORR) of 63 percent (95 percent Confidence Interval [CI], range, 55.270.4) was observed in patients with triple class exposed multiple myeloma, with a complete response (CR) or better achieved in 39.4 percent of patients.1 Study participants had three or more prior lines of therapy, with a median of five prior lines, including a prior proteasome inhibitor, immunomodulatory drug and anti-CD38 antibody.1 The majority of patients were triple-class refractory and/or refractory to their last line of treatment.1Although response duration data are not mature, the median duration of response at this time is 18.4 months and has not been reached in patients who achieved a CR or better (95 percent CI, 14.9 not estimable).1 This suggests responses to teclistamab were durable and deepened over time.1 The medium progression-free survival (PFS) was 11.3 months (95 percent CI, 8.817.1).1 Adverse events (AEs) were low-grade for the most part and manageable with no new safety signals seen.1

These results from the MajesTEC-1 study were also simultaneously published online in The New England Journal of Medicine.2

"The MajesTEC-1 study update suggests patients with relapsed or refractory multiple myelomareceiving teclistamab achieved a deep response that was also durable," said Ajay K. Nooka, M.D., MPH, FACP, Associate Professor of Hematology and Medical Oncology at Emory School of Medicine and principal study investigator. "These longer-term data, notably the overall response rate and progression-free survival, are encouraging in this heavily pretreated patient population."

No new safety signals were observed with longer follow-up.1 In 14.1 month follow-up data presented at ASCO 2022, the most common grade 3/4 hematologic AEs were neutropenia (64.2 percent); anemia (37 percent); lymphopenia (32.7 percent) and thrombocytopenia (21.2 percent). Infections occurred in 76.4 percent of patients (44.8 percent grade 3/4).1 The most common nonhematologic AE was cytokine release syndrome (CRS), all of which were grade 1/2 except for 1 transient grade 3 CRS (72.1 percent all grade).1The median time to CRS onset was two days (range, 16) and median duration was two days (range, 19).1 There were five treatment-related deaths, and dose reductions and discontinuations due to AEs were infrequent.1

First Results from Cohort C of the MajesTEC-1 Study of Teclistamab in Patients with RRMM with Prior Exposure to BCMA Targeted Treatment (Abstract #8013)

Initial results were also presented from Cohort C of the MajesTEC-1 study evaluating teclistamab in the treatment of patients with RRMM who had previously been exposed to an anti-BCMA treatment.3 These patients had received a median of six prior lines of therapy, most (85 percent) were triple-class refractory and 35 percent were penta-drug refractory.3The use of teclistamab following prior treatment with chimeric antigen receptor T cell (CAR-T) therapy and/or an antibody drug conjugate (ADC) (e.g., belantamab mafodotin) targeting BCMA resulted in a promising response rate in patients with heavily pretreated RRMM.3At a median follow-up of 12.5 months (0.7-14.4), the ORR was 52.5 percent (95 percent CI, 36.168.5) among 40 patients who received teclistamab in Cohort C.3 Responses to teclistamab occurred early and deepened over time, with comparable response rates in patients previously treated with an ADC and/or CAR-T.3

A tolerable side-effect profile was observed in patients previously treated with anti-BCMA treatment, with no dose reductions or discontinuations due to AEs.3 The safety profile for Cohort C was comparable with that observed in BCMA treatment-naive patients, with no new safety signals.3 In 12.5 month follow-up data, 26 patients (65 percent; 30 percent grade 3/4) had infections.3 The most common AEs (n=40) were CRS (65 percent any grade), with a median time to CRS onset and duration of two days (range, 2-6) and two days (range, 1-4) respectively.3 Cytopenias (grade 3/4) were noted as follows; neutropenia (62.5 percent); thrombocytopenia (30 percent); anemia (35 percent); and lymphopenia (42.5 percent).3

Initial Patient-Reported Health-Related Quality of Life (HRQoL) Outcomes in Patients with RRMM Treated with Teclistamab (Abstract #8033)

Initial results from an analysis of patient-reported health-related quality of life (HRQoL) outcomes following treatment with teclistamab were also shared in a poster session.4 The study analyzed patient-reported assessments of quality of life metrics among patients in the MajesTEC-1 trial who had received their first treatment dose by March 18, 2021.4The metrics analyzed include function (physical, role, emotional, cognitive, social); symptoms (fatigue, nausea/vomiting, pain, appetite loss, constipation, diarrhea); and generic health (mobility, self-care, usual activities, pain/discomfort, anxiety/depression).4 Over 80 percent of the 110 patients included in the patient-reported outcomes (PRO) analysis noted meaningful improvement (percentages of patients with clinically meaningful change from baseline [EORTC QLQ-C30 scales: 10 points]) in at least one of the symptom scales.4 Reduction in pain scores occurred as early as cycle two.4 At the moment, no meaningful improvement was observed in the scales for physical functioning and fatigue.4 These initial PRO results complement recent clinical data and support teclistamab as a potential off-the-shelf, T-cell redirecting therapy for patients with RRMM.4

As of September 7, 2021, median duration of treatment was 5.7 months and median follow-up was 7.8 months.4 Global healthstatus scores significantly improved from baseline (95 percent CIs for least squares mean change did not cross 0) at cycles four, six, and eight; emotional functioning significantly improved at all time points.4 PRO assessments included European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 item (EORTC QLQ-C30).4 PROs were assessed on day one of each treatment cycle (28 days per cycle).4Additional follow-up is needed to assess the full benefit of meaningful improvement in functional outcomes.4

Two Studies Investigate the Safety and Efficacy of Teclistamab and DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in Combination for the Treatment of Patients with RRMM

Updated results from the Phase 1 TRIMM-2 study (NCT04108195) were featuredduring a poster session (Abstract #8032) at ASCO 2022, evaluating teclistamab in combination with DARZALEX FASPRO, a CD38-directed monoclonal antibody approved to be given subcutaneously for the treatment of patients with multiple myeloma.5 In the study, patients received a median of five prior lines of therapy; 75.4 percent had prior exposure to anti-CD38 therapies, and 63.1 percent were refractory to anti-CD38 treatment.5 Evaluable patients achieved an ORR of 76.5 percent at a median follow-up of 8.6 months (0.319.6).5

A poster presentation for the ongoing multicenter, open-label, randomized Phase 3 MajesTEC-3 (NCT05083169) study comparing the efficacy of teclistamab in combination with daratumumab versus investigator's choice of daratumumab in combination with pomalidomide and dexamethasone (DPd) or bortezomib and dexamethasone (DVd) (Poster TPS8072)in patients with RRMMwas also presented at ASCO.6

Additional data from both the teclistamab (Abstract #S188) and talquetamab (Abstract #S183) cohorts of the TRIMM-2 study will be featured as oral presentations at the European Hematology Association (EHA) 2022 Congress taking place in Vienna, Austria, June 9-12.7,8

"The updated data presented at ASCO support the ongoing evaluation of teclistamab as a monotherapy and in combination with standard of care treatments," said Yusri Elsayed, M.D., M.HSc., Ph.D., Vice President, Disease Area Leader, Hematologic Malignancies, Janssen Research & Development, LLC. "These resultsunderscore our ongoing commitment to address the unmet need for new therapeutic options and our effort to bring forward novel treatments for multiple myeloma patients in the near future."

About Teclistamab

Teclistamab is an investigational, fully humanized IgG4, T-cell redirecting, bispecific antibody targeting both BCMA (B-cell maturation antigen) and CD3, the T-cell receptor. BCMA is expressed at high levels on multiple myeloma cells.9,10,11,12,13Teclistamab redirects CD3-positive T-cells to BCMA-expressing myeloma cells to induce killing of tumor cells.8

Teclistamab is currently being evaluated in several monotherapy and combination studies. In2020, the European Commission and the U.S. Food and Drug Administration (FDA) each granted teclistamab Orphan Drug Designation for the treatment of multiple myeloma. In January 2021 and June 2021, teclistamab receiveda PRIority MEdicines (PRIME) designation by the European Medicines Agency (EMA) and Breakthrough Therapy Designation (BTD) by the U.S. FDA, respectively. PRIME offers enhanced interaction and early dialogue to optimize drug development plans and speed up evaluation of cutting-edge, scientific advances that target a high unmet medical need.14 The U.S. FDA grants BTD to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition and is based on preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.15 In December 2021, Janssen submitted a Biologics License Application (BLA) to the FDA seeking approval of teclistamab for the treatment of patients with relapsed or refractory multiple myeloma; a marketing authorization application (MAA) was submitted to the EMA for teclistamab approval in January 2022.

About DARZALEX FASPRO

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered into a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab. DARZALEX FASPRO is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma and now light chain (AL) amyloidosis. DARZALEX FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE drug delivery technology.

DARZALEX FASPRO is indicated for the treatment of adult patients with multiple myeloma:

DARZALEX FASPRO in combination with bortezomib, cyclophosphamide, and dexamethasone is indicated for the treatment of adult patients with newly diagnosed AL amyloidosis. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Limitations of Use

DARZALEX FASPRO is not indicated and is not recommended for the treatment of patients with AL amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.

Full prescribing information for DARZALEX FASPRO is available here.

DARZALEX FASPROIMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

DARZALEX FASPROis contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase or any of the components of the formulation.

WARNINGS AND PRECAUTIONS

Hypersensitivity and Other Administration Reactions

Both systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO. Fatal reactions have been reported with daratumumab-containing products, including DARZALEX FASPRO.

Systemic Reactions

In a pooled safety population of 898 patients with multiple myeloma (N=705) or light chain (AL) amyloidosis (N=193) who received DARZALEX FASPROas monotherapy or in combination, 9% of patients experienced a systemic administration-related reaction (Grade 2: 3.2%, Grade 3: 1%). Systemic administration-related reactions occurred in 8% of patients with the first injection, 0.3% with the second injection, and cumulatively 1% with subsequent injections. The median time to onset was 3.2 hours (range: 4 minutes to 3.5 days). Of the 140 systemic administration-related reactions that occurred in 77 patients, 121 (86%) occurred on the day of DARZALEX FASPRO administration. Delayed systemic administration-related reactions have occurred in 1% of the patients.

Severe reactions included hypoxia, dyspnea, hypertension and tachycardia. Other signs and symptoms of systemic administration-related reactions may include respiratory symptoms, such as bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, as well as anaphylactic reaction, pyrexia, chest pain, pruritis, chills, vomiting, nausea, and hypotension.

Pre-medicate patients with histamine-1 receptor antagonist, acetaminophen and corticosteroids. Monitor patients for systemic administration-related reactions, especially following the first and second injections. For anaphylactic reaction or life-threatening (Grade 4) administration-related reactions, immediately and permanently discontinue DARZALEX FASPRO. Consider administering corticosteroids and other medications after the administration of DARZALEX FASPROdepending on dosing regimen and medical history to minimize the risk of delayed (defined as occurring the day after administration) systemic administration-related reactions.

Local Reactions

In this pooled safety population, injection-site reactions occurred in 8% of patients, including Grade 2 reactions in 0.7%. The most frequent (>1%) injection-site reaction was injection site erythema. These local reactions occurred a median of 5 minutes (range: 0 minutes to 6.5 days) after starting administration of DARZALEX FASPRO. Monitor for local reactions and consider symptomatic management.

Cardiac Toxicity in Patients with Light Chain (AL) Amyloidosis

Serious or fatal cardiac adverse reactions occurred in patients with light chain (AL) amyloidosis who received DARZALEX FASPROin combination with bortezomib, cyclophosphamide and dexamethasone. Serious cardiac disorders occurred in 16% and fatal cardiac disorders occurred in 10% of patients. Patients with NYHA Class IIIA or Mayo Stage IIIA disease may be at greater risk. Patients with NYHA Class IIIB or IV disease were not studied. Monitor patients with cardiac involvement of light chain (AL) amyloidosis more frequently for cardiac adverse reactions and administer supportive care as appropriate.

Neutropenia

Daratumumab may increase neutropenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX FASPROuntil recovery of neutrophils. In lower body weight patients receiving DARZALEX FASPRO, higher rates of Grade 3-4 neutropenia were observed.

Thrombocytopenia

Daratumumab may increase thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Consider withholding DARZALEX FASPRO until recovery of platelets.

Embryo-Fetal Toxicity

Based on the mechanism of action, DARZALEX FASPROcan cause fetal harm when administered to a pregnant woman. DARZALEX FASPROmay cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX FASPROand for 3 months after the last dose.

The combination of DARZALEX FASPROwith lenalidomide is contraindicated in pregnant women, because lenalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide prescribing information on use during pregnancy.

Interference with Serological Testing

Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive Indirect Antiglobulin Test (Indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab administration. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient's serum. The determination of a patient's ABO and Rh blood type are not impacted.

Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX FASPRO. Type and screen patients prior to starting DARZALEX FASPRO.

Interference with Determination of Complete Response

Daratumumab is a human IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some DARZALEX FASPRO-treated patients with IgG kappa myeloma protein.

ADVERSE REACTIONS

The most common adverse reaction (20%) with DARZALEX FASPRO monotherapy is upper respiratory tract infection. The most common adverse reactions with combination therapy (20% for any combination) include fatigue, nausea, diarrhea, dyspnea, insomnia, pyrexia, cough, muscle spasms, back pain, vomiting, upper respiratory tract infection, peripheral sensory neuropathy, constipation, pneumonia, and peripheral edema.

The most common adverse reactions (20%) in patients with light chain (AL) amyloidosis who received DARZALEX FASPRO are upper respiratory tract infection, diarrhea, peripheral edema, constipation, fatigue, peripheral sensory neuropathy, nausea, insomnia, dyspnea, and cough.

The most common hematology laboratory abnormalities (40%) with DARZALEX FASPRO are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin.

Please see full Prescribing Information for DARZALEX FASPRO.

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that affects some white blood cells called plasma cells, which are found in the bone marrow.16 When damaged, these plasma cells rapidly spread and replace normal cells in the bone marrow with tumors. In 2020, worldwide an estimated 176,000 people were diagnosed with multiple myeloma.17 In 2022, it is estimated that more than 34,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the U.S.18 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems or infections.19

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism, & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.

Learn more at http://www.janssen.com. Follow us at http://www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC is one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Dr. Nooka has served as a paid consultant to Janssen; he has not been paid for any media work.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of teclistamaband DARZALEX FASPRO. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC or any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 2, 2022, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

______________________________

1 Nooka A et al. Teclistamab, a B-cell maturation antigen (BCMA) x CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma (RRMM): Updated efficacy and safety results from MajesTEC-1. 2022 ASCO Annual Meeting American Society of Clinical Oncology. June 2022. 2 Moreau P et al. Teclistamab, a BCMAxCD3 antibody, in triple class exposed multiple myeloma. The New England Journal of Medicine, June 2022. 3 Touzeau C et al. Efficacy and safety of teclistamab (tec), a B-cell maturation antigen (BCMA) x CD3 bispecific antibody, in patients (pts) with relapsed/refractory multiple myeloma (RRMM) after exposure to other BCMA-targeted agents. 2022 ASCO Annual Meeting American Society of Clinical Oncology. June 2022. 4 Martin T et al. Health-related quality of life in patients with relapsed/refractory multiple myeloma (RRMM) treated with teclistamab, a B-cell maturation antigen (BCMA) x CD3 bispecific antibody: patient-reported outcomes in MajesTEC-1. 2022 ASCO Annual Meeting American Society of Clinical Oncology. June 2022. 5 Rodriguez-Otero P et al. A novel, immunotherapy-based approach for the treatment of relapsed/refractory multiple myeloma (RRMM): Updated phase 1b results for daratumumab in combination with teclistamab (a BCMA x CD3 bispecific antibody). 2022 ASCO Annual Meeting American Society of Clinical Oncology. June 2022. 6 Mateos M et al. Randomized, phase 3 study of teclistamab plus daratumumab versus investigator's choice of daratumumab, pomalidomide, and dexamethasone or daratumumab, bortezomib, and dexamethasone in patients with relapsed/refractory multiple myeloma. 2022 ASCO Annual Meeting American Society of Clinical Oncology. June 2022. 7 Rodriguez-Otero P et al. A novel, immunotherapy-based approach for the treatment of relapsed/refractory multiple myeloma (RRMM): Updated phase 1b results for daratumumab in combination with teclistamab (a BCMA x CD3 bispecific antibody). EHA 2022 Congress European Hematology Association. June 2022. 8 WJC van de Donk N et al. Novel Combination Immunotherapy for the Treatment of Relapsed/Refractory Multiple Myeloma: Update Phase 1B Results for Talquetamab (A GPRC5D x CD3 Bispecific Antibody) in Combination with Daratumumab. EHA 2022 Congress European Hematology Association. June 2022. 9 Labrijn AF et al. Proc Natl Acad Sci USA. 2013;110:5145. 10 Frerichs KA et al.Clin Cancer Res. 2020; doi: 10.1158/1078-0432.CCR-19-2299. 11 Cancer Research Institute. "Adoptive Cell Therapy: TIL, TCR, CAR T, AND NK CELL THERAPIES." Available at:https://www.cancerresearch.org/immunotherapy/treatment-types/adoptive-cell-therapy. 12 Cho SF et al. Frontiers in Immunology. 2018; 9: 1821. 13 Benonisson H et al. Molecular Cancer Therapeutics. 2019 (18) (2) 312-322. 14 European Medicines Agency. PRIME Factsheet. Available at: https://www.ema.europa.eu/en/human-regulatory/research-development/prime-priority-medicines. Accessed December 2021. 15 The U.S. Food and Drug Administration. "Expedited Programs for Serious Conditions." Available at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf. Accessed December 2021. 16 Rajkumar SV. Multiple myeloma: 2020 update on diagnosis, risk-stratification and management. Am J Hematol.2020;95(5):548-5672020;95(5):548-567. http://www.ncbi.nlm.nih.gov/pubmed/32212178 17 Cancer.Net. "Multiple Myeloma: Statistics." Available at:https://www.cancer.net/cancer-types/multiple-myeloma/statistics#:~:text=Worldwide%2C%20an%20estimated%20176%2C404%20people,worldwide%20died%20from%20multiple%20myeloma. Accessed June 3, 2022. 18 American Cancer Society. "Key Statistics About Multiple Myeloma." Available at: https://cancerstatisticscenter.cancer.org/?_ga=2.84250769.967379196.1642100198-1705811479.1642100198#!/. Accessed April 2022. 19 American Cancer Society. "What Is Multiple Myeloma?" Available at: https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html. Accessed January 2022.

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Updated Data for Janssen's Bispecific Teclistamab Suggest Continued Deep and Durable Responses in the Treatment of Patients with Relapsed or...

IPSCs For Democratized Cell Therapy – BioProcess Online

By Matthew Pillar, Editor, BioProcess Online

Differentiated Focus On Harnessing The Innate Immune System

Cytovia Therapeutics was launched in 2019 on the premise that allogeneic, innate immune cells held the best promise for next-generation cell therapy development in oncology. The co-founders of Cytovia, CEO Dr. Daniel Teper and Board Director Dr. Laurent Audoly, built the company on two complementary technologies: (1) natural killer cells differentiated from stem cells (iNK cells), that could potentially be edited, and (2) multifunctional tetravalent cell engager antibodies that boost the activity of natural killer cells (dubbed FLEX-NK cell engagers). Both technologies, says Dr. Teper, generate so-called off the shelf therapeutics that can be suited to all patients.

The unmet needs Cytovia seeks to address represent some very large patient populations. Worldwide, there are close to 800,000 hepatocellular carcinoma patients, and about 100,000 suffering from myeloma. Myeloma, while representing a smaller patient population, is a more mature market. In recent years, pharmaceutical treatments for myeloma grew from a few billion in worldwide sales to more than 20 billion, and sales are expected to approach 30 billion by 2026, says Dr. Teper. The largest product in that category is the CD38 antibody DARZALEX (daratumumab) from J&J, which alone tallied $6 billion in sales in 2021.

Daniel Teper, Co-Founder, Chairman & CEO, Cytovia Therapeutics, IncHepatocellular carcinoma, on the other hand, represents a new frontier. Less than 30 percent of the patients with advanced disease responds to current treatment, with an average of just 6.8 months of progression-free survival, says Teper.

That technology has given rise to a preclinical pipeline that company co-founder, chairman, and CEO Dr. Daniel Teper repeatedly characterizes as differentiated. We noticed that a number of cell therapy companies have migrated toward targets that are well-validated, but very crowded, such as CD19 or BCMA, he says. Noting that theres nothing wrong with that and hes right, because competition yields innovation in drug development he acknowledges that the business risk of joining the well-validated masses gets real at the clinical stage. Once you validate the technology and order clinical trials, if youre number seven of 25 CD19 or BCMA therapies, youve got a big challenge ahead of you, he surmises.

Regarding Cytovias differentiation strategy, its programs display different indications and treatment modalities, including a FLEX-NK cell engager targeting GPC3 for the treatment of solid tumors including hepatocellular carcinoma, another FLEX-NK cell engager targeting CD38 for multiple myeloma, and even a CAR-iNK cell candidate targeting epidermal growth factor receptor (EGFR) for glioblastoma. Its a balanced portfolio of relatively novel targets, he says.

Fast Moving R&D Efforts And A Compelling Strategy

In April, Cytovia Chief Medical Officer Stanley R. Frankel, MD and Chief Scientific Officer Wei Li, Ph.D. presented at the annual meeting of the American Association for Cancer Research (AACR). Dr. Teper calls it a milestone for two reasons. First, this marked the initial presentation of our own data at one of the most relevant scientific meetings, which is an important achievement for a young company. Second, consistently with our mission to differentiate, were the only company thats developed both an IPSC-derived NK cell platform and an NK engager antibody platform. At the AACR meeting, we presented in vivo proof-of-concept data combining our iNK cells together with our GPC3-targeting NK engagers, demonstrating that we could reduce the tumor burden and the relevant biomarker protein in hepatocellular carcinoma, he says.

The combination of antibodies and cells is unique and important, says Dr. Teper, because as the disease becomes more severe, the patients functional NK cell count is depleted. The capability of an antibody that redirects NK cells to kill tumor cells is limited if those NK cells arent functional when theyre engaged.

The ability to add billions of NK cells, off the shelf, to reestablish the patients immune pool, leads to very significant efficacy, says Dr. Teper. He says the approach might be an alternative to CAR-NK therapy, or it might be complimentary, but it will definitely improve accessibility. He anticipates the therapy being administered on an outpatient basis due to the limited risk of cytokine release syndrome and GVHD.

If clinical trials confirm that the combination of the two is safe and effective, we're essentially opening up the opportunity for many more patients to benefit from cell therapy.

Included among those patients, he says, are those suffering from solid tumors, which have presented cell therapy developers with a particularly vexing challenge. The differentiator in Cytovias NK cell engagers, says Dr. Teper, is that they target NKp46, an activating receptor on the NK cell. Unlike some other activating receptors, NKp46 is very stable in its expression in infiltrating NK cells and we believe this is a potential advantage in targeting solid tumor., he says. Gene editing techonology will allow the company to consider edits to further reduce the inhibition of the tumor microenvironment and perhaps, he says, increase the persistence of NK cells.

Locking Down Best-In-Class Allogeneic Cell Therapy Manufacturing

Dr. Teper says that while the currently marketed autologous products are working for many patients, their production process is complex, the cost to produce them is too high, and the risk of side effects including cytokine release syndrome (CRS) and graft-versus-host disease (GVHD) limit their use. Allogeneic CAR T-cell products have initially demonstrated some promising data, but not to the level of autologous products, he says. In contrast, allogeneic NK and CAR NK approaches have shown initial efficacy, have very good safety profiles, and are more reasonably manufactured. While most of those approaches to-date have been produced from donor-derived cells, Dr. Teper believes induced pluripotent stem cells (IPSCs) are the way of the future due to the consistency and scalability they lend to the manufacturing process. In addition to batch-to-batch consistency challenges in donor-derived cells, which limit their scalability, their lack of homogeneity makes gene editing more difficult, he says. IPSCs, on the other hand, offer excellent product characterization, better scalability, a lower cost of goods, and easier gene editing opportunity. Thats because they originate from a highly controlled master cell bank that enables engineers to differentiate, expand, and cryopreserve trillions of highly characterized cells. There are inherent process development, manufacturing, and cost advantages to IPSCs, and we think the FDA and other global regulatory agencies will increasingly request that cell therapy products be perfectly characterized. That's much easier to do when you have a monoclonal cell bank and you're able to characterize the product at every step of development.

For its part, Cytovia is manufacturing its current supply internally. The CDMOs are catching up with new cell therapy manufacturing technologies, and IPSC technologies in particular, says Dr. Teper. That requires a sometimes-inefficient transfer of knowledge and processes. We believe that internal control of manufacturing allows us to control the quality and availability of the product for clinical trials, and these are both extremely important for a young company.

Rather than wholly outsource to a CDMO, Cytovia partners on R&D and GMP manufacturing with organizations including Cellectis, CytoImmune, the Hebrew University of Jerusalem, INSERM, the New York Stem Cell Foundation, STC Biologics, and the University of California San Francisco. In partnership with BioSciencesCorp, the company maintains a dedicated 100,000 square-foot facility in Puerto Rico comprised of six clean rooms and a process development lab, staffed entirely by Cytovia, which is currently producing clinical CGMP batches in anticipation of filing INDs late this year in preparation for clinical trials in early 2023.

Tracking To Plan On Securing Capital To Enable R&D And Clinical Trials

Pending the closings, proceeds from private placements, funds in Isleworth's trust account (net of redemptions), and proceeds from other prospective financings in the aggregate of up to $100 million, Cytovia forecasts up to two years of operating capital for further development of its gene-edited iNK and FLEX-NK cell engager technologies. The company plans to focus on multiple milestones, the most near-term being the filing of the companys first INDs in 2022 and early 2023 for its GPC3 FLEX-NK cell engager antibody (CYT-303) and its non-edited iNK cell (CYT-100) in hepatocellular carcinoma and its CD38 FLEX-NK cell engager antibody (CYT-338) for multiple myeloma. In clinical trials, the company plans to study the antibodies and the cells alone and in combination. By the end of 2023, it intends to bring two additional productsCYT -150, a gene-edited iNK cell and CYT -503, a GPC3-targeted CAR iNK productto the clinic. Its a franchise of multiple modalities, and our phase 1/2 trial will interrogate the safety and clinical response of each of them in one therapy or in combination, and then determine which well move forward for pivotal trials, says Dr. Teper.

By the end of 2023, it intends to bring two additional productsfor hepatocellular carcinomaCYT -150, a gene edited iNK cell and CYT -503, a GPC3-targeted CAR iNK productto the clinic. Its a franchise of multiple modalities that can be used alone or in combination, and our phase 1/2 trial will interrogate the safety and clinical response of each of them in one therapy or in combination, and then determine which well move forward for pivotal trials, says Dr. Teper.

Learn more about Cytovia Therapeutics at http://www.cytoviatx.com

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IPSCs For Democratized Cell Therapy - BioProcess Online

Bioabsorbable Stents Market to Grow at a Fine CAGR of 9.6% through 2032: Improvements in Healthcare Infrastructure and Growing Geriatric Population to…

Owing to Rising Demand for Less Invasive Treatments Among Heart Patients, Fact.MR Study Opines the Global Bioabsorbable Stents Market Share is Estimated to Reach a Value of Nearly US$ 1 Billion by 2032 from US$ 372 Million in 2021

Growing incidences of physicians and healthcare professionals preferring bioabsorbable stents over conventional stents is believed to have rapidly surged the bioabsorbable stent market growth in the global market.

Fact.MR, a Market Research and Competitive Intelligence Provider - The global bioabsorbable stents market is predicted to witness a moderate growth rate of 9.6% during the forecast years 2022 to 2032. The net worth of the bioabsorbable stents market share is expected to be valued at around US$ 1 Billion by the year 2032, growing from a mere US$ 372 Million recorded in the year 2021.

The growing prevalence of cardiovascular disease is sighted to be the leading cause of heart-related mortality worldwide. Around 17.5 million people die each year as a result of cardiovascular disease as a consequence of changing lifestyles, dietary habits, and rising blood pressure difficulties. All these factors have boosted the demand for bioabsorbable stents in the global market.

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Cardiovascular illnesses were responsible for more than 32% of fatalities in 2015, and this number is anticipated to grow to 45 per cent by 2030. The number of people diagnosed with diabetes has increased. Obesity, which is the leading cause of type 2 diabetes in adults, has increased as a result of changes in trends, food patterns, and regular exercise. The proliferation of such correlated diseases is suggested to be the major driving factor for the sales of bioabsorbable stents across the globe.

However, due to an increase in the prevalence of coronary artery disease, increased knowledge of bioabsorbable stents, increased demand for minimally invasive surgery, and increased adoption of unhealthy lifestyles, Asia-Pacific is predicted to have the highest CAGR from 2021 to 2032.

What is the Bioabsorbabale Stents Market Outlook in Asia Pacific Region?

As per the global market study on bioabsorbable stents, Asia Pacific is predicted to develop at the quickest rate. The rising number of cardiac patients in the Asia Pacific countries with the highest population count is predicted to drive the demand for bioabsorbable stents in the regional market.

During the projected period, the China bioabsorbable stents market is predicted to lead at the fastest rate of 8.8% in this geographical region. The net worth of the market is estimated to be around US$ 28 Million in 2022 and is projected to reach a total valuation of US$ 71.6 Million in the year 2032.

Other than that, bioabsorbable stents market opportunities in Japan and South Korea are also quite promising for the forecasted years, with an estimated growth rate of 8.1% and 7.3%, respectively. This new market research report on bioabsorbable stents also sheds light on the growth prospects in Indian Market as well.

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Recent Developments in the Market

Fact.MRs Domain Expertise in Healthcare Sector

Our healthcare consulting team guides organizations at each step of their business strategy by helping you understand how the latest influencers account for operational and strategic transformation in the healthcare sector. Our expertise in recognizing the challenges and trends impacting the global healthcare industry provides indispensable insights and support - encasing a strategic perspective that helps you identify critical issues and devise appropriate solutions.

Point of Care Diagnostics Market - Shipments of point of care test (POCT) kits are projected to surge at a CAGR of around 7% from 2021 to 2028, as per this new analysis. In 2020, the global point of care diagnostics market stood at US$ 34.1 Bn, and is anticipated to surge to a valuation of US$ 66 Bn by the end of 2028.

Spectrometry Market - The global spectrometry market is projected to increase from a valuation of US$ 7.1 Bn in 2020 to US$ 13.8 Bn by 2028, expanding at a CAGR of 6.4% during the forecast period, Demand for mass spectrometry is set to increase faster at a CAGR of 7.4% over the forecast period 2021-2028.

Coronary Stents Market- Worldwide sales of coronary stents were valued at around US$ 10.1 Bn in 2020. The global coronary stents market is projected to register 12.9% CAGR and reach a valuation of US$ 25.7 Bn by the end of 2028.

Osteoporosis Therapeutics Market- The global osteoporosis therapeutics market stands at a valuation of US$ 12.7 Bn currently, and is predicted to reach US$ 14.2 Bn by the end of 2026. Consumption of osteoporosis therapeutic drugs is anticipated to increase at a CAGR of 2.9% from 2022 to 2026.

CNS Therapeutics Market- The CNS therapeutics market stands at a valuation of US$ 116.7 Bn in 2022, and is expected to reach US$ 142.1 Bn by the end of 2026. CNS drug sales are projected to rise at a steady CAGR of 4.9% from 2022 to 2026.

Induced Pluripotent Stem Cell (iPSC) Market- The global induced pluripotent stem cell (iPSC) market stands at a valuation of US$ 1.8 Bn in 2022, and is projected to climb to US$ 2.3 Bn by the end of 2026. Over the 2022 to 2026 period, worldwide demand for induced pluripotent stem cells is anticipated to rise rapidly at a CAGR of 6.6%.

Doxorubicin Market- Demand for doxorubicin is anticipated to increase steadily at a CAGR of 5.3% from 2022 to 2026. At present, the global doxorubicin market stands at US$ 1.1 Billion, and are projected to reach a valuation of US$ 1.3 Billion by the end of 2026.

Heart Attack Diagnostics Market- The heart attack diagnostics market is predicted to grow at a moderate CAGR of 7.1% during the forecast period of 2022 to 2032. The global heart attack diagnostics market is estimated to reach a value of nearly US$ 22.2 Billion by 2032 by growing from US$ 10.4 Billion in 2021.

Smart Implants Market- The global smart implants market is estimated at US$ 3.9 billion in 2022, and is forecast to surpass a market value of US$ 22.2 billion by 2032. Smart implants are expected to contribute significantly to the global implants market, with demand surging at a CAGR of 19% from 2022 to 2032.

Facial Implants Market- The global facial implant market was valued at US$ 2.7 Billion in 2022, and is expected to rise at a 7.7% value CAGR, likely to reach US$ 5.6 Billion by the end of the 2022-2032 forecast period.

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Bioabsorbable Stents Market to Grow at a Fine CAGR of 9.6% through 2032: Improvements in Healthcare Infrastructure and Growing Geriatric Population to...

Theranexus : THERANEXUS PARTICIPATES IN SEVERAL LEADING SCIENTIFIC CONFERENCES AND BUSINESS CONVENTIONS – Marketscreener.com

Lyon, France 9 June 2022 6 pm CEST Theranexus, a biopharmaceutical company innovating in the treatment of neurological diseases and pioneer in the development of drug candidates modulating the interaction between neurons and glial cells, today announces its participation in several scientific and business events including the Federation of European Neuroscience Societies (FENS) Forum, the Batten Disease Support and Research Association (BDSRA) Conference and the BIO International Convention to be held in June and July 2022.

Theranexus will be presenting at the BIO International Convention which will bring together more than 15,000 life science players from over 70 countries running from June 13 to 19, 2022 in San Diego, United States. The company will have the benefit of speaking during a face-to-face session, this will give Theranexus the opportunity to present its latest innovations and meet companies as part of its development strategy approach.

Julien Veys, Chief Business Development Officer of Theranexus stated, "I am delighted to be able to share with fellow industry professionals the company's new strategic direction and its assets in the field of rare neurological diseases on Tuesday 14 June at 11am during the BIO International Convention, our sector's biggest business convention gathering the full complement of international stakeholders from the pharma and biopharma industry".

In addition, Theranexus will be at the Federation of European Neuroscience Societies FENS 2022 Forum, running from 9 to 13 July 2022 in Paris and presenting the latest innovations to emerge from its NeuroLead platform, in collaboration with the French Alternative Energies and Atomic Energy Commission (CEA) and the Collge de France:

Theranexus will also be presenting progress on its Batten-1 clinical program in Batten disease at the annual Batten Disease Support and Research Association (BDSRA) Conference to be held in Cleveland, Ohio from 8 to 10 July 2022.

Finally, Theranexus gave a presentation entitled "Pharmacological modulation of brain connectivity and visual response in a pathological rat model revealed by functional ultrasound imaging" at the Functional ultrasound imaging of the Brain conference fUSbrain 2022 held in Corsica in early June, and on 31 May took part in the French Rare Diseases Foundation's annual scientific symposium at the Collge de France, delivering a presentation of the company and its assets.

Mathieu Charvriat, Deputy CEO and Chief Scientific Officer concluded: "These different presentations highlighting advances in both our Batten-1 drug candidate in clinical application for Batten disease and the discovery of novel drug candidates with our NeuroLead platform in the field of rare neurological diseases. These presentations give us an opportunity to strengthen our visibility and connection with academic and industry stakeholders and patient organizations and confirm the remarkable dynamism and recognition of the scientific merits of our R&D teams".

Next financial publication:

Tuesday 12 July: Cash position as of 30 June 2022

About Theranexus

Theranexus is an innovative biopharmaceutical company that emerged from the French Alternative Energies and Atomic Energy Commission (CEA). It specializes in the treatment of central nervous system disorders and is a pioneer in the development of drug candidates targeting both neurons and glial cells.

Theranexus has a unique drug candidate of advanced therapy identification and characterization platform focused on rare neurological disorders and an initial drug candidate in clinical development for Batten disease.

Theranexus is listed on the Euronext Growth market in Paris (FR0013286259- ALTHX).

Presentation at the Bio Convention on Tuesday 14 June at 11am PST in Theater 1

2022 ActusNews

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Theranexus : THERANEXUS PARTICIPATES IN SEVERAL LEADING SCIENTIFIC CONFERENCES AND BUSINESS CONVENTIONS - Marketscreener.com

Fifth annual University of Rhode Island Research and Scholarship Photo Contest winners announced – University of Rhode Island

KINGSTON, R.I. June 7, 2022 The University of Rhode Islands fifth annual Research and Scholarship Photo Contest attracted a stunning collection of photos from university students, staff, and faculty.

The contest provides a unique opportunity for URIs researchers and scholars to convey their ideas and work, as well as their unique perspectives, through the photographs and digital images they capture.

The annual contest is co-sponsored and coordinated byUniversity of Rhode Island Magazine;the URI Division of Research and Economic Development magazine,Momentum: Research & Innovation; and the Rhode Island Sea Grant/URI Coastal Institute magazine,41N: Rhode Islands Ocean andCoastalMagazine. A panel of judges, which includes URI alumni and staff, selects the winning images.

This year, for the first time, all winning photos were submitted by URI studentsboth undergraduate and graduate students, and all our winning entries were from work being done in the same college, the College of the Environment and Life Sciences.

The stunning photos reinforce that time-tested adage: A picture is worth a thousand words. Winning photographers are listed below, with descriptions of their photos.

FIRST PLACE Water Collection of a Honeybee Casey Johnson, graduate student in plant sciences and entomology, of Warwick.

In the heat of summer, honeybees can often be found collecting water from puddles, gutters, and other unsavory sources, says Johnson, who is a graduate student in Professor Steven Alms lab at the URI Agricultural Experiment Station at East Farm in Kingston. She continues, We noticed that our honeybees were drinking water from sphagnum moss in the pots of pitcher plants, which led us to investigate the water-collecting behavior of honeybees on four local moss species. Here, a water forager honeybee rests on one of our observational moss setups, drinking water that she will bring back to her hive.

SECOND PLACE Jam-Packed Micromussa Michael Corso 24, aquaculture and fisheries science major, of Medford, Massachusetts.

This Micromussa lordhowensis coral colony was shot at Love the Reef, a marine animal distributor/coral aquaculture facility in Wilmington, Massachusetts, where I work, says Corso, who aspires to preserve tropical marine species. He continues, In the wild, this species is found in the South Pacific and along Australias Great Barrier Reef. The bioluminescent colors emanate from the corals symbiont algae, zooxanthella. Rising ocean temperatures and acidification can prevent the corals from holding onto the algae they depend upon, resulting in coral bleaching. Land-based sustainable aquaculture efforts may be the last chance coral species like these have at surviving in our future environment.

THIRD PLACE Piping Plover Chick Branden Costa, graduate student in environmental science and management, focused on conservation biology, of Westport, Massachusetts.

Costa observed this juvenile piping plover foraging after a rainstorm on Washburn Island (Massachusetts). These birds, says Costa, who studies migratory bird behavior and population dynamics are vulnerable to many threats before and after hatching, including predation, desiccation, human disturbances, and storm surges. They begin foraging for themselves mere hours after hatching and remain flightless for 2530 days as they develop flight feathers for end-of-season migration. This chick was the last surviving member of its brood. The others were taken by two off-leash domestic dogs. This chick demonstrates the unwavering resilience piping plovers must exhibit to survive.

HONORABLE MENTION Last Nerve Michelle Gregoire, doctoral student in cell and molecular biology, of Goshen, Connecticut.

Nerves relay sensory or motor information in the body and are made up of nerve cells, or neurons, says Gregoire. In Professor Claudia Fallinis lab, where I do my research, we study cellular pathologies in amyotrophic lateral sclerosis and frontotemporal dementia (ALS/FTD). We differentiate the neurons we study from induced pluripotent stem cells (iPSC), derived from patient skin or blood cells. Using immunofluorescence and our Leica DMi8 Widefield Fluorescence microscope, we visualized this stunning motor neuron. During the differentiation process, not all the stem cells differentiated into neurons, instead forming a mass of cells, visible here above the lone neuron.

HONORABLE MENTION Radiotagged Diamondback Terrapin Hatchling, Spring 2021 Carolyn Decker, graduate student in natural resources science, of South Deerfield, Massachusetts.

This nine-month-old, rare salt marsh turtle is about the size of a poker chip and has just emerged from the secret sandy burrow where he spent his first winter, says Decker. For my masters thesis, I documented the movements and habitat use of this species. This individual turtle helped us better understand the differing needs of hatchling and adult terrapins. My observations helped us to make wildlife management and conservation recommendations to protect the animals at all ages. This photo shows the tiny radio transmitter that was glued to the terrapins shell so researchers could track his movements.

HONORABLE MENTION Microplastic Particle from Narragansett Bay Sarah Davis, doctoral student in biological and environmental sciences, of New York City

This strangely beautiful image of a 1 millimeter microplastic particle was captured with an Olympus BX63 automated light microscope, says Davis, who works with Professors Coleen Suckling and Andrew Davies on a Rhode Island Sea Grant project investigating microplastic particles in Narragansett Bay. For this project, she says, we trawl a plankton net behind a URI vessel. The net collects material floating on and just below the waters surface; the material collected is processed and analyzed in the lab. By studying the concentration and characteristics of microplastics in our local environment, we can help inform decisions about mitigating pollution at the source.

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Fifth annual University of Rhode Island Research and Scholarship Photo Contest winners announced - University of Rhode Island

Senti Bio Debuts as Publicly Traded Company Focused on Developing Next-Generation Cell and Gene Therapies Engineered with Gene Circuits -…

- Business combination with Dynamics Special Purpose Corp. completed today; gross proceeds from transaction to Senti Bio expected to total approximately $156.5 million -

- Combined company Senti Bio will be listed on the Nasdaq Global Market under ticker symbol "SNTI" -

- IND filings for preclinical oncology candidates SENTI-202 and SENTI-301 anticipated in 2023 -

SOUTH SAN FRANCISCO, Calif., June 09, 2022 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Senti Bio), a biotechnology company developing next-generation cell and gene therapies using its proprietary gene circuit platform, today announced the completion of its business combination with Dynamics Special Purpose Corp. (DYNS; Nasdaq: DYNS), a special purpose acquisition company. Senti Biosciences, Inc., the resulting combined company, will commence trading on the Nasdaq Global Market under the symbol SNTI on June 9, 2022.

Over the last year, we have made significant pipeline progress in optimizing our gene circuit technology and generating promising data across our lead programs, SENTI-202 and SENTI-301, which we plan to advance toward IND filings in 2023, said Timothy Lu, MD, PhD, Chief Executive Officer and Co-Founder of Senti Bio. We believe that with the funding from this successful transaction, we are well positioned to maximize this unique opportunity to develop the next generation of gene circuit-enabled cell and gene therapies for patients in need.

Senti Bio is developing next-generation cell and gene therapies engineered with gene circuits, which are designed to reprogram cells with biological logic to sense inputs, compute decisions and respond to their respective cellular environments. Senti Bio's oncology pipeline uses healthy adult donor-derived, natural killer (NK) cells engineered with chimeric antigen receptor (CAR) gene circuits that are cryopreserved and dosed off-the-shelf. Senti Bios oncology pipeline is primarily focused on three preclinical-stage programs: SENTI-202, a Logic Gated (OR+NOT) off-the-shelf CAR-NK cell therapy designed to target and eliminate acute myeloid leukemia (AML) cells while sparing the healthy bone marrow; SENTI-301, a regulatable Multi-Armed off-the-shelf CAR-NK cell therapy designed for the treatment of hepatocellular carcinoma (HCC); and SENTI-401, a Logic Gated (NOT) off-the-shelf CAR-NK cell therapy designed to target and eliminate colorectal cancer (CRC) cells while sparing healthy cells elsewhere in the body. In addition, the company is collaborating with Spark Therapeutics (a member of the Roche Group) and BlueRock Therapeutics (a wholly-owned and independently operated subsidiary of Bayer AG) on applications of its gene circuit technology outside of oncology.

Omid Farokhzad, MD, Executive Chair of the DYNS Board of Directors, said, We believe in the powerful potential of engineering gene circuits with programmable computer-like logic in cell and gene therapies. We look forward to continued progress from the Senti Bio team including advancing product candidates towards and into clinical trials, solidifying its clinical-scale cGMP manufacturing capabilities, and expanding its gene circuit offerings across multiple diseases and modalities via partnering opportunities.

Mostafa Ronaghi, PhD, CEO of DYNS added, We have been very impressed with Sentis approach and platform, which has the potential to define the future of cell and gene therapy. Sentis scientific founders and management are pioneers in the field of mammalian synthetic biology and have assembled a highly qualified team to use this platform to improve the lives of patients in oncology and many other disease categories.

Senti Bio received gross proceeds of approximately $140.3 million of the expected $156.5 million in connection with the business combination, which included funds held in DYNS's trust account of $84.5 million (net of redemptions), $50.6 million of the expected $66.8 million in proceeds from a private investment in public equity (PIPE) financing that closed concurrently with the consummation of the business combination, and a recent $5.2 million investment by Leaps by Bayer, the impact investment arm of Bayer AG, through the purchase of a convertible note that was exchanged (at $10.00 per share, with accrued interest canceled) at the closing of the business combination for common equity with the same rights as the PIPE shares. Senti Bio expects the proceeds from this transaction, combined with cash on hand, to fund operations into 2024.

Investors in DYNS include funds managed by ARK Investment Management LLC, funds and accounts managed by Counterpoint Global (Morgan Stanley Investment Management), Invus, and funds and accounts advised by T. Rowe Price Associates, Inc., among others.

Investors participating in the PIPE financing as of the closing of the business combination included 8VC, Amgen Ventures, funds and accounts managed by Counterpoint Global (Morgan Stanley Investment Management), Invus, NEA, Parker Institute for Cancer Immunotherapy, and T. Rowe Price funds, among others. Of the $66.8 million in subscriptions for the PIPE financing, $16.2 million has yet to be funded as one investor, who entered into a subscription agreement concurrently with Senti Bio and DYNSs execution of the business combination agreement in December 2021, has not funded its commitment. Senti Bio intends to enforce such one investor's legal obligations under its subscription agreement. Solely for purposes of consummating the business combination on June 8, 2022, Senti Bio agreed to waive the $150 million available cash closing condition under the business combination agreement previously entered into with DYNS (as a result of such one investor failing to timely fund its $16.2 million commitment).

DYNSs board members, Dr. Omid Farokhzad and David Epstein, have joined the Senti Bio Board of Directors. The other Senti Bio board members are Susan Berland, Dr. James Collins, Dr. Brenda Cooperstone, Dr. Timothy Lu and Edward Mathers.

Uses of Proceeds and Planned Milestones Proceeds from the transaction are expected to provide Senti Bio with capital to further develop its gene circuit technologies and therapeutic pipeline, including:

Summary of Progress to Date

Advisors J.P. Morgan acted as lead capital markets advisor to DYNS and as co-placement agent to DYNS on the PIPE. Morgan Stanley & Co. LLC acted as financial advisor to DYNS and as co-placement agent to DYNS on the PIPE. BofA Securities acted as exclusive financial advisor to Senti Bio and as co-placement agent to DYNS on the PIPE. Davis Polk & Wardwell LLP acted as legal advisor to DYNS. Goodwin Procter LLP acted as legal advisor to Senti Bio. Latham & Watkins LLP acted as legal advisor to J.P. Morgan, Morgan Stanley & Co. LLC and BofA Securities in their roles as placement agents for the PIPE.

About Senti Bio Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases using novel and unprecedented approaches. To accomplish this, we are building a synthetic biology platform that may enable us to program next-generation cell and gene therapies with what we refer to as Gene Circuits. These Gene Circuits, which are created from novel and proprietary combinations of DNA sequences, are designed to reprogram cells with biological logic to sense inputs, compute decisions and respond to their cellular environments. We aim to design Gene Circuits to improve the intelligence of cell and gene therapies in order to enhance their therapeutic effectiveness, precision and durability against a broad range of diseases that conventional medicines do not readily address. Our synthetic biology platform utilizes off-the-shelf chimeric antigen receptor natural killer (CAR-NK) cells, outfitted with these Gene Circuit technologies, to target particularly challenging liquid and solid tumor oncology indications. Our lead programs include SENTI-202 and SENTI-301. SENTI-202 is a Logic Gated OR+NOT off-the-shelf CAR-NK cell therapy designed to target and eliminate acute myeloid leukemia (AML) cells while sparing the healthy bone marrow. SENTI-301 is a Multi-Armed off-the-shelf CAR-NK cell therapy designed for the treatment of hepatocellular carcinoma (HCC). We anticipate filing Investigational New Drug (IND) applications in 2023 for both candidates. Over the past several months, Senti Bio scientists have presented preclinical proof-of-concept data across various programs including at the annual meetings of the American Society of Gene and Cell Therapy (ASGCT), the American Association for Cancer Research (AACR), and the American Society of Hematology (ASH). We have also demonstrated the breadth of our Gene Circuits in other modalities and diseases outside of oncology and have executed partnerships with Spark Therapeutics and BlueRock Therapeutics to advance these capabilities. For more information, please visit the Senti Bio website at https://www.sentibio.com.

About Dynamics Special Purpose Corp. DYNS was formed in May 2021 for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization, or similar business combination with one or more businesses. It focused its search in healthcare and the life sciences, including development platforms that enable applications in prevention, diagnosis, treatment, or advanced biomaterials and, within that context, life-sciences tools, enabling software, synthetic biology and novel drug discovery.

Forward-Looking Statements This press release contains certain forward-looking statements within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995 with respect to DYNS and Senti Bio. These forward-looking statements generally are identified by the words believe, could, predict, continue, ongoing, project, expect, anticipate, estimate, intend, strategy, future, opportunity, plan, may, should, will, would, will be, will continue, will likely result, forecast, seek, target and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations of Senti Bios and DYNSs management and assumptions, whether or not identified in this document, and, as a result, are subject to risks and uncertainties. Forward-looking statements include, but are not limited to, statements regarding estimates and forecasts of financial and performance metrics, projections of market opportunity and market share, expectations and timing related to preclinical, clinical and regulatory milestones, potential benefits of the business combination and the potential success of Senti Bio's business strategy, the initial market capitalization and cash runway of the combined company, the benefits of the business combination, as well as statements about the potential attributes and benefits of Senti Bios product candidates and the progress and timing of Senti Bios product development activities, IND filings and clinical trials and expectations related to the effects of the business combination and the PIPE financing, including the unfunded portion thereof. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Senti Bio and DYNS. Many factors could cause actual future events to differ materially from the forward-looking statements in this document, including but not limited to: (i) changes in domestic and foreign business, market, financial, political and legal conditions, (ii) risks that the transaction disrupts current plans and operations of Senti Bio and potential difficulties in Senti Bio employee retention as a result of the transaction, (iii) the outcome of any legal proceedings that may be instituted against Senti Bio or DYNS related to the Business Combination Agreement or the transaction, or any governmental or regulatory proceedings, investigations or inquiries, (iv) volatility in the price of Senti Bios securities, which may arise due to a variety of factors, including changes in the competitive and highly regulated industries in which Senti Bio currently operates and plans to operate, variations in operating performance across competitors, changes in laws and regulations affecting DYNSs or Senti Bios business and changes in the capital structure of the combined company, (v) the ability to implement business plans, forecasts and other expectations after the completion of the transaction, to realize the anticipated benefits of the transaction, and to identify and realize additional opportunities, (vi) the risk of downturns and a changing regulatory landscape in Senti Bios highly competitive industry, (vii) risks relating to the uncertainty of any projected financial information with respect to Senti Bio, (viii) risks related to uncertainty in the timing or results of Senti Bios preclinical studies and any future clinical trials, product acceptance and/or receipt of regulatory approvals for Senti Bios product candidates, (ix) the ability of the combined company to compete effectively and its ability to manage growth, (x) risks related to delays and other impacts from the COVID 19 pandemic, (xi) the ability of the combined company to issue equity or equity-linked securities in the future, and (xii) the success of any future research, development and commercialization efforts by the combined company.

Readers are cautioned not to put undue reliance on forward-looking statements, and Senti Bio assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Senti Bio gives no assurance that Senti Bio will achieve its expectations. The inclusion of any statement in this communication does not constitute an admission by Senti Bio or any other person that the events or circumstances described in such statement are material.

Non-Solicitation This press release does not constitute (i) a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the Business Combination or (ii) an offer to sell, a solicitation of an offer to buy, or a recommendation to purchase any security of Senti Bio, or any of its respective affiliates. No such offering or securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Additional Information About the Business Combination and Where To Find It DYNS filed a registration statement on Form S-4 (the Registration Statement) with the SEC, which was declared effective on May 13, 2022. The Registration Statement includes a proxy statement/prospectus. The proxy statement/prospectus contains important information about DYNS, Senti Bio and the business combination. Senti Bios stockholders may access a copy of the Registration Statement, as well as other documents filed with the SEC by DYNS, without charge at the SEC's website located at http://www.sec.gov.

INVESTMENT IN ANY SECURITIES DESCRIBED HEREIN HAS NOT BEEN APPROVED OR DISAPPROVED BY THE SEC OR ANY OTHER REGULATORY AUTHORITY NOR HAS ANY AUTHORITY PASSED UPON OR ENDORSED THE MERITS OF THE BUSINESS COMBINATION OR THE ACCURACY OR ADEQUACY OF THE INFORMATION CONTAINED HEREIN. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.

Find more information atsentibio.com Follow us on Linkedin:Senti Biosciences Follow us on Twitter:@SentiBio

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Senti Bio Debuts as Publicly Traded Company Focused on Developing Next-Generation Cell and Gene Therapies Engineered with Gene Circuits -...

Global Cell Therapy Market 2022 – Featuring JCR Pharmaceuticals, PHARMICELL and Osiris Therapeutics Among Others – ResearchAndMarkets.com – Business…

DUBLIN--(BUSINESS WIRE)--The "Cell Therapy Global Market Report 2022, Type, Therapy Type, Application" report has been added to ResearchAndMarkets.com's offering.

This report provides strategists, marketers and senior management with the critical information they need to assess the global cell therapy market.

This report focuses on cell therapy market which is experiencing strong growth. The report gives a guide to the cell therapy market which will be shaping and changing our lives over the next ten years and beyond, including the markets response to the challenge of the global pandemic.

The global cell therapy market is expected to grow from $7.2 billion in 2020 to $7.82 billion in 2021 at a compound annual growth rate (CAGR) of 8.6%.

The growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $12.06 billion in 2025 at a CAGR of 11%.

Companies Mentioned

Reasons to Purchase

The cell therapy market consists of sales of cell therapy and related services. Cell therapy (CT) helps repair or replace damaged tissues and cells. A variety of cells are used for the treatment of diseases includes skeletal muscle stem cells, hematopoietic (blood-forming) stem cells (HSC), lymphocytes, mesenchymal stem cells, pancreatic islet cells, and dendritic cells.

The main type in cell therapy are stem cell therapy, cell vaccine, adoptive cell transfer (act), fibroblast cell therapy and chondrocyte cell therapy. Stem cell treatment, also known as regenerative medicine, uses stem cells or their derivatives to stimulate the healing response of sick, defective, or wounded tissue. The different types of therapies include allogeneic therapies, autologous therapies and is used in various applications such as oncology, cardiovascular disease (CVD), orthopedic, wound healing, others.

The regions covered in this report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The rising prevalence of chronic diseases contributed to the growth of the cell therapy market. According to the US Centers for Disease Control and Prevention (CDC), chronic disease is a condition that lasts for one year or more and requires medical attention or limits daily activities or both and includes heart disease, cancer, diabetes, and Parkinson's disease. Stem cells can benefit the patients suffering from spinal cord injuries, type 1 diabetes, Parkinson's disease (PD), heart disease, cancer, and osteoarthritis.

For instance, according to the Center for Diseases Control and Prevention report in 2021, due to poor nutrition, and lack of physical activity, 6 in 10 adults in the USA are suffering from a chronic disease and 4 in 10 have two or more diseases. According to International Diabetes Federation, in 2019, globally 463 million people have diabetes and the number is expected to rise to 700 million by 2045.

According to the Parkinson's Foundation, every year, 60,000 Americans are diagnosed with PD, and more than 10 million people are living with PD worldwide. The growing prevalence of chronic diseases increased the demand for cell therapies and contributed to the growth of the market.

The high cost of cell therapy hindered the growth of the cell therapy market. Cell therapies have become a common choice of treatment in recent years as people are looking for the newest treatment options. Although there is a huge increase in demand for cell therapies, they are still very costly to try. Basic joint injections can cost about $1,000 and, based on the condition, more specialized procedures can cost up to $ 100,000. In 2020, the average cost of stem cell therapy can range from $4000 - $8,000 in the USA. Therefore, the high cost of cell therapy restraints the growth of the cell therapy market.

Key Topics Covered:

1. Executive Summary

2. Cell Therapy Market Characteristics

3. Cell Therapy Market Trends And Strategies

4. Impact Of COVID-19 On Cell Therapy

5. Cell Therapy Market Size And Growth

6. Cell Therapy Market Segmentation

7. Cell Therapy Market Regional And Country Analysis

For more information about this report visit https://www.researchandmarkets.com/r/bhhj92

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Global Cell Therapy Market 2022 - Featuring JCR Pharmaceuticals, PHARMICELL and Osiris Therapeutics Among Others - ResearchAndMarkets.com - Business...

Synthetic Receptor Could Alleviate Need for Chemo Treatment Before T-Cell Therapy – Technology Networks

Before a patient can undergo T cell therapy designed to target cancerous tumors, the patients entire immune system must be destroyed with chemotherapy or radiation. The toxic side effects are well known, including nausea, extreme fatigue and hair loss.

Now a research team, led by UCLAsAnusha Kalbasi, MD, in collaboration with scientists from Stanford and the University of Pennsylvania, has shown that a synthetic IL-9 receptor allows those cancer-fighting T cells to do their work without the need for chemo or radiation. T cells engineered with the synthetic IL-9 receptor, designed in the laboratory of Christopher Garcia, PhD, at Stanford, were potent against tumors in mice, aspublished Wednesday in Nature.

When T cells are signaling through the synthetic IL-9 receptor, they gain new functions that help them not only outcompete the existing immune system but also kill cancer cells more efficiently, Kalbasi said. I have a patient right now struggling through toxic chemotherapy just to wipe out his existing immune system so T cell therapy can have a fighting chance. But with this technology you might give T cell therapy without having to wipe out the immune system beforehand.

Kalbasi, a researcher at theUCLA Jonsson Comprehensive Cancer Centerand an assistant professor of radiation oncology at theDavid Geffen School of Medicine at UCLA, began the work while under the mentorship ofAntoni Ribas, MD, PhD, a senior investigator on the study. The study was also led by Mikko Siurala, PhD, from the laboratory of Carl June, MD, at Penn, and Leon L. Su, PhD, of the Garcia Lab at Stanford.

This finding opens a door for us to be able to give T cells a lot like we give a blood transfusion, Ribas said.

Ribas and Garcia collaborated on a paper published in 2018 that focused on the concept that a synthetic version of interleukin-2 (IL-2), a critical T cell growth cytokine, could be used to stimulate T cells engineered with a matching synthetic receptor for the synthetic IL-2. With this system, T cells can be manipulated even after they have been given to a patient, by treating the patient with the synthetic cytokine (which has no effect on other cells in the body). Intrigued by that work, Kalbasi and colleagues were interested in testing modified versions of the synthetic receptor that transmit other cytokine signals from the common-gamma chain family: IL-4, -7, -9 and -21.

It was clear early on that, among the synthetic common-gamma chain signals, the IL-9 signal was worth investigating, Kalbasi said, adding that unlike other common-gamma chain cytokines, IL-9 signaling is not typically active in naturally occurring T cells. The synthetic IL-9 signal made T cells take on a unique mix of both stem-cell and killer-like qualities that made them more robust in fighting tumors. In one of our cancer models, we cured over half the mice that were treated with the synthetic IL-9 receptor T cells.

Kalbasi said the therapy proved to be effective in multiple systems. They targeted two types of hard-to-treat cancer models in mice pancreatic cancer and melanoma and used T cells targeted to cancer cells through the natural T cell receptor or a chimeric antigen receptor (CAR). The therapy also worked whether we gave the cytokine to the whole mouse or directly to the tumor. In all cases, T cells engineered with synthetic IL-9 receptor signaling were superior and helped us cure some tumors in mice when we couldnt do it otherwise.

Reference:Kalbasi A, Siurala M, Su LL, et al. Potentiating adoptive cell therapy using synthetic IL-9 receptors. Nature. 2022:1-6. doi:10.1038/s41586-022-04801-2

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Synthetic Receptor Could Alleviate Need for Chemo Treatment Before T-Cell Therapy - Technology Networks