Stem Cell Clinic

NASA’s Solution to Stem Cell Production is Out of this World – BioSpace

NASA and Cedars-Sinai Medical Center are launching stem cells into space. In the study, funded by NASA and being conducted by scientists at Cedars-Sinai Medical Center in Los Angeles, the stem cells have been sent into space and will orbit for just over a months time to determine whether they grow differently without G-force.

A remotely controlled container of cells, with reagents and equipment needed to remotely sustain the cells, arrived at the International Space Station over the weekend. Two queries are presented alongside the launch details: do cells age differently in low orbit and can the Earthly challenges of stem cell growth amplification be overcome in space?

The human body is comprised of a full library of cell types, cataloged by specialty and location such as the striated cardiac muscles or the branching neurons in the brain. Each of these cells began as a raw stem cell and has developed in a particular manner. The cells can multiply to become a plentiful stem cell line under the correct conditions, but laboratory settings that would generate the quantity needed for medicinal purposes pose challenges that require innovative thinking.

Despite being featured in many biologic candidates currently under research and development and in clinical trials, mass-producing stem cells for use in these therapeutics isnt feasible. To prevent conglomeration or losing the stem cells at the bottom of a reactor tank, the bioreactor must be stirred at a rate that causes probable cell death. The end result is very few stem cells suitable for therapeutic and research use. By launching stem cells into space, the Cedars-Sinai research team is hoping to overcome these production limitations.

With stem cells, the possibilities and applications are increasing each day. They can work as models for testing drug safety and efficacy, thus reducing the burden placed on animal model research, be used as regenerative cells for those that have suffered damage as a result of injury or disease and even as a basic tool to help researchers further understand the human body.

By pushing the boundaries like this, its knowledge and its science and its learning, Clive Svendsen, executive director at the Cedars-Sinai Regenerative Medicine Institute, commented. Svendsen has sent a part of himself along with the project, as the donor of the stem cells.

Various other studies are being conducted by research teams around the globe in an effort to better understand the potential of stem cells.

Just last week, researchers from the University of Malta announced the launch of a similar mission that will be conducted aboard a SpaceX craft. The Maleth II project is the second installment of the Maleth Program that is designed to evaluate how human skin tissue cell genetics react to low earth orbit. A remotely controlled biocube will orbit the Earth for 60 days while the single cells are analyzed for changes.

The student researchers at the university are being directly supported by Maltas national Research, Innovation, Development Trust and the study itself is in collaboration with the Ministry of Foreign and European Affairs, Singleron Biotechnologies

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NASA's Solution to Stem Cell Production is Out of this World - BioSpace

The Human Trial Is A Documentary You Don’t Want To Miss [Review] – That Hashtag Show

Its not every day that a documentary comes out and is showing something that has been years in the making. But that could also just be because certain stories never get documented on video.

Well, The Human Trial is pulling the curtain back on a treatment that has been many years in the making.

More than a decade in the making, THE HUMAN TRIAL follows a groundbreaking clinical trial that peels back the headlines to show the sweat, passion, and sacrifice behind every breakthrough cure. In 2011, Lisa Hepner and her husband Guy Mossman heard about a radical stem cell treatment for diabetes, a disease that shockingly kills more than five million people each year. Driven by a desire to cure Lisa of her own type 1 diabetes (T1D), the filmmakers were given unprecedented, real-time access to a clinical trial only the sixth-ever embryonic stem cell trial in the world. What follows is an intimate journey with the patients and scientists who put themselves on the line to be first.

This documentary, from the outside, looks like any normal documentary. But The Human Trial shows something that has never been documented before.

The film says that the cure for Type 1 Diabetes is always 5 Years Away. And that is, in this case, actually true. But the biotech company featured in the film, Viacyte, wants to change that. They have been trying to find a way to use stem cells to cure the disease.

Now they show the actual device as well. And inside of the device, it has the stem cells in it. As for the device itself, it will act as a bio-artificial pancreas. Now, for trials like this, it usually takes a while to make sure the drug is going to be safe. And the documentary makes a point to mention that.

As for the actual trials themselves, we do get to see two different patients getting involved with the stem cell testing. Both Maren and Greg got their trials done at the University Of Minnesotas Medical Center. And for Maren, the stem cells started working for her within three weeks of implantation.

But there is another side to a trial like this, and that is funding. The team at Viacyte went all around the world to get more funding for their experimental drug. Then there is also removing the plants from the patient and testing them to see if they are working normally.

But all in all, this documentary shows what its like living with a disease like this, and the hard work that goes into making a cure.

One moment that did surprise me the most was watching Marens journey during the whole trial. She was the first person to do the trial, and it did seem like the cells were working for her. But when she found out the cells were not working, I was very shocked. And I was mostly shocked because she was the only one who had cells that were not working right. That is the case for most drug trials. They sometimes work, and other times they just dont work for one reason or another.

Learn more about The Human Trial here.

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The Human Trial Is A Documentary You Don't Want To Miss [Review] - That Hashtag Show

ASCT No Longer Suitable for the Majority of Patients with DLBCL – OncLive

Most patients with diffuse large B-cell lymphoma do not derive significant benefit from treatment with autologous stem cell transplantation and better therapeutic options are currently available for this population.

Most patients withdiffuse largeB-celllymphoma (DLBCL) do not derive significant benefit from treatment with autologous stem cell transplantation (ASCT) and better therapeutic options are currently available for this population, according to a presentation at the 2022 Pan Pacific Lymphoma Conference.1

ASCT is lousy therapy in the modern era, said Jeremy S. Abramson, MD, MMSc. There are select patients who are still appropriate for ASCT, but that is a tiny minority in the modern era.

Abramson is the director of the Lymphoma Program and the Jon and Jo Ann Hagler Chair in Lymphoma at the Massachusetts General Hospital Cancer Center and an associate professor of medicine at Harvard Medical School, both in Boston, Massachusetts.

Salvage treatment with high-dose chemotherapy plus ASCT for patients with DLBCL who responded to their initial treatment often fails most patients, Abramson explained. Approximately 75% of patients who relapse do so within a year of receiving their frontline therapy, he noted, adding that approximately half of patients with relapsed/refractory DLBCL are not eligible for treatment with ASCT because of factors such as age or comorbidities.

Abramson cited data from the phase 3 ORCHARRDtrial (NCT01014208), which compared the efficacy of ofatumumabplus cisplatin, cytarabine, and dexamethasone (DHAP) followed by ASCT with that of rituximab (Rituxan)plus DHAP followed by ASCT among patients with relapsed/refractory DLBCL. The 2-year progression-free survival (PFS) rates were 24% and 26%, respectively (HR, 1.12; 95% CI, 0.89-1.42;P= .33). Moreover, the 2-year event-free survival (EFS) rates were 18% and 16%, respectively HR, 1.10; 95% CI, 0.90-1.36;P= .35).2

In another study, the phase 3 NCIC-CTG LY.12 trial (NCT00078949), investigators evaluated gemcitabine, dexamethasone, and cisplatin followed by ASCT vs DHAP in patients with relapsed/refractory aggressive lymphoma. Patients with B-cell lymphoma were also given rituximab. No significant differences were noted in 4-year EFS (HR, 0.99; 95% CI, 0.82-1.21; stratified log-rankP= .95), overall survival (OS; HR, 1.03; 95% CI, 0.83-1.28; P = .78), or PFS (HR, 0.99; 95% CI, 0.82-1.21; P = .95).3

More contemporary trials [such as] ORCHARRD and the NCIC-CTG LY.12 study [have shown] durable remissions in fewer than a quarter of patients. Abramson said. This is not good therapy.

Abramson said that CAR T-cell therapy is a superior choice for most patients with DLBCL. CAR T-cell agents have proven especially useful in the treatment of patients with primary refractory or early relapsed disease, he said.

In the phase ZUMA-7 trial (NCT03391466), the CAR T-cell agent axicabtagene ciloleucel (axi-cel; Yescarta) was evaluated against the standard of care of chemoimmunotherapy followed by high-dose chemotherapy with ASCT in patients who responded to the chemoimmunotherapy. The trial included patients with relapsed/refractory large B-cell lymphoma who were relapsed or refractory less than 1 year after their first-line treatment. Patients were randomly assigned 1:1 to receive either axi-cel (n = 180) or the standard of care (n = 179).4

At a median follow-up of 24.9 months, the median EFS in the axi-cel arm was 8.3 months (95% CI, 4.5-15.8) compared with 2.0 months (95% CI, 1.6-2.8) in the standard of care arm (HR, 0.40; 95% CI, 0.31-0.51; P < .001). The median PFS was 14.7 months (95% CI, 5.4-not estimable [NE]) vs 3.7 months (95% CI, 2.9-5.3) in the axi-cel and standard-of-care arms, respectively (HR, 0.49; 95% CI, 0.37-0.65). Notably, the median OS in the axi-cel arm was not reached (95% CI, 28.3-NE) vs 35.1 months (95% CI, 18.5-NE) in the standard-of-care arm (HR, 0.73; 95% CI, 0.53-1.01).

In terms of response, axi-cel was also superior to the standard of care. The overall response rate (ORR) was 83% vs 50%, respectively. Patients who received axi-cel also achieved a complete response (CR) rate of 65% compared with 32% among patients treated with the standard of care. Additionally, axi-cel was associated with improved quality of life as evaluated by patient reported outcomes.

The safety findings were mostly similar between the 2 arms; all patients in both arms experienced an adverse effect (AE) of any grade. Grade 3 or higher AEs occurred in 91% of patients and 83% of patients in the investigational and control arms, respectively. However, any grade cytokine release syndrome (CRS) was present in 92% of patients in the axi-cel arm and any grade neurologic AEs were more common in the axi-cel arm compared with the standard-of-care arm (60% vs 20%).

With CAR T-cell [therapy] we expect some CRS and neurotoxicity; we see a fair amount of that with axi-cel, Abramson said. The majority of patients did develop CRS, but it was severe in only 6%. Also, [most] patients developed neurologic toxicity, [but it was] severe in only 20%. And these toxicities are almost entirely reversible.

Another trial of a CAR T-cell agent, the phase 3 TRANSFORM trial (NCT03575351), examined the efficacy and safety of lisocabtagene maraleucel (liso-cel; Breyanzi) compared with the standard of care among patients with relapsed/refractory LBCL. Patients included in the trial had primary refractory or early relapsed disease.5

At a median follow-up of 6.2 months (range, 4.4-11.5), the median EFS was 10.1 (95% CI, 6.1-NE) compared with 2.3 months (95% CI, 2.2-4.3) in the liso-cel (n = 92) and standard-of-care arms (n = 92), respectively (HR, 0.35; 95% CI, 0.23-0.53; P < .0001). The median PFS was 14.8 months and 5.7 months, respectively (HR, 0.41; 95% CI, 0.25-0.66). The median OS was not reached vs 16.4 months, respectively (HR, 0.51; 95% CI, 0.26-1.00).

Similar to findings from the ZUMA-7 trial, liso-cel also resulted in a higher ORR compared with the standard of care (86% vs 48%). Patients in the liso-cel arm also achieved a CRR of 66% vs 39% in the standard-of-care arm. Over half of the standard-of-care arm (54%) crossed over to be treated with liso-cel and quality of life by patient reported outcomes again favored the CAR T-cell agent.

Treatment emergent AEs (TEAEs) occurred in nearly all patients in both arms (100% vs 99%). Grade 3 or higher TEAEs were slightly more common in the liso-cel arm (92%) compared with the standard-of-care arm (87%). Any grade CRS was present in 49% of patients who received liso-cel.

As was shown on ZUMA-7 not a single subset [of patients] favored high dose chemotherapy and ASCT over CAR T-cell [therapy] in this trial, Abramson said. This was an exceedingly well tolerated and entirely reversible therapy for patients who had a higher likelihood of cure with this treatment compared to standard of care.

Despite the convincing evidence against the use of ASCT, there is still a subset of patients with DLBCL for whom the treatment can be effective, argued Craig S. Sauter, MD, the director of the Blood and Marrow Transplant Programat the Cleveland Clinic in Cleveland, Ohio.

Value-based care has many facets, including not just end points [such as] EFS, PFS, and OS, but costs strain on limited resources within the space, patient quality of life, Sauter said. Financial toxicity is a real issue. Access to resources is a real issue. This will be an ongoing conversation.

Sauter went on to explain that access to CAR T-cell therapy is limited in the United States and across the world. The cost effectiveness of CAR T-cell agents in the second line is also unclear, Sauter noted. Axi-cel was found to have an $80,000 per quality adjusted life year vs standard of care and CAR T-cell therapy in general was shown to have up to a $2 million per quality adjusted life year compared with standard of care, he said.

Additionally, Sauter noted that ASCT has been shown to provide durable remissions in patients with DLBCL with a PET-positive partial response (PR). According to data from the Center for International Blood and Marrow Transplant Research, the median PFS for patients with DLBCL who received ASCT was comparable both among patients with and without early chemoimmunotherapy failure (P = .22).6

Stauter also pointed out that findings recently published in Blood showed that ASCT may actually be superior to CAR T-cell therapy for patients with DLBCL who are in PR following salvage chemotherapy. The 2-year PFS rates favored ASCT (52%) over CAR T-cell therapy (42%; P = .06). Moreover, the 2-year OS rates were 69% and 47%, respectively (P = .007).7

There may be a signal of improved durability of ASCT, Sauter said. But [these are] very different groups [of patients] and registry-level data that has to be taken with a grain of salt.

Originally posted here:
ASCT No Longer Suitable for the Majority of Patients with DLBCL - OncLive

Kite’s CAR T-cell Therapy Tecartus Receives Positive CHMP Opinion in Relapsed or Refractory Acute Lymphoblastic Leukemia (r/r ALL) – Business Wire

SANTA MONICA, Calif.--(BUSINESS WIRE)--Kite, a Gilead Company (Nasdaq: GILD), today announces that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Tecartus (brexucabtagene autoleucel) for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (ALL). If approved, Tecartus will be the first and only Chimeric Antigen Receptor (CAR) T-cell therapy for this population of patients who have limited treatment options. Half of adults with ALL will relapse, and median overall survival (OS) for this group is only approximately eight months with current standard-of-care treatments.

Kites goal is clear: to bring the hope of survival to more patients with cancer around the world through cell therapy, said Christi Shaw, CEO, Kite. Todays CHMP positive opinion in adult ALL brings us a step closer to delivering on the promise that cell therapies have to transform the way cancer is treated.

Following this positive opinion, the European Commission will now review the CHMP opinion; the final decision on the Marketing Authorization is expected in the coming months.

Adults with relapsed or refractory ALL often undergo multiple treatments including chemotherapy, targeted therapy and stem cell transplant, creating a significant burden on a patients quality of life, said Max S. Topp, MD, professor and head of Hematology, University Hospital of Wuerzburg, Germany. If approved, patients in Europe will have a meaningful advancement in treatment. Tecartus has demonstrated durable responses, suggesting the potential for long-term remission and a new approach to care.

Results from the ZUMA-3 international multicenter, single-arm, open-label, registrational Phase 1/2 study of adult patients (18 years old) with relapsed or refractory ALL, demonstrated that 71% of the evaluable patients (n=55) achieved complete remission (CR) or CR with incomplete hematological recovery (CRi) with a median follow-up of 26.8 months. In an extended data set of all patients dosed with the pivotal dose (n=78) the median overall survival for all patients was more than two years (25.4 months) and almost four years (47 months) for responders (patients who achieved CR or CRi). Among efficacy-evaluable patients, median duration of remission (DOR) was 18.6 months. Among the patients treated with Tecartus at the target dose (n=100), Grade 3 or higher cytokine release syndrome (CRS) and neurologic events occurred in 25% and 32% of patients, respectively, and were generally well-managed.

About ZUMA-3

ZUMA-3 is an ongoing international multicenter (US, Canada, EU), single arm, open label, registrational Phase 1/2 study of Tecartus in adult patients (18 years old) with ALL whose disease is refractory to or has relapsed following standard systemic therapy or hematopoietic stem cell transplantation. The primary endpoint is the rate of overall complete remission or complete remission with incomplete hematological recovery by central assessment. Duration of remission and relapse-free survival, overall survival, minimal residual disease (MRD) negativity rate, and allo-SCT rate were assessed as secondary endpoints.

About Acute Lymphoblastic Leukemia

ALL is an aggressive type of blood cancer that develops when abnormal white blood cells accumulate in the bone marrow until there isnt any room left for blood cells to form. In some cases, these abnormal cells invade healthy organs and can also involve the lymph nodes, spleen, liver, central nervous system and other organs. The most common form is B cell precursor ALL. Globally, approximately 64,000 people are diagnosed with ALL each year, including around 3,300 people in Europe.

About Tecartus

Please see full FDA Prescribing Information, including BOXED WARNING and Medication Guide.

Tecartus is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

U.S. IMPORTANT SAFETY INFORMATION

BOXED WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITIES

Cytokine Release Syndrome (CRS), including life-threatening reactions, occurred following treatment with Tecartus. In ZUMA-2, CRS occurred in 91% (75/82) of patients receiving Tecartus, including Grade 3 CRS in 18% of patients. Among the patients who died after receiving Tecartus, one had a fatal CRS event. The median time to onset of CRS was three days (range: 1 to 13 days) and the median duration of CRS was ten days (range: 1 to 50 days). Among patients with CRS, the key manifestations (>10%) were similar in MCL and ALL and included fever (93%), hypotension (62%), tachycardia (59%), chills (32%), hypoxia (31%), headache (21%), fatigue (20%), and nausea (13%). Serious events associated with CRS included hypotension, fever, hypoxia, tachycardia, and dyspnea.

Ensure that a minimum of two doses of tocilizumab are available for each patient prior to infusion of Tecartus. Following infusion, monitor patients for signs and symptoms of CRS daily for at least seven days for patients with MCL and at least 14 days for patients with ALL at the certified healthcare facility, and for four weeks thereafter. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated.

Neurologic Events, including those that were fatal or life-threatening, occurred following treatment with Tecartus. Neurologic events occurred in 81% (66/82) of patients with MCL, including Grade 3 in 37% of patients. The median time to onset for neurologic events was six days (range: 1 to 32 days) with a median duration of 21 days (range: 2 to 454 days) in patients with MCL. Neurologic events occurred in 87% (68/78) of patients with ALL, including Grade 3 in 35% of patients. The median time to onset for neurologic events was seven days (range: 1 to 51 days) with a median duration of 15 days (range: 1 to 397 days) in patients with ALL. For patients with MCL, 54 (66%) patients experienced CRS before the onset of neurological events. Five (6%) patients did not experience CRS with neurologic events and eight patients (10%) developed neurological events after the resolution of CRS. Neurologic events resolved for 119 out of 134 (89%) patients treated with Tecartus. Nine patients (three patients with MCL and six patients with ALL) had ongoing neurologic events at the time of death. For patients with ALL, neurologic events occurred before, during, and after CRS in 4 (5%), 57 (73%), and 8 (10%) of patients; respectively. Three patients (4%) had neurologic events without CRS. The onset of neurologic events can be concurrent with CRS, following resolution of CRS or in the absence of CRS.

The most common neurologic events (>10%) were similar in MCL and ALL and included encephalopathy (57%), headache (37%), tremor (34%), confusional state (26%), aphasia (23%), delirium (17%), dizziness (15%), anxiety (14%), and agitation (12%). Serious events including encephalopathy, aphasia, confusional state, and seizures occurred after treatment with Tecartus.

Monitor patients daily for at least seven days for patients with MCL and at least 14 days for patients with ALL at the certified healthcare facility and for four weeks following infusion for signs and symptoms of neurologic toxicities and treat promptly.

REMS Program: Because of the risk of CRS and neurologic toxicities, Tecartus is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta and Tecartus REMS Program which requires that:

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur due to dimethyl sulfoxide (DMSO) or residual gentamicin in Tecartus.

Severe Infections: Severe or life-threatening infections occurred in patients after Tecartus infusion. Infections (all grades) occurred in 56% (46/82) of patients with MCL and 44% (34/78) of patients with ALL. Grade 3 or higher infections, including bacterial, viral, and fungal infections, occurred in 30% of patients with ALL and MCL. Tecartus should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after Tecartus infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.

Febrile neutropenia was observed in 6% of patients with MCL and 35% of patients with ALL after Tecartus infusion and may be concurrent with CRS. The febrile neutropenia in 27 (35%) of patients with ALL includes events of febrile neutropenia (11 (14%)) plus the concurrent events of fever and neutropenia (16 (21%)). In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated.

In immunosuppressed patients, life-threatening and fatal opportunistic infections have been reported. The possibility of rare infectious etiologies (e.g., fungal and viral infections such as HHV-6 and progressive multifocal leukoencephalopathy) should be considered in patients with neurologic events and appropriate diagnostic evaluations should be performed.

Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

Prolonged Cytopenias: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and Tecartus infusion. In patients with MCL, Grade 3 or higher cytopenias not resolved by Day 30 following Tecartus infusion occurred in 55% (45/82) of patients and included thrombocytopenia (38%), neutropenia (37%), and anemia (17%). In patients with ALL who were responders to Tecartus treatment, Grade 3 or higher cytopenias not resolved by Day 30 following Tecartus infusion occurred in 20% (7/35) of the patients and included neutropenia (12%) and thrombocytopenia (12%); Grade 3 or higher cytopenias not resolved by Day 60 following Tecartus infusion occurred in 11% (4/35) of the patients and included neutropenia (9%) and thrombocytopenia (6%). Monitor blood counts after Tecartus infusion.

Hypogammaglobulinemia: B cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with Tecartus. Hypogammaglobulinemia was reported in 16% (13/82) of patients with MCL and 9% (7/78) of patients with ALL. Monitor immunoglobulin levels after treatment with Tecartus and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement.

The safety of immunization with live viral vaccines during or following Tecartus treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least six weeks prior to the start of lymphodepleting chemotherapy, during Tecartus treatment, and until immune recovery following treatment with Tecartus.

Secondary Malignancies may develop. Monitor life-long for secondary malignancies. In the event that one occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

Effects on Ability to Drive and Use Machines: Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following Tecartus infusion. Advise patients to refrain from driving and engaging in hazardous activities, such as operating heavy or potentially dangerous machinery, during this period.

Adverse Reactions: The most common non-laboratory adverse reactions ( 20%) were fever, cytokine release syndrome, hypotension, encephalopathy, tachycardia, nausea, chills, headache, fatigue, febrile neutropenia, diarrhea, musculoskeletal pain, hypoxia, rash, edema, tremor, infection with pathogen unspecified, constipation, decreased appetite, and vomiting. The most common serious adverse reactions ( 2%) were cytokine release syndrome, febrile neutropenia, hypotension, encephalopathy, fever, infection with pathogen unspecified, hypoxia, tachycardia, bacterial infections, respiratory failure, seizure, diarrhea, dyspnea, fungal infections, viral infections, coagulopathy, delirium, fatigue, hemophagocytic lymphohistiocytosis, musculoskeletal pain, edema, and paraparesis.

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with manufacturing operations in North America and Europe. Kites singular focus is cell therapy to treat and potentially cure cancer. As the cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company. For more information on Kite, please visit http://www.kitepharma.com. Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of Gilead and Kite to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Tecartus; the risk that physicians may not see the benefits of prescribing Tecartus for the treatment of blood cancers; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gileads Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation and disclaim any intent to update any such forward-looking statements.

U.S. Prescribing Information for Tecartus including BOXED WARNING, is available at http://www.kitepharma.com and http://www.gilead.com.

Kite, the Kite logo, Tecartus and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies.

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Kite's CAR T-cell Therapy Tecartus Receives Positive CHMP Opinion in Relapsed or Refractory Acute Lymphoblastic Leukemia (r/r ALL) - Business Wire

Calendar of events, awards and opportunities – ASBMB Today

Every week, we update this list with new meetings, awards, scholarships and events to help you advance your career.If youd like us to feature something that youre offering to the bioscience community, email us with the subject line For calendar. ASBMB members offerings take priority, and we do not promote products/services. Learn how to advertise in ASBMB Today.

The American Society for Investigative Pathology, American Society for Matrix Biology and the histochemical Society have teamed up for a series of webinars about science careers. The next one will be at noon Eastern on July 27 titled "Career Options in Science Industry vs. Academia." It will have four panelists from Genentech, FENIX Group, GE Healthcare and the University of Saskatchewan. Learn more and register.

The National Institutes of Health Office of Research on Women's Health has a free quarterly lecture series titled "Diverse Voices: Intersectionality and the Health of Women." The July 28 event will include presentations from Heather Shattuck-Heidorn of the University of Southern Maine and Stephaun Wallace of the Fred Hutchinson Cancer Research Center. Register.

The National Institutes of Health is holding a series of listening sessions for members of the scientific community from certain populations. According to the event announcement, "Any member of the community or ally will have an opportunity to share their perspectives on workforce related challenges and solutions." NIH Acting Director Lawrence Tabak and others will be in attendance. See the August schedule below. Other listening sessions are slated for subsequent months. Register.

Aug. 3, 23 p.m.: Black/African American

Aug. 19, 910 a.m.: Hispanic/Latino

Aug. 22, 11 a.m. 12 p.m., Native American

This in-person meeting will be held Sept. 29 through Oct. 2 in Snowbird, Utah. Sessionswill cover recent advances and new technologies in RNA polymerase II regulation, including the contributions of non-coding RNAs, enhancers and promoters, chromatin structure and post-translational modifications, molecular condensates, and other factors that regulate gene expression. Patrick Cramer of the Max Planck Institute will present the keynote address on the structure and function of transcription regulatory complexes. The deadline for abstracts for talks is now July 21. The early registration deadline ($50 in savings) is Aug. 1. The deadline for poster presentation abstracts is Aug. 18. The regular registration deadline is Aug. 28.Learn more.

Most meetings on epigenetics and chromatin focus on transcription, while most meetings on genome integrity include little attention to epigenetics and chromatin. This conference in Seattle will bridge this gap to link researchers who are interested in epigenetic regulations and chromatin with those who are interested in genome integrity. The oral and poster abstract deadline and early registration deadline is Aug. 2. The regular registration deadline is Aug. 29.Learn more.

This five-day conference will be held Aug. 1418 in person in Cambridge, Massachusetts, and online. It will be an international forum for discussion of the remarkable advances in cell and human protein biology revealed by ever-more-innovative and powerful mass spectrometric technologies. The conference will juxtapose sessions about methodological advances with sessions about the roles those advances play in solving problems and seizing opportunities to understand the composition, dynamics and function of cellular machinery in numerous biological contexts. In addition to celebrating these successes, the organizers also intend to articulate urgent, unmet needs and unsolved problems that will drive the field in the future. The registration deadline was July 1, but you have until July 12 to register to participate virtually.Learn more.

For Discover BMB, the ASBMB's annual meeting in March in Seattle, we're seeking two types of proposals:

The American Physiological Society is hosting a free webinar that will cover polycystic ovary syndrome, an endocrine disorder associated with modestly elevated androgens, and hormone therapy for transmen, which elevates androgens greatly to achieve levels similar to those in cisgender men. The event announcement says: "The role that these two different concentrations play in cardiovascular physiology and pathophysiology remains unclear. Gaps and opportunities in basic research and clinical practice will be highlighted." The speaker will be Licy Yanes Cardozo, a physician-scientist at the University of Mississippi Medical Center. Learn more and register.

In May, the Howard Hughes Medical Institute launched a roughly $1.5 billion program to "help build a scientific workforce that more fully reflects our increasingly diverse country." The Freeman Hrabowski Scholars Program will fund 30 scholars every other year, and each appointment can last up to 10 years. That represents up to $8.6 million in total support per scholar. HHMI is accepting applications from researchers "who are strongly committed to advancing diversity, equity, and inclusion in science." Learn more.

Undergraduate students interested in interning at a U.S. Department of Energy laboratory in the spring must apply by Oct. 5. There are two programs to be aware of: the Science Undergraduate Laboratory Internships program and the Community College Internships program. In both cases, students work at national laboratories on research or technology projects supporting the agency's mission. All full-time students or recent grads are eligible for the first program, and community college students are eligible for the other. These are paid positions. Learn more.

The U.S. Department of Energy has expanded its opportunities for faculty members from historically underrepresented groupsto engage in research at national labs. The Visiting Faculty Program is intended to create partnerships between national labs and two-year colleges, minority-serving institutions and other colleges and universities nationwide. About 50% of participants are from MSI, and one-third of those are from historically Black colleges and universities. The deadline to apply is Oct. 5. Learn more.

The NASA Science Mission Directorate Bridge Program is intended to improve diversity, equity, inclusion and accessibility at NASA and in the broader STEM community. The agency seeks to partner with minority-serving institutions, primarily undergraduate institutions and Ph.D.-granting universities and provide paid research student positions "to transition science and engineering students from undergraduate studies into graduate schools and employment by NASA," according to the announcement. A virtual workshop will be held from Oct. 17 through Oct. 21. You have to formally express interest in attending. Learn more.

Save the date for the ASBMB Career Expo. This virtual event aims to highlight the diversity of career choices available to modern biomedical researchers. No matter your career stage, this expo will provide a plethora of career options for you to explore while simultaneously connecting you with knowledgeable professionals in these careers. Each 60-minute session will focus on a different career path and will feature breakout rooms with professionals in those paths. Attendees can choose to meet in a small group with a single professional for the entire session or move freely between breakout rooms to sample advice from multiple professionals. Sessions will feature the following five sectors: industry, government, science communication, science policy and other. The expo will be held from 11 a.m. to 5 p.m. Eastern on Nov. 2. Stay tuned for a link to register!

The Journal of Science Policy & Governanceand the National Science Policy Network issued a call for papersfor an issue containingpolicy ideas from the next generation of scientists. The submission deadline is Nov. 6. Theyencourage submissions "that highlight policy opportunities and audiences related to the 2022 U.S. midterm elections at the local, stateor national level as well as related foreign policy issues."Read the press release.

The ASBMB provides members with a virtual platform to share scientific research and accomplishments and to discuss emerging topics and technologies with the BMB community.

The ASBMB will manage the technical aspects, market the event to tens of thousands of contacts and present the digital event live to a remote audience. Additional tools such as polling, Q&A, breakout rooms and post event Twitter chats may be used to facilitate maximum engagement.

Seminars are typically one to two hours long. A workshop or conference might be longer and even span several days.

Prospective organizers may submit proposals at any time. Decisions are usually made within four to six weeks.

Propose an event.

If you are a graduate student, postdoc or early-career investigator interested in hosting a #LipidTakeover, fill out this application. You can spend a day tweeting from the Journal of Lipid Research's account (@JLipidRes) about your favorite lipids and your work.

The Federation of American Societies for Experimental Biology has launched the Career Advancement and Research Excellence Support (CARES) Program, which provides financial support for caregiving, enabling FASEB society members to continue their scientific training, professional development and career progression. Read the eligibility requirements and apply.

The International Union of Biochemistry and Molecular Biology is offering $500 to graduate students and postdocs displaced from their labs as a result of natural disaster, war or "other events beyond their control that interrupt their training." The money is for travel and settling in. Learn more and spread the word to those who could use assistance.

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Calendar of events, awards and opportunities - ASBMB Today