BioLineRx to Host Investor and Analyst Breakfast Meeting on December 5, 2019 in New York – P&T Community

TEL AVIV, Israel, Nov. 26, 2019 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, announced today that it will host an investor breakfast meeting on Thursday, December 5, 2019 at the Convene Conference Center near Grand Central Terminal in New York, N.Y.

The investor meeting schedule is as follows:

7:45 am EST Registration and breakfast8:10-9:30 am EST Formal presentations

Location:

Convene Conference Center237 Park Avenue (on 46th St. between Park and Lex)New York, N.Y.(888) 730-7307

The event will feature a presentation by Talia Golan, MD, from The Chaim Sheba Medical Center,who will discuss the current treatment landscape as well as the unmet medical need for treating patients with metastatic pancreatic adenocarcinoma (PDAC). Dr. Golan will be available to answer questions at the conclusion of the event.

BioLineRx's management team will also provide an update on the COMBAT/KEYNOTE-202 triple combination study in metastatic PDAC under its collaboration with Merck. In addition, the management team will provide a comprehensive overview of the Company's other developments for BL-8040, as well as its second lead asset, AGI-134. BL-8040 is a novel short synthetic peptide that functions as a high-affinity antagonist for CXCR4, which BioLineRx is developing for the treatment of solid tumors, acute myeloid leukemia (AML) and stem-cell mobilization for bone-marrow transplantation. AGI-134, a synthetic Gal novel immunotherapy, is currently in Phase 1/2a development for solid tumors.

Talia Golan, MD is a clinician-scientist currently conducting translational laboratory research while also serving as medical director ofthe Phase I Unit and the Pancreatic Cancer (PC) Center at Sheba Medical Center in Tel Aviv, one of the leading medical centers in the world. Her clinical interest is in patients with pancreatic cancer. Dr. Golan's career goals include expertise in clinical medicine, translational laboratory research, and drug development. Dr Golan is PI on multiple early-phase trials on immune modulators. Her clinical and research expertise focuses on the understanding and treatment of hereditary pancreatic cancer patients. Dr. Golan is co-global PI of the first biomarker-selected (BRCA) Phase III clinical trial in PC, the POLO study.Dr. Golan's translational research lab, established in 2011, is an integral part of theSheba Pancreatic Cancer Program (SPCC). The research in the lab focuses on improving the standard of care options for pancreatic cancer patients by both finding targeted treatments tailored for each patient based on his own genetic background and developing state of the art early detection methodology. Disease heterogeneity and late detection are still the main challenges of pancreatic cancer treatment.

This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited.For those who are unable to attend in person, a live webcast and replay of the event will be accessible here.If you would like to ask a question during the live Q&A portion of the event, please submit your request via email.

About BioLineRx

BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

The Company'slead program, BL-8040, is a cancer therapy platform currently being evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA and chemotherapy under a collaboration agreement with MSD. BL-8040 is also being evaluated in a Phase 2b study in consolidation AML and a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation. In addition, the Company has an ongoing collaboration agreement with Genentech, a member of the Roche Group, evaluating BL-8040 in combination with Genentech's atezolizumab in two Phase 1b/2 solid tumor studies.

BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being undergoing in a Phase 1/2a study.

For additional information on BioLineRx, please visit the Company's website at http://www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events. BioLineRx industry updates are also regularly updated on Facebook,Twitter, and LinkedIn.

Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 28, 2019. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

Contact:

Tim McCarthyLifeSci Advisors, LLC+1-212-915-2564tim@lifesciadvisors.com

or

Tsipi HaitovskyPublic Relations+972-52-598-9892 tsipihai5@gmail.com

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SOURCE BioLineRx Ltd.

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BioLineRx to Host Investor and Analyst Breakfast Meeting on December 5, 2019 in New York - P&T Community

AVITA Medical and the Gates Center for Regenerative Medicine at the University of Colorado Anschutz Medical Campus Enter into Collaboration to Explore…

VALENCIA, Calif., MELBOURNE, Australia & AURORA, Colo.--(BUSINESS WIRE)--AVITA Medical (ASX: AVH, NASDAQ: RCEL), a regenerative medicine company with a technology platform positioned to address unmet medical needs in therapeutic skin restoration, and scientists at the Gates Center for Regenerative Medicine at the University of Colorado School of Medicine announced today a preclinical research collaboration to establish proof-of-concept and explore further development of a spray-on treatment of genetically modified cells for patients with epidermolysis bullosa (EB), with potential applicability to other genetic skin disorders.

The partnership will pair AVITA Medicals patented and proprietary Spray-On Skin Cells technology and expertise with the Gates Centers innovative, patent-pending combined reprogramming and gene-editing technology to allow cells to function properly. Under the terms of the Sponsored Research Agreement (SRA), AVITA Medical retains the option to exclusively license technologies emerging from the partnership for further development and commercialization. The Gates Center team is further supported by the EB Research Partnership in New York, the Los Angeles-based EB Medical Research Foundation, the London-based Cure EB Charity, and government grants in a collaborative effort to rapidly develop and translate this technology to the clinic for meaningful impact on patient lives.

The Gates Center is a leader in developing therapeutic approaches for genetic skin diseases. Researchers at the Gates Center have developed a powerful new approach for treating genetic skin disorders and improving the lives of patients with epidermolysis bullosa, said Dr. Mike Perry, Chief Executive Officer of AVITA Medical and adjunct professor at the Gates Center for Regenerative Medicine. We look forward to collaborating with the team at the Gates Center on the expanded use of our technology. This agreement marks an important milestone in AVITAs mission to harness the potential of regenerative medicine to address unmet medical needs across a broad range of dermatological indications, including genetic disorders of the skin.

Epidermolysis bullosa is a group of rare and incurable skin disorders caused by mutations in genes encoding structural proteins resulting in skin fragility and blistering, leading to chronic wounds and, in some sub-types, an increased risk of squamous cell carcinoma or death. There are no approved curative therapies, and current treatment is palliativefocused primarily on pain and nutritional management, itching relief, wound care, and bandaging.

Its very exciting to partner with AVITA Medical to help advance our epidermolysis bullosa program, said Director of the Gates Center for Regenerative Medicine Dr. Dennis Roop. Were looking forward to exploring a novel approach to delivering gene-edited skin cells to patients that addresses current treatment challenges.

We believe that Spray-On Skin Cells technology combined with our genetically corrected cells has the potential to be game changing in the treatment of this disease. This combination could reduce time to treatment, lower manufacturing complexity, reduce costs, and improve patient outcomes, said Dr. Ganna Bilousova, assistant professor of dermatology, who is a co-principal investigator on this research program.

ABOUT THE CHARLES C. GATES CENTER FOR REGENERATIVE MEDICINE

The Charles C. Gates Center for Regenerative Medicine was established in 2006 with a gift in memory of Denver industrialist and philanthropist Charles C. Gates, who was captivated by the hope and benefit stem cell research promised for so many people in the world. The Gates Center aspires to honor what he envisionedby doing everything possible to support the collaboration between basic scientific researchers and clinical faculty to transition scientific breakthroughs into clinical practice as quickly as possible.

Led by Founding Director Dennis Roop, Ph.D., the Gates Center is located at the University of Colorados Anschutz Medical Campus, the largest new biomedical and clinical campus in the United States. Operating as the only comprehensive Stem Cell Center within a 500-mile radius, the Gates Center shares its services and resources with an ever-enlarging membership of researchers and clinicians at the Anschutz Medical Campus, which includes University of Colorado Hospital, Childrens Hospital Colorado, and the Veterans Administration Medical Center, as well as the Boulder campus, Colorado State University, the Colorado School of Mines, and business startups. This collaboration is designed to draw on the widest possible array of scientific exploration relevant to stem cell technology focused on the delivery of innovative therapies in Colorado and beyond.

ABOUT THE UNIVERSITY OF COLORADO SCHOOL OF MEDICINE

Faculty at the University of Colorado School of Medicine work to advance science and improve care. These faculty members include physicians, educators, and scientists at University of Colorado Hospital, Childrens Hospital Colorado, Denver Health, National Jewish Health, and the Denver Veterans Affairs Medical Center. The school is located on the Anschutz Medical Campus, one of four campuses in the University of Colorado system. To learn more about the medical schools care, education, research, and community engagement, visit its web site.

ABOUT AVITA MEDICAL LIMITED

AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medicals patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patients own skin. The medical devices work by preparing a REGENERATIVE EPIDERMAL SUSPENSION (RES), an autologous suspension comprised of the patients skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.

AVITA Medicals first U.S. product, the RECELL System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin Cells using a small amount of a patients own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. Burn Centers and real-world use in more than 8,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information, including contraindications, warnings, and precautions.

In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications, including burns, chronic wounds, and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe.

To learn more, visit http://www.avitamedical.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This letter includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as anticipate, expect, intend, could, may, will, believe, estimate, look forward, forecast, goal, target, project, continue, outlook, guidance, future, other words of similar meaning and the use of future dates. Forward-looking statements in this letter include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward- looking statement contained in this letter is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the companys control. Investors should not place considerable reliance on the forward-looking statements contained in this letter. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this letter speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.

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AVITA Medical and the Gates Center for Regenerative Medicine at the University of Colorado Anschutz Medical Campus Enter into Collaboration to Explore...

Fred Hutch at ASH: Latest CAR T data BCMA, CD19, CD20 plus new insights on transplantation, gene therapy and more – Newswise

MEDIA CONTACT

Available for logged-in reporters only

For Immediate Release

Newswise SEATTLE Nov. 21, 2019 Fred Hutchinson Cancer Research Centers latest findings on CAR (chimeric antigen receptor) T-cell therapy, gene therapy, precision oncology, immune repair and transplantation will be featured at the 61st American Society of Hematology Annual Meeting and Exposition, which will be held Dec. 710 in Orlando, Florida.

Fred Hutch transplantation physician-scientist Dr. Stephanie Lee will become the new president of ASH at the end of the meeting, T-cell therapy pioneer Dr. Philip Greenberg will give the E. Donnall Thomas Lecture, and Dr. Andrew Cowan will present the latest on a new BCMA, or B-cell maturation antigen, CAR T-cell therapy for multiple myeloma. More details and other meeting highlights can be found below. All presentations will be held in the Orange County Convention Center.

Reporters requesting additional information or interviews, contact Molly McElroy who will be at the conference: mwmcelro@fredhutch.org, 206.941.8146 (cell).

IMMUNOTHERAPY

See preliminary results of a Phase 1 multiple myeloma trial with a CAR T-cell therapy combined with a repurposed Alzheimers drug, discussion of a new CD20 CAR T trial, plus various deep dives on the science of how CD19 CAR T-cell therapy works and how to improve it.

BCMA CAR T-CELL THERAPY / MULTIPLE MYELOMA

Efficacy and safety of fully human BCMA CAR T cells in combination with a gamma secretase inhibitor to increase BCMA surface expression in patients with relapsed or refractory multiple myelomaFred Hutch scientists are developing a novel immunotherapy approach for multiple myeloma, which involves a CAR T cell that targets BCMA proteins on multiple myeloma cells, plus a drug called a gamma secretase inhibitor, which increases the BCMA target on cancer cells. In an oral presentation, Dr. Andrew Cowan will present promising results from the first cohort of patients on the trial, all of whom responded to the treatment. The researchers published earlier findings of the trial in Blood in September.Abstract No. 204 (oral presentation)Saturday, Dec. 7, 1:15 p.m.Valencia A (W415A), Level 4

Response to BCMA CART cells correlates with pretreatment target density and is improved by small-molecule inhibition of gamma secretase Dr. Damian Green will present findings from multiple myeloma patients that demonstrate a relationship between the number of BCMA targets on multiple myeloma cells and response to a BCMA-directed CAR T-cell therapy. The findings suggest that using a gamma secretase inhibitor to increase the amount of BCMAs on the cell surface could make CAR T work better. Abstract No. 1856 (poster presentation)Saturday, Dec. 7, 5:307:30 p.m.Hall B, Level 2

CD19 CAR T-CELL THERAPIES

With the success of CAR T-cell therapies for some blood cancers, Fred Hutch physician-scientists are taking a closer look to understand how patients respond to the therapy and what could be done to make the treatment work better.

Impact of Lisocabtagene Maraleucel (liso-cel) treatment on health-related quality of life and health utility in patients (pts) with relapsed/refractory (R/R) aggressive B-cell non-Hodgkin lymphoma (NHL): TRANSCEND NHL 001Physician-scientist Dr. David Maloney will present findings from the TRANSCEND trial for CD19 CAR T that show how patients had improved quality-of-life measures (reduced fatigue and pain symptoms) starting six months after receiving CAR T-cell therapy. As medical director of the Cellular Immunotherapy Integrated Research Center at Fred Hutch, Maloney is at the forefront of clinical trials to develop cell therapies for blood and other cancers, including understanding side effects of CAR Ts and how to deliver them in outpatient settings. He cares for patients at the Bezos Family Immunotherapy Clinic at Seattle Cancer Care Alliance, the Hutchs clinical-care partner.Abstract No. 66 (poster presentation)Saturday, Dec. 7, 8:45 a.m.W308, Level 3

Factors associated with response, CAR T cell in vivo expansion, and progression-free survival after repeat infusions of CD19 CAR T cellsDoes a second dose of CAR T cells help if the first doesnt lead to a lasting remission? A team of Fred Hutch physician-scientists led by Dr. Cameron Turtleexamined outcomes of 44 patients who received a second cycle of CD19 CAR T-cell immunotherapy for acute lymphoblastic leukemia, chronic lymphocytic leukemia or non-Hodgkin lymphoma. The type of chemotherapy given before the first infusion of CAR T cells and a higher dose of CAR T cells for the second infusion were associated with better outcomes.Abstract No. 201 (oral presentation)Saturday, Dec. 7, 12:30 p.m.Valencia A (W415A), Level 4

Severe cytokine release syndrome is associated with impaired hematopoietic recovery after CD19-targeted CART-cell therapyDr. Krishna Juluri, a hematology-oncology fellow at Fred Hutch, will discuss how blood cells recover following CAR T treatment. The researchers found patients who experienced more severe cytokine release syndrome had slower recovery of blood counts. Since CRS can be treated, the Fred Hutch team concludes preventing it might improve blood-cell recovery.Abstract No. 3229 (poster presentation)Sunday, Dec. 8, 68 p.m.Hall B, Level 2

Combination of NKTR-255, a polymer-conjugated human IL-15, with CD19 CAR T-cell immunotherapy in a preclinical lymphoma modelDr. Cassie Chou will present preclinical studies that show how a novel IL-15 receptor agonist activates the interleukin 15 immune system pathway to enhance growth and anti-tumor efficacy of human CD19 CAR T cells in immunodeficient mice bearing human lymphoma. Future clinical trials will explore whether the compound can improve responses to CAR T-cell therapy. Chou is a research fellow and clinician who works in the lab ofDr. Cameron Turtle. Abstract No. 2866 (poster presentation)Sunday, Dec. 8, 68 p.m.Hall B, Level 2

Relapsed or refractory CLL after CD19-specific CART therapy: Treatment patterns and clinical outcomesTreating high-risk chronic lymphocytic leukemia remains challenging with a 65% relapse rate following CAR T-cell therapy. Looking at outcomes of patients with progressive disease after CAR-T, Dr. Mazyar Shadman reports that CAR T-cell therapy did not work as well for patients who had already been treated with more than one other therapy for CLL. This study defines a benchmark for future trials that target relapsed CLL after CAR-T, and it also argues for referring patients to CAR T before they have exhausted other therapeutic options.Abstract No. 4294 (poster presentation)Monday, Dec. 9, 68 p.m.Hall B, Level 2

CD20 CAR T-CELL THERAPY

CD20 targeted chimeric antigen receptor T cells for treatment of high-risk B-cell non-Hodgkin lymphomasMost CAR T-cell therapies for blood cancers target a cancer-specific protein marker called CD19. But more targets are needed. Another CAR T-cell therapy that targets the CD20 protein on cancer cells is being developed by Fred Hutch scientists. Dr. Mazyar Shadman will give an overview of the trial, which is recruiting patients at the Hutchs clinical-care partner, Seattle Cancer Care Alliance. Results of the trial are not ready and will not be reported at ASH.Abstract No. 3235 (poster presentation)Sunday, Dec. 8, 68 p.m.Hall B, Level 2

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TRANSPLANTATION

Extending the benefit of transplantation to more patientsSirolimus combined with Cyclosporine (CSP) and Mycophenolate Mofetil (MMF) As graft-vs-host disease (GVHD) prophylaxis after nonmyeloablative (NMA) hematopoietic cell transplantation (HCT) using HLA Class I or Class II antigen mismatched donors: Results from a Phase II multicenter trialStem cell transplants can save lives, but their success depends on the availability of compatible donors. Unfortunately, depending upon ethnicity, fully HLA-matched donors cannot be found for 25-84% of patients. Dr. Brenda Sandmaier is presenting results from a Phase 2 trial that shows how a triple-drug combination improves outcomes for patients treated with mismatched donors. Abstract No. 369 (oral presentation)Sunday, Dec. 8, 8 a.m.W230, Level 2

Cord blood transplantationTransplantation of blood stem cells from umbilical cord blood can treat blood disorders in patients who have been unable to find a suitable match among other donor sources. This is particularly true for patients of mixed ethnicities. Dr. Filippo Milano, associate director of Fred Hutchs Cord Blood Program, is involved in the following presentations.

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GENE THERAPY

Scientists in the lab of Dr. Hans-Peter Kiem, director of Fred Hutchs Stem Cell and Gene Therapy Program, are pioneering a variety of gene therapy approaches for HIV/AIDS, sickle cell anemia, blood cancers and other diseases. Below are their presentation abstracts.

Fully closed, large-scale, and clinical grade cell sorting of hematopoietic stem cell (HSC)-enriched CD90+ cells for transplantation and gene therapyDr. Stefan Radtke, a Fred Hutch staff scientist, will show for the first time in human blood samples how to isolate a rare stem cell subset that Fred Hutch researchers identified as capable of repopulating the entire blood and immune system. He used commercially available cell-sorting equipment to isolate the cells, an approach that has the potential to make gene therapy more efficient and affordable.Abstract No. 3246 (poster presentation)Sunday, Dec. 8, 68 p.m.Hall B, Level 2

CRISPR/Cas9-mediated protection of normal hematopoiesis combined with the CD33/CD3 bispecific T-cell engager (BiTE) antibody AMG330 for improved AML therapyCD33, a protein marker of cancerous cells in acute myeloid leukemia, is also found on healthy blood stem cells, which makes targeting CD33 toxic, as it kills both healthy cells and cancerous ones. Dr. Olivier Humbert, a staff scientist, used CRISPR to remove the CD33 target from healthy cells. Then, in a mouse model of acute myeloid leukemia, he found that T cells effectively use the CD33 bispecific T-cell engager (BiTE) antibody to attack cancer while sparing CRISPR-edited healthy cells.Abstract No. 4427 (poster presentation)Monday, Dec. 9, 68 p.m.Hall B, Level 2 _______________________________________________________________________________________________________________________

PRECISION MEDICINE / PEDIATRIC AML

Researchers from the lab of Dr. Soheil Meshinchi, a pediatric oncologist and acute myeloid leukemia specialist, will present oral presentations that map genetic mutations to patient outcomes. He says the ongoing genomic profiling work can help guide targeted treatments for patients with AML, the deadliest leukemia among children and young adults.

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ASH NOTABLES

ASH E. Donnall Thomas Lecture and PrizeThe long road to develop adoptive therapy for T cells that can effectively target acute myeloid leukemia and other malignanciesAt the annual E. Donnall Thomas Lecture, Dr. Philip Greenberg, head of the Program in Immunology at Fred Hutch, will talk about how T cells have been engineered to target acute myeloid leukemia and our latest understanding of why cell therapies like CAR T-cell therapy work for some patients and not others, but can potentially be engineered to overcome these obstacles. ASHs E. Donnall Thomas Lecture and Prize recognizes pioneering research achievements in hematology that have changed the field and is named for the Hutchs Dr. E. Donnall Thomas, who received a Nobel Prize for his pioneering efforts in bone marrow transplantation. Thomas was also a colleague and mentor to Greenberg. Learn more about the lecture in an ASH news release.Monday, Dec. 9, 910 a.m.Hall D, Level 2

Incoming ASH President Dr. Stephanie LeeASH will recognize Dr. Stephanie Lee, a hematologist and transplant physician-scientist at Fred Hutch, as its new president at the societys business meeting. Lee cares for stem cell transplant patients at the Hutchs clinical-care partner, Seattle Cancer Care Alliance, and at UW Medicine. Her research aims to improve the lives of transplant recipients. Lee directs the Hutchs Long-Term Follow-Up Research Program, which tracks the outcomes of more than 5,000 transplant survivors.Tuesday, Dec. 10, 11:1511:30 a.mHall D, Level 2

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ON THE HORIZON / OTHER ABSTRACTS

Other notable experts and newsy topics at ASH:

Chronic myeloid leukemia: Meeting global need with better molecular testingDr. Jerald Radich is a medical oncologist who specializes in chronic myeloid leukemia, a relatively rare, slow-growing cancer that is fatal if left untreated. His Fred Hutch research lab examines the molecular genetics of leukemias in an effort to develop methods to improve the detection and treatment of the disease. At an ASH education session, Radich will talk about his award-winning collaboration with The Max Foundation, a Seattle-area nonprofit, which has led to more people in under-resourced areas being tested for CML. He will also give an oral presentation about a molecular test he developed that can predict which CML patients will have a sustained, deep molecular response to treatment.

Repairing immune function

Underappreciated by most, the thymus is a gland in the chest that acts like a boot camp for T cells, training them to identify and kill foreign invaders. The gland wears out with stress, infection and age, and finding ways to boost its productivity could help sustain human health. Researchers in the lab of Dr. Jarrod Dudakov, a Fred Hutch immunologist, will present the latest in understanding the signaling pathways of the thymus. Discovering master regulators could be targets for helping the thymus to repair itself. Below are their presentation abstracts.

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Note: Fred Hutch and its scientists who contributed to these discoveries may stand to benefit from their commercialization. See links above to ASH abstracts for more details on individual researchers disclosures.

The clinical trials referenced above involve investigational products and/or therapies that have not been approved for commercial marketing by the U.S. Food and Drug Administration or any other regulatory authority. Results may vary, and encouraging results from early-stage clinical trials may not be supported in later-stage clinical trials. No conclusions should be drawn from the information in this report about the safety, efficacy or likelihood of regulatory approval of these investigational products and/or therapies.

# # #

Media Contact:Molly McElroyO: 206.667.2210M: 206.941.8146mwmcelro@fredhutch.org

At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutchs pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nations first National Cancer Institute-funded cancer prevention research program, as well as the clinical coordinating center of the Womens Health Initiative and the international headquarters of the HIV Vaccine Trials Network.

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Fred Hutch at ASH: Latest CAR T data BCMA, CD19, CD20 plus new insights on transplantation, gene therapy and more - Newswise

ALS Stem Cell Therapy Developer Seeks Amendment to its AstroRx Trial – ALS News Today

Kadimastem plans to submit an amendment to the protocol of its ongoing Phase 1/2a trial in Israel assessing the use of AstroRx, an off-the-shelf stem cell therapy, for the treatment of amyotrophic lateral sclerosis (ALS).

The company wants to change the planned dosage in one of the studys cohorts and test repeated injections of a low dose of AstroRx, instead of the medium dose that was originally planned.

The request is based on positive interim data from the first set of five patients given a single intrathecal (into the spinal canal) injection of the lowest dose (100 x 106 cells) of AstroRx. At this dose, the therapy was found to be safe with no serious side effects or dose-limiting toxicities identified, according to the data, which was released in September.

Moreover, AstroRx significantly reduced disease progression after three months of treatment, compared to the start (baseline) of the trial. The ALS Functional Rating Scale revised (ALSFRS-R) score decreased on average by 0.87 per month during the three months before treatment; however, it started to increase again (on average by 0.26 per month) in the three months after treatment. The ALSFRS-R score is a validated assessment of disability progression, with lower scores indicating greater motor impairment.

Evidence suggests that poorly working astrocytes (cells which support and protect neurons) are involved in the progression of ALS. AstroRx is composed of healthy functional astrocytes, which have been derived from human embryonic stem cells. The treatment, injected into a patients spinal fluid, is thought to compensate for the diseased astrocytes and prevent the death of motor neurons, thereby slowing disease progression.

AstroRx was granted orphan drug status by the U.S. Food and Drug Administration in November 2018 for the treatment of ALS.

Preclinical (in the lab) studies have shown that AstroRx was safe, delayed disease onset, maintained muscle function, and increased survival in rodent models of ALS.

The ongoing open-label Phase 1/2a clinical trial (NCT03482050) is testing the safety and effectiveness of AstroRx in ALS patients. The trial is being conducted at Hadassah Ein-Kerem Medical Center in Israel where it recruited 21 patients withearly stagedisease.

The trials original protocol included four doses of AstroRx delivered into the spinal canal: a low (100 x 106 cells), medium (250 x 106 cells), or high (500 x 106 cells) dose.

The primary outcome of the trial is to assess the safety and tolerability of AstroRx. Secondary outcome measures include changes in patients ALSFRS-R scores, respiratory muscle strength, hand grip strength, limb muscle strength, and quality of life.

In cohort A, participants received a single low dose of the therapy. In cohort B, participants received a single medium dose of the therapy. Results from cohort A are expected to be reported by the end of 2019, and cohort B results are expected in 2020.

Based on the positive interim results from cohort A, Kadimastem is seeking to amend the therapy regime being assessed in cohort C and D, so that cohort C will receive two injections of the low dose (instead of the originally planned medium dose), with the injections being separated by two to three months. Results from this section of the trial are expected to be reported in the first half of 2021. Under the amendment, cohort D participants will receive the regimen originally planned for cohort C (repeated administration of the medium dose, 250 x 106). Cohort D dosing will be dependent on the results of the previous cohorts.

We are the first to treat ALS patients with astrocyte cells. Following our positive interim results, we look forward to achieving a prolonged therapeutic effect in the repeated low dose administration, bringing new hope for patients with this incurable disease Rami Epstein, CEO of Kadimastem, said in a press release.

Kadimastem expects to submit an investigational new drug application to the U.S. Food and Drug Administration by mid-2021 with the aim of testing AstroRx in a multi-center clinical trial, which will compare the current and frozen version of the therapy.

Patricia holds a Ph.D. in Cell Biology from University Nova de Lisboa, and has served as an author on several research projects and fellowships, as well as major grant applications for European Agencies. She has also served as a PhD student research assistant at the Department of Microbiology & Immunology, Columbia University, New York.

Total Posts: 279

Margarida graduated with a BS in Health Sciences from the University of Lisbon and a MSc in Biotechnology from Instituto Superior Tcnico (IST-UL). She worked as a molecular biologist research associate at a Cambridge UK-based biotech company that discovers and develops therapeutic, fully human monoclonal antibodies.

Continued here:
ALS Stem Cell Therapy Developer Seeks Amendment to its AstroRx Trial - ALS News Today

Stem Cell Alopecia Treatment Market: moving from experimentation to transformation in 2024 – WindStreetz

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Stem Cell Alopecia Treatment Market: moving from experimentation to transformation in 2024 - WindStreetz

For veterans, theres no better cause to push than helping other vets – Snoqualmie Valley Record

Two veterans in East King County are just two of many working to help other veterans.

North Bend veteran Jim Curtis doesnt mince words. If he supports something, youll know it.

The same can be said about things hes not a fan of. Hes vocal about his disdain for President Donald Trump and his actions while in office. And politicians, in general, who use veterans as a means for election.

Politicians use us to get elected or re-elected, Curtis said. But after they accomplish that goal, its sayonara until its time for campaigning again.

He channels his ideas through poetry. Mostly, he pours the passion into helping other veterans.

The cause that had his attention on Oct. 24 was this years Mother Brundage Memorial Raffle. He was raising funds for the family of Andrew Yoder, a U.S. Marine Corps combat veteran who was killed when a crane crashed down in Seattle last spring. The raffle would happen a few weeks later, on Nov. 10, the Marine Corps birthday.

Curtis sold tickets for $5 at the North Bend QFC and Mount Si Sports and Fitness. Even as he traveled south to the American Lake VA Medical Center in his red, 2011 Ford Ranger truck, he pushed for others to purchase raffle tickets.

When he approached the check-in desk, after briefly responding to a question prompted by the man at the counter, he popped his own.

Were doing this raffle, he often began his pitch. Curtis would often end his interactions with the words Semper Fi, the Marine Corps motto and short for semper fidelis a Latin phrase that translates to mean always faithful.

Semper Fi, hed say before leaving.

He used similar words each time, having memorized the phrases he echoed to try and convince the listener on the importance of the raffle. And, of course, to shell out some cash to help.

But what could one expect? When it came to serving especially when Curtis did, during the highly-controversial Vietnam War it was other veterans who understood. And it was other veterans who offered their support. Even if that support meant hanging flyers in a VA hospital nearly 55 miles south from Curtiss North Bend home. Or when it meant reaching out to politicians again. And again. And again.

Other causes

Before he began fundraising for Yoders family, Curtis was busy commuting south to Olympia, where he testified before state House and Senate committees. He thought Purple Heart license plates, those given to wounded military or family of those killed in action, should be issued free of payment of any fees or taxes. He had his own Purple Heart, after shrapnel from a mortar blast flew into his back, legs and derriere. This happened in 1969, during his first year in Vietnam, where he was a machine gunner.

Curtis presented the idea to Democrat Paul Graves, at the time house representative for District 5. When Lisa Callan was elected into the seat in November 2018, after defeating Graves by more than 3,000 votes, she approached him on his idea. She had met him previously while doorbelling in the area.

(The change) was the very least of what we could do to say Thank you, Callan said by phone, on Veterans Day. It gives veterans a way to share their story by even having that plate We need to do so much more for those who receive the Purple Heart and their families.

Curtis has other causes now. Hes invited Rep. Callan to visit the VA hospital he visits regularly, to see the condition of the buildings and to hopefully get some kind of change. The facilities are in a degraded state, compared to the state of medical buildings elsewhere, Curtis said. The walls have dark scuff marks, in some spots reaching about a foot in height. And for veterans, who sacrificed their time and had their lives on the line, it just wasnt up to par. Callan hasnt yet paid a visit to the hospital, but said that was in the works.

His other effort entails getting Gregory Pappy Boyingtons name recognized somewhere along the Medal of Honor Memorial Highway. Boyington was a graduate of Lincoln High School in Tacoma and an American combat pilot.He received the honor, the highest and most prestigious, after he spent months shy of two years in a Japanese prison camp.

There are plaques honoring vets there, but no Pappy in sight, Curtis said.

For another veteran, Curtis is simply looking for answers on why stem cell therapy is given to active-duty military at the Walter Reed National Military Medical Center in Bethesda, Maryland, and not an option for a disabled veteran Curtis knows in North Bend. The center serves military beneficiaries in the Washington, D.C. area as well as those from across the country and around the globe, according to its website.

He has contacted Congresswoman Kim Schrier about the issue, but has so far been having back-and-forth conversations with her staff via email, staff who, Curtis said, say shes too busy to leave her office. He figured the doctor he knocked on doors for, who at some point worked at Virginia Mason Medical Center in Issaquah, would be willing to make the drive, considering its not that far a commute, he said. Schrier did not return a request for comment by press deadline.

Gorman

But its not only Curtis helping other veterans. Marine veteran and Redmond resident Mark Gorman has been working to locate safe spaces for veterans without homes to sleep. He started the effort in 2004, when he owned a shop in Kingston. Everyday he spotted an older man fishing. And after that first initial contact, he struck up a friendship with the homeless man.

At one point, he just wasnt there fishing anymore, Gorman said. Three and four weeks went by, and Gorman decided to find the mans hide the safe spot he had carved out for himself outdoors. This guys all alone, no family. He died on his own of malnutrition and his heart gave up.

In the U.S., on a single night in January 2018, there were more than 37,800 veterans experiencing homelessness, according to the U.S. Department of Veteran Affairs. Of that number on that same night, about 23,300 were living unsheltered. Although there was a 5.4 percent decrease from the previous year, in the estimated number derived from the point-in-time count, Gorman said theres still a need.

When he moved to the Eastside in 2013, he realized there was an even bigger need locally. He began to help veterans, who for different, complex reasons, had lost their housing. Some he could help. Others, he said, werent mentally ready for the world.

They camp out in tents, others in trailers, some sleep in cars in church parking lots. Others sleep in Gormans backyard.

Three things in life we do as veterans sacrifice, duty and selflessness, Gorman said of his reasoning for helping. If those three things are not instilled in a boy as a young man, he will never become a real man. A man sacrifices for not only family and self but also for others around him.

Someday

While at the VA that cloudy afternoon in October, Curtis struck up a conversation with a gentleman who was also pushing his own cause to help veterans. He had acquired small American flags from another, and pinned one to Curtiss lapel, on the opposite side of where his Purple Heart medal pin sat. In exchange, Curtis offered a poem he wrote for sergeant first class Nathan Chapman, the first soldier killed during the war in Afghanistan. He was from Puyallup.

Someday well talk about this war, just like those weve had before, was one line he recited in the waiting room. And the spectator, in response, cried. The two shook hands and bonded over the shared experience of serving the country.

Curtis turned to walk away, but not before saying Semper Fi.

After a quick chat in the waiting room of the American Lake VA Medical Center, Jim Curtis, right, is given a small American flag pin by a fellow veteran. Curtis was there drawing attention to his fundraising efforts. Staff photos / Ashley Hiruko

A sign hangs on the bulletin board at the VA medical center for the Ocean Warriors Birthday Party. Curtis hung others, like these, in areas with many eyes to see.

On a foggy October morning, Curtis drives south toward the Tacoma area. He had his flyers in hand, and raffle tickets to sell. They would benefit the family of Andrew Yoder, a Marine Veteran who died in Seattle during the crane collapse this spring. Staff photo/Ashley Hiruko

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For veterans, theres no better cause to push than helping other vets - Snoqualmie Valley Record

What to Know in Washington: Trump Ally in Impeachment Spotlight – Bloomberg Government

After weeks of Republican complaints that the Democrats impeachment inquiry relied on secondhand information, the centerpiece of this weeks public hearings is testimony from a man with a direct line to President Donald Trump.

The political peril for Trump, who was dealt a series of setbacks last week, will be heightened as the House investigation accelerates with three days of public hearings starting tomorrow.

No witness is more central than Gordon Sondland, the U.S. ambassador to the European Union, a Trump donor and a confederate with Rudy Giuliani in back-channel diplomatic efforts for the president in Ukraine.

Sondland, scheduled to testify Wednesday, has already amended his previous closed-door testimony once because of discrepancies with other witnesses. And now there will be new questions for him to answer about Trumps pressure on the government in Kyiv to launch a probe entangling former Vice President Joe Biden and other political foes of the president.

David Holmes, a member of the embassy staff in Kyiv, came forward last week to tell impeachment investigators that following a phone conversation between Sondland and Trump, the EU envoy told him the president didnt give a s about Ukraine and that the president only cares about the big stuff that benefits him like the Biden investigation that Giuliani, Trumps personal lawyer, was promoting.

Testimony from Tuesday through Thursday will come from a disparate cast of witnesses, some of whom could prove pivotal to the impeachment inquiry, including officials from the State Department, the White House national security teams, and Vice President Mike Pences office. Read more from Ryan Teague Beckwith and Billy House.

Former Adviser SaysAid Was Tied to Probe: A former top White House adviser told House impeachment investigators Ukrainians were advised Sept. 1 that U.S. military aid was being withheld until their president announced an investigation of a company that had hired Bidens son, Hunter. Tim Morrison, a former senior director of European and Russian affairs at the National Security Council, said Sondland told him how he had informed a high-ranking Ukrainian official that release of $400 million in aid was being linked to the investigations, according to a transcript of his closed-door testimony released Saturday.

The House committee also released testimony from Jennifer Williams, an aide to Vice President Mike Pence, who said she found some of the discussion on the July 25 call between the two leaders to be unusual and inappropriate. Read more from Billy House.

Funding Deadline: Lawmakers are facing a deadline of Thursday to pass legislation to continue funding the government, before they depart for a recess through the week of Thanksgiving. House and Senate leadership have expressed optimism that both chambers will pass a measure ahead of the deadline, though no continuing resolution has been introduced as of this morning and the House schedule offered few details of the timing of a vote.

I hope we pass the CR, House Majority Leader Steny Hoyer (D-Md.) said on the floor Friday. I hope its as clean as it can be. The measure will contain some usual anomalies, noncontroversial changes in funding levels or legislative language, Hoyer said.

FDA Pick to Face Questions on Frankenfish, Stem Cells, Vaping: Trumps selection to be the next head of the FDA will face a barrage of questions this week about his views on vaping, oversight of stem-cell therapies and even Frankenfish. Stephen Hahn, chief medical executive of the prestigious MD Anderson Cancer Center at the University of Texas in Houston, will go before the Senate Health, Education, Labor and Pensions Committee Wednesday for his first public hearing since being nominated to become commissioner of the Food and Drug Administration. Alex Ruoff details what to expect.

Risch Warns Erdogan of Sanctions: Senate Foreign Relations Chairman Jim Risch (R-Idaho) warned that if Turkish President Recep Tayyip Erdogan persists in the deployment of a Russian air defense system, he will move ahead with a sanctions bill. It is his choice, and he knows the consequences, Risch said in a statement on Friday evening. Just a day earlier, Risch had said that the Senate should hold off on sanctions over Turkeys invasion of Syria if Erdogan agreed to give up the S-400 anti-aircraft missile system. Read more from John Harney.

Anti-Robocall Agreement Reached: House and Senate negotiators on Friday reached an agreement on bipartisan legislation to combat illegal robocalls, and anticipate a vote on the measure this year. The House and Senate passed separate legislation earlier this year with broad bipartisan support, and staff has been working since August to reach an agreement on provisions from the two anti-robocall bills. Read more from Rebecca Kern.

Democrats Subpoena EPA Over Formaldehyde Analysis: Rep. Eddie Bernice Johnson (D-Texas), chairwoman of the House Science, Space, and Technology Committee, sent two subpoenas to the EPA Friday over the agencys alleged refusal to provide answers about removing formaldehyde from its review program outlook. Johnson said in an accompanying letter to EPA Administrator Andrew Wheeler that the committee had suffered through eight months of delayed and insufficient responses. The subpoenas were sent to Wheeler and David Dunlap, deputy assistant administrator for the agencys Office of Research and Development. Read more from Stephen Lee.

Democrats Use Super-PACs to Combat Trump: Wealthy Democratic donors are pouring money into outside groups as part of their effort to defeat Trump in 2020, avoiding contributions to a party apparatus that lost in 2016 and to leading candidates who dont want their help. Outside groups aligned with Democrats have pledged to spend more than $300 million attacking Trump, far more than the $67 million raised by the Democratic National Committee. With little primary opposition, Trump and the Republican Party are already in general election mode, free to spend millions in states hell need to win a second term. The Democratic groups are being fueled by seven-figure checks necessary to advertise in battleground states, blunting Trumps big campaign cash advantage. Read more from Bill Allison.

Buttigieg Wants Public College Free for Some: Pete Buttigieg called for spending $120 billion on the Pell Grant program and making public colleges tuition-free for students eligible for those federal grants as part of his proposal released Monday to improve college affordability. Unlike some of his primary opponents, Buttigieg isnt calling for public colleges to be tuition-free for all students, or for total student-debt cancellation. Hes said families that make over a certain income threshold should pay at least some of the cost of their kids higher education. The plan released Monday focuses on helping lower- and middle-income families. Read more from Tyler Pager.

Louisiana Governors Re-election May Offer Lessons for 2020: John Bel Edwards proved its possible to buck Trumps popularity, winning a second term to remain the only Democratic governor in the Deep South. His victory will give political strategists important insights on what it takes to motivate turnout going into 2020, said University of Pennsylvania political science professor Daniel J. Hopkins. Voters may feel more empowered to back a moderate Democrat, said Hopkins, who explores the nationalization of state politics in his book, The Increasingly United States.

In Louisiana, Trump headlined three rallies to try to drive turnout for Republican Eddie Rispone. Edwards, meanwhile, ran on a record of demonstrated independence from his national party. Read more from Jennifer Kay.

North Carolina Lawmakers Back New Congressional Map: North Carolina lawmakers have approved new congressional boundaries to be used in the 2020 elections. The 13 current U.S. House district lines were redrawn after a state court decided Oct. 28 that the map in place since 2016 couldnt be used, pending further review. The North Carolina Superior Court for Wake County had found that plaintiffs were likely to prevail in a lawsuit claiming the boundaries were illegally drawn to maximize Republican advantage. Read more from Andrew M. Ballard.

Barr Blasts Democrats: Attorney General William Barr fired a broadside against critics of Trump and congressional Democrats in particular while defending the presidents actions. In a fiery speech before the conservative Federalist Society on Friday, Barr said Trumps opponents are using every tool they can to intentionally sabotage his administration. Immediately after President Trump won election, opponents inaugurated what they called the Resistance, Barr said. They essentially see themselves as engaged in a war, to cripple by any means necessary, a duly elected government. Read more from Chris Strohm.

Trump, Kim at Odds Ahead of Deadline: The bonhomie between Trump and North Korean leader Kim Jong Un is nearing a key deadline showing new signs of strain. Trump urged Kim over the weekend to act quickly to get a nuclear deal done, suggesting the two leaders could meet again soon. His comments came hours after North Korea ruled out nuclear talks without a policy change by the U.S. and reported on a military drill observed by Kim himself.

Veteran North Korea nuclear adviser Kim Kye Gwan told Trump that Pyongyang will no longer give him things to boast about, the states official KCNA news agency today quoted him as saying. He added North Korea is no longer interested in talks that the U.S. uses to buy time. Read more from Glen Carey and Jihye Lee.

Lawmaker Speaks Out Against U.S. Defense-Cost Hike: Rep. Grace Meng (D-N.Y.) said Trump is destabilizing the U.S.s relationship with South Korea by demanding the Asian nation pay about $5 billion, or five times the amount of its current one-year deal, to host U.S. troops, Jihye Lee reports. Meng tweeted a letter Friday asking Defense Secretary Mark Esper and Secretary of State Michael Pompeo to devise a better strategy that values the alliance, adding that such a hike would be extorting South Korea. Meng said such a request also puts U.S. national security and economic interests in jeopardy. She asked the U.S. officials to reconsider and engage in good faith negotiations.

Esper Has Great Faith in U.S. Military Justice System: Secretary Esper expressed his faith in the countrys military justice system, after Trump last week pardoned two soldiers convicted in Afghanistan killings, Glen Carey reports. Id say first of all that we have a very effective military justice system, Esper said during a press conference at the Asean Defense Ministers Meeting-Plus in the Thai capital of Bangkok yesterday. U.S. military personnel are trained from day one about the laws of armed conflict and how to conduct themselves during wartime, he said.

China, U.S. Trade Talks Continue: Top negotiators from China and the U.S. talked again this weekend, after signs of concessions from both sides on some of the outstanding issues. Chinas Vice Premier Liu He, the countrys key negotiator in the trade talks with the U.S., spoke with Treasury Secretary Steven Mnuchin and Trade Representative Robert Lighthizer by phone on Saturday morning Beijing time, according to the Chinese Commerce Ministry. They had constructive discussions about each sides core concerns in the phase-one deal, and agreed to stay in close communication, the statement said. The USTR confirmed the call took place. Read more.

Trump to Tour Apples Austin Plant: President Donald Trump is scheduled to tour an Apple manufacturing plant in Austin, Texas, on Wednesday, the White House said yesterday. The president plans to visit the plant along with Apple CEO Tim Cook, according to a tweet by spokesman Judd Deere. The Austin American-Statesman newspaper reported that Trump will travel with Treasury Secretary Steven Mnuchin and other administration officials.

The company announced in September that its new Mac Pro computer will be assembled in Texas after it received exclusions from the Trump administration from tariffs on certain parts imported from China. The visit also comes at a time the U.S. and China are close to finalizing the first phase of a highly-anticipated trade deal. Read more from Hailey Waller.

Facebook, Google Donate Heavily to Privacy Advocacy Groups: Few companies have more riding on proposed privacy legislation than Google and Facebook. To try to steer the bill their way, the giant advertising technology companies spend millions of dollars to lobby each year, a fact confirmed by government filings. Not so well-documented is spending to support highly influential think tanks and public interest groups that are helping shape the privacy debate, ostensibly as independent observers.

Bloomberg Law examined seven prominent nonprofit think tanks that work on privacy issues that received a total of $1.5 million over an 18-month period ending Dec. 31, 2018. The groups included such organizations as the Center for Democracy and Technology, the Future of Privacy Forum and the Brookings Institution. The actual total is undoubtedly much higherexact totals for contributions were difficult to pin down. Read more from Daniel R. Stoller.

Scalia Says Big Law is Unwilling to Defend Conservative Views: Major law firms are shying away from defending conservative viewpoints in court, a trend that should trouble the legal profession, Labor Secretary Eugene Scalia told a group of right-leaning lawyers at a Federalist Society event on Friday. It is appropriate, admirable, and necessary for lawyers to take on clients and advance positions that may offend some observers, Scalia said. But some of the countrys biggest law firms appear to be disinclined to protect free speech and free trade in ideas, he argued, calling that evidence of a broad trend of conservative political views being under attack. Read more from Jaclyn Diaz.

To contact the reporters on this story: Zachary Sherwood in Washington at zsherwood@bgov.com; Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Giuseppe Macri at gmacri@bgov.com; Loren Duggan at lduggan@bgov.com

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What to Know in Washington: Trump Ally in Impeachment Spotlight - Bloomberg Government

Possible Treatment Found for Contractures in CP, Childhood Paralysis, Early Study Shows – Cerebral Palsy News Today

Scientists at Cincinnati Childrens Hospital Medical Center have found that using the cancer medicine Velcade (bortezomib) in mice prevents the formation of muscle contractures, or tightness of muscles one of the most disabling problems faced by children with cerebral palsy (CP) or brachial plexus injury (NBPI).

This research paves the way for a new and more effective treatment approach for preventing contractures in children born with these conditions, the investigators said.

Their study, Proteasome inhibition preserves longitudinal growth of denervated muscle and prevents neonatal neuromuscular contractures, was published in the journal JCI Insight.

Over time, muscle contractures which develop when normally elastic tissues are replaced by non-stretchy, fiber-like ones disrupt childrens growth in cerebral palsy and NBPI, leading to pain and loss of mobility. Patients may undergo surgery or other treatments to ease the symptoms.

No therapies currently exist that directly tackle the root cause of contractures in childhood paralysis because scientists did not know their biological cause.

But now, a team of researchers at Cincinnati Childrens discovered the culprit to be too much protein destruction in muscles. These scientists found that an approved therapy to treat multiple myeloma andmantle cell lymphoma, called Velcade (marketed by Takeda), can counteract the process and prevent contractures in mice.

In a previous study of a mouse model of NBPI, the team led by Roger Cornwall, MD, a pediatric surgeon at Cincinnati Childrens had found that contractures occurred because paralyzed muscles cannot grow normally in length during early muscle development.

In their new study, the researchers observed that longitudinal muscle growth was actually halted due to a higher than normal breakdown of muscle proteins.

This discovery challenged the long-held view that muscle growth depends mostly on the activity of muscle progenitors, or stem cells.

For decades, neuromuscular contractures have been considered a mechanical problem absent any biological explanation, and only palliative mechanical solutions for them have been available, the researchers said.

Based on the findings, the team tested a new approach to this debilitating and previously unsolved clinical problem. They tested the use of Velcade a chemotherapy known to inhibit protein breakdown in mice models of NBPI shortly after birth.

The treatment proved effective, but required a second medication, [Gly14]-Humanin G, to reduce Velcades known toxic effects.

After four weeks of treatment shortly after birth, our study found that bortezomib [Velcade] significantly reduced shoulder and elbow contractures in a mouse model that mimics these common childhood conditions, Cornwall said in a press release.

Although animal models of CP contractures do not exist, researchers believe the NBPI model can offer valuable insights into the mechanism behind, and therapeutic strategies to prevent contractures in both conditions.

Contractures in CP also are marked by impaired longitudinal muscle growth and appear early after birth, identical to what is seen in the mouse model of NBPI.

Future studies confirming the efficacy of this approach could ultimately render obsolete the destructive surgeries currently required to alleviate contractures in a variety of conditions, Cornwell said.

Given Velcades toxicity, it remains unclear whether it would be deemed safe to test the new therapy in clinical trials.

It also is not known how much older children might benefit from this approach, since the treatments benefits appear to be strongest when given soon after birth.

But the positive results of these early experiments give scientists a starting point from which to work, and could eventually lead to a treatment that could transform childhood paralysis care.

This discovery provides, for the first time, a proof of concept that something we have always considered to be a purely mechanical consequence of limb immobility is actually a biological problem with a medical, rather than physical, solution, Cornwall said.

These findings provide the first strategy to prevent neuromuscular contractures by correcting the underlying deficit in longitudinal muscle growth. Moreover, such an approach may well be harnessed to prevent this same problem resulting from other neuromuscular disorders, the researchers said.

Ana is a molecular biologist with a passion for discovery and communication. As a science writer she looks for connecting the public, in particular patient and healthcare communities, with clear and quality information about the latest medical advances. Ana holds a PhD in Biomedical Sciences from the University of Lisbon, Portugal, where she specialized in genetics, molecular biology, and infectious diseases.

Total Posts: 70

Ana holds a PhD in Immunology from the University of Lisbon and worked as a postdoctoral researcher at Instituto de Medicina Molecular (iMM) in Lisbon, Portugal. She graduated with a BSc in Genetics from the University of Newcastle and received a Masters in Biomolecular Archaeology from the University of Manchester, England. After leaving the lab to pursue a career in Science Communication, she served as the Director of Science Communication at iMM.

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Possible Treatment Found for Contractures in CP, Childhood Paralysis, Early Study Shows - Cerebral Palsy News Today

Asia’s Top Firms Recognized at the 2019 Frost & Sullivan Asia-Pacific Best Practices Awards – Yahoo Finance

Global Awards

Global Contract Research Organization (CRO) Customer Value Leadership Award

COVANCE INC

Global Halal Glove Company of the Year

KOSSAN RUBBER INDUSTRIES BHD

Global High Performance Liquid Chromatography New Product Innovation Award

SHIMADZU

Global Integrated Drug Development in CRO Industry Competitive Strategy Innovation & Leadership Award

WUXI APPTEC

Asia-Pacific Awards

Asia-Pacific Medical Computing Solutions Company of the Year

ADVANTECH CO., LTD.

Asia-Pacific Home Water Treatment Company of the Year

AMWAY

Asia-Pacific Biotech Entrepreneurial Company of the Year

AUM BIOSCIENCES

Asia-Pacific Inbound Contact Routing Systems Market Share Leadership Award

AVAYA

Asia-Pacific Telecoms Digital Services Platform Growth Excellence Leadership Award

BB TECHNOLOGY CO., LTD

Asia-Pacific Emerging Market Telecom Service Provider of the Year

CHUNGHWA TELECOM

Asia-Pacific Home Water Treatment Customer Service Leadership Award

COWAY

Asia-Pacific Telecoms Tower Company of the Year

EDOTCO GROUP SDN BHD

Asia-Pacific CRO Customer Service Leadership Award

EPS HOLDINGS INC

Asia-Pacific AMI Growth Excellence Leadership Award

ITRON

Asia-Pacific Facilities Management Company of the Year

JLL

Asia-Pacific Logistics Service Provider of the Year

KERRY LOGISTICS NETWORK

Asia-Pacific Road Freight Service Provider of the Year

KERRY LOGISTICS NETWORK

Asia-Pacific Inorganic Disinfectants for Healthcare Industries New Product Innovation Award

LOCAL POWER CO. LTD.

Asia-Pacific SIEM Growth Excellence Leadership Award

LOGRHYTHM

Asia-Pacific Biotech CRO Company of the Year

NOVOTECH (AUSTRALIA) PTY. LTD.

Asia-Pacific Customer Experience System Integrator of the Year

NTT LTD.

Asia-Pacific End-to-End UCC Service Provider of the Year

NTT LTD.

Asia-Pacific Managed Security Service Provider of the Year

NTT LTD.

Asia-Pacific Cloud Contact Center Service Provider of the Year

ORANGE BUSINESS SERVICES

Asia-Pacific Critical Power Infrastructure Vendor of the Year

SCHNEIDER ELECTRIC

Asia-Pacific Secure IOT Service Provider of the Year

SINGTEL

Asia-Pacific Mobile Wallet Provider of the Year

SINGTEL DASH

Asia-Pacific Ultra-low Weight Nitrile Glove Product Leadership Award

SMART GLOVE HOLDINGS

Asia-Pacific Managed UC Service Provider of the Year

TATA COMMUNICATIONS

Asia-Pacific Neurodegenerative Disease Management Technology Innovation Award

TAURX PHARMACEUTICALS LTD

Asia-Pacific Customer Contact Outsourcing Technology Leadership Award

TELEPERFORMANCE INDIA

Asia-Pacific Customer Contact Enabling Technology Leadership Award

TETHERFI

Asia-Pacific Customer Contact Outsourcing Customer Service Leadership Award

TRANSCOM WORLDWIDE PHILIPPINES INC.

Asia-Pacific Critical Infrastructure Solutions Growth Excellence Leadership Award

VERTIV CO.

Asia-Pacific Data Center Power Systems Customer Value Leadership Award

VERTIV CO.

Southeast Asia Awards

Emerging Southeast Asia Smart City Governance Agency of the Year

SMART SELANGOR DELIVERY UNIT

Southeast Asia Contact Center Applications Market Share Leadership Award

AVAYA

Southeast Asia Stem Cell Banking Growth Excellence Leadership Award

MEDEZE

Southeast Asia Unified Communications System Integrator of the Year

NTT LTD.

Southeast Asia Smart Buildings Competitive Strategy Innovation and Leadership Award

QUANTUM AUTOMATION PTE LTD

Southeast Asia Managed Security Service Provider of the Year

TRUSTWAVE, A SINGTEL COMPANY

Country Awards

Australia Customer Contact Outsourcing Service Provider of the Year

STELLAR

Indonesia Payment Gateway Company of the Year

FASPAY

Indonesia Healthcare IT Growth Excellence Leadership Award

HOPE BY PT MEDIA TIGA WARNA

Indonesia Cloud Infrastructure Services Provider of the Year

LINTASARTA

Indonesia Emerging Hospital of the Year

MAYAPADA HEALTHCARE

Indonesia Data Center Services Provider of the Year

PT. SIGMA CIPTA CARAKA (TELKOMSIGMA)

Indonesia IOT Services Provider of the Year

PT TELEKOMUNIKASI INDONESIA TBK

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Asia's Top Firms Recognized at the 2019 Frost & Sullivan Asia-Pacific Best Practices Awards - Yahoo Finance

Takeda, Anderson Cancer Center team up for cell therapy – BSA bureau

Takeda and Anderson Cancer Center announce cooperation to accelerate the development of clinical stage, out-of-the-box CAR NK cell therapy platform

University of Texas MD Anderson Cancer Center(The University of Texas MD Anderson Cancer Center)and Takeda Pharmaceutical Company Limited (Takeda Pharmaceutical hasannounced an exclusive licensing agreement and research agreement to develop cord blood-derived chimeric antigen receptors for "arming" IL-15 for the treatment of B-cell malignancies and other cancers Chimeric Antigen Receptor-directed Natural Killer (CAR NK) cell therapy.

Under the agreement, Takeda will receive access to the CAR NK platform of the Anderson Cancer Center and the exclusive rights to develop and commercialize up to four projects, including a CD19-targeted CAR NK cell therapy and a B-cell maturation. The antigen (BCMA) is the target of CAR NK cell therapy.The Takeda and Anderson Cancer Center will conduct a research collaboration to further develop the above CAR NK project.

Katy Rezvani, MD, Ph.D.,Professor ofStem Cell Transplantation and Cell Therapyat theAnderson Cancer Center,said: "Our vision is to improve existing treatments by developing armored CAR NK, which can be administered in outpatient settings. Out of the box, more patients can get effective, fast and least toxic treatment. Takeda's expertise in hematological malignancies and the commitment to develop next-generation cell therapies make it an ideal partner for our team. Promote CAR NK cell therapy for patients with therapeutic needs."

New ways to deliver out of the box ready to use CAR in outpatient facilitiesallogeneic Anderson Cancer Center platform CAR NK NK cells isolated from umbilical cord blood, the fight against certain cancers expressing CAR targets after processing.CAR NK cells are modified by retroviral vectors to deliver genes and enhance their efficacy against specific tumors.CD19 CAR increases the specificity of these cells against B cell malignancies, while the immune cytokine IL-15 enhances the proliferation and survival of CAR NK cells in vivo.

Existing CAR T cell therapy drugs use patient-generated genetically modified T cells, and the preparation process takes several weeks. In contrast, CAR NK cells are designed to be prepared from non-relative donor sources and stored in an out-of-the-box manner. So that treatment can be implemented faster.

CD19 CAR NK cell therapy is expected to be administered in an outpatient setting.In an ongoing phase 1/2a clinical study, patients with relapsed refractory B-cell malignancies who received CD19 CAR NK cell therapy did not see severe cytokine release syndrome (CRS) observed in existing CAR-T treatments. ) or neurotoxicity.

Anderson Cancer Center to develop CAR NK platform led by Dr. Rezvani, and withadoptive cell therapy platform,Chronic Lymphocytic Leukemia Moon ShotandB-the Cell Lymphoma Moon Shotfurther support of the project were the hospitalMoon Shots Programof In part, the project is a collaborative effort to rapidly develop scientific discoveries into meaningful clinical advances that can save patients' lives.

Takeda: CAR accelerate the development of next-generation multiple platformsAndy Plump Takeda, president of R & D, MD, Ph.D., said: "Anderson Cancer Center CAR NK cell therapy platform represents a potential cure for the drug, which is what we are to CD19 CAR NK Established as a leader in the treatment of drug candidates for cancer in the field. We must work flexibly and purposefully, so we plan to start the pivotal study of CD19 CAR NK in 2021."

In addition to CAR NK cell therapy, Takeda and its partners are investigating ways to improve the safety, efficacy, and accessibility of first-generation CAR T cell therapies, includinggamma delta CAR T,induced pluripotent stem cell-derived CAR T,with solid tumors as targets of CAR Tandother next-generation methods.Takeda plans to the end of fiscal year 2020 to promote the five kinds of tumor cell therapy to clinical stage.The platform is being developed through collaboration with partners and the use of Takeda's expertise in transforming cell therapy engines that provide bioengineering, chemistry, manufacturing and control (CMC), clinical and transformation functions in a single location to overcome cell therapy drugs. Numerous manufacturing challenges in development.

Takeda is responsible for the development, manufacture and commercialization of the CAR NK products produced by the agreement.The Anderson Cancer Center will receive upfront payments and be eligible to receive royalties for development and commercialization milestones for each target and for any CAR NK product net sales.

The Anderson Cancer Center and Takeda will continue to conduct research on other targets and the CAR NK platform under the direction of a joint research committee.The Anderson Cancer Center will deploy aninstitutional conflict of interest management and monitoring programfor the study.

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Takeda, Anderson Cancer Center team up for cell therapy - BSA bureau