Week of July 27

This weekly post looks to identify important advancements in the areas of oncology, CNS disorders and neurodegeneration, technologies, and industry and corporate developments. More in-depth reading and analysis can be found in the attached links.

Oncology

  • The EMA’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion on approving GSK’s belantamab mafodotin to treat multiple myeloma. Belantamab mafodotin will be recommended as monotherapy to patients who have received at least four prior lines of therapy. Link


  • Having overcome a challenging synthesis program, Q Biomed and Chemveda Life Sciences will move forward with testing Uttroside-B in liver cancer. The companies plan to perform preclinical testing and validation over the next few months, to be followed by an Orphan Drug application and an Investigational New Drug (IND) application. Link


CNS Disorders and Neurodegeneration

  • Eli Lilly announced they will showcase the results from 17 research studies at the upcoming Alzheimer's Association International Conference. These results focus on Lilly’s efforts in developing both disease-modifying therapies and early detection diagnostics in Alzheimer's disease. Link


  • BioXcel announced positive Phase 3 results for BXCL501 to treat acute agitation in schizophrenia and bipolar disorder. BioXcel looks to expand BXCL501 to other designations including dementia and opioid withdrawal symptoms. Link


Technologies

  • FDA granted Fast Track Designation for Sarepta Therapeutics’ SRP-9001 in treating Duchenne Muscular Dystrophy. This designation comes after one year of favorable safety and tolerability data in four participants and upcoming results from a randomized, double-blind, placebo-controlled study in early 2021. Link


  • FDA decided not to lift its clinical hold on Solid Biosciences’ SGT-001 in Duchenne Muscular Dystrophy. The Phase 1/2 trial has been on hold since November due to a serious adverse event in one patient, who has since recovered. Link


  • FDA approved Kite Pharma’s CAR-T cell therapy Tecartus to treat relapsed and refractory mantle cell lymphoma. Tecartus is the first and only CAR-T cell therapy in this indication and Kite Pharma is the first company with two FDA approved CAR-T cell therapies. Link


  • ProMab Biotechnologies, announced positive safety and efficacy results for their humanized CD19 CAR-T cell therapy to treat relapsed and refractory CD19+ B-cell malignant hematological tumors. Seven of ten patients were in continuous remission for up to 9 months and only 5 patients had level 1 cytokine release syndrome side effects. Link


Industry and Corporate Developments

  • AstraZeneca entered an $1B agreement with Daiichi Sankyo. AstraZeneca will help in the develop and commercialization of Daiichi’s trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC), DS-1062. Link


  • GSK announced a strategic collaboration agreement with CureVac. GSK will help in the development, manufacturing, and commercialization of CureVac’s mRNA-based vaccines and monoclonal antibodies (mAbs) targeting infectious disease pathogens. Link


  • JW Therapeutics, a joint-venture company established by Juno Therapeutics and WuXi AppTec, acquired Eureka Therapeutics' Chinese subsidiary Syracuse Biopharma. This merger helps JW Therapeutics advance its pursuit of filing an IND for a CAR-T cell therapy in China, a relatively untapped market for CAR-T cell therapy.Link


  • Michael McDonnell, CFO of IQVIA, will replace Jeffrey Capello as CFO of Biogen in August. The unexpected move has prompted M&A rumors after Biogen received pressure to expand its pipeline portfolio. Link


  • Olema Oncology, a San Francisco-based biotech, closed $54M Series B Financing to advance the company’s lead candidate OP-1250, a complete estrogen receptor antagonist, to treat ER+, HER2- breast cancer. Link


  • The UK government announced it will invest £100M ($127M) into a Cell and Gene Therapy Catapult Manufacturing Center to manufacture millions of COVD-19 vaccines per month, along with vaccines for other emerging diseases. This center is due to open in December 2021. Link


  • Vesigen Therapeutics closed $28.5M Series A Financing from Leaps by Bayer and Morningside Ventures. Vesigen Therapeutics is using a new class of extracellular vesicles as packaging and delivery tools in cell and gene therapy. Link


  • Taro Pharmaceutical Industries announced they will pay the US Department of Justice a total of $419M to settle claims of fixing generic drug pricing. Link


  • The US government agreed to pay Pfizer and BioNTech $1.95B for the first 100 million COVID-19 vaccine doses and up to a total of 600 million doses. The US is roughly paying $19.50 per dose while other COVID-19 vaccine deals are pricing as low as $3 to $4 per dose. Link


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