Week of August 31

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


  • FDA approved Foundation Medicine’s pan-tumor liquid biopsy diagnostic, FoundationOne. This comprehensive genomic profiling test reports genomic alterations including NTRK fusions, microsatellite instability, and single-gene alterations. Since August 28th, FoundationOne is available for clinical use across all solid tumors. Link


  • Norvartis announced positive Phase 3 results for asciminib to treat chronic myeloid leukemia patients. Asciminib outperformed Pfizer’s Bosulif by having a greater major molecular response (MMR) rate at 24 weeks. Link


  • European Commission approved AstraZeneca’s Imfinzi to treat extensive-stage small cell lung cancer (ES-SCLC) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin. This approval was based on positive Phase 3 results demonstrating Imfinzi in combination with chemotherapy had clinically meaningful overall survival (OS) as a 1st-line treatment in ES-SCLC patients. Link


  • European Commission approved GSK’s BLENREP to treat relapsed and refractory multiple myeloma. BLENREP, a first-in-class humanized anti-BCMA treatment, received FDA approval less than a month ago. Link


  • Eli Lilly published Phase 1/2 results for Retevmo in the New England Journal of Medicine. Retevmo demonstrated durable objective responses in both metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) and advanced or metastatic RET-mutant medullary thyroid cancer (MTC). Link


  • FDA approved Bristol Myers Squibb’s Onureg for the continued treatment of patients with acute myeloid leukemia. The approval is based on pivotal Phase 3 results demonstrating Onureg provided clinically meaningful improvement in overall survival compared to placebo. Link


CNS Disorders and Neurodegeneration


  • Amylyx Pharmaceutical announced positive Phase 2/3 results for AMX0035 to treat patients with amyotrophic lateral sclerosis. After six months, AMX0035 demonstrated improved motor function evaluated by the Revised ALS Functional Rating Scale compared to the placebo. Link


  • Bristol Myers Squibb announced positive interim Phase 3 results for Zeposia to treat patients with relapsing forms of multiple sclerosis. Patients taking Zeposia were relapse-free and 3- and 6-month confirmed disability progression. Link


  • Roche announced that they will present Phase 3b results for Ocrevus at MSVirtual2020. Ocrevus demonstrated that patients with relapsing-remitting MS (RRMS) achieved a high rate of no evidence of disease activity (NEDA). Link


Technologies


  • Sanofi and GSK announced the start of their clinical trial for their adjuvanted COVID-19 vaccine. The Phase 1/2 trial will enroll 440 healthy adults to evaluate the safety and efficacy of their vaccine candidate. Link


  • Janssen Pharmaceutical Companies of Johnson & Johnson announced their decision to discontinue the develop of pimodivir to treat influenza A infections. This decision is due to negative interim Phase 3 results demonstrating that pimodivir in combination with the standard of care (SOC) was unlikely to provide benefit to hospitalized patients with influenza A compared to SOC treatment alone. Link


  • FDA approved Roche’s HIV-1/HIV-2 Qualitative Test to be used on the fully automated cobas systems. The test provides a single result to confirm HIV-1 and HIV-2 diagnosis. Link


  • GSK announced positive Phase 2a results for GSK3228836 (GSK’836) to treat chronic hepatitis B. The investigational antisense oligonucleotide reduced hepatitis B surface antigen (HBsAg) and hepatitis B virus DNA levels compared to placebo. Link


Industry and Corporate Developments


  • Triumvira Immunologics closed $55M Series A Financing from Bayer and Northpond Ventures. Triumvira is developing novel T-cell therapies to be safer and more efficacious than current cell therapies including CAR T-cell and engineered T-cell receptor therapies. Link

 

  • Athera Pharma, a Seattle based biotech company focused on developing treatments for neurodegenerative diseases, filed for an IPO after raising $85M series B financing a few months ago.  Link


  • AstraZeneca and Catalent entered into a manufacturing deal to support the production of AstraZeneca’s Covid-19 vaccine, AZD1222. Catalent will help produce the vaccine candidate drug substance at its gene therapy facility in Maryland. Link


  • Yumanity Therapeutics and Proteostasis Therapeutics announced they have entered into a definitive merger agreement. The companies, now called Yumanity Therapeutics, hope to advance Yumanity’s pipeline of disease-modifying programs for neurodegenerative diseases. Link


  • Boehringer Ingelheim announced that Jean-Michel Boers has been appointed to the board of directors of the Pharmaceutical Research and Manufacturers of America (PhRMA). Link


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