Week of June 16

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


  • Eli Lilly announced positive results in Verzenio’s Phase 3 trial in HR+, HER2- early breast cancer. Verzenio in combination with standard adjuvant endocrine therapy met its primary endpoint of invasive disease-free survival (IDFS) compared to standard adjuvant endocrine therapy alone. Link


  • The Institute of Cancer Research, The Royal Marsden NHS Foundation Trust, and UK general practitioners reported success in recruiting healthy men for their BARCODE 1 study. The study hopes to guide prostate cancer screening by genetically screening 5000 men from the general UK population. Link


  • Pfizer announced positive results in Xtandi’s Phase 3 trial in men with high-risk, non-metastatic castration-resistant prostate cancer. Xtandi in combination with androgen deprivation therapy had a greater median overall survival compared to androgen deprivation therapy alone. Link


  • The National Health Service England announced that newly diagnosed prostate cancer patients will have access to Xtandi and Zytiga due to the COVID-19 pandemic stopping chemotherapy treatments. Link


  • While Merck announced negative results in Keytruda’s Phase 3 in first-line bladder cancer, Pfizer’s and Merck KGaA’sBavencio announced positive results in their Javelin Bladder 100 study. Link


  • Jazz Pharmaceuticals and PharmaMar received FDA approval for Zepzelca in treating metastatic small cell lung cancer on or after platinum-based chemotherapy disease progression. Link


CNS Disorders and Neurodegeneration


  • Biogen announced it will push FDA filing of aducanumab to Q3 of 2020 notwithstanding negative phase 3 results in March 2019. Link


  • Acadia Pharmaceuticals submitted a supplemental NDA for Nuplazid to treat hallucinations and delusions associated with dementia-related psychosis. If approved, Nuplazid would be the first approved drug in this space. Link


Technologies


  • To improve the safety of human pluripotent stem cell-derived cell transplantation (hPSC) therapies, Stanford researchers have developed two small molecules to eliminate undifferentiated hPSC or all hPSC-derived cell-types in case adverse events arise. Link


  • Sarepta announced positive results for their gene therapy, SRP-9003, in treating three patients with limb-girdle muscular dystrophy. With no severe adverse events, Sarepta hopes to set up a pivotal trial by next year. Link


Industry and Corporate Developments


  • Lycia Therapeutics received a $50 million investment from Versant Ventures to develop lysosomal targeting chimeras. Link


  • Executives from Johnson & Johnson and Takeda indicated that the global pandemic is not changing how the biopharma industry approaches mergers and acquisitions. Link


  • To treat diabetic comorbidities, Novo Nordisk acquired the AstraZeneca spinoff Corvidia for $750 million with the potential of additional milestone payments adding up to $2.1 billion. Link

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