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