Week of November 2

Oncology

• The FDA granted Priority Review and accepted AstraZeneca’s and Daiichi Sankyo’s supplemental Biologics License Application for Enhertu (trastuzumab deruxtecan) to treat HER2+ metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. Enhertu is a HER2-directed antibody drug conjugate (ADC) attached with a topoisomerase I inhibitor. Link

• The FDA granted priority review to Regeneron’s Libtayo, to treat metastatic locally advanced or metastatic NSCLC in the first-line setting. The tumors require expressing PD-L1 greater than or equal to 50% using the PD-L1 IHC 22C3 pharmDx kit. Link

• NCI presented results at the American Society for Radiation Oncology Annual Meeting supporting the addition of fluciclovine, an advanced PET radiotracer, as standard practice for treating prostate cancers. A Phase 2/3 study found that 75.5% of relapsed prostate cancer patients included fluciclovine to plan future treatments were disease-free compared to 63% of whom only conventional imaging was used. Link

• Both the European Commission and China’s National Medical Products Administration (NMPA) approved Roche’s combination of Tecentriq (atezolizumab) and Avastin (bevacizumab) to treat advanced or unresectable hepatocellular carcinoma (HCC) in patients who have not received prior systemic therapy. This approval is based on Phase 3 results demonstrating Tecentriq and Avastin had clinically significant reductions in the risk of death and risk of disease progression compared to sorafenib. Link

• Additionally, the European Commission approved GlaxoSmithKline’s Zejula (niraparib) as a first-line maintenance monotherapy maintenance to treat advanced epithelial high-grade ovarian cancer who are in complete or partial response following chemotherapy. Link

CNS Disorders and Neurodegeneration

• The EMA accepted the marketing authorization application for Biogen’s and Eisai aducanumab (BIIB037), an investigational antibody against amyloid-beta to treat Alzheimer's disease. Link

• C2N Diagnostics launched a blood test for clinicians to detect Alzheimer’s brain pathology in people with memory and cognitive issues. The test utilizes mass spectrometry to measure the concentration of amyloid-beta 42 and 40 and apolipoprotein E (ApoE) isoforms in blood. Link

• Due to CMC data delays and third-party fill/finish issues, Axovant Gene Therapies announced delaying their Phase 2 AXO-Lenti-PD gene therapy to treat Parkinson’s patients until late 2021. Link

Industry and Corporate Developments

• Exact Sciences announced the acquisition of both Thrive Earlier Detection for $2.15B and Base Genomics for $410M. These acquisitions will advance Exact Sciences development of multi-cancer screening and early cancer detection diagnostic tools. Link

• Chinese biopharmaceutical company Gracell Biotechnologies raised $100M in Series C for Gracell’s CAR-T platforms with lower production costs and a shorter manufacturing times than current CAR-T treatments. Link

• Novartis secured the first approved site for commercial CAR-T cell therapy manufacturing in Japan. The site will manufacture and supply Kymriah to treat patients in Japan. Link

• Novartis and Molecular Partners announced a collaboration on two Molecular Partners’ anti-COVID-19 custom-build protein therapeutics, DARPin, candidates MP0420 and MP0423. Under the agreement, Molecular Partners will finish preclinical work and conduct Phase 1 clinical trials while Norvartis will conduct Phase 2 and 3 clinical trials. Link

• Bristol Myers Squibb entered into a five-year research agreement with Insitro, a machine-learning driven drug discovery and development company, to discover and develop novel treatments to treat amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). Link