Week of February 1

Oncology

• In Phase 3 clinical trials, Astra Zeneca’s Tagrisso demonstrated a reduction in risk of disease or death by 84% and 77% of NSCLC patients with an EGFR mutation who had received prior adjuvant chemotherapy or who had no prior adjuvant therapy, respectively. Link

• AstraZeneca and Daiichi Sankyo’s antibody drug conjugates, Datopotamab deruxtecan (Dato-DXd; DS-1062) and Enhertu (trastuzumab deruxtecan), showed promising Phase 1 and interim Phase 2 results in treating patients with advanced NSCLC. The data was presented during the World Conference on Lung Cancer (WCLC). Link

• In a strategic collaboration with BeiGene, Amgen received their first Chinese Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) for sotorasib (AMG-510) to treat locally advanced or metastatic NSCLC with a KRASG12Cmutation. Link

• Johnson & Johnson’s investigational BCMA-directed CAR-T therapy to treat relapsed and/or refractory multiple myeloma, ciltacabtagene autoleucel (cilta-cel), received accelerated assessment for market approval from the European Medicines Agency (EMA). Cita-cel had previously received EMA’s PRIority MEdicines (PRIME) designation back in April 2019. Link

• The FDA lifted a hold on Bellicum Pharmaceuticals’s Phase 1/2 trial for BPX-601 and rimiducid to treat metastatic prostate and pancreatic tumors. While the trial was initially paused after the death of a participant with pancreatic cancer, the FDA ruled the death to be unrelated to the treatment. Link

• In a Phase 3 trial treating chronic lymphocytic leukemia, AstraZeneca’s Calquence (acalabrutinib) met its progression-free survival (PFS) primary endpoint compared to ibrutinib. Calquence also demonstrated a statistically significant reduction in atrial fibrillation incidences, an adverse effect associated with ibrutinib treatment. Link

CNS Disorders and Neurodegeneration

• Biogen and Eisai announced the FDA has extended the review period for their Biologics License Application (BLA) of aducanumab, an investigational treatment for Alzheimer’s disease. This extension follows Biogen’s response to an additional information request from the FDA, which it considered a major amendment to the application. Link

Technologies

• Asklepios BioPharmaceutical, a subsidiary of Bayer, acquired Brain Neurotherapy Bio to expand their gene therapy pipeline in treating neurodegenerative diseases, including Parkinson’s disease and multiple system atrophy (MSA). Brain Neurotherapy Bio’s lead candidate, a glial cell line-derived neurotrophic factor (GDNF) gene therapy (AAV2-GDNF), looks to utilize the brain’s cellular machinery to continuously produce GDNF to promote the survival and functioning of vulnerable brain cells in both indications. Parkinson’s and MSA patients are currently being recruited into two Phase 1 trials evaluating the safety and efficacy of AAV2-GDNF. Link

• Artiva Biotherapeutics announced an exclusive worldwide collaboration and license agreement with Merck to develop up to three allogenic chimeric antigen receptor- natural killer (CAR-NK) cell therapies to treat solid tumors. Compared to CAR-T cell therapy, CAR-NK has some advantages including reduced risk of cytokine release syndrome and increased feasibility for ‘off-the-shelf’ manufacturing. Utilizing Artiva’s NK cell manufacturing platform, Artiva will advance the CAR-NK cell therapy candidates to IND approval then Merck will advance them through clinical and commercial development. Link

Industry and Corporate Developments

• Eli Lilly acquired the exclusive rights to Asahi Kahei Pharma’s orally bioavailable P2X7 receptor antagonist to treat chronic pain conditions, AK1780. Asahi Kahei Pharma will receive $20M in upfront payments and may be eligible for up to $210M in development and regulatory milestones. Link