Week of January 18

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


  • At the 2021 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), GlaxoSmithKline announced positive Phase 1 data in one patient cohort of a dostarlimab trial, which demonstrated a 38.7% objective response rate in mismatch repair-deficient (dMMR) non-endometrial solid cancers after 2+ prior lines of systemic therapy. Link


  • Also presented at the 2021 ASCO GI Symposium, Roche’s Tecentriq (atezolizumab) and Avastin (bevacizumab) combination demonstrated improved overall survival (OS, 19.2 months) in unresectable hepatocellular carcinoma (HCC) patients compared to Nexavar (sorafenib, 13.4 months). Link


  • Pfizer’s Xalkori (crizotinib) received FDA approval for the treatment of pediatric and young adult patients with ALK+ relapsed or refractory systemic anaplastic large cell lymphoma (ALCL), a rare form of non-Hodgkin lymphoma. Xalkori is the first biomarker therapy approved for the treatment of ALCL patients under the age of 18 years old. Link


  • The European Commission approved AstraZeneca’s Imfinzi (durvalumab) for an additional dosing option to treat locally advanced, unresectable PD-L1+ NSCLC that has not progressed following platinum-based chemoradiation therapy. The new dosing option of a 1,500mg fixed dose every four weeks is consistent with the approved Imfinzi dosing to treat extensive-stage small cell lung cancer. Link


CNS Disorders and Neurodegeneration


  • Cognito Therapeutics received FDA breakthrough device designation for their non-invasive neurostimulation device to treat memory and cognition in Alzheimer's patients. Link


Industry and Corporate Developments


  • Bluebird bio announced a plan to spin off its oncology drug development into a new publicly-traded company thus far referred to as Oncology Newco. Bluebird will focus on its pipeline of rare disease treatments, with expected filing dates schedules for 2021 and 2022. Oncology Newco and bluebird have a March 2021 FDA decision date for bb2121 to treat multiple myeloma. Link


  • Boehringer Ingelheim and Enara Bio announced a collaboration and licensing agreement focused on developing new immunotherapies for patients with difficult to treat lung and gastrointestinal cancers. The companies will utilize Enara Bio’s Dark Antigen™ discovery platform to identify antigens presented by MHC receptors on the surface of tumor cells. Link


  • NextCure hired a new CMO 6 months after its former CMO quit following weak trial results and Eli Lilly abruptly pulled out of its research deal with NextCure. The new CMO, who previously held the same title at NexImmune, will oversee NextCure’s oncology pipeline targeting highly immunosuppressive cells. Link


  • The former director of medical and scientific affairs for Merck has been charged with stealing trade secrets about Keytruda. The defendant allegedly emailed confidential and proprietary materials to his new employer AstraZeneca, though neither Merck nor AstraZeneca are named in the case. If convicted, Shafat Quadri, Ph.D could face 10 years in prison and a fine up to $250,000. Link


  • A newly formed venture fund created by racially diverse and historically underrepresented business leaders, Unseen Capital Health Fund LP, received a $30M limited partner investment from Eli Lilly to support early-stage companies founded by underrepresented populations looking to develop solutions for marginalized communities. Unseen Capital is looking to reach its initial investment target of $100M. Link


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