Week of January 11

Oncology

• At the 2021 Gastrointestinal Cancers Symposium, Roche will present updated Phase 3 overall survival (OS) data evaluating Tecentriq in combination with Avastin to treat patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. The updated data demonstrated that the Tecentriq combination had an OS of 19.2 months compared to 13.4 months for sorafenib. Link

• At the World Conference on Lung Cancer (WCLC) on Jan 28-31, Amgen will present on two lung cancer drug candidates. Phase 2 data evaluating sotorasib (AMG 510) in KRAS G12C-mutated advanced NSCLC and Phase 1 data evaluating AMG 757, an investigational BiTE molecule, targeting delta-like ligand 3 (DLL3) in SCLC will be showcased. Link

• Tiragolumab, Roche’s anti-TIGIT monoclonal antibody, received FDA breakthrough therapy designation in combination with Tecentriq to treat metastatic NSCLC which has high PD-L1 expression and no EGFR or ALK mutations. Tiragolumab is the first anti-TIGIT that has received FDA’s breakthrough therapy designation. The dual blockage of TIGIT and PD-L1, via tiragolumab and Tecentriq respectively, may synergistically re-activate T-cells and enhance NK-cells’ anti-tumor activity to enhance the body’s immune response to cancer cells. Link

CNS Disorders and Neurodegeneration

• Eli Lilly’s investigational antibody that targets a modified form of beta amyloid called N3pG met its Phase 2 primary endpoint of slowing cognitive decline in early symptomatic Alzheimer's disease patients. After 76 weeks, patients receiving Donanemab had a slowing of decline in cognition and daily function. In addition, improvements in overall cognition and function compared to placebo were recorded, but did not reach statistical significance. This is the first positive study supporting the amyloid targeting hypothesis to treat Alzheimer’s disease in some time.  Link

• Pfizer initiated a Phase 3 trial evaluating the safety and efficacy of their gene therapy candidate PF-06939926 to treat Duchenne muscular dystrophy (DMD). The first participant, out of the expected 99 ambulatory male patients, was given PF-06939926 which has received Fast Track, Orphan Drug, and Rare Pediatric Disease designations. Link

• BioXcel Therapeutics announced that BXCL501, a selective alpha-2a receptor agonist, met both primary and secondary endpoints in a Phase 1b/2 dementia and Alzheimer's disease study. Primary endpoints were focused on safety and tolerability while secondary endpoints included efficacy in reducing agitation in dementia and Alzheimer’s patients. Link

Industry and Corporate Developments

• Hologic, a women’s health biotech company, announced two acquisitions, Biotheranostics for $230M and SOMATEX for $64M, to enhance its breast cancer diagnostics offerings and expand into European markets. Link