Gritstone Bio

A study in China found that immune checkpoint inhibitor (ICI)-based treatments improved survival in heavily pretreated microsatellite stable (MSS) metastatic colorectal cancer (mCRC) patients.

• Self-amplifying mRNA (samRNA) vaccines offer potential advantages like extended efficacy and lower doses compared to traditional mRNA vaccines. • Regulatory hurdles and a lack of extensive experience have slowed the widespread adoption of samRNA technology. • Arcturus Therapeutics' Kostaive, approved in Japan, remains one of the few samRNA vaccines to reach the market, benefiting from pandemic-era acceleration. • Technical complexities and concerns about potential immune responses to the replicon component pose challenges for samRNA vaccine development.

• The FDA approved Roche's Itovebi, inavolisib, for HR-positive, HER2-negative breast cancer with PIK3CA mutation, to be used with Pfizer’s Ibrance and endocrine therapy. • Turnstone Biologics is restructuring, laying off 60% of its workforce to focus on a Phase 1 cancer cell therapy program for solid tumors, with updates expected next year. • Pfizer's Talzenna combined with Xtandi showed prolonged survival in advanced prostate cancer patients, regardless of genetic alterations, seeking expanded use. • Gritstone bio filed for bankruptcy after disappointing vaccine study results; Denali Therapeutics' multiple sclerosis drug, oditrasertib, failed in Phase 2 trial.

Gritstone Bio has filed for Chapter 11 bankruptcy to facilitate a strategic alternatives process and potentially save its clinical programs.

Interim Phase 2 data shows Gritstone's GRANITE vaccine, combined with immune checkpoint inhibitors, reduces the risk of disease progression or death by 21% in advanced colorectal cancer patients.