Gritstone Bio

DelveInsight's report on KRAS Inhibitors covers market trends, epidemiology, and pipeline developments in the US, EU4, UK, and Japan. The market is driven by cancer incidence and personalized treatments, with key companies like Novartis, Roche, and Verastem Oncology leading in KRAS inhibitor therapies.

GRANITE-based maintenance therapy (GRT-C901/GRT-R902, atezolizumab, ipilimumab, bevacizumab, fluoropyrimidine) showed improved progression-free survival (PFS) vs bevacizumab plus fluoropyrimidine alone in MSS mCRC patients, with a 27% reduced risk of death. Notably, increased PFS benefit was observed in patients with low ctDNA levels. Safety data indicated GRANITE was tolerable, with OS data expected in 2025.

Self-amplifying mRNA (samRNA) vaccines face scientific and regulatory challenges, but experts believe they will eventually enter the market, especially for infectious diseases and cancer. Despite initial setbacks, Gennova Biopharmaceuticals' Gemcovac and Arcturus Therapeutics' Kostaive have gained approvals in India and Japan, respectively. The success of Kostaive is attributed to strategic timing and unique trial conditions. While samRNA therapeutics offer potential benefits over standard mRNA vaccines, technical hurdles and safety concerns remain, affecting their widespread adoption.

Wave Life Sciences' RNA editing platform demonstrated successful editing of mutant Z-AAT mRNA in humans, leading to a 74% stock surge. Korro Bio and ProQR Therapeutics also saw significant stock gains due to their RNA editing therapies. Investors were impressed by the rapid and durable effects of Wave's WVE-006, with wild-type M-AAT protein reaching 6.9 micromolar at day 15. Analysts predict Wave's RNA editing platform will advance its pipeline and validate its technology.

Turnstone Biologics to lay off 60% of workforce, focus on cancer cell therapy. FDA approves Roche's Itovebi for breast cancer, competing with Novartis' Piqray. Gritstone bio files for bankruptcy, in talks for potential buyer. Sanofi halts Denali Therapeutics' Phase 2 MS trial after study failure. Pfizer's Talzenna-Xtandi combo extends prostate cancer survival. Paul Parker joins Flagship Pioneering as managing partner. Zealand Pharma's hypoglycemia drug dasiglucagon rejected by FDA again.

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Gritstone bio filed for bankruptcy to complete a strategic alternatives process, potentially saving its clinical program. The biotech aims to undergo a stalking horse transaction and continue operations normally. Gritstone's vaccine programs include cancer and infectious diseases, with an encouraging Phase II readout for its colorectal cancer vaccine. The company reported $61.7 million in cash as of June 30, insufficient for 12 months of operations.

Gritstone bio, Inc. files for Chapter 11 restructuring to preserve value and continue strategic alternatives process, with interest from parties. The company aims to enter a value-maximizing transaction to advance its next-generation vaccines and immunotherapies for oncology and infectious diseases.

Gritstone bio's Phase 2 study of GRANITE vaccine in advanced colorectal cancer shows 21% relative risk reduction of disease progression or death, with 33% of patients remaining progression-free. The vaccine's efficacy is more pronounced in patients with low disease burden, and it has a favorable safety profile. Gritstone plans to discuss PFS data with the FDA for potential Phase 2 or 3 trials. Despite promising results, financial challenges persist, with a net loss of $23 million in Q2 and concerns about cash reserves.