Gritstone bio, Inc. clinical-stage biotechnology company, which engages in developing the next generation of cancer immunotherapies to fight multiple cancer types. The company was founded by Andrew Allen, Timothy Chan, Mark Cobbold, Graham Lord, Naiyer Rizvi and Jean-Charles Soria in August 2015 and is headquartered in Emeryville, CA.
Clinical Trials
8
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2015
Active, not recruiting
1
12.5%
Completed
6
75.0%
Withdrawn
1
12.5%
No approval data available
- 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. - Combinations of ICI with tyrosine kinase inhibitors (TKIs), with or without chemotherapy, demonstrated meaningful survival improvements and a manageable safety profile. - Another phase 2 trial showed that GRANITE, combined with ICIs and bevacizumab/chemotherapy, improved progression-free survival (PFS) in first-line MSS mCRC, especially in patients with low ctDNA levels. - These findings support further investigation of immunotherapy rechallenge and personalized neoantigen targeting in MSS mCRC, addressing a critical unmet need.
• 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. - The company is in discussions for a stalking horse transaction, aiming to maximize asset value and continue development of its vaccine programs. - Gritstone's pipeline includes a Phase II personalized vaccine for colorectal cancer (Granite) and a therapeutic vaccine for HIV in partnership with Gilead. - Interim Phase II data from the Granite program showed a 21% relative risk reduction of progression or death, with greater benefit in patients with lower disease burden.
- 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. - In patients with low circulating tumor DNA (ctDNA), the vaccine demonstrated a more significant 38% relative risk reduction of progression or death. - The GRANITE vaccine was well-tolerated, with no treatment discontinuations due to adverse events, mainly causing mild, flu-like symptoms. - Gritstone plans to discuss these findings with the FDA to determine the next steps, potentially including a Phase 2 or 3 trial using ctDNA levels for patient selection.
- Moderna is being sued by Genevant Sciences and Arbutus Biopharma for allegedly infringing six US patents related to lipid nanoparticle (LNP) technology used in its COVID-19 vaccine. - The lawsuit seeks royalties for the use of patented LNP formulations that protect mRNA in vaccines, with potential damages based on Moderna's $18 billion projected 2021 vaccine sales. - The patent dispute stems from a long-standing legal battle dating back to 2018, when Moderna first attempted to invalidate Arbutus' key LNP patents. - Moderna denies the allegations and claims its vaccine is based on proprietary technology developed through years of mRNA platform research.
