On Monday, Gritstone Bio Inc. (NASDAQ:GRTS) revealed interim Phase 2 data from the ongoing Phase 2 study evaluating GRANITE, its individualized neoantigen-targeting immunotherapy, in frontline microsatellite-stable colorectal cancer (MSS-CRC).
The study is designed to evaluate the clinical benefit of maintenance therapy with GRANITE (GRT-C901/GRT-R902) in combination with immune checkpoint inhibitors in addition to fluoropyrimidine/bevacizumab versus fluoropyrimidine/bevacizumab alone.
The company says the greatest benefit was observed in the 50% of patients with lower disease burden at study entry, as measured by circulating tumor DNA (ctDNA) at study baseline.
- In all treated populations, GRANITE vs. standard of care (SOC) control was associated with a 21% relative risk reduction of progression or death.33% (13/39) GRANITE and 23% (7/30) of control patients remain on study and free of progression.
- Clinical benefit was most notable in patients with low disease burden.38% relative risk reduction of progression or death with GRANITE vs. SOC control with low ctDNA subgroup
Gritstone plans to review the progression-free survival (PFS) data with the FDA in the coming months and agree on the next steps to advance GRANITE, including a potential Phase 2 or 3 trial using ctDNA levels as eligibility criteria.
Concurrently, Gritstone announced that it engaged Raymond James as its financial advisor.
JMP Securities downgraded Gritstone bio from Market Outperform to Market Perform.
The analyst writes, “with signals of benefit in the low-risk subgroup, but likely insufficient to excite many investors.”
JMP analyst says, “We continue to like the fundamentals of the GRANITE neoantigen technology, but as of today see limited paths forward that provide meaningful upside to shares from current levels.”
Price Action: GRTS stock is down 57.5% at $0.25 at last check Tuesday.
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