Gritstone bio Announces Strengthening of Maturing Phase 2 PFS Data for GRANITE Study and Provides Business Update-- 27% relative risk reduction of progression or death with GRANITE vs. control in all treated population (HR=0.73 [90% CI, 0.44, 1.21]) --
Gritstone bio Announces Interim Phase 2 Data for GRANITE Individualized Neoantigen Targeting Immunotherapy in Frontline Metastatic Microsatellite Stable Colorectal Cancer--Encouraging progression-free survival data in overall population; continued follow-up needed to allow data to mature further, especially in low ctDNA subgroup where events accrue more slowly
Gritstone bio Reports Second Quarter 2024 Financial Results and Provides Corporate Updates-- Preliminary randomized Phase 2 data suggest GRANITE (personalized neoantigen vaccine) could drive meaningful clinical benefit in front-line metastatic microsatellite-stable colorectal cancer (MSS-CRC); mature progression-free survival (PFS) data expected in the third quarter of 2024 --
Gritstone bio Reports First Quarter 2024 Financial Results and Provides Corporate Updates-- Favorable progression-free survival (PFS) trend observed in preliminary data from the randomized Phase 2 study evaluating GRANITE (personalized neoantigen vaccine) in front-line metastatic, microsatellite-stable colorectal cancer (MSS-CRC); mature PFS data expected in the third quarter of 2024 --
Gritstone bio Announces Positive Preliminary Progression-free Survival and Long-term Circulating Tumor DNA (ctDNA) Data from Phase 2 Portion of Ongoing Phase 2/3 Study of its Personalized Cancer Vaccine, GRANITE, in Front-line Metastatic Microsatellite-- Early progression-free survival (PFS) trends favor GRANITE recipients with hazard ratios of 0.82 in the overall population ([95% CI, 0.34-1.67]; 62% censored) and 0.52 (48% relative risk reduction of progression or death with GRANITE vs. control) in a high-risk group, where clinical data are more mature ([95% CI, 0.15-1.38]; 44% censored); >90% of high-risk patients have liver metastases --
Gritstone bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Updates-- Preliminary data from Phase 2 portion of Phase 2/3 study evaluating GRANITE, Gritstone’s personalized cancer vaccine in front-line metastatic, microsatellite-stable colorectal cancer (MSS-CRC) remain expected in 1Q 2024 --
Gritstone bio Reports Third Quarter 2023 Financial Results and Provides Corporate Updates-- BARDA contract and IDWeek presentations position Gritstone’s self-amplifying mRNA (samRNA) as a leading next-generation approach to COVID-19 prevention; preparations underway for Phase 2b head-to-head study evaluating samRNA candidate versus an approved COVID-19 vaccine --
Presentations at IDWeek 2023 Highlight Potentially Differentiated Immunogenicity of Gritstone bio’s Next Generation COVID-19 Vaccine-- High neutralizing antibody (nAb) responses sustained through at least 12 months, highlighting potential for durable clinical protection --
Gritstone bio Awarded BARDA Contract to Conduct Comparative Phase 2b Study Evaluating Next-Generation Vaccine Candidate for COVID-19 Valued at up to $433 Million-- 10,000 participant randomized Phase 2b study will evaluate Gritstone’s self-amplifying mRNA (samRNA) vaccine candidate containing Spike plus other viral targets with an approved vaccine against COVID-19 --
Gritstone bio Reports Second Quarter 2023 Financial Results and Provides Corporate Updates-- Enrollment completed in Phase 2 portion of Phase 2/3 study evaluating GRANITE (personalized cancer vaccine [PCV]) in first-line metastatic microsatellite-stable colorectal cancer (MSS-CRC); preliminary efficacy data expected in 1Q 2024 --
Gritstone bio Reports First Quarter 2023 Financial Results and Provides Corporate Updates-- Robust enrollment in Phase 2 portion of randomized Phase 2/3 study of GRANITE (personalized vaccine in first-line metastatic microsatellite-stable colorectal cancer [MSS-CRC]) to date; 71 of 80 patients (initial target) enrolled as of May 10, 2023 --
Gritstone bio Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Updates-- Preliminary data from GRANITE Phase 2/3 study (individualized vaccine for first-line microsatellite-stable colorectal cancer [MSS-CRC]) remain expected in 4Q 2023 --
Gritstone Reports Third Quarter 2022 Financial Results and Provides Business Update-- Two Phase 1 CORAL (SARS-CoV-2) studies deliver positive results, provide further proof-of-concept for application of self-amplifying mRNA (samRNA) as infectious disease vaccine platform --
