GRANITE / Gritstone bio - LARVOL DELTA

A randomized phase 2 study of an individualized neoantigen-targeting immunotherapy in patients with newly diagnosed metastatic microsatellite stable colorectal cancer (MSS-CRC). (ASCO-GI 2025) - P2/3 | "This randomized study shows GRANITE may benefit patients, especially those with low burden disease, in this front line setting of metastatic MSS-CRC that has not benefitted from immunotherapy. Updated analysis will be presented."

Clinical • Late-breaking abstract • Metastases • P2 data • Tumor-specific neoantigens • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Study of an Individualized Vaccine Targeting Neoantigens in Combination With Immune Checkpoint Blockade for Patients With Colon Cancer (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Gritstone bio, Inc. | Terminated ➔ Withdrawn

Checkpoint inhibition • Trial withdrawal • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor • CEACAM5

Gritstone bio Announces Strengthening of Maturing Phase 2 PFS Data for GRANITE Study and Provides Business Update (GlobeNewswire) - P2/3 | N=700 | NCT05141721 | Sponsor: Gritstone bio, Inc. | "An updated October analysis of progression-free survival (PFS) per RECIST v1.1 included an additional two months of follow-up. 28% (11/39) GRANITE and 13% (4/30) of control patients remain on study and free of progression vs. 33% (13/39) GRANITE and 23% (7/30) of control patients from August analysis; the majority of GRANITE patients still on study have undetectable ctDNA using Gritstone’s high-sensitivity, tumor-informed assay. Clinical benefit improved compared to previous analysis in patients with low and high disease burden (based on ctDNA levels). Clinical benefit was most notable in patients with low disease burden at study entry. Low baseline ctDNA levels (eg at study entry) is a likely prognostic and predictive factor. Overall survival data remain immature, with mature data expected in 2H 2025."

P2 data • Colorectal Cancer

Gritstone bio Announces Interim Phase 2 Data for GRANITE Individualized Neoantigen Targeting Immunotherapy in Frontline Metastatic Microsatellite Stable Colorectal Cancer (GlobeNewswire) - P2/3 | N=700 | NCT05141721 | Sponsor: Gritstone bio, Inc. | "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; 21% relative risk reduction of progression or death with GRANITE vs. control in all treated population (HR=0.79 [95% CI, 0.42-1.50]); 38% relative risk reduction of progression or death with GRANITE vs. control in low ctDNA subgroup (HR=0.62 [95% CI, 0.23-1.70]); GRANITE was generally well-tolerated with no treatment discontinuations due to adverse events; Overall survival data expected in 2H 2025."

P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Gritstone bio to Host Virtual KOL Event to Discuss Unmet Need and Potential Role of Its Personalized Cancer Vaccine, GRANITE, in Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC) (GlobeNewswire) - "Gritstone bio, Inc...announced it will host a virtual key opinion leader (KOL) event on Friday, August 2 at 9:00 AM ET featuring J. Randolph Hecht, MD, (Professor, UCLA Gastrointestinal Oncology Program) and Howard Brown (CRC Survivor, Patient and Advocate) who will discuss the unmet need and current treatment landscape for patients with metastatic microsatellite stable colorectal cancer (MSS-CRC). Gritstone management will also highlight the development of Gritstone’s personalized neoantigen vaccine program, GRANITE, as a potential treatment for immunologically 'cold' tumors including MSS-CRC. Mature progression-free survival data from a randomized Phase 2 study of GRANITE in frontline MSS-CRC are expected in the third quarter of 2024."

P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Gritstone bio to Participate in Upcoming Investor and Scientific Conferences (Gritstone Bio Press Release) - "Gritstone bio, Inc...announced that management will be participating in the following investor and scientific conferences. Select events (marked by) will be webcasted live and webcast details will be available on the ‘Events’ page of Gritstone bio’s website...7th International Neoantigen Summit (Presentation)..."

Clinical data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

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 Stable Colorectal Cancer (MSS-CRC) (GlobeNewswire) - P2/3 | N=700 | NCT05141721 | Sponsor: Gritstone bio, Inc. | "Gritstone bio...announced positive preliminary data from the ongoing, signal seeking Phase 2 portion of the Phase 2/3 study evaluating GRANITE...in front-line metastatic microsatellite stable colorectal cancer (MSS-CRC)....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....GRANITE was generally well-tolerated with manageable adverse events; no patients have discontinued GRANITE due to adverse events....Mature PFS data expected in the third quarter of 2024; overall survival data expected in 1H 2025."

Diagnostic • P2 data • Colorectal Cancer • Oncology

Gritstone bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Updates (GlobeNewswire) - "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; National Cancer Institute-led Phase 1 study evaluating Gritstone's 'off-the-shelf' cancer vaccine, SLATE, combined with neoantigen cell therapy expected to begin in the coming months."

P2 data • Trial status • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

FDA Fast Tracks Gritstone’s Innovative Colorectal Cancer Immunotherapy, Granite-001 (BNN Breaking) - "In a significant stride toward revolutionizing colorectal cancer treatment, Gritstone Oncology Inc. has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its pioneering personalized immunotherapy, Granite-001."

Fast track designation • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

GRANITE: A Study of a Patient-Specific Neoantigen Vaccine in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer (clinicaltrials.gov) - P2/3 | N=700 | Active, not recruiting | Sponsor: Gritstone bio, Inc. | Recruiting ➔ Active, not recruiting

Checkpoint block • Checkpoint inhibition • Combination therapy • Enrollment closed • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

GRANITE: A Study of a Personalized Neoantigen Vaccine in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer (clinicaltrials.gov) - P2/3 | N=665 | Recruiting | Sponsor: Gritstone bio, Inc. | Not yet recruiting ➔ Recruiting

Checkpoint inhibition • Combination therapy • Enrollment open • Colorectal Cancer • Gastrointestinal Cancer • Immune Modulation • Inflammation • Oncology • Solid Tumor

A Study of a Personalized Neoantigen Vaccine in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer (clinicaltrials.gov) - P2/3; N=665; Not yet recruiting; Sponsor: Gritstone Oncology, Inc.

Checkpoint inhibition • Clinical • Combination therapy • New P2/3 trial • Colorectal Cancer • Gastrointestinal Cancer • Immune Modulation • Inflammation • Oncology • Solid Tumor

Gritstone bio Presents Advances in Neoantigen Prediction and Cancer Vaccine Immunogenicity at the 2023 AACR Annual Meeting (GlobeNewswire) - P1/2 | N=29 | NCT03639714 | Sponsor: Gritstone bio, Inc. | "And continued evaluation of GRANITE...for which we expect preliminary Phase 2/3 data in the fourth quarter of 2023, reinforces the potential of our personalized approach to unlock MSS-CRC and other cold tumors....GRANITE Phase 1/2 Presentation: Key Highlights: Comprehensive ctDNA longitudinal monitoring enables real-time assessment of clinical response and acquired resistance; Paired pre- and post-vaccine biopsy analyses show upregulation of gene signatures associated with immune infiltration, supporting T cell expansion and induction of dynamic T cell receptor (TCR) repertoire changes in the tumor and periphery; Neoantigen-directed immunotherapy drives durable immune pressure on the tumor of patients with advanced disease where checkpoint inhibitors alone have provided minimal benefit."

P1/2 data • P2/3 data • Oncology • Solid Tumor

Gritstone bio Announces Presentations on Neoantigen Prediction Capabilities and Cancer Vaccine Programs at the 2023 AACR Annual Meeting (GlobeNewswire) - "Gritstone bio, Inc...announced multiple presentations at the 2023 American Association for Cancer Research (AACR) Annual Meeting, taking place April 14-19, 2023 in Orlando, Florida. The poster presentations will address the company’s proprietary neoantigen prediction capabilities (EDGE™) and 'off-the-shelf' neoantigen vaccine program, SLATE. The minisymposium will review results from the Phase 1/2 study of GRANITE, the company’s fully-individualized neoantigen vaccine program which is now in a randomized Phase 2/3 study for first-line microsatellite-stable colorectal cancer (MSS-CRC)."

Clinical data • P1/2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Study of a Personalized Neoantigen Cancer Vaccine (clinicaltrials.gov) - P1/2 | N=29 | Completed | Sponsor: Gritstone bio, Inc. | Active, not recruiting ➔ Completed | N=214 ➔ 29 | Trial completion date: Mar 2023 ➔ Nov 2022 | Trial primary completion date: Jul 2022 ➔ Nov 2022

Checkpoint block • Checkpoint inhibition • Combination therapy • Enrollment change • Metastases • Trial completion • Trial completion date • Trial primary completion date • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Immune Modulation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer

Study of an Individualized Vaccine Targeting Neoantigens in Combination With Immune Checkpoint Blockade for Patients With Colon Cancer (clinicaltrials.gov) - P2 | N=1 | Terminated | Sponsor: Gritstone bio, Inc. | N=142 ➔ 1 | Trial completion date: Sep 2026 ➔ Sep 2022 | Recruiting ➔ Terminated | Trial primary completion date: Sep 2026 ➔ Sep 2022; terminated due to reprioritization

Checkpoint inhibition • Combination therapy • Enrollment change • Minimal residual disease • Trial completion date • Trial primary completion date • Trial termination • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Immune Modulation • Inflammation • Oncology • Solid Tumor • CEACAM5

Gritstone Announces Updated Overall Survival Results from GRANITE Phase 1/2 Study and Poster at SITC 2022 (GlobeNewswire) - P1/2 | N=214 | NCT03639714 | Sponsor: Gritstone bio, Inc | "Gritstone bio, Inc...announced updated overall survival (OS) results from its Phase 1/2 study evaluating GRANITE, an individualized vaccine-based immunotherapy, for the treatment of advanced solid tumors....'The median overall survival (MOS) in patients with MSS-CRC that had a molecular response has still not been reached and will now exceed 22 months; an additional four months since our last update in May 2022. This is a notable difference compared to the 6–7-month MOS typically observed in third-line MSS-CRC and the 7.8 month MOS in patients without a molecular response within our study....The randomized Phase 2/3 GRANITE study in first-line CRC, where patients generally have more time to mount an immune response, is ongoing and preliminary data are expected in 4Q2023'."

P1/2 data • P2/3 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Phase 2/3, randomized, open-label study of an individualized neoantigen vaccine (self-amplifying mRNA and adenoviral vectors) plus immune checkpoint blockade as maintenance for patients with newly diagnosed metastatic colorectal cancer (GRANITE). (ASCO 2022) - P2/3 | " GO-010 is a Phase 2/3, randomized, open-label, multi-center study evaluating the efficacy and safety of 2 neoantigen-containing vectors (GRT-C901-adenoviral vector plus GRT-R902-self-amplifying mRNA vector) as prime/boost in combination with CPIs as an add-on to fluoropyrimidine/bevacizumab (bev) following 1L therapy with FOLFOX/bev in patients with mCRC...After completing oxaliplatin, patients will enter the study treatment stage...The vaccine regimen consists of GRT-C901/GRT-R902 as well as SC ipilimumab (30 mg) and IV atezolizumab (1680 mg)...Atezolizumab will be administered every 4 weeks for up to 2 years. Study assessments include imaging, ctDNA, safety, immunogenicity and exploratory biomarker analysis."

Checkpoint inhibition • Clinical • IO biomarker • P2/3 data • Tumor-specific neoantigens • Colorectal Cancer • Gastrointestinal Cancer • Immune Modulation • Inflammation • Oncology • Solid Tumor • CD8

Gritstone Reports Third Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - "Clinical Program Updates...Preliminary data from the Phase 2 portion of GRANITE-CRC-1L are expected in 4Q 2023."

P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology

Study of an Individualized Vaccine Targeting Neoantigens in Combination With Immune Checkpoint Blockade for Patients With Colon Cancer (clinicaltrials.gov) - P2 | N=142 | Recruiting | Sponsor: Gritstone bio, Inc.

Checkpoint inhibition • Combination therapy • Minimal residual disease • New P2 trial • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Immune Modulation • Inflammation • Oncology • Solid Tumor • CEACAM5

Gritstone Announces Updated Overall Survival Results in Advanced Colorectal Cancer Patients from Phase 1/2 Study of GRANITE and Trial in Progress Poster at ASCO (GlobeNewswire) - P1/2 | N=214 | NCT03639714 | Sponsor: Gritstone bio, Inc | " Additionally, the company announced it is presenting a 'Trial in Progress' poster summarizing the Phase 2/3 GRANITE-CRC-1L- study (randomized study for first-line maintenance treatment of metastatic, microsatellite stable colorectal cancer) at the 2022 American Society for Clinical Oncology (ASCO) Annual Meeting...Updated overall survival data from GRANITE Phase 1/2: 4 of 9 treated patients with MSS-CRC had a molecular response (as reported during the ESMO 2021 data presentation) and the observed median overall survival in this group will now exceed 18 months (median OS not yet reached versus 7.8 months in those who did not have a molecular response). All patients with MSS-CRC assessed for molecular response and alive at the time of the ESMO 2021 data presentation remain alive after an additional 35 weeks of follow-up."

P1/2 data • P2/3 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Gritstone Announces Three Presentations for Tumor-Specific Neoantigen (TSNA) Oncology Programs, GRANITE and SLATE, at the 2022 AACR Annual Meeting (GlobeNewswire) - "Gritstone bio, Inc...announced three abstracts have been accepted for presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2022, taking place April 8-13, 2022, in New Orleans, Louisiana. In the poster presentations, Gritstone representatives will review data from individualized neoantigen program, GRANITE, and the 'off-the-shelf' neoantigen vaccine program, SLATE. In the oral presentation, Christine D Palmer, PhD will discuss how immunodominant human T cell responses to tumor specific neoantigens presented by the same HLA in a first-generation construct informed development of a second-generation candidate that exhibits immunogenic superiority over version 1 in preclinical models within SLATE. This optimized candidate, SLATE-KRAS, exclusively includes KRASmut epitopes and is now in Phase 2 testing in solid tumor patients."

Preclinical • Oncology • Solid Tumor

Gritstone Announces First Patient Enrolled for Phase 2/3 Trial Evaluating Individualized Neoantigen Vaccine GRANITE for First Line (1L) Maintenance Treatment of Metastatic, Microsatellite-Stable Colorectal Cancer (MSS-CRC) (GlobeNewswire) - P1/2, N=214; NCT03639714; Sponsor: Gritstone Bio, Inc.; "Additionally, the company reported updated overall survival (OS) data from its Phase 1/2 GRANITE trial evaluating individualized immunotherapy in combination with nivolumab (OPDIVO®) and ipilimumab (YERVOY®) in patients with advanced solid tumors, specifically end-stage metastatic MSS-CRC. Patients with MSS-CRC who experienced a molecular response (as evidenced by a decrease in circulating tumor DNA [ctDNA]) continue to have an OS advantage compared to those patients who did not have a molecular response....Gritstone will address these developments and present the updated OS data (from the Phase ½ trial in patients with advanced solid tumors) in a presentation at the 40th Annual JP Morgan Healthcare Conference occurring at 8:15am ET today."

P1/2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Gritstone Announces First Patient Enrolled for Phase 2/3 Trial Evaluating Individualized Neoantigen Vaccine GRANITE for First Line (1L) Maintenance Treatment of Metastatic, Microsatellite-Stable Colorectal Cancer (MSS-CRC) (GlobeNewswire) - "Gritstone bio...announced that the first patient has been enrolled for inclusion in the Phase 2/3 GRANITE-CRC-1L trial. The trial evaluates the individualized neoantigen vaccine GRANITE in combination with immune checkpoint blockade for the first line (1L) maintenance treatment of newly diagnosed patients with metastatic, microsatellite-stable colorectal cancer (MSS-CRC). This trial has registrational intent and has been discussed previously with the FDA....'We expect to report initial Phase 2 data from the GRANITE-CRC-1L trial in mid-2023'."

P2 data • Trial status • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Gritstone Reports Third Quarter 2021 Financial Results and Business Update (GlobeNewswire) - "Clinical Highlights and Updates - Tumor-Specific Neoantigen (TSNA) Oncology Programs: (i) A Phase 2/3 randomized, controlled trial of maintenance GRANITE immunotherapy in newly diagnosed metastatic, MSS-CRC patients is expected to initiate in the first quarter of 2022; This Phase 2/3 trial has registrational intent and has been discussed with the FDA; (ii) A Phase 2 randomized trial of adjuvant GRANITE immunotherapy in MSS-CRC patients with stage II/III disease who are ctDNA+ after definitive surgery is expected to initiate in the second quarter of 2022."

FDA event • New P2 trial • New P2/3 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology