SLATE-KRAS / Gritstone bio - LARVOL DELTA

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

Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer (clinicaltrials.gov) - P1 | N=210 | Recruiting | Sponsor: National Cancer Institute (NCI) | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer (clinicaltrials.gov) - P1 | N=210 | Not yet recruiting | Sponsor: National Cancer Institute (NCI)

New P1 trial • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

A Study of a Personalized Cancer Vaccine Targeting Shared Neoantigens (clinicaltrials.gov) - P1/2 | N=39 | Completed | Sponsor: Gritstone bio, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Mar 2023 | Trial primary completion date: Dec 2023 ➔ Mar 2023

Checkpoint block • Checkpoint inhibition • Combination therapy • IO biomarker • Metastases • Trial completion • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • KRAS

A NOVEL MOLECULAR ASSAY TO EVALUATE KRAS MUTATIONS IN TUMOR AND PLASMA SAMPLES OF PATIENTS WITH PANCREATIC DUCTAL ADENOCARCINOMA AND THEIR PROGNOSTIC IMPACT: ONE STEP CLOSER TO TRANSLATE KRAS GENOTYPING INTO CLINICAL PRACTICE (DDW 2023) - "ARMS/HRMA has higher sensitivity and accuracy than SS to assess KRAS mutations in PDAC tumor and plasma samples, with additional advantages of fastness and lower cost. KRAS mutations detected with ARMS/HRMA in tumor and ctDNA, respectively, were associated with lower OS and PFS in surgical and palliative patients. Considering that inhibitors for specific KRAS mutations are becoming available, this strategy may help to perform precision medicine in these highly aggressive cancers."

Clinical • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • KRAS

Gritstone bio Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Updates (GlobeNewswire) - "...'We also plan to initiate a new, randomized Phase 2 trial of a KRAS-directed SLATE in patients with newly-diagnosed metastatic cancer in the second half of the year'."

New P2 trial • Oncology • Solid Tumor

A Study of a Personalized Cancer Vaccine Targeting Shared Neoantigens (clinicaltrials.gov) - P1/2 | N=39 | Active, not recruiting | Sponsor: Gritstone bio, Inc. | Recruiting ➔ Active, not recruiting | N=144 ➔ 39

Checkpoint block • Checkpoint inhibition • Combination therapy • Enrollment change • Enrollment closed • IO biomarker • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • EGFR • KRAS

Gritstone bio and the National Cancer Institute (NCI) Establish a Clinical Trial Agreement to Evaluate a Neoantigen Cell Therapy-Vaccine Combination (GlobeNewswire) - P1/2 | N=39 | NCT03953235 | Sponsor: Gritstone bio, Inc. | "An 'off the shelf' neoantigen vaccine candidate, SLATE-KRAS demonstrated early evidence of efficacy as defined by molecular response in immune checkpoint blockade (ICB)-resistant/refractory subjects in the Phase 2 portion of an ongoing Phase 1/2 study (NCT03953235). Based on the results to date from the Phase 1/2 study, Gritstone has elected to initiate a separate, randomized Phase 2 study evaluating SLATE against a KRASmut-driven tumor type. Gritstone expects to initiate this separate, randomized study in the second half of 2023."

New P2 trial • P2 data • Oncology • Solid Tumor

Gritstone bio and the National Cancer Institute (NCI) Establish a Clinical Trial Agreement to Evaluate a Neoantigen Cell Therapy-Vaccine Combination (GlobeNewswire) - "Gritstone bio, Inc....announced that it has entered into a clinical trial agreement with the National Cancer Institute (NCI), an institute of the National Institutes of Health, to evaluate an autologous T cell therapy expressing a T cell receptor targeting mutated KRAS in combination with Gritstone’s KRAS-directed vaccine candidate, SLATE-KRAS, in a Phase 1 study. The study will be led by Steven A. Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the NCI's Center for Cancer Research.Under the terms of the agreement, NCI will identify patients with metastatic cancer that are eligible for adoptive cell transfer based on the presence of a G12V or G12D KRAS mutation (KRASmut). Gritstone will provide the SLATE-KRAS vaccine as requested by NCI for the trial."

Licensing / partnership • Oncology • Solid Tumor

A Study of a Personalized Cancer Vaccine Targeting Shared Neoantigens (clinicaltrials.gov) - P1/2 | N=144 | Recruiting | Sponsor: Gritstone bio, Inc. | Trial primary completion date: Dec 2022 ➔ Dec 2023

Checkpoint block • Checkpoint inhibition • Combination therapy • IO biomarker • Metastases • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • EGFR • KRAS

Personalized, off-the-shelf KRAS neoantigen-specific immunotherapy for the treatment of advanced solid tumors: Clinical benefit associated with decreases in ctDNA (SLATE-KRAS) (ESMO 2022) - P1/2 | "Pts receive an adenovirus prime followed by boosts with a self-amplifying mRNA with IV nivolumab 480 mg Q4W +/- SC ipilimumab 30 mg with vaccinations. The most common (>20%) treatment-related adverse events (TRAEs) were low grade, transient pyrexia, fatigue, nausea, injection-site reactions, vomitting, and chills and consistent across V1 and V2. Conclusions This off-the-shelf, neoantigen-specific vaccine demonstrated promising anti-tumor activity in pts with advanced solid tumors with tumor regression and/or molecular response."

Circulating tumor DNA • Clinical • IO biomarker • Tumor-specific neoantigens • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BRAF • CD8 • IFNG • KRAS • TP53

Gritstone Presents Positive Initial Phase 2 Data in Late-Line Solid Tumor Patients Treated With KRAS-Directed Immunotherapy (SLATE) at ESMO 2022 (GlobeNewswire) - P1/2 | N=144 | NCT03953235 | Sponsor: Gritstone bio, Inc. | "The majority of patients enrolled (31/38) had either advanced non-small cell lung cancer (NSCLC; n=18) or microsatellite stable colorectal cancer (MSS-CRC; n=13). In the Phase 1/2 study, both SLATE-KRAS and SLATE v1 vaccine-based immunotherapies demonstrated...Consistent and potent immunogenicity: Induction of KRAS-specific CD8+ T cells: 55% of patients treated with SLATE-KRAS versus 31% of patients treated with v1 (by ex vivo ELISpot assay). Early objective evidence of efficacy as measured by reduction in ctDNA (molecular response): 39% (7/18) molecular response rate in evaluable patients with MSS-CRC and NSCLC. Evaluable subjects had detectable KRASmut ctDNA at baseline and a post-baseline sample. All patients with NSCLC had progressed on prior (chemo)immunotherapy."

P1/2 data • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung 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 Reports Third Quarter 2021 Financial Results and Business Update (GlobeNewswire) - "Clinical Highlights and Updates - Tumor-Specific Neoantigen (TSNA) Oncology Programs: SLATE v2, a mutant KRAS-focused version optimized for increased immune response, is currently being evaluated in a Phase 2 trial in patients with NSCLC and MSS-CRC. Initial clinical data are anticipated by mid-2022."

P2 data • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Gritstone Announces Dosing of First Solid Tumor Patient with Optimized SLATE “Off-the-Shelf” Mutant KRAS-directed Neoantigen Immunotherapy in Phase 2 Clinical Trial (GlobeNewswire) - “Gritstone bio, Inc…announced results with its SLATE v1 product (‘off-the-shelf’ shared neoantigen immunotherapy in combination with intravenous nivolumab and subcutaneous ipilimumab) and dosing of the first patient in a Phase 2 clinical trial of the optimized SLATE v2 product…'We expect that these treatment settings will enable us to demonstrate the differentiated therapeutic potential of SLATE v2, and we anticipate having initial data by mid-2022'…. The SLATE v2 Phase 2 portion of the study is expected to enroll up to 60 patients with KRAS mutant-driven tumors in total across three cohorts: NSCLC post chemo-immunotherapy, first line MSS-CRC and third-line MSS-CRC.”

P1/2 data • Trial status • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Gritstone Announces Dosing of First Solid Tumor Patient with Optimized SLATE “Off-the-Shelf” Mutant KRAS-directed Neoantigen Immunotherapy in Phase 2 Clinical Trial (GlobeNewswire) - P1/2, N=144; NCT03953235; Sponsor: Gritstone Oncology, Inc; “SLATE v1 exhibited evidence of efficacy in patients with NSCLC who had all progressed on prior anti-PD-(L)1 therapy (often in combination with chemotherapy) – with molecular responses (>50% decrease in ctDNA levels in the blood from baseline) observed in 3/5 NSCLC patients who were eligible for analysis. SLATE v1 demonstrated the greatest activity in 6 NSCLC patients with the KRASmut G12C presented by the HLA protein A*02:01. Among these patients, ctDNA responses were observed in 66% of these patients (2/3 eligible for analysis), correlating with clinical benefit, and a RECIST radiologic response (unconfirmed) was observed in one 2nd line patient who had progressed after 3 months of 1st line chemo-immunotherapy. One patient who had progressed on prior chemo-immunotherapy after 8 months of treatment is nearing completion of 2 years of therapy with persistent ~20% tumor lesion shrinkage."

P1/2 data • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Gritstone to Host Data Update on Neoantigen Oncology Programs for the Treatment of Solid Tumors During ESMO 2021 (GlobeNewswire) - "Gritstone bio...announced that it will host a data update webcast for investors and analysts during the European Society of Medical Oncology (ESMO) Annual Meeting 2021, September 17, 2021 at 1:30 p.m. ET. The event will highlight the GRANITE (individualized neoantigen immunotherapy) Phase 1/2 data in advanced solid tumors which is being presented during a mini- oral presentation at ESMO 2021, in addition to data from the SLATE v1 shared neoantigen immunotherapy program in KRAS mutant advanced solid tumors."

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

Gritstone Reports Second Quarter 2021 Financial Results and Business Update (GlobeNewswire) - “GRANITE – Individualized, TSNA-directed immunotherapy…Two randomized Phase 2 trials evaluating GRANITE in MSS-CRC patients at earlier disease stages are expected to initiate in the first half of 2022…SLATE – ‘Off-the-shelf’ neoantigen-directed immunotherapy…A data update will be provided in the third quarter of 2021…Gritstone intends to submit an IND for SLATE v3 targeting an unnamed shared neoantigen before the end of 2021.”

Clinical data • IND • New P2 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology

Gritstone Reports Fourth Quarter and Full Year 2020 Financial Results and Business Highlights (GlobeNewswire) - "Anticipated Upcoming Milestones: Present additional efficacy and safety data from the Phase 1 GRANITE study, including at the higher GRANITE dose level, in the first half of 2021; Present data from Phase 2 SLATE v1 cohorts in the first half of 2021; Initiate new Phase 2 clinical trial cohorts for GRANITE and SLATE, including a cohort evaluating a SLATE v2 cassette optimized for KRAS neoantigens for patients with NSCLC, in the first half of 2021...Present data from Phase 2 GRANITE cohorts in advanced MSS-CRC and gastric cancers in the second half of 2021; Report data from SLATE v2 cassette in the first half of 2022."

P2 data • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Urothelial Cancer

Gritstone Oncology Announces $110 Million Private Placement (GlobeNewswire) - "Gritstone Oncology, Inc...announced that it has executed a securities purchase agreement to raise gross proceeds of $110 million resulting from the sale of shares of its common stock and/or pre-funded warrants through a private investment in public equity (PIPE) financing at a price per share of $3.34...The company expects to use net proceeds from this private placement to...clinical development of its lead cancer immunotherapies, GRANITE and SLATE...vaccine platforms, as well as for working capital and other general corporate purposes."

Commercial • Oncology • Solid Tumor

Gritstone Oncology Reports Third Quarter Financial Results and Recent Highlights (GlobeNewswire) - "Anticipated Upcoming Milestones...Nominate a lead bispecific antibody development candidate directed towards a novel solid tumor-specific HLA-peptide complex by the end of 2020; Present additional efficacy and safety data from the Phase 1 GRANITE study, including at the higher GRANITE dose level, in the first half of 2021; Present data from Phase 2 SLATE cohorts (v1 cassette) in the first half of 2021; Launch a SLATE v2 cassette into clinical trials in NSCLC patients in the first half of 2021, optimized for KRAS neoantigens; Present data from Phase 2 GRANITE cohorts in the second half of 2021; Report data from SLATE v2 cassette in the second half of 2021"

Clinical • New trial • P1 data • P2 data • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Neoantigen Immunotherapy GRANITE and its Off-the-Shelf Neoantigen Immunotherapy SLATE (GlobeNewswire) - "Gritstone Oncology, Inc...announced that it has begun dosing patients in the Phase 2 expansion cohorts of the Phase 1/2 clinical studies for GRANITE and SLATE, its neoantigen-based immunotherapies...'we look forward to presenting the full dataset by mid-2021.'...In the Phase 2 part of the SLATE Phase 1/2 study (GO-005), the company has begun enrolling non-small cell lung cancer patients with relevant KRAS mutations who have progressed on prior immunotherapy, and patients with tumors where a relevant TP53 mutation exists."

Enrollment open • P1/2 data • Trial status • Colorectal Cancer • GastroEsophageal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Gritstone Oncology Reports Second Quarter Financial Results and Recent Highlights (GlobeNewswire) - "Anticipated Upcoming Milestones: Present additional efficacy and safety data from the Phase 1 GRANITE study, including at the higher GRANITE dose level, in 2020; Initiate single-arm Phase 2 expansion cohorts with GRANITE for patients with MSS CRC and gastroesophageal cancer in 2020; Initiate single-arm Phase 2 expansion cohorts with SLATE for patients with NSCLC following previous therapy with checkpoint inhibitors and patients with TP53 mutations in 2020; Nominate a lead bispecific antibody development candidate directed towards a novel solid tumor-specific HLA-peptide complex in 2020; Present data from Phase 2 SLATE cohorts in the first half of 2021; Present data from Phase 2 GRANITE cohorts in the second half of 2021; Report data from SLATE cassette optimized for KRAS mutations in patients with NSCLC in the second half of 2021."

P1 data • P2 data • Trial status • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Gritstone Oncology reports first quarter financial results and recent highlights (GlobeNewswire) - "Anticipated Upcoming Milestones...Present additional efficacy and safety data from the Phase 1 studies of SLATE and GRANITE in a company-hosted webcast event in mid-2020; Initiate Phase 2 expansion cohorts in the second half of 2020; Initiate Phase 2 adjuvant study/studies in early 2021; Nominate a lead bispecific antibody development candidate directed towards a novel solid tumor-specific HLA-peptide complex in the second half of 2020"

Clinical • New P2 trial • P1 data • Bladder Cancer • Colorectal Cancer • Gastric Cancer • GastroEsophageal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • Urothelial Cancer

Gritstone Oncology reports fourth quarter and full year 2019 financial results and recent highlights (GlobeNewswire) - "Present additional efficacy and safety data from the Phase 1 studies of SLATE and GRANITE at an upcoming scientific congress by mid-2020; For SLATE, initiate Phase 2 expansion cohorts in patients with third-line MSS-CRC, refractory/resistant NSCLC and pancreatic cancer in the second half of 2020; For GRANITE, initiate Phase 2 expansion cohorts in patients with third-line MSS-CRC and second-line gastro-esophageal cancers in the second half of 2020; Initiate a Phase 2 adjuvant study in high-risk localized tumors, such as NSCLC, pancreatic cancer and MSS-CRC, with SLATE in the first half of 2021; Initiate a Phase 2 adjuvant study in high-risk localized tumors, such as NSCLC and gastro-esophageal adenocarcinoma, with GRANITE in the first half of 2021"

New P2 trial • P1 data