Building a Pipeline
of Immunotherapies

For a description of our ongoing clinical studies, please visit clinicaltrials.gov. An overview of our compassionate use policy can be found here.

Pre-clinical
Phase 1
Phase 2
Phase 3
Commercial Rights
Oncology Programs
GRANITE
Randomized Phase 2/3 in MSS-CRC (1L maintenance)
Gritstone Bio
SLATE
p53, KRAS Advanced Solid Tumors
Gritstone Bio
KRASmut Solid Tumors
Gritstone Bio
Unnamed Solid Tumor
Gritstone Bio
Infectious Disease
CORAL
SARS-CoV-2 BOOST (healthy subjects)
Gritstone Bio
SARS-CoV-2 in South Africa, Naïve, Convalescent, and HIV+ Patients
Gritstone Bio
SARS-CoV-2 Naïve and Booster
Gritstone Bio
Pan-Corona
Gritstone Bio
Other Pathogens
Flu; HPV Eradication; Undisclosed
Gritstone Bio
HIV
HIV treatment/cure
Gilead

Gritstone’s Individualized Neoantigen Immunotherapy GRANITE

Our first oncology product candidate, GRANITE, is an individualized neoantigen-based immunotherapy. It is being evaluated in multiple studies, including a Phase 2/3 study evaluating GRANITE as a maintenance treatment in patients with newly diagnosed, metastatic microsatellite-stable colorectal cancer (MSS-CRC) who have completed FOLFOX- bevacizumab induction therapy. GRANITE was granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of MSS-CRC.

For each patient, our individualized immunotherapy starts with a routine clinical biopsy. We then sequence the tumor sample in-house and apply our proprietary EDGE™ platform to derive a set of predicted patient-specific neoantigens likely to be presented on the patient’s tumor. Using these predicted neoantigens, we will then design an individualized immunotherapy containing the relevant neoantigens to be administered by simple intramuscular injection. We intend to deliver the immunotherapy in a community oncology setting where a vast majority of cancer patients are treated.

Routine Biopsy

Routine FFPE clinical biopsy as input material

Sequencing

Tumor exome
Normal exome
Tumor transcriptome

Neoantigen Prediction

Gritstone EDGE™
AI model for tumor antigen prediction trained on human tumor data

Individualized Immunotherapy

Patient specific predicted neoantigens inserted into Gritstone immunotherapy

Simple Injection

Immunotherapy administered in conjuction with checkpoint inhibitors

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Gritstone’s “Off the Shelf”
Neoantigen Immunotherapy
SLATE

Our second product candidate, SLATE, utilizes the same neoantigen delivery system as GRANITE but contains a fixed set of neoantigens that are shared across a subset of cancer patients rather than neoantigens unique to an individual patient, providing us with an off-the-shelf alternative to GRANITE. SLATE is being evaluated in the Phase 2 portion of a Phase I/2 clinical study in combination with checkpoint inhibitors for the treatment of non-small cell lung cancer in patients with relevant KRAS mutations who have progressed on prior immunotherapy, and for cancer types where a relevant TP53 mutation exists.

The routine clinical biopsy used to identify individualized patient mutations can also identify patients that have common mutations within their tumor from commercially available genomic panel sequencing. These common driver mutations have been shown to produce shared neoantigens as identified by Gritstone’s EDGE platform in a subset of patients. Similar to patient-specific neoantigens, shared neoantigens are a class of immune targets that present mutated peptides on the surface of the tumor cell. Because these neoantigens are shared, an “off-the-shelf” therapy may be able to treat additional patients across multiple tumor types.

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COVID-19: CORAL

Our CORAL program is a second-generation SARS-CoV-2 vaccine platform designed to deliver Spike and additional SARS-CoV-2 T cell epitopes, which we believe could offer the potential for more durable protection and broader immunity against SARS-CoV-2 variants.

Through a license agreement with the La Jolla Institute for Immunology (LJI), one of the leading global organizations dedicated to studying the immune system, we have access to validated SARS-CoV-2 antigens that have been identified through LJI’s studies of hundreds of patients recovering from COVID-19. Using such antigens, EDGE™ and vaccine platform technologies, Gritstone has developed novel vaccine candidates containing Spike (similar to first generation vaccines) but also additional viral antigens that we believe offer potential targets for broad T cell immunity. By targeting several viral antigens, some of which are highly conserved between viral strains (such as SARS and SARS-CoV-2), our vaccine may have pan-coronavirus potential to protect against both current and future coronavirus pandemics.

Gritstone has conducted preclinical and clinical studies demonstrating that our SARS-CoV-2 vaccine can induce significant and sustained levels of neutralizing antibodies and T cells against the Spike protein, plus a broad T cell response against epitopes from multiple viral genes outside of Spike.

We have received a grant from the Bill and Melinda Gates Foundation to support the preclinical evaluation of the vaccine. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is supporting the Phase 1 clinical trial, which is being conducted through the Infectious Diseases Clinical Research Consortium (IDCRC). We also have an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) that provides funding to conduct a Phase 1 clinical trial of Gritstone’s vaccine candidate in South Africa.

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HIV Therapeutic

We have a collaboration established with Gilead Sciences to research and develop a vaccine-based immunotherapy as part of Gilead’s efforts to cure patients with human immunodeficiency virus (HIV) infection. The companies are developing an HIV-specific therapeutic vaccine using Gritstone’s proprietary prime-boost vaccine platform, comprised of self-amplifying mRNA (samRNA) and adenoviral vectors.

Gritstone has conducted preclinical studies with our prime-boost vaccine technology utilizing simian immunodeficiency virus (SIV) derived antigens as model antigens. These antigens are very similar to those in HIV-1. The data demonstrated strong, durable and broad anti-SIV CD8+ T cell responses and T cell memory data. Gritstone and Gilead jointly performed further preclinical experiments that generated additional compelling data on the vaccine platform’s potential utility against HIV, and the companies are preparing to advance the program into a Phase 1 clinical trial.

Cancer Cell Therapies

We are leveraging EDGE™ to define targets for T-cell receptor (TCR) directed cell therapies. These additional targets that were identified and validated by Gritstone EDGE™ enable us to partner with others or develop additional therapeutic approaches to redirect T cells onto tumors using these highly specific targets.

We have a collaboration with 2seventy bio, an affiliate of bluebird bio, to identify tumor-specific targets and natural TCRs directed to those targets for use in bluebird bio’s established cell therapy platforms. bluebird bio will conduct all development, manufacturing and commercial activities. Gritstone will provide 10 tumor-specific targets across several tumor types and, in certain cases, TCRs directed to those targets to 2seventy bio.

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