Nature Medicine Releases Interim Results of Gritstone Bio’s Phase 1/2 Study of GRANITE, … | New

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— The article reports that Gritstone’s tumor-specific neo-antigen vaccination approach results in the priming and stimulation of tumor-specific T cells, including CD8+ cytotoxic T cells —

— T cells linked to molecular responses in patients with advanced colorectal cancer (CRC) and associated with prolonged overall survival, which was observed in follow-up Phase 1/2 study —

— GRANITE is now in a Phase 2/3 randomized controlled trial in newly diagnosed microsatellite stable metastatic colorectal cancer (MSS-CRC) with initial results expected in 2H2023 —

EMERYVILLE, Calif., Aug. 15, 2022 (GLOBE NEWSWIRE) — Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company focused on developing the world’s most potent vaccines, today announced that Interim results from the Phase 1/2 trial of GRANITE, its individualized immunotherapy vaccine candidate for solid tumor cancers, were published today in natural medicine. The article, “Individualized, Heterologous Chimpanzee Adenovirus and Self-Amplifying Neoantigen mRNA Vaccine for Advanced Metastatic Solid Tumors: Interim Results from the Phase 1 Trial,” details results demonstrating that GRANITE elicited responses of strong, persistent and functional tumor-specific CD4+ and CD8+ T cells that have broad potential applicability in a range of pathological settings. The published data was initially presented at the European Society for Medical Oncology (ESMO) Congress 2021 and served as the basis for the initiation of two randomized, controlled studies of GRANITE, including a phase 2/3 trial which has an intention (GRANITE-CRC-1L).

“The publication of this study in Nature Medicine underscores the importance, novelty, and potential clinical value of the GRANITE program, and reinforces our fundamental hypothesis that targeting multiple neoantigens based on the mutations of each individual tumor could lead to clinical benefits. significant, including prolonged overall survival. said Andrew Allen, MD, Ph.D., co-founder, president and CEO of Gritstone. “Now we are advancing GRANITE in earlier disease settings, where immune responses are likely stronger, and patients generally have longer for immune tumor destruction to take effect.”

Since the start of the Phase 1/2 study, Gritstone has followed study participants and observed an increase in overall survival (OS) in patients with colorectal cancer (CRC) who demonstrated a molecular response ( measured by a reduction in circulating tumor DNA [ctDNA] reference levels) compared to those who did not. As of May 2022, the median OS for this subset (treated third-line CCR patients who demonstrated molecular response) exceeded 18 months, with the median not yet reached. This compares to the median OS of 7.8 months for patients who did not demonstrate a molecular response, results which are generally consistent with extensive previous data from patients receiving various third-line treatments. The basic characteristics of these two patient populations are similar. The phase 1/2 study is still ongoing.

“Personalized neoantigen immunotherapy is a rational approach to treat solid tumor cancers given the abundant evidence that T cells can recognize neoantigens and drive tumor destruction,” said Karin Jooss, Ph. D., Executive Vice President and Head of R&D. “We carefully constructed the GRANITE platform and studied it in a translation-rich clinical program, demonstrating the sequence of desired biological events in patients with advanced cancer. Specifically, we have shown de novo induction of neoantigen-specific T cells, trafficking of these same T cells to tumors, conversion of cold to warm tumor microenvironments, and key antitumor effects such as pseudo-progression, molecular responses and suggestions for overall survival in molecular responders. In a tough type of tumor like metastatic colorectal cancer, these data are striking enough to warrant publication in Nature Medicine. We are proud of this achievement. »

GRANITE is currently being evaluated in two randomized early-stage disease studies; 1) GRANITE-CRC-1L (NCT05141721), a Phase 2/3 trial in newly diagnosed stable and metastatic microsatellite colorectal cancer (MSS-CRC) that has registration intent. The first patient was treated in this study in July 2022, and the first results of this study are expected in the second half of 2023. 2) GRANITE-ADJUVANT (NCT05456165), a phase 2 study in high-risk stage II patients /III colon cancer which are ctDNA+ after definitive surgery.

About GRANITE

Gritstone’s neoantigen-based immunotherapies are designed to elicit a significant T-cell (particularly CD8+ cytotoxic T-cell) response against mutation-derived tumor-specific neoantigens (TSNA), which Gritstone identifies at the using its proprietary artificial intelligence platform, EDGE™. GRANITE is an individualized neoantigen-based immunotherapy and uses an adenoviral priming vector (GRT-C901) and a self-amplified mRNA vector (GRT-R902) to deliver personalized immunotherapy containing the relevant neoantigens. GRANITE has received Fast Track Designation from the United States Food and Drug Administration for the treatment of MSS-CRC.

About Gritstone

Gritstone bio, Inc. (Nasdaq: GRTS) is a clinical-stage biotechnology company focused on creating the world’s most potent vaccines. We leverage our innovative vectors and payloads to train multiple arms of the immune system to attack critical disease targets. Independently and with our collaborators, we are developing a portfolio of product candidates to treat and prevent viral diseases and solid tumors with the goal of improving patient outcomes and eliminating disease. www.gritstonebio.com

Gritstone Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to the potential of Gritstone’s therapeutic programs; the progress of the company’s ongoing clinical trials; the timing of data announcements related to ongoing clinical trials and the initiation of future clinical trials. These forward-looking statements involve substantial risks and uncertainties that could cause Gritstone’s research and clinical development programs, future results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements. These risks and uncertainties include, among others, uncertainties inherent in the drug development process, including the stage of clinical development of Gritstone’s programs, the process for designing and conducting preclinical and clinical trials, the approval processes regulatory filings, the challenges associated with pharmaceutical manufacturing, Gritstone’s ability to successfully establish, protect and defend its intellectual property and other matters that could affect the sufficiency of existing liquidity to fund operations. Gritstone assumes no obligation to update or revise any forward-looking statements. For a more detailed description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the company’s business generally, see Gritstone’s latest quarterly report on the Form 10-Q filed August 4, 2022 and all current and periodic reports filed with the Securities and Exchange Commission.

Grindstone Contacts

Media:

Dan Budwick

1AB

(973) 271-6085

[email protected]

Investors:

George E. MacDougall

Director, Investor Relations and Corporate Communications

Organic wheel

[email protected]

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