Gritstone Advances Second Generation COVID-19 Vaccine “CORAL” Program with Support from NIAID

EMERYVILLE, Calif., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer and infectious disease immunotherapies, today announced that it is advancing development of a second generation vaccine against SARS-CoV-2, the virus that causes COVID-19, with potential for both prolonged protection and potency against Spike mutants. Gritstone and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, have entered into a clinical trial agreement to initiate clinical testing. A Phase 1 clinical trial, expected to be conducted through the NIAID-supported Infectious Diseases Clinical Research Consortium (IDCRC), is in development. The Bill & Melinda Gates Foundation (Gates Foundation) is supporting the preclinical evaluation of the vaccine.


Through a license agreement with the La Jolla Institute for Immunology (LJI), one of the leading global organizations dedicated to studying the immune system, Gritstone has access to validated SARS-CoV-2 epitopes that have been identified through LJI’s studies of hundreds of patients recovering from COVID-19. Using these epitopes and the company’s proprietary Gritstone EDGETM and vaccine platform technologies, Gritstone is developing a novel vaccine against COVID-19, containing Spike (similar to first generation vaccines) but also additional viral epitopes that offer good targets for T cell immunity. Gritstone uses both self-amplifying mRNA and adenoviral vectors to deliver the SARS-CoV-2 viral antigens. The vaccine may have pan-SARS/coronavirus potential to protect against future coronavirus pandemics.


“Gritstone’s vaccine may provide more comprehensive viral protection by inducing a better combination of T cell responses and neutralizing antibodies as compared to the currently available vaccines,” said Daniel Hoft, M.D., Ph.D., director of Saint Louis University’s Center for Vaccine Development and Division of Infectious Diseases, Allergy and Immunology, National Vaccine Advisory Committee member, and protocol chair and lead principal investigator of Gritstone’s COVID study. “It is important that we move forward with developing these next generation vaccines because we do not yet know whether the existing vaccines that have been granted emergency use authorization will provide long-term immunity or prevent transmission. Improved vaccines that can accomplish these additional benefits may be needed to continue mitigating the ongoing pandemic.”


The company has received a grant from the Gates Foundation to support the preclinical evaluation of the vaccine. NIAID is supporting development of the Phase 1 clinical trial through the IDCRC.


“Since inception, Gritstone has developed two core assets – cutting-edge T cell epitope identification and potent vaccines shown to activate a strong and broad immune response in humans – and both of these have been deployed in our quest for a second generation SARS-CoV-2 vaccine,” said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone. “We are excited to be working with the experienced teams at NIAID and the IDCRC as well as the experts at the Gates Foundation and LJI who have helped us design and pre-clinically test our novel vaccine concepts.”


Karin Jooss, Ph.D., chief scientific officer at Gritstone, commented, “Our preclinical work has shown that our SARS-CoV-2 vaccines can induce sustained, high-titer neutralizing antibodies and CD8+ T cell responses against the Spike protein, plus a broad CD8+ T cell response against epitopes from multiple viral genes outside of Spike. As well as a potential role in protection against SARS-CoV-2, the notion of using evolutionarily conserved viral antigens (in addition to Spike) as the basis for a vaccine that induces antibody and T-cell responses to provide protection against future coronavirus pandemics is an exciting concept that springs from our current work. We plan to pursue this in 2021.”


Gritstone Conference Call

To participate in the teleconference, please dial (866) 866-1333 (domestic) or (404) 260-1421 (international) and refer to conference ID 50081021. Live audio of the teleconference and accompanying slides will be simultaneously webcast and will be available within the Investors & Media section of the Gritstone Oncology website at https://ir.gritstoneoncology.com/investors/events. An archived replay will be accessible for 30 days following the event.


About Gritstone Oncology


Gritstone Oncology (Nasdaq: GRTS), a clinical-stage biotechnology company, is developing the next generation of immunotherapies against multiple cancer types and infectious diseases. Gritstone develops its products by leveraging two key pillars—first, a proprietary machine learning-based platform, Gritstone EDGETM, which is designed to predict antigens that are presented on the surface of cells, such as tumor or virally-infected cells, that can be seen by the immune system; and second, the ability to develop and manufacture potent immunotherapies utilizing these antigens to potentially drive the patient’s immune system to specifically attack and destroy disease-causing cells. The company’s lead oncology programs include an individualized neoantigen-based immunotherapy, GRANITE, and an “off the shelf” shared neoantigen-based immunotherapy, SLATE, which are being evaluated in clinical studies. The company also has a bispecific antibody (BiSAb) program for solid tumors in lead optimization. Within its infectious disease pipeline, Gritstone is advancing CORAL, a COVID-19 program to develop a second-generation vaccine with support from departments within the National Institutes of Health (NIH) and the Bill & Melinda Gates Foundation and a license agreement with La Jolla Institute for Immunology. For more information, please visit gritstoneoncology.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 advancements in the Company’s ongoing clinical trials; the timing of data announcements related to ongoing clinical trials and the initiation of future clinical trials. Such 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 significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including Gritstone’s programs’ early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Gritstone’s ability to successfully establish, protect and defend its intellectual property and other matters that could affect the sufficiency of existing cash to fund operations. Gritstone undertakes no obligation to update or revise any forward-looking statements. For a further 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 business of the company in general, see Gritstone’s most recent Quarterly Report on Form 10-Q filed on November 5, 2020 and any current and periodic reports filed with the Securities and Exchange Commission.


Gritstone Contacts

Media:

Dan Budwick

1AB

(973) 271-6085

dan@1abmedia.com


Investors:

Alexandra Santos

Wheelhouse Life Science Advisors

(510) 871-6161

asantos@wheelhouselsa.com

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