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Gritstone bio Announces Update to Comparative Phase 2b COVID-19 Clinical Trial

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Gritstone bio, Inc. (Nasdaq: GRTS) is adjusting the timeline for the Phase 2b trial of its next-generation COVID-19 vaccine to Fall 2024 to incorporate fully GMP-grade raw materials, enhancing regulatory value and study interpretability. The company aims to address the latest seasonal variant and express gratitude to FDA and BARDA for their support.
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The decision by Gritstone bio to postpone their Phase 2b trial of a next-generation COVID-19 vaccine to ensure the use of fully GMP-grade raw materials is a strategic move that prioritizes regulatory compliance and the integrity of trial results. The incorporation of Good Manufacturing Practice (GMP) standards is crucial for ensuring the safety, quality and efficacy of pharmaceutical products. GMP compliance is a non-negotiable requirement for regulatory approval by agencies such as the FDA.

From a research standpoint, this shift could enhance the credibility of the trial outcomes, making the data more robust for regulatory scrutiny. Additionally, the ability to potentially address the latest seasonal variant could position Gritstone bio's vaccine as a more relevant and competitive product in the market, which is important considering the rapid evolution of the SARS-CoV-2 virus.

The delay in Gritstone bio's vaccine trial may have mixed implications for investors. On one hand, the use of GMP-grade materials could lead to a stronger regulatory submission and potentially a smoother approval process. On the other hand, delays can be costly and may impact the company's cash flow and timeline to market, which are critical factors for a clinical-stage biotech firm.

Investors will need to weigh the potential for a higher quality and more competitive vaccine against the risks associated with delayed revenue generation. It's also worth noting that the company's collaboration with BARDA and the receipt of federal funds could offset some financial concerns and provide additional validation of the vaccine's potential.

In terms of market dynamics, Gritstone bio's entry into the COVID-19 vaccine space, albeit delayed, could disrupt the current landscape if their vaccine proves to be more effective against emerging variants. The demand for COVID-19 vaccines that can address new strains is ongoing and the market is responsive to innovations that can provide broader and more durable protection.

The success of this trial could therefore not only benefit public health but also alter market shares among vaccine providers. It will be important to monitor the trial's progress and results, as they will have implications for both the competitive environment and future demand for COVID-19 vaccines.

EMERYVILLE, Calif., Feb. 12, 2024 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today announced that it is now preparing to launch the Phase 2b head-to-head trial of its next-generation COVID-19 vaccine in the Fall of 2024 rather than 1Q24. This is to allow use of fully GMP-grade raw materials in the vaccine, which is expected to increase the regulatory utility of the trial.

“After recent communication with the FDA and input from our colleagues at BARDA, we are now making the necessary preparations to begin the Phase 2b study later this year using fully GMP-grade materials in the manufacture of our self-amplifying mRNA (samRNA) vaccine,” said Andrew Allen, MD, PhD, Co-founder President & CEO of Gritstone bio. “The change likely increases the regulatory value of this large study, is expected to improve study interpretability, and may enable us to contemporaneously address the latest seasonal variant. We would like to thank the FDA for their collaboration and BARDA for their teamwork in support of this study, which aims to help deliver to the world a broader and more durable vaccine against COVID-19.”

This project has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50123C00062.

About the CORAL-BARDA study
The CORAL-BARDA study is an intended 10,000 participant, randomized Phase 2b double-blinded study to compare the efficacy, safety, and immunogenicity of Gritstone bio’s next-generation COVID-19 vaccine candidate with an approved COVID-19 vaccine. The goal of this study is to determine whether Gritstone bio’s next-generation vaccine candidate, a self-amplifying mRNA (samRNA) vaccine, can provide better and longer protection against COVID-19 than the currently FDA-approved vaccines.

About Self-amplifying mRNA (samRNA)
Self-amplifying mRNA (samRNA) is rapidly emerging as a well-tolerated, scalable and widely-applicable platform technology which can be used to develop multiple vaccines simply by changing the sequence of the antigen (the target of the immune system) that is encoded in the vector RNA and delivered in a lipid nanoparticle. Like traditional mRNA vaccines, samRNA vaccines use the host cell’s translation system to convert mRNA to protein target antigens in order to stimulate immunity. Unlike traditional mRNA, samRNA creates multiple copies of the antigen RNA once in the cell, potentially leading to extended duration and magnitude of antigen expression. Gritstone designs novel immunogens, the vaccine regions encoding virus antigens, and includes both Spike antigen (similar to first-generation COVID-19 vaccines) and evolutionarily conserved, non-Spike antigens likely to drive T cell responses in its next-generation COVID-19 vaccines. Potential benefits of this samRNA “Spike plus” approach include (1) strong and durable induction of neutralizing antibodies to Spike, (2) broad and durable T cell immunity (CD4+ and CD8+) to multiple viral proteins, (3) potency at lower doses (dose sparing), and (4) refrigerator stability.

About Gritstone bio
Gritstone bio, Inc. (Nasdaq: GRTS) is a clinical-stage biotechnology company that aims to develop 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 advancing a portfolio of product candidates to treat and prevent viral diseases and solid tumors in pursuit of improving patient outcomes and eliminating disease. www.gritstonebio.com

Forward Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to our clinical and regulatory development plans for our next-generation COVID-19 vaccine, the timing of commencement of our CORAL-BARDA study and our belief regarding the use of GMP-grade raw materials in the vaccine manufacturing process and its impact on the regulatory utility of our CORAL-BARDA trial; our expectations regarding the data to be derived in our ongoing and planned clinical trials; our ability to discover, develop, manufacture and advance product candidates into, and successfully complete, clinical trials, including, in particular, our next-generation COVID-19 vaccine. 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’ clinical 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 Annual Report on Form 10-K filed on March 9, 2023 and any subsequent current and periodic reports filed with the Securities and Exchange Commission.

Gritstone Contacts
Investors:
George E. MacDougall
Gritstone bio, Inc.
ir@gritstone.com

Media:
Dan Budwick
1AB
(973) 271-6085
dan@1abmedia.com


FAQ

When will Gritstone bio, Inc. launch the Phase 2b trial of its next-generation COVID-19 vaccine?

Gritstone bio, Inc. will launch the Phase 2b trial in Fall 2024 instead of 1Q24.

What is the reason for the delay in the Phase 2b trial timeline?

The delay is to allow the use of fully GMP-grade raw materials in the vaccine to enhance regulatory utility.

Who is the President & CEO of Gritstone bio, Inc.?

Andrew Allen, MD, PhD, is the Co-founder President & CEO of Gritstone bio.

What does the Phase 2b trial aim to achieve?

The trial aims to help deliver a broader and more durable vaccine against COVID-19.

Which organizations have supported the project?

The project has been supported by the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA).

Gritstone bio, Inc.

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