Benzinga | Mar 29, 2021 07:01AM EDT

Gritstone Announces First Person Dosed With its Second-Generation COVID-19 Vaccine In Phase 1 Study Conducted And Supported By NIAID/IDCRC

-- Preliminary Data from Phase 1 Study of CORAL Expected Mid-year --

-- Study will Assess Antibody and CD8+ T Cell Responses to Spike and Additional Non-Spike Antigens from SARS-CoV-2 with Aim of Augmenting Clinical Protection Against Spike Variants of Concern --

-- Phase 2 Study Evaluating CORAL as a Boost Vaccine Following Vaccination

with Authorized First-Generation COVID-19 Vaccines Planned --

EMERYVILLE, Calif., March 29, 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 the first person has been dosed under Gritstone's "CORAL" program with its candidate COVID-19 vaccine in a Phase 1 study. The study is evaluating the immunogenicity and safety of using its self-amplifying mRNA (SAM) and/or adenoviral vectors to deliver SARS-CoV-2 viral antigens, including both Spike and other viral antigens outside of Spike that are not included in currently authorized vaccines. The Phase 1 study (clinicaltrials.gov identifier: NCT04776317) is supported by the National Institute of Allergy and Infectious Diseases (NIAID) and is being conducted through their Infectious Diseases Clinical Research Consortium (IDCRC).

"This study has been met with great enthusiasm as Gritstone's vaccine is differentiated in its potential to broaden the immune response to SARS-CoV-2, potentially preserving clinical protection even if Spike variants arise," 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-19 vaccine study. "Based on pre-clinical work and data from Gritstone's cancer patients, we hope and expect to see strong neutralizing antibodies to Spike, as well as CD8+ T cell responses to both Spike and additional viral antigens, which may provide clinical protection against emerging Spike variants. We are also exploring the potential to use a lower dose of the self-amplifying mRNA vaccine, which could enable more patients to be treated with a given amount of manufactured vaccine."

The Phase 1 clinical trial is a multicenter, open-label, dose- and age-escalation study to examine the immunogenicity and safety of Gritstone's CORAL COVID-19 vaccine in healthy adult volunteers. Both heterologous and homologous prime-boost vaccinations of the adenoviral vector and/or SAM vector expressing either SARS-CoV-2 Spike alone or Spike plus additional SARS-CoV-2 T cell epitopes are being studied in a parallel design.

"We are excited to be advancing CORAL, our second-generation COVID-19 vaccine candidate, under our clinical collaboration with NIAID," said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone. "As we look to the future, we believe CORAL has the potential to address coronavirus immunity challenges that are likely to emerge, particularly around novel Spike variants of concern. Building on this NIAID/IDCRC first-in-human study, we are planning to examine the expected broad immunity elicited by our vaccine by delivering it as a boost for people who have received first-generation vaccines in a Phase 2 study starting later this year. We hope that strong CD8+ T cell immunity generated against key non-Spike gene fragments will provide protection against future Spike variants."

Dr. Allen continued, "Additionally, the repeated emergence of new coronavirus epidemics/pandemics over the last 20 years supports the desire for a pan-coronavirus vaccine to prevent or mitigate future pandemics. Certain non-Spike genes, some of which are included in our vaccine, tend to be conserved in coronaviruses over time and across variants. This observation may catalyze the development of a pan-coronavirus vaccine."