Gritstone

Gritstone bio Reports Third Quarter 2023 Financial Results and Provides Corporate Updates

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星期三, 十一月 8, 2023
PCV, SLATE, CORAL, FDA, Biomedical Advanced Research and Development Authority, Research, IND, Gritstone bio, NCI, Food, Health, Infection, Vaccine, Human services, National Institutes of Health Clinical Center, Administration for Strategic Preparedness and Response, HIV, Gates, BARDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, United States Department of Health and Human Services, Administration, Development, Gilead, NAB, Clinical trial, COVID-19, National Cancer Institute, Messenger, Collaboration, Immunotherapy, Safety, Office of Inspector General, U.S. Department of Health and Human Services, Cancer, CEPI, Chemistry, Patient, Pharmaceutical industry, Gritstone, LNP

EMERYVILLE, Calif., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today reported financial results for the third quarter ended September 30, 2023 and provided recent corporate and clinical updates.

Key Points: 
  • In oncology, preliminary findings from the randomized Phase 2/3 study of our personalized cancer vaccine, GRANITE, in MSS-CRC are rapidly approaching.
  • The scientific bedrock of GRANITE extends to SLATE, where our collaboration with Steven A. Rosenberg and the NCI is now advancing.
  • Gritstone met its enrollment target of 100 patients randomized in August 2023.
  • An IND to run a Phase 1 study was cleared by the U.S. Food and Drug Administration (FDA) in October 2023.

Gritstone bio Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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星期二, 十一月 7, 2023
Gritstone bio, Employment, Compensated emancipation, Vaccine, Pharmaceutical industry, Gritstone

EMERYVILLE, Calif., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, today announced that the Compensation Committee of the company’s Board of Directors granted one employee nonqualified stock options to purchase an aggregate of 4,600 shares of its common stock with an exercise price of $1.83, which is equal to the closing price of Gritstone’s common stock on November 2, 2023, the date of the grant.

Key Points: 
  • EMERYVILLE, Calif., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, today announced that the Compensation Committee of the company’s Board of Directors granted one employee nonqualified stock options to purchase an aggregate of 4,600 shares of its common stock with an exercise price of $1.83, which is equal to the closing price of Gritstone’s common stock on November 2, 2023, the date of the grant.
  • These stock options are part of an inducement material to the new employees becoming an employee of Gritstone, in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The stock options will vest over a four-year period, with 25% of the options vesting on the first anniversary of the employees’ date of hire, and 1/48th of the options vesting monthly thereafter, subject to the employees’ continued employment with Gritstone on such vesting dates.
  • The stock options are subject to the terms and conditions of Gritstone’s 2021 Employment Inducement Incentive Award Plan and the stock option agreement covering the grant.

Genevant Sciences LNP Technology Used in samRNA Covid-19 Vaccine Candidate Behind Gritstone bio’s BARDA Award

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星期四, 十月 12, 2023
COVID-19, Development, LNP, Therapy, Safety, Biomedical Advanced Research and Development Authority, CORAL, Messenger, BARDA, Vaccine, Gritstone

VANCOUVER, British Columbia and BASEL, Switzerland, Oct. 12, 2023 (GLOBE NEWSWIRE) -- Genevant Sciences, a leading nucleic acid delivery company with world-class platforms and a robust and expansive lipid nanoparticle (LNP) patent portfolio, today announced the use of its LNP technology in Gritstone bio’s (Nasdaq: GRTS) self-amplifying mRNA (samRNA) vaccine candidate against COVID-19 in its CORAL program.

Key Points: 
  • VANCOUVER, British Columbia and BASEL, Switzerland, Oct. 12, 2023 (GLOBE NEWSWIRE) -- Genevant Sciences, a leading nucleic acid delivery company with world-class platforms and a robust and expansive lipid nanoparticle (LNP) patent portfolio, today announced the use of its LNP technology in Gritstone bio’s (Nasdaq: GRTS) self-amplifying mRNA (samRNA) vaccine candidate against COVID-19 in its CORAL program.
  • The BARDA award, received by Gritstone following results from multiple Phase 1 studies of its COVID-19 vaccine candidate, is for the conduct of a 10,000 participant, randomized Phase 2b double-blinded study to compare the efficacy, safety, and immunogenicity of Gritstone’s COVID-19 vaccine candidate with an approved COVID-19 vaccine.
  • “We value our longstanding relationship with Gritstone bio and congratulate the Gritstone team on receiving the BARDA award,” said Pete Lutwyche, Ph.D., President and Chief Executive Officer, Genevant Sciences Corporation.
  • “As longtime leaders in the field, we know that delivery is often the difference in the success of nucleic acid-based medicines and we are thrilled with the contribution of our LNP technology to Gritstone’s achievement.”

Presentations at IDWeek 2023 Highlight Potentially Differentiated Immunogenicity of Gritstone bio’s Next Generation COVID-19 Vaccine

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星期三, 十月 11, 2023
COVID-19, NIAID, National Institute of Allergy and Infectious Diseases, Vaccine, RNA, Immunity, Immunogenicity, Gritstone bio, Group A, Infection, PLWH, HIV, CORAL, Epitope, NAB, Reactogenicity, Messenger, Infectious Disease Clinics of North America, Pharmaceutical industry, Gritstone, Safety

EMERYVILLE, Calif., Oct. 11, 2023 (GLOBE NEWSWIRE) -- October 11, 2023 (GLOBE NEWSWIRE) – Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today announced the presentation of results from three ongoing Phase 1 studies evaluating its self-amplifying mRNA (samRNA) vaccine candidates against COVID-19 (part of the company’s CORAL program) at IDWeek 2023, occurring October 11-15, 2023, in Boston, MA.

Key Points: 
  • Gritstone will present further follow up data from the CORAL-CEPI and CORAL-BOOST studies (most recent prior presentation in April 2023, press release ).
  • CORAL-BOOST (NCT05148962) is a Phase 1 study evaluating a samRNA-based COVID-19 vaccine candidate containing spike plus other viral targets in older adults ≥60 years of age (N = 40).
  • Broad T cell responses induced against Spike and non-Spike T cell epitopes included in the vaccine.
  • To view Gritstone’s IDWeek 2023 poster presentations, visit ir.gritstonebio.com/investors/events .

Gritstone bio Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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星期二, 十月 10, 2023
Gritstone bio, Employment, Compensated emancipation, Vaccine, Pharmaceutical industry, Gritstone

EMERYVILLE, Calif., Oct. 10, 2023 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, today announced that the Compensation Committee of the company’s Board of Directors granted three employees nonqualified stock options to purchase an aggregate of 47,000 shares of its common stock with an exercise price of $2.41, which is equal to the closing price of Gritstone’s common stock on October 5, 2023, the date of the grant.

Key Points: 
  • EMERYVILLE, Calif., Oct. 10, 2023 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, today announced that the Compensation Committee of the company’s Board of Directors granted three employees nonqualified stock options to purchase an aggregate of 47,000 shares of its common stock with an exercise price of $2.41, which is equal to the closing price of Gritstone’s common stock on October 5, 2023, the date of the grant.
  • These stock options are part of an inducement material to the new employees becoming an employee of Gritstone, in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The stock options will vest over a four-year period, with 25% of the options vesting on the first anniversary of the employees’ date of hire, and 1/48th of the options vesting monthly thereafter, subject to the employees’ continued employment with Gritstone on such vesting dates.
  • The stock options are subject to the terms and conditions of Gritstone’s 2021 Employment Inducement Incentive Award Plan and the stock option agreement covering the grant.

Gritstone bio Announces Presentations from Phase 1 Studies Evaluating Next-Generation Vaccine Candidate for COVID-19 at IDWeek 2023

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星期三, 十月 4, 2023
Vaccine, Nextgen, Biomedical Advanced Research and Development Authority, Therapy, Office of Inspector General, U.S. Department of Health and Human Services, HHS, National Institute of Allergy and Infectious Diseases, Gritstone bio, COVID-19, Infection, Messenger, Development, Infectious Disease Clinics of North America, NIAID, CORAL, BARDA, Gritstone, Pharmaceutical industry

EMERYVILLE, Calif., Oct. 04, 2023 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today announced results from all three (3) Phase 1 studies evaluating its self-amplifying mRNA (samRNA) vaccine candidates against COVID-19 (part of the company’s CORAL program) are to be presented at IDWeek 2023, occurring October 11-15, 2023, in Boston, MA.

Key Points: 
  • EMERYVILLE, Calif., Oct. 04, 2023 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today announced results from all three (3) Phase 1 studies evaluating its self-amplifying mRNA (samRNA) vaccine candidates against COVID-19 (part of the company’s CORAL program) are to be presented at IDWeek 2023, occurring October 11-15, 2023, in Boston, MA.
  • Last week, Gritstone bio announced a contract with the Biomedical Advanced Research and Development Authority (BARDA) to advance the program into a 10,000 patient, randomized Phase 2b comparative study against COVID-19.
  • Gritstone last presented data from the CORAL-BOOST and CORAL-CEPI studies in April 2023 ( press release ).
  • At IDWeek, Gritstone will present further follow up from both of those studies.

Gritstone bio Awarded BARDA Contract to Conduct Comparative Phase 2b Study Evaluating Next-Generation Vaccine Candidate for COVID-19 Valued at up to $433 Million

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星期三, 九月 27, 2023
Vaccine, United States Department of Health and Human Services, Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Health, Nextgen, Therapy, Office of Inspector General, U.S. Department of Health and Human Services, HHS, Fred Hutchinson Cancer Research Center, SARS-CoV-2, Human services, Gritstone bio, COVID-19, Infection, Federal, Messenger, Assistant, Government, Development, Trust, Controversies regarding COVID-19 contracts in the United Kingdom, NIAID, CORAL, BARDA, Safety, Pharmaceutical industry, Gritstone

EMERYVILLE, Calif., Sept. 27, 2023 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, announced today that it was awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA) to conduct a Phase 2b comparative study evaluating Gritstone’s self-amplifying mRNA (samRNA) vaccine candidate containing Spike plus other viral targets to protect against COVID-19. The agreement, which is valued at up to $433 million, was awarded as part of ‘Project NextGen,’ an initiative by the U.S. Department of Health and Human Services (HHS) to advance a pipeline of new, innovative vaccines and therapeutics providing broader and more durable protection for COVID-19.

Key Points: 
  • Under the contract, Gritstone bio will conduct a 10,000 participant, randomized Phase 2b double-blinded study to compare the efficacy, safety, and immunogenicity of the Gritstone next-generation COVID-19 vaccine candidate with an approved COVID-19 vaccine.
  • Preparations for the study are underway, and execution of the study will be fully funded by BARDA.
  • CORAL was designed to address these limitations by inducing durable neutralizing antibody and T cell-based immunity against current and future SARS-CoV-2 variants.
  • We are excited about this opportunity to work alongside BARDA and look forward to initiating the Phase 2b study (CORAL-BARDA) in the first quarter of 2024.

Gritstone bio Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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星期三, 九月 13, 2023
Vaccine, Gritstone bio, Employment, Compensated emancipation, Pharmaceutical industry, Gritstone

EMERYVILLE, Calif., Sept. 13, 2023 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, today announced that the Compensation Committee of the company’s Board of Directors granted one employee nonqualified stock options to purchase an aggregate of 14,000 shares of its common stock with an exercise price of $1.71, which is equal to the closing price of Gritstone’s common stock on September 6, 2023, the date of the grant.

Key Points: 
  • EMERYVILLE, Calif., Sept. 13, 2023 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, today announced that the Compensation Committee of the company’s Board of Directors granted one employee nonqualified stock options to purchase an aggregate of 14,000 shares of its common stock with an exercise price of $1.71, which is equal to the closing price of Gritstone’s common stock on September 6, 2023, the date of the grant.
  • These stock options are part of an inducement material to the new employees becoming an employee of Gritstone, in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The stock options will vest over a four-year period, with 25% of the options vesting on the first anniversary of the employees’ date of hire, and 1/48th of the options vesting monthly thereafter, subject to the employees’ continued employment with Gritstone on such vesting dates.
  • The stock options are subject to the terms and conditions of Gritstone’s 2021 Employment Inducement Incentive Award Plan and the stock option agreement covering the grant.

Gritstone bio Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
星期三, 八月 16, 2023
Vaccine, Gritstone bio, Employment, Compensated emancipation, Pharmaceutical industry, Gritstone

EMERYVILLE, Calif., Aug. 16, 2023 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, today announced that the Compensation Committee of the company’s Board of Directors granted two employees nonqualified stock options to purchase an aggregate of 32,500 shares of its common stock with an exercise price of $1.70, which is equal to the closing price of Gritstone’s common stock on August 7, 2023, the date of the grant.

Key Points: 
  • EMERYVILLE, Calif., Aug. 16, 2023 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, today announced that the Compensation Committee of the company’s Board of Directors granted two employees nonqualified stock options to purchase an aggregate of 32,500 shares of its common stock with an exercise price of $1.70, which is equal to the closing price of Gritstone’s common stock on August 7, 2023, the date of the grant.
  • These stock options are part of an inducement material to the new employees becoming an employee of Gritstone, in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The stock options will vest over a four-year period, with 25% of the options vesting on the first anniversary of the employees’ date of hire, and 1/48th of the options vesting monthly thereafter, subject to the employees’ continued employment with Gritstone on such vesting dates.
  • The stock options are subject to the terms and conditions of Gritstone’s 2021 Employment Inducement Incentive Award Plan and the stock option agreement covering the grant.

Gritstone bio and Genevant Sciences Announce Option and License Agreement

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星期二, 八月 15, 2023
Vaccine, Therapy, Complementarity, Gritstone bio, Infection, Geneve L. A. Shaffer, RNA, LNP, Pharmaceutical industry, Gritstone

EMERYVILLE, Calif., VANCOUVER, British Columbia, and BASEL, Switzerland, Aug. 15, 2023 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, and Genevant Sciences, a leading nucleic acid delivery company with world-class platforms and a robust and expansive lipid nanoparticle (LNP) patent portfolio, today announced an agreement pursuant to which Gritstone bio, Inc. will have a multi-year option for a non-exclusive license under Genevant’s LNP technology on a pathogen-by-pathogen basis to develop and commercialize self-amplifying RNA (samRNA) vaccines.

Key Points: 
  • EMERYVILLE, Calif., VANCOUVER, British Columbia, and BASEL, Switzerland, Aug. 15, 2023 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, and Genevant Sciences, a leading nucleic acid delivery company with world-class platforms and a robust and expansive lipid nanoparticle (LNP) patent portfolio, today announced an agreement pursuant to which Gritstone bio, Inc. will have a multi-year option for a non-exclusive license under Genevant’s LNP technology on a pathogen-by-pathogen basis to develop and commercialize self-amplifying RNA (samRNA) vaccines.
  • “Our previous collaborations with Genevant have demonstrated the powerful potential of combining the strengths of two technology leaders, and we are pleased to expand our relationship with this new agreement,” said Andrew Allen, M.D., Ph.D., Co-founder, President and Chief Executive Officer of Gritstone bio.
  • “As leaders in the field, we are thrilled to build upon our relationship with Gritstone to pursue new and better approaches to combat infectious disease.”
    Under the terms of the agreement, Genevant is eligible to receive from Gritstone option maintenance and exercise fees in the single digit millions, up to $136 million in contingent milestone payments per product, subject to increase for multi-pathogen products and in other specified circumstances, and royalties ranging from the mid to high single digits on future product sales.
  • If Gritstone outlicenses an applicable infectious disease program, in lieu of certain of these payments, Genevant may be entitled to a percentage of amounts that Gritstone receives from its sublicensee.