Gritstone bio is a clinical-stage American biotechnology company which develops cancer and infectious disease immunotherapies and vaccines. It was founded in August 2015 as Gritstone Oncology, Inc., and is based in Emeryville, California.
In September 2021 it raised $55.0 million from the sale of 5,000,000 shares. [1]
It started a Phase 1 trial of its self-amplifying mRNA second generation SARS-CoV-2 vaccine, GRT-R910, in the NIHCR Manchester Clinical Research Facility at Manchester Royal Infirmary, in September 2021. [2] This is to explore the ability of GRT-R910 to boost and expand the immunogenicity of AstraZeneca's first-generation COVID-19 vaccine AZD1222 (Vaxzevria) in healthy adults of more than 60 years. It uses lipid nanoparticles to deliver a broad set of antigens against SARS-CoV-2 that includes both stabilized spike protein and highly conserved viral protein regions containing T cell epitopes. [3] Prof. Andrew Ustianowski is the study’s chief investigator. [4]
On 10 November 2021, Gritstone announced positive preclinical data of its second-generation self-amplifying mRNA (SAM) vaccine against SARS-CoV-2 in non-human primate models. [5]
It is involved in a Phase 1/2 study, in collaboration with Bristol Myers Squibb, in 26 patients with metastatic solid tumors. [6]
In October 2024, Gritstone filed for Chapter 11 bankruptcy protection in efforts to move forward with its "strategic alternatives process". The company is looking for a stalking-horse bid that would allow for the company to continue operating.
Arcturus Therapeutics Holdings Inc. is an American RNA medicines biotechnology company focused on the discovery, development and commercialization of therapeutics for rare diseases and infectious diseases. Arcturus has developed proprietary lipid nanoparticle RNA therapeutics for nucleic acid medicines including small interfering RNA (siRNA), messenger RNA (mRNA), gene editing RNA, DNA, antisense oligonucleotides, and microRNA.
An mRNAvaccine is a type of vaccine that uses a copy of a molecule called messenger RNA (mRNA) to produce an immune response. The vaccine delivers molecules of antigen-encoding mRNA into cells, which use the designed mRNA as a blueprint to build foreign protein that would normally be produced by a pathogen or by a cancer cell. These protein molecules stimulate an adaptive immune response that teaches the body to identify and destroy the corresponding pathogen or cancer cells. The mRNA is delivered by a co-formulation of the RNA encapsulated in lipid nanoparticles that protect the RNA strands and help their absorption into the cells.
A COVID‑19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID‑19).
The Moderna COVID‑19 vaccine, sold under the brand name Spikevax, is a COVID-19 vaccine developed by the American company Moderna, the United States National Institute of Allergy and Infectious Diseases (NIAID), and the Biomedical Advanced Research and Development Authority (BARDA). Depending on the jurisdiction, it is authorized for use in humans aged six months, twelve years, or eighteen years and older. It provides protection against COVID-19, which is caused by infection by the SARS-CoV-2 virus.
The Pfizer–BioNTech COVID-19 vaccine, sold under the brand name Comirnaty, is an mRNA-based COVID-19 vaccine developed by the German biotechnology company BioNTech. For its development, BioNTech collaborated with the American company Pfizer to carry out clinical trials, logistics, and manufacturing. It is authorized for use in humans to provide protection against COVID-19, caused by infection with the SARS-CoV-2 virus. The vaccine is given by intramuscular injection. It is composed of nucleoside-modified mRNA (modRNA) that encodes a mutated form of the full-length spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles. Initial guidance recommended a two-dose regimen, given 21 days apart; this interval was subsequently extended to up to 42 days in the United States, and up to four months in Canada.
The CureVac COVID-19 vaccine was a COVID-19 vaccine candidate developed by CureVac N.V. and the Coalition for Epidemic Preparedness Innovations (CEPI). The vaccine showed inadequate results in its Phase III trials with only 47% efficacy. In October 2021 CureVac abandoned further development and production plans for CVnCoV and refocused efforts on a cooperation with GlaxoSmithKline.
ARCT-021, also known as LUNAR-COV19, is a COVID-19 vaccine candidate developed by Arcturus Therapeutics.
The Sanofi–GSK COVID-19 vaccine sold under the brand name VidPrevtyn Beta, is a COVID-19 vaccine developed by Sanofi Pasteur and GSK.
iNCOVACC is an intranasal COVID-19 vaccine candidate developed by Bharat Biotech, American company Precision Virologics and the Washington University School of Medicine in St Louis, Missouri, United States.
AWcorna, originally termed ARCoV and also known as the Walvax COVID-19 vaccine, is an mRNA COVID-19 vaccine developed by Walvax Biotechnology, Suzhou Abogen Biosciences, and the PLA Academy of Military Science. In contrast to other mRNA COVID vaccines, such as those by Pfizer-BioNtech and Moderna, this vaccine primarily targets the Sars-CoV-2 receptor-binding domain of the spike protein, rather than the entire spike protein. It is approved for Phase III trials in China, Mexico, Indonesia, and Nepal.
V-01 is a protein subunit COVID-19 vaccine candidate developed by a subsidiary of Livzon Pharmaceutical Group Inc.
Razi Cov Pars is a COVID-19 vaccine developed by the Iranian Razi Vaccine and Serum Research Institute Razi Cov Pars is a covid-19 vaccine based on recombinant protein, which is being produced by Razi Vaccine and Serum Research Institute, Iran. This vaccine is the first injectable-intranasal recombinant protein corona vaccine.It's the second Iranian COVID-19 vaccine reaching human trials and is currently in phase III of clinical research during which it's compared to the Sinopharm BIBP vaccine.
mRNA-1283 is a COVID-19 vaccine candidate developed by Moderna.
COVI-VAC is a COVID-19 vaccine developed by Codagenix, Inc. In December 2020, COVI-VAC started a Phase I clinical trial, involving 48 participants. The trial was scheduled to complete in June 2021, with results to be reported by May 2022. On September 29, 2021, Codagenix presented positive phase 1 data for COVI-VAC at IDWEEK2021. Data indicates that COVI-VAC is well tolerated, with no significant adverse events reported and that administration of the intranasal vaccine was immunogenic and capable of blocking nasal replication of the virus with minimal viral shedding, recorded at levels lower than those likely to result in subsequent transmission of COVID-19. Furthermore, COVI-VAC was shown to stimulate both serum and mucosal antibody immune responses.
ARCT-154, also known as VBC-COV19-154 in Vietnam, is a COVID-19 vaccine candidate developed by Arcturus Therapeutics. For its development, Arcturus collaborated with Vinbiocare, a Vietnamese company, for support with clinical trials and manufacturing. The vaccine was authorised in Japan in November 2023.
AdCLD-CoV19 is a COVID-19 vaccine candidate developed by Cellid Co, a company from South Korea.
COVID-19 vaccine clinical research uses clinical research to establish the characteristics of COVID-19 vaccines. These characteristics include efficacy, effectiveness, and safety. As of November 2022, 40 vaccines are authorized by at least one national regulatory authority for public use:
Soberana Plus, technical name FINLAY-FR-1A, is a COVID-19 candidate vaccine produced by the Finlay Institute, a Cuban epidemiological research institute.
S-268019-b is a protein subunit COVID-19 vaccine candidate developed by Shionogi.
Self-amplifying RNA (saRNA), also termed self-replicating RNA (srRNA), is a type of mRNA molecule engineered to replicate itself within host cells, enhancing protein expression and boosting the immune response, making it a promising tool for vaccines and other therapeutic applications. As a "next-generation" mRNA, saRNA is designed to achieve greater protein expression with a reduced dose compared to conventional mRNA. Unlike conventional mRNA, which has a short half-life and limited ability to express proteins for an extended time, saRNA can sustain protein expression for longer periods. saRNA are based on positive single stranded RNA viruses most commonly alphaviruses such as Venezuelan equine encephalitis virus.