Felix Biotechnology | March 07, 2022
Felix Biotechnology, a biopharmaceutical business focusing on developing first-in-class, long-lasting antibacterial medicines to treat chronic drug-resistant infections, announced that it has received a Therapeutics Development Award from the Cystic Fibrosis Foundation. The funding will aid Felix's efforts to develop a novel medication to treat chronic Pseudomonas aeruginosa lung infections.
Chronic P. aeruginosa infections affect half of the persons with cystic fibrosis, many of whom are multidrug-resistant. Since infections are the leading cause of death in cystic fibrosis patients, innovative treatments are urgently needed. Felix offers a novel strategy by turning bacteria's natural predators, microscopic viruses known as bacteriophage (or phage), into long-lasting, broadly effective medicines.
Felix's phage therapies are specifically designed to examine and drive positive evolutionary effects of phage treatment, based on foundational research by Yale University's Drs. Paul Turner, Ben Chan, and Jon Koff. This results in a more long-lasting treatment, which is essential given the requirement to regularly deliver phage to treat chronic infections. This medication is now being tested in a clinical trial at Yale University. More information about the experiment can be found here, and interested patients are encouraged to enroll if they are eligible.
We are incredibly honored and excited to receive this support from the CF Foundation, This award will speed Felix in its mission to provide new therapeutic options to patients dealing with life-threatening infections and to develop phage as a broadly applicable antibacterial therapy."
Dr. Paul Turner, Ph.D., co-founder of Felix.
CELL AND GENE THERAPY
IndyGeneUS AI | May 20, 2021
Through collaborations, IndyGeneUS AI has acquired genomic analysis and testing capabilities. This pathogen sequencing capacity has emerged at a critical moment in efforts to improve genomic surveillance and monitor COVID-19 variant strains across the continent.
IndyGeneUS founder and CEO Yusuf Henriques emphasized the importance of this work. "COVID-19 and its variants pose a danger to the entire African continent, so we must act quickly. Our partners understand the urgency of this mission and are united with their cooperation."
Next-generation sequencing (NGS)-based genotyping, targeted sequencing, and comprehensive bioinformatics analysis are among the capabilities. Comparative genomic analysis, disease genetics, epigenomics, and genome mapping are some of the applications of our capabilities.
Bradford Wilson, Ph.D., Chief Scientific Officer at IndyGeneUS AI, said, "These capabilities are pivotal for the Continent and the future of precision medicine." "We are currently in talks with several large pharmaceutical firms that see the value of what we are developing to combat infectious and non-communicable diseases alike," he said.
In less than a year, IndyGeneUS AI has partnered with Kenyan organizations such as the KAVI Institute of Clinical Research at the University of Nairobi and Afya Rekod. We've also teamed up with Encrypgen, which has created a blockchain-encrypted marketplace for commercializing insights gleaned from our repository and compensating participants who contribute data.
IndyGeneUS has certainly understood the increasing need for infrastructure to sustain genomic surveillance activities by developing sequencing capabilities. Following the introduction of COVID-19 variant strains, the World Health Organization (WHO) and the African Centres for Disease Control (Africa CDC) established a network of laboratories last year to improve the continent's capacity to identify emerging variants of concern. More funding and infrastructure are needed for these initiatives. IndyGeneUS intends to accelerate sequencing capabilities across Africa by using public and private partnerships.
About IndyGeneUS AI
IndyGeneUS AI is a genomics company based in Nairobi is also developing the world's largest block-chain encrypted repository of African clinical and multi-omics data for disease prevention and diagnosis, drug discovery and development, clinical disease management, and the promotion of precision health equity. Mr. Yusuf Henriques, COO Dr. Wilmot Allen, and CSO Dr. Bradford Wilson formed IndyGeneUS. The company, which is owned by African Americans and Africans, has offices in Washington, DC, and a presence in South Africa through the Founder Institute. The Founder Institute is the world's largest pre-seed startup accelerator.
CELL AND GENE THERAPY
Gritstone bio | December 07, 2021
Gritstone bio, Inc. a clinical-stage biotechnology company developing next generation cancer and infectious disease immunotherapies, and CEPI, the Coalition for Epidemic Preparedness Innovations, announced the expansion of their agreement in order to support the development of a self-amplifying mRNA vaccine designed to tackle the Omicron COVID-19 variant. CEPI will provide up to $5 million in additional funding to conduct a Phase 1 clinical trial of Gritstone’s Omicron vaccine candidate in South Africa, where a CEPI-funded clinical trial of Gritstone’s Beta variant COVID-19 vaccine is due to begin shortly. The SARS-CoV-2 T cell epitopes administered within Gritstone’s SAM COVID-19 vaccines are minimally impacted by mutations found within the Omicron variant, reinforcing the platform’s potential to address both Omicron and future variants of concern.
CEPI is already funding up to $20.6 million to support preclinical studies, manufacturing process optimization, and a Phase 1 trial of Gritstone’s Beta variant vaccine candidate which will be initiated by South Africa’s University of the Witwatersrand in the coming weeks. The funding announced today will expand the Phase 1 trial to include additional arms to evaluate an Omicron-specific version of the vaccine. Gritstone has commenced manufacturing its SAM vaccine to specifically target the Omicron variant, and the Omicron arms of the Phase 1 trial are expected to begin in Q2 2022, subject to regulatory approval.
The recently described Omicron variant, first identified in South Africa on November 9, 2021, was designated a variant of concern by the World Health Organization (WHO) on November 26, 2021. Early evidence suggests that Omicron carries an increased risk of re-infection, and sequence analysis has revealed many mutations in Spike, which may reduce clinical effectiveness of existing vaccines and/or therapeutic antibodies.
Enabling equitable access
CEPI is committed to global equitable access to COVID-19 vaccines so, through this agreement, CEPI and Gritstone have agreed that this Omicron vaccine candidate will be made available to the COVAX Facility for procurement and allocation, if it is proven to be safe and effective. The COVAX Facility aims to deliver equitable access to COVID-19 vaccines for all countries, at all levels of development, that wish to participate.
“While key questions are yet to be answered about Omicron, its transmissibility, and its potential ability to evade our current vaccines, the stakes are too high to delay developing Omicron-specific vaccine candidates. Given the uncertainties, we must accelerate crucial R&D so vaccines are available to tackle Omicron as soon as possible – just in case we need them. There is no time to lose, so I’m pleased that within 10 days of Omicron being declared a Variant of Concern by the WHO, CEPI is expanding its partnership with Gritstone to support a new Omicron vaccine candidate which can be made globally accessible through COVAX.”
Dr Richard Hatchett, CEO of CEPI
“Our vaccine platforms are built on the premise that a best-in-class vaccine against a virus will drive strong neutralizing antibodies directed to surface antigens such as Spike, and strong cytotoxic T cell responses against other conserved viral antigens to eliminate virally infected cells. This broad immune response would, in principle, provide superior protection against a virus that is mutating its surface protein. Omicron is an example of a novel SARS-CoV-2 variant that may escape clinical protection conferred by vaccines that only afford narrow, Spike-specific immunity,” said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone. “Our SAM technology provides an innovative platform likely capable of delivering on the attractive concept of broad, durable immunity. We are thrilled to be quickly expanding our relationship with CEPI in our shared goal of finding new vaccine solutions to battle this deadly virus on a global scale and help prevent current and perhaps future COVID outbreaks.”
Self-amplifying mRNA vaccines
As with the mRNA-based COVID-19 vaccines that are now in global use, self-amplifying mRNA vaccines use the body’s own machinery to make antigenic protein itself rather than injecting the antigen directly into the body.
However, in self-amplifying mRNA vaccines, viral RNA is adapted in a way that allows only the genetic sequence for a specific antigen to be expressed, while keeping the part of the RNA that allows it to produce multiple copies of itself—the self-amplification machinery.
The benefit of this approach is that the dose of RNA can be reduced while maintaining the potency of the vaccine. Gritstone’s vaccine candidate may also elicit T-cell immune responses against non-Spike gene fragments, which are slower to mutate than the genes associated with the SARS-CoV-2 Spike protein and could potentially provide broad protection against other SARS-CoV-2 strains.
CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines against future epidemics. Prior to COVID-19 CEPI’s work focused on developing vaccines against Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever virus and Chikungunya virus – it has over 20 vaccine candidates against these pathogens in development. CEPI has also invested in new platform technologies for rapid vaccine development against unknown pathogens.
During the current pandemic, CEPI initiated multiple programmes to develop vaccines against SARS-CoV-2 and its variants with a focus on speed, scale and access. These programmes leverage the rapid response platforms developed by CEPI’s partners prior to the emergence of COVID-19 as well as new collaborations. The aim is to advance clinical development of a diverse portfolio of safe and effective COVID-19 candidates and to enable fair allocation to these vaccines worldwide through COVAX.
CEPI’s 5-year plan lays out a $3.5 billion roadmap to compress vaccine development timelines to 100 days, develop a universal vaccine against COVID-19 and other Betacoronaviruses, and create a “library” of vaccine candidates for use against known and unknown pathogens.
About the CORAL Program
Gritstone’s CORAL program is a second-generation SARS-CoV-2 vaccine platform delivering spike and additional SARS-CoV-2 T cell epitopes, offering the potential for more durable protection and broader immunity against SARS-CoV-2 variants. Delivery vectors can comprise a chimpanzee adenovirus, self-amplifying mRNA or both (mix and match). The program is supported by several key relationships: Bill & Melinda Gates Foundation, National Institute of Allergy and Infectious Disease (NIAID), and the Coalition for Epidemic Preparedness Innovations (CEPI). An ongoing Gritstone-sponsored Phase 1 trial is evaluating SAM as a boost and immunogenicity enhancer of AstraZeneca's first-generation COVID-19 vaccine AZD1222 (Vaxzevria) in healthy adults ≥ 60 years in the UK. A two-dose SAM regimen is also being evaluated in an ongoing clinical trial sponsored by the National Institute of Health (NIH) Division of Microbiology and Infectious Disease and in the Coalition for Epidemic Preparedness Innovations-funded, Gritstone-sponsored clinical trial in South Africa expected to begin by year end 2021.
Gritstone bio, Inc. 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. 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), the Bill & Melinda Gates Foundation, the Coalition for Epidemic Preparedness Innovations (CEPI) and through a license agreement with La Jolla Institute for Immunology (LJI). Additionally, the company has a global collaboration for the development of a therapeutic HIV vaccine with Gilead Sciences.
COVAX, the vaccines pillar of the Access to COVID-19 Tools Accelerator, is co-convened by CEPI, Gavi, the Vaccine Alliance Gavi) and the World Health Organization – working in partnership with UNICEF as key implementing partner, developed and developing country vaccine manufacturers, the World Bank, and others. It is the only global initiative that is working with governments and manufacturers to ensure COVID-19 vaccines are available worldwide to both higher-income and lower-income countries.