Whole-Virion Inactivated SARS-CoV-2 Vaccine

SEATTLE--( BUSINESS WIRE )--The Access to Advanced Health Institute (AAHI) announced today that it has been awarded the first stage of funding for a $12.7-million project through the Medical CBRN Defense Consortium (MCDC) Other Transaction Authority (OTA) to develop a novel immune-stimulating adjuvant formulation that will improve the human immune response to vaccines, providing broader and longer lasting protection against disease. This five-year prototype project will support AAHI’s development and optimization of “NanoAlum” – a novel nanoparticle adjuvant formulation, made from aluminum salts (“alum”). Alum has been used for nearly 100 years to enhance immune responses to vaccines, and vaccines adjuvanted with alum work well against some diseases, such as hepatitis A and B and pneumococcus. Alum-adjuvanted vaccines have been less effective against diseases such as tuberculosis and influenza, which are more complex to target and can be challenging to manufacture because they require special sterilization methods. AAHI’s NanoAlum formulation changes the size, shape, and charge of alum particles to enhance specific immune responses for better vaccine protection against complex diseases. Vaccines formulated with NanoAlum can be sterilized using standard methods for ease of manufacture, and NanoAlum is designed to be stable at extreme temperatures to ensure accessibility in low-resource areas of the world, such as those most burdened by tuberculosis. “The team hopes to get a better understanding of how the physical characteristics of adjuvant formulations alter and improve the human immune response to vaccines,” says Christopher Fox, PhD, Senior Vice President of Formulations at AAHI, and the lead scientist on the project. “By optimizing those characteristics in a new adjuvant formulation, we may unlock approaches to providing improved protection against the most complex and difficult diseases to target, like tuberculosis and influenza.” The MCDC prototype project will evaluate AAHI’s NanoAlum formulated with 3M’s immune-stimulating “3M-052” molecule – an extremely promising adjuvant characterized as a toll-like receptor (TLR) agonist. Formulations of 3M-052 have demonstrated ability to generate robust and durable immune responses and are currently being used in clinical trials of several HIV vaccines with encouraging results. Adjuvant formulations containing TLR agonists are a critical component of some of today’s newest and most successful vaccines, including currently licensed vaccines against shingles (Shingrix®), respiratory syncytial virus (AREXVY®), malaria (RTS,S®), and COVID-19 (Covaxin®). AAHI’s prototype project for MCDC will pair the combined 3M-052 and NanoAlum formulation with tuberculosis and pandemic influenza vaccine antigens. The resulting vaccine candidates will be evaluated through preclinical studies and toxicology testing to prepare for use in clinical trials. “Currently available vaccine technology does not yet provide highly effective solutions that prevent infection and reduce or eliminate transmission against some of the most difficult and pervasive infectious diseases worldwide,” says Corey Casper, MD, MPH, CEO of AAHI. “Adjuvant formulations, particularly TLR agonists, have proven to be the most efficient technology to date, but they must be formulated to be safe and effective when used in human vaccines. This award will allow us to advance the oldest and safest vaccine adjuvant technology and combine it with the newest and most promising adjuvant molecule in a way that can safely enhance modern vaccines and do so in a way that is easily manufacturable and accessible to people around the globe. We hope this work will lead to accessible and potent vaccines that reduce the burden of tuberculosis and pandemic influenza, two of the leading infectious disease killers across the world.” AAHI’s NanoAlum research project is supported by federal funds from the Department of Defense under OTA number #W15QKN-16-9-1002. The U.S. Government is authorized to reproduce and distribute reprints for Governmental purposes, notwithstanding any copyright notation thereon. The views and conclusions contained herein are those of the authors and should not be interpreted as necessarily representing the official policies or endorsements, either expressed or implied, of the U.S. Government. AAHI is a nonprofit biotech research institute located in Seattle, Washington, that combines the high-quality science of an academic research organization with the product development capabilities of a biotech company to help combat some of the world’s deadliest diseases, including infectious diseases such as COVID-19, mosquito and tick-borne diseases, cancer, fungal and parasitic infections, and other non-communicable diseases. For nearly three decades, AAHI, previously known as the Infectious Disease Research Institute, has focused on creating immune-enhancing technologies that improve the body’s natural response to disease. Through collaborations, AAHI brings innovative products from the lab to the clinic to the people, furthering AAHI’s mission to bring together the best experts, technologies, and platforms to create accessible, high-quality products and solutions. AAHI is working to build a world in which every person has access to tools that harness their immune system and allow them to live a healthy life free of illness and disease. For more information, go to AAHI.org or follow us on LinkedIn .

The RBD antigen of SARS-CoV-2 producing yeast strain from Texas Children's Hospital / Baylor College of Medicine was used by Biological E Limited, India to develop & manufacture CORBEVAX ®, the COVID-19 vaccine and approximately 100 million doses have been administered to people in India HOUSTON, Jan. 22, 2024 /PRNewswire/ -- Texas Children's Hospital announces today that Biological E's CORBEVAX®, a traditional, recombinant protein-based COVID-19 vaccine has received World Health Organization (WHO) approval under Emergency Use Listing (EUL). CORBEVAX® is developed and commercialized by Biological E Limited, an established global vaccine supplier based in Hyderabad, India, using Pichia pastoris yeast strain expressing Receptor Binding Domain (RBD) protein of SARS-CoV-2 engineered by Texas Children's Hospital Center for Vaccine Development (CVD) and Baylor College of Medicine (BCM), WHO's EUL procedure applies international standards to evaluate the acceptability of vaccine quality, safety and effectiveness in the context of a public health emergency. The mission of WHO pre-qualification is to work in close cooperation with national regulatory agencies and other partner organizations, such as UNICEF and other UN agencies, to make quality priority medical products available for those who urgently need them. "The latest approval of CORBEVAX® under WHO's EUL procedure is a testament to Texas Children's Hospital's established methodology to express important antigenic proteins which will help in the worldwide fight against COVID-19," said Mark A. Wallace, Chief Executive Officer of Texas Children's Hospital. "The recombinant yeast strains enable production of the RBD protein which can be further utilized by vaccine researchers globally to develop & manufacture effective and low-cost vaccines. By providing access to the yeast strains via non-exclusive licensing, we continue our mission to support global vaccine accessibility and availability." Texas Children's Hospital Center for Vaccine Development and BCM Ventures, Baylor College of Medicine's integrated commercialization arm, licensed the recombinant Pichia pastoris yeast strain that expresses the RBD protein of SARS-CoV-2 to Biological E Limited in 2020. Biological E subsequently developed large scale manufacturing technology for production of the RBD protein complying with Good Manufacturing Practices (GMP) as well as testing & characterization suitable for use as vaccine antigen. The RBD protein was then used as an antigen and formulated with optimized adjuvants (Alum and CpG1018) to develop a COVID-19 candidate vaccine. Biological E advanced the candidate vaccine through multiple clinical trials which led to the approval of CORBEVAX® in India under Emergency Use Authorization by Drugs Controller General of India (DCGI) in a two-dose regimen for the primary immunization. These approvals were first granted for adults (18+ years) in December 2021, followed by adolescents (12-18 Years) in February 2022 and then children (5-12 Years) in April 2022. In June 2022, CORBEVAX® received EUA from DCGI, for use as a heterologous booster for people over the age of 18 who received COVAXIN or COVISHIELD for their primary immunization. Over 100 million doses of CORBEVAX® have been administered to people in India so far. "Achieving approval under WHO's EUL procedure represents an important step toward our goal of helping development of low-cost vaccines for the world's most vulnerable populations," said Dr. Peter Hotez, Co-Director of the Center for Vaccine Development at Texas Children's Hospital and Dean of the National School of Tropical Medicine at Baylor College of Medicine. "Countries around the world will rely on the WHO's EUL to CORBEVAX® and Biological E's established manufacturing and supply capacity to provide safe, effective inoculation against COVID-19." "WHO's recognition that CORBEVAX® qualifies under its EUL procedure will expedite the availability of a safe and effective COVID-19 vaccine developed using the RBD antigen of SARS-CoV-2 producing strain from Texas Children's Hospital," said Dr. Maria Elena Bottazzi, Co-Director of the Center for Vaccine Development at Texas Children's Hospital and Associate Dean of the National School of Tropical Medicine at Baylor College of Medicine. "Our team of scientists has worked diligently for years to bring effective and affordable technologies to those who have been overlooked, with the ultimate goal of providing global solutions to health emergencies." Ms. Mahima Datla, Managing Director, Biological E Limited, said: ``We are pleased to receive this significant endorsement from WHO for CORBEVAX®, our COVID-19 vaccine. This approval will provide us with an opportunity to get closer to complete the fight against COVID-19 and make our vaccine available worldwide." Biological E has also licensed a yeast strain expressing XBB.1.5 RBD variant of SARS-CoV-2 virus from BCM/CVD and has developed a candidate vaccine based on CORBEVAX® platform as per WHO TAG-CO-VAC guidelines for future COVID19 vaccines to address the currently circulating variants. Biological E has completed requisite pre-clinical studies and have received approval from the Central Drugs Standard Control Organization (CDSCO) to begin pivotal clinical trials in India Drs. Peter Hotez and Maria Elena Bottazzi and their team received the David and Beatrix Hamburg Award for Advances in Biomedical Research and Clinical Medicine for their vaccine technology development work from the National Academy of Medicine. In 2022, Drs. Hotez and Bottazzi were nominated for the 2022 Nobel Peace Prize and also named two of Fast Company's 2022 Most Creative People in Business for their work in bringing a safe, streamlined, low-cost vaccine technology to the world. ABOUT TEXAS CHILDREN'S HOSPITAL Texas Children's Hospital, a not-for-profit health care organization, is committed to creating a healthier future for children and women throughout the global community by leading in patient care, education and research. Consistently ranked as the best children's hospital in Texas, and among the top in the nation, Texas Children's has garnered widespread recognition for its expertise and breakthroughs in pediatric and women's health. The hospital includes the Jan and Dan Duncan Neurological Research Institute; the Feigin Tower for pediatric research; Texas Children's Pavilion for Women, a comprehensive obstetrics/gynecology facility focusing on high-risk births; Texas Children's Hospital West Campus, a community hospital in suburban West Houston; and Texas Children's Hospital The Woodlands, the first hospital devoted to children's care for communities north of Houston. The organization also created Texas Children's HealthPlan, the nation's first HMO for children; has the largest pediatric primary care network in the country, Texas Children's Pediatrics; Texas Children's Urgent Care clinics that specialize in after-hours care tailored specifically for children; and a global health program that's channeling care to children and women all over the world. Texas Children's Global Health program leads efforts that advance health care equity through innovative collaboration in care, education and research for underserved populations globally. Texas Children's Hospital is affiliated with Baylor College of Medicine. For more information, go to. Get the latest news by visiting the online newsroom and Twitter at twitter.com/texaschildrens. ABOUT TEXAS CHILDREN'S HOSPITAL CENTER FOR VACCINE DEVELOPMENT Texas Children's Hospital Center for Vaccine Development is one of the leading vaccine development centers in the world. Established in Washington DC as the Sabin Vaccine Institute Product Development Partnership (PDP) in the year 2000 and after relocating to the Texas Medical Center in 2011, it rebranded as Texas Children's Center for Vaccine Development. For the past two decades it has acquired an international reputation as a non-profit PDP, advancing vaccines for poverty-related neglected tropical diseases (NTDs) and emerging infectious diseases of pandemic importance. In addition, it builds and strengthens capacity for vaccine development locally and with foreign nations and leads global efforts to guide and influence vaccine policy and advocacy through "vaccine diplomacy" as an international bridge for peace and vaccine development capacity. ABOUT BIOLOGICAL E. LIMITED Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to more than 130 countries and its therapeutic products are sold in India and the USA, Europe. BE currently has 8 WHO-prequalified vaccines and 10 USFDA approved generic Injectables in its portfolio. In recent years, BE has embarked on new initiatives for organizational expansion such as developing specialty injectable products for global markets as a means to manufacture APIs sustainably and developing novel vaccines for the global market. SOURCE Texas Children's Hospital