Baiya SARS-CoV-2 Vax 2, an adjuvant-containing protein vaccine based on antigens produced in plants by BaiyaPharmingTM, is undergoing clinical trials after showing favorable induced response to SARS-CoV-2 in animal models.
Preliminary results of the first clinical trial on humans show that the vaccine is safe and that clinical trials should continue.
Study Design
The ongoing phase 1 trial is a dose-escalating open-label study to evaluate the Baiya SARS-CoV-2 Vax2 vaccine in healthy adult participants. This first-in-human clinical trial aims to evaluate the safety, tolerability, and reactogenicity of the escalation to potentially therapeutic doses of Baiya SARS-CoV-2 Vax 2. More information about this trial can be accessed at Clinicaltrials.gov (identifier: NCT05197712). This ongoing trial is reviewed by an independent Data Safety Monitoring Board (DSMB). During the latest review, the DSMB identified an acceptable safety profile and recommended the trial continue with the second cohort.
About Baiya SARS-CoV-2 Vax 2
Baiya’s SARS-CoV-2 Vax 2 is a second-generation plant-produced vaccine modelled on the prototype (Wuhan) SARS-CoV-2 RBD antigen adjuvanted with 3M-052-AF-alum. The preclinical study demonstrated that the vaccine strongly improved immune responses against SARS-CoV-2 and its variants, compared to our first-generation vaccine. Data demonstrates high protective efficacy of the second-generation lead candidate, Baiya SARS-CoV-2 Vax 2, in an animal model during the SARS-CoV-2 challenge study. Across the safety and toxicity studies in non-human primates and rats, our vaccine candidate showed a favorable safety and tolerability profile.
About 3M-052-AF adjuvant formulation
3M-052-AF comprises a toll-like receptor (TLR) 7/8 agonist developed by 3M and formulated by the Access to Advanced Health Institute. The adjuvant formulation has been tested in human clinical trials with a proven safety profile. Preclinical studies evaluating 3M-052-AF in combination with various SARS-CoV-2 protein antigens show that the adjuvant formulation plays an important role in inducing broadly neutralizing antibodies, providing protection against variants of concern. Learn more about 3M-052-AF used with alum by visiting the National Institute of Health’s Vaccine Adjuvant Compendium profile.
Phase 1 Preliminary safety results
This first-in-human clinical trial of Baiya SARS-CoV-2 Vax 2 began in March 2022 and enrolled healthy adults aged 18 to 64 years to receive the vaccine at the assigned dose via two intramuscular injections 21 days apart. The preliminary data from the first cohort of 12 participants demonstrated that there were no clinically significant changes in vital signs during the first 120 minutes of observation.
All the clinical parameters remained within normal ranges after each vaccination. The common local and systemic reactions solicited adverse events on day 7 after each vaccination and subsided by day 14. There was no report of medically attended adverse events or new-onset of chronic medical conditions from day 1 up to day 50. In addition, no serious adverse events related to the study investigational product were reported. No participant withdrew from the study due to adverse events. The adverse events were predictable and manageable.
Baiya SARS-CoV-2 Vax 2 is safe for healthy adults with the potential to induce immune responses.
About BaiyaPhytopharm
BaiyaPhytopharm is a clinical-stage biopharmaceutical company focused on strengthening health security for all people using the BaiyaPharmingTM platform. The platform has the flexibility to produce biopharmaceutical products of interest within weeks rather than months or years, resulting in faster and lower-cost research and development.
Our team combines deep technical expertise in plant biotech, pharmaceutical production and clinical development capabilities to create biologic candidates with high unmet medical needs in the ASIA-Pacific region. We have generated a broad proprietary portfolio of candidates including monoclonal antibodies for cancer or infectious disease and new vaccines for neglected tropical diseases. For more information, please visit www.baiyaphytopharm.com or follow us on Twitter @baiyaphytopharm and Linkedin.
About AAHI
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 COVID-19, 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 innovation 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 and Twitter @AAHITweets.
3M (NYSE: MMM) believes science helps create a brighter world for everyone. By unlocking the power of people, ideas and science to reimagine what’s possible, our global team uniquely addresses the opportunities and challenges of our customers, communities, and planet. Learn how we’re working to improve lives and make what’s next at 3M.com/news or on Twitter at @3M or @3MNews.
Media Contacts:
Casey Benadof
Media@aahi.org
(206) 960-1479
Kittinop Kittirotruji
info@baiyaphytpopharm.com
+66 (98)745-0529