(LOWER GWYNEDD, Pennsylvania, April 5, 2022) Tavotek Biotherapeutics announced today that its first pipeline biologic asset, TAVO103A, had been successfully dosed in two human subjects in the ICON Phase 1 Clinical Trial Center in Salt Lake City, Utah. TAVO103A is a best-in-class human monoclonal antibody developed for chronic inflammation. This study, termed TAVO103A-0001, is a double-blind, randomized, placebo-controlled Phase 1 evaluation of the safety, tolerability, immunogenicity, and PK/PD of TAVO103A in human volunteer subjects. The US IND was filed in late December 2021 and was approved by the FDA in January 2022.
Meanwhile, the IND of another biologic, TAVO101, has also been approved for human testing in Australia in January 2022 at the CMAX Phase 1 Clinical Trial Center in Adelaide, Australia. TAVO101 is also a best-in-class human monoclonal antibody developed for allergic diseases. The study, termed TAVO101-0001, is also a double-blind, randomized, placebo-controlled Phase 1 study. The study site is actively screening subjects for first-in-human dosing that will occur soon. Dr. Mann Fung, CEO of Tavotek stated, “Today is a historic moment for Tavotek, not only because our pipeline asset was first dosed in the human subjects, but this also officially transforms Tavotek from a preclinical company to a clinical-stage company. We are eager to bring our innovative assets to patients with unmet medical needs.”
“We are excited for the great progress that Tavotek has made over the past few years, “ said Dr. Mark Chiu, CSO of Tavotek. “Besides immunology assets, our first-in-class multispecific antibody for patients with solid tumors, TAVO412, is in late stage of preclinical development. We plan to file an IND to the US FDA and start human dosing in the second half of 2022. We are very excited and proud of our accomplishments.”
Tavotek is a biopharmaceutical company focused on discovering, acquiring, developing, and commercializing medicines for patients suffering from debilitating diseases with significant unmet medical needs. Tavotek has a rich pipeline of product candidates at various stages of development for cancer, autoimmune conditions, and inflammatory diseases. For more information, please visit www.tavotek.com.