(LOWER GWYNEDD, Pennsylvania, October 28, 2022) Tavotek Biotherapeutics announced today that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a two-part Phase 1, first-in-human (FIH), clinical study of TAVO412 for the treatment of advanced or metastatic solid tumors. TAVO412 is a novel multi-specific antibody targeting cMET, EGFR, and VEGF and was created and engineered by using the company’s proprietary TavoSelect^TM and TavoPrecise^TM platforms. The US IND was filed in late September 2022 and was approved by the FDA within 30 days.

TAVO412 can synergistically block angiogenesis within tumors while shutting down the cMET and EGFR signaling pathways. In addition, unique Fc engineering further enhances the molecule through antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement-dependent cytotoxicity (CDC). These mechanistic biological activities ensure a maximum killing effect on tumor cells.

TAVO412 maximizes anti-tumor efficacy through multi-target synergistic effects within the tumor microenvironment. When compared to competitive products in the market, TAVO412 demonstrated better efficacy and greater safety in preclinical animal models of diverse solid tumors that include, but not limited to, lung cancers, pancreatic cancers, triple-negative breast cancers, and gastric cancers. Furthermore, the safety profile of TAVO412 in the targeted therapeutic doses from preclinical non-human primate studies was also very favorable.

Dr. Mann Fung, CEO of Tavotek, said: “We are pleased with the FDA’s clearance of our TAVO412 IND application. This is our third approved clinical trial, and we are excited to keep this momentum going. Tavotek has the opportunity to bring first-in-class multi-specific antibodies to cancer patients who have high unmet medical needs, which is the core driving force behind the development of our company. We have established a number of innovative R&D pipelines for targeting oncology and autoimmune diseases, as well as multi-specific antibody technology platforms. The continued success of these assets demonstrated Tavotek has the capability and expertise to develop novel therapeutic products for patients and we look forward to having an important impact in the field of providing innovative cancer treatments.”

In addition to receiving clinical approval for the TAVO412 IND application, the company reported that its two other clinical assets, TAVO101 and TAVO103, are advancingly smoothly in Phase 1 trials in Australia and the United States, respectively. TAVO101 is a best-in-class human monoclonal TSLP antibody developed for allergic diseases. TAVO103 is a best-in-class human monoclonal IL-1b antibody developed for chronic inflammation. TAVO103 has completed dosing for all subjects in the Phase 1 trial, with TAVO101 also nearing completion. The available data have shown that TAVO101 and TAVO103 have significant advantages by extending the half-life significantly, when compared to other competitive products currently in the market. Both assets are expected to finish off their Phase I clinical trials by the end of the year and early 2023.

About Tavotek

Tavotek Biotherapeutics is a multi-specific antibody drug company with the world's cutting-edge protein engineering technology, focusing on oncology and immunology diseases. The company's R&D is mainly built on three innovative breakthrough technology platforms, namely: TavoSelect^TM, a bacteriophage biobank with AI assisted 3D selection; TavoPrecise^TM, a sophisticated protein engineering platform that supports the development of bispecific and multi-specific antibodies, and TavoELITE^TM, an innovative synthetic biologic platform focusing on overcoming intracellular undruggable targets with particular focus on protein-protein interaction.

With unique innovative R&D capabilities, biomarker-driven clinical development strategies, and efficient execution efficiency, Tavotek will provide treatment options with better efficacy, safety and convenience to advance medical care for patients.