San Diego, CA (Press Release) – Fortis Therapeutics, Inc., an immuno-oncology bio­tech devel­op­ing a novel anti­body-drug con­ju­gate (ADC) against CD46, today announced the U.S. Food and Drug Admin­istra­tion (FDA) has cleared two inves­ti­ga­tional new drug (IND) appli­ca­tions for the com­pany’s lead can­di­date, FOR46, for the treat­ment of metastatic castration-resistant prostate cancer and late-stage multiple myeloma. The Phase 1 trial of FOR46 in metastatic castration-resistant prostate cancer is planned to launch by the end of the year. The second pro­gram, in late-stage multiple myeloma, is ex­pec­ted to move into clin­i­cal trials in early 2019.

FOR46 targets a novel immune modulatory re­cep­tor, CD46, which is highly ex­pressed in multiple tumor types and is part of the tumor’s immune defense shield. While CD46 is ex­pressed through­out the body, pre­clin­i­cal studies show that FOR46 activity is primarily restricted to prostate and other tumor tissue types, as opposed to nor­mal tissue.

“CD46 is an attractive target for a number of cancers but has yet to be exploited due to its role in healthy tissues,” said Jay Lichter, Ph.D., Pres­i­dent and CEO of Fortis Therapeutics. “FOR46 cracks the code, in a sense, by binding a specific conformational epitope of CD46, that appears to be specific to tumor cells. This results in targeted tumor killing, while not impacting the natural role of CD46 in the complement sys­tem.”

Discovery of FOR46

The FOR46 pro­gram originated at the University of California, San Francisco, in the laboratory of Bin Liu, Ph.D. It was identified through an anti­body selection process that uses living tumor cells residing in their tissue microenvironment, thereby preserving the natural range of surface an­ti­gens present on the cells.

“It’s really a testament to the work of our scientists and the scientists at UCSF. By generating anti­bodies against tumor cells in situ, we devel­oped a drug that readily translates to animal studies and, soon, human trials,” said Marc Nasoff, Ph.D., Chief Scientific Officer of Fortis Therapeutics. “We're confident in the science and in our thera­peutic, which builds upon decades of inno­va­t and refinement of anti­body-drug con­ju­gates.”

To create FOR46, the fully human anti­body was con­ju­gated to a potent pay­load using a proven chemistry plat­form with well-characterized in vivo properties. Early in vitro studies of FOR46 have dem­onstrated its poten­tial to kill tumor cells with no effect on nor­mal cells. In rodents with human prostate cancer, it elim­i­nated the tumor and led to long-term survival.

Fortis Therapeutics exclusively licensed rights to the anti­body in 2016, and the com­pany main­tains a strong intellectual property position.

About Fortis Therapeutics

Fortis Therapeutics is an immuno-oncology bio­tech devel­op­ing a novel anti­body-drug con­ju­gate for late-stage multiple myeloma and metastatic castration-resistant prostate cancer. Fortis Therapeutics was founded based on tech­nology exclusively licensed from UCSF and devel­oped in the laboratory of Bin Liu, Ph.D. The com­pany’s in­­vestors are Avalon Ventures, Bregua Corpo­ra­tion, Lilly Asia Ventures, Osage University Partners, and Vivo Capital. Fortis Therapeutics is located in COI Pharma­ceu­ticals, Avalon’s Community of Innovation, in San Diego. For more in­for­ma­tion, please visit http://www.coipharma.com/portfolio/.

UC Disclaimer

The in­for­ma­tion stated above was prepared by Fortis Therapeutics and reflects solely the opinion of the corporation. Nothing in this state­ment shall be construed to imply any sup­port or endorsement of Fortis Therapeutics, or any of its prod­ucts, by The Regents of the University of California, its officers, agents and employees.

Source: Fortis Therapeutics.