Fortis Therapeutics Receives FDA Clearance of Two IND Applications for Novel Anti-CD46 Therapeutic for Treatment of Late-Stage Prostate Cancer and Multiple Myeloma

SAN DIEGO--(BUSINESS WIRE)-- 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 innovation 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

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.



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Source: Fortis Therapeutics, Inc.

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