FDA Clears Two IND Applications for Fortis Therapeutics Novel Anti-CD46 Candidate for Prostate Cancer and Multiple Myeloma

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  • In rodents with human prostate cancer, FOR46 eliminated the tumor and led to long-term survival
  • At this point, Fortis is focused on moving a single asset (FOR46) forward


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.”

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. In a discussion in January of 2018,  Fortis CEO, Jay Lichter, said that the company was formed to move FOR46 forward. Though the company was not considering offers at the time of the interview, Lichter did say that the ideal outcome would be to sell the company once FOR46 development was more advanced.