13 November 2018 - - The US Food and Drug Administration has cleared two investigational new drug applications for US-based immuno-oncology biotechnology company Fortis Therapeutics, Inc's lead candidate, FOR46, for the treatment of metastatic castration-resistant prostate cancer and late-stage multiple myeloma, the company said.

The Phase 1 trial of FOR46 in metastatic castration-resistant prostate cancer is planned to launch by the end of the year. The second programme, 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.

The FOR46 programme 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.

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.

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 Corp., Lilly Asia Ventures, Osage University Partners, and Vivo Capital. Fortis Therapeutics is located in COI Pharmaceuticals, Avalon's Community of Innovation, in San Diego.