On March 29, 2021 Fortis Therapeutics, Inc., an immuno-oncology biotech developing FOR46, a novel antibody drug conjugate (ADC) against CD46, reported the close of a $40 million Series A financing (Press release, Fortis Therapeutics, MAR 29, 2021, View Source [SID1234577290]). Participating in this financing are existing investors, Avalon Ventures, Bregua Corporation, Lilly Asia Ventures, Osage University Partners, and Vivo Capital, as well as new investors, the Myeloma Investment Fund, the venture philanthropy fund of the Multiple Myeloma Research Foundation (MMRF), and Fulcrum 2020, LLC, which shares a portion of its profits with the Prostate Cancer Foundation (PCF) to fund future research. The proceeds of the financing will be used to advance FOR46 in clinical trials for the treatment of relapsed or refractory multiple myeloma and metastatic castration-resistant prostate cancer (mCRPC).

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"Our existing investors and new investors, the Myeloma Investment Fund and Fulcrum 2020, see the promise of FOR46 ADC therapy that could help patients where other treatments have failed," said Jay Lichter, Ph.D., President and CEO of Fortis. "Our preliminary clinical data is very exciting, and we are actively advancing our clinical studies in prostate cancer and multiple myeloma and pursuing additional indications."

"PCF is pleased that the 2017 funding to UCSF for their research on CD46 has been leveraged by Fortis for a meaningful Series A financing," said Howard R. Soule, PhD, Executive Vice President and Chief Science officer of PCF. "We are hopeful that CD46 treatment strategies will become a therapeutic option for patients with advanced prostate cancer." In 2017, PCF funded translational research of CD46 that supported clinical advancement of FOR46 through a PCF Challenge Award, which provides $1 million for innovative research with the highest potential for accelerating new and improved treatments for advanced prostate cancer.

In addition, the MMRF supported early development of FOR46 through an immune translational research grant to Fortis Founder Bin Liu at UCSF. The results of that research, published in The Journal of Clinical Investigation in 2016, identified CD46 as a promising target for treatment of multiple myeloma.

For the clinical study in relapsed or refractory multiple myeloma, Fortis has completed single patient cohorts and dose finding and is now enrolling patients in an expansion cohort for treatment with 2.4 mg/kg or FOR46 (ClinicalTrials.gov Identifier: NCT03650491). For the clinical study in mCRPC, Fortis has completed patient enrollment in the dose escalation cohorts (up to 3.0 kg/mg) and is beginning enrollment in dose expansion cohorts in mCRPC and additional indications (ClinicalTrials.gov Identifier: NCT03575819).

About FOR46

FOR46 binds a specific conformational epitope of CD46, a novel immune modulatory receptor. CD46 is highly expressed in multiple tumor types, is part of the tumor’s immune defense shield, and appears to be specific to tumor cells. FOR46 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 demonstrated its potential to kill tumor cells with no effect on normal cells. Fortis Therapeutics exclusively licensed rights to the antibody in 2016 and maintains a strong intellectual property position.