Potenza Therapeutics Unveils Pipeline of Immuno-Oncology Programs

– Next Generation Checkpoint Inhibitor Enters Phase 1 Study –

CAMBRIDGE, Mass. — (BUSINESS WIRE) — Potenza Therapeutics today provided insights into its portfolio of immuno-oncology therapies that turn on or off the signaling mechanisms that control a patients‘ own immune system to recognize and destroy cancer. The lead program in Potenza's portfolio is its next-generation checkpoint inhibitor, a novel TIGIT antagonist PTZ-201 (ASP8374) which is being developed in partnership with Astellas Pharma Inc. and its affiliates (“Astellas”). In addition, Potenza and Astellas are jointly working on two additional preclinical molecules expected to complete IND-enabling studies in 2018: PTZ-329, which targets a novel immune regulatory pathway; and PTZ-522, a novel approach to a well-validated but as-yet ineffectively addressed immune activating pathway.

“The team has made substantial scientific discovery and pre-clinical development progress since we launched Potenza in 2014 and established our R&D Collaboration with Astellas in April 2015,” said Dan Hicklin, PhD, co-founder of Potenza and the company’s Chief Executive Officer. “The current portfolio was carefully chosen and includes potential therapies that will be studied for use alone, in combination with standard of care, and in unique combination regimens with each other. The three programs that Potenza is pursuing may have the potential to provide benefit for patients in indications for whom there are currently no effective treatments.”

The Phase 1 clinical trial for PTZ-201 (ASP8374) is a dose escalation and expansion safety study in patients with advanced solid tumors with plans to expand into efficacy expansion cohorts in responding tumor types, and is sponsored by Astellas Pharma Global Development, Inc. The primary purpose of the study is to evaluate the tolerability and safety profile of ASP8374 in patients with locally advanced (unresectable) or metastatic solid tumors and to characterize the pharmacokinetic profile of ASP8374 and to determine the recommended Phase 2 dose (RP2D) of ASP8374. The secondary purpose of this study is to evaluate whether ASP8374 has an anti-tumor effect as monotherapy and ultimately in combination with a PD1 inhibitor. Details can be found at www.clinicaltrials.gov.