– 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 atwww.clinicaltrials.gov.
About Astellas Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. We focus on Urology, Oncology, Immunology, Nephrology and Neuroscience as prioritized therapeutic areas while advancing new therapeutic areas and discovery research leveraging new technologies/modalities. We are also creating new value by combining internal capabilities and external expertise in the medical/healthcare business. Astellas is on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website athttps://www.astellas.com/en.
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Founded in 2014, Potenza Therapeutics, Inc. is a clinical-stage biotechnology company focused on building a portfolio of oncology programs that utilize the body’s own immune system to seek out, recognize and destroy tumors through a diversity of mechanisms that influence tumor immunity. In April 2015 Potenza and Astellas Pharma Inc. entered an exclusive collaboration that includes an option for Astellas to acquire Potenza. Potenza’s offices and laboratories are located in Cambridge, MA.