Ascentage Pharma, a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that its global licensee, UNITY Biotechnology, Inc., has reported encouraging data from a Phase I clinical study of UBX1325, an investigational Bcl-xL inhibiting compound, in patients with certain advanced vascular eye diseases, and has already dosed the first patient in the subsequent Phase IIa clinical study. UBX1325 is developed from BM-962, a drug candidate licensed to UNITY by Ascentage Pharma for the clinical development targeting age-related diseases. According to the terms of the licensing agreement previously entered into between Ascentage Pharma and UNITY, this progress in clinical development will qualify Ascentage Pharma for a milestone payment in the amount of US$2 million, which will be paid in UNITY common stock.

UBX1325 is a small-molecule inhibitor of Bcl-xL, and the first senolytic therapeutic clinically evaluated in an ophthalmological setting. UBX1325 is designed to inhibit the function of proteins that senescent cells rely on for survival and could potentially provide a valuable alternative or adjunctive treatment option to anti-VEGF therapies. As UNITY reported in its press release1, in the Phase I study that evaluated the safety of UBX1325 in patients with advanced diabetic macular edema (DME) or wet age-related macular degeneration (wet AMD) for whom anti-VEGF therapy was no longer considered beneficial, the majority of patients with DME or wet AMD treated with a single injection of UBX1325 achieved rapid improvement in key outcome measures. In terms of tolerability and safety, UBX1325 was shown to be well-tolerated with no treatment-related adverse events or dose-limiting toxicities (DLT). Furthermore, the first patient has already been dosed in a Phase IIa clinical study assessing the safety and efficacy of UBX1325 in a broader population of patients with DME.

In 2016, Ascentage Pharma, a bio pharmaceutical company and UNITY entered into a strategic licensing agreement, whereby UNITY is authorized to screen Ascentage Pharma's Bcl-2 compound series for developing treatments for age-related diseases. The compound BM-962 was selected by UNITY from Ascentage Pharma's library for the development of UBX1325. Pursuant to the licensing agreement, Ascentage Pharma retains the rights to such compound in the Greater China region and plans to potentially establish a joint venture company with UNITY in the future for the development and commercialization of the compound in China.

UNITY is committed to focusing on the development of senolytic therapeutics that eliminate or modulate senescent cells, to slow, halt, or even reverse age-related diseases.

"The continued progress in the clinical development of UBX1325 demonstrated Ascentage Pharma's capabilities in the research and development of apoptosis-targeted therapies," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "We hope UNITY will achieve more encouraging results from this clinical development program. Together, the two companies will strive to advance the development of senolytic therapeutics and bring hope to patients around the world."

Reference

1.    UNITY Biotechnology announces positive data from Phase I clinical trial of UNX1325 in patients with advanced vascular eye disease. Link: https://ir.unitybiotechnology.com/news-releases/news-release-details/unity-biotechnology-announces-positive-data-phase-1-clinical