Ascentage Pharma Announces Another Milestone Payment from Its Licensee UNITY Biotechnology, Rapidly Advancing the Clinical Development of Senolytic Drug Candidate UBX1325

Rhea-AI Summary

Ascentage Pharma has announced a milestone payment of US$2 million from its licensee, UNITY Biotechnology (NASDAQ:UBX), following positive Phase I clinical data for UBX1325, a Bcl-xL inhibitor aimed at advanced vascular eye diseases. The study showed that most patients with advanced diabetic macular edema or wet age-related macular degeneration improved rapidly after treatment. The first patient has also been dosed in the subsequent Phase IIa study, indicating significant progress in the clinical development of senolytic therapeutics.

Positive

• Milestone payment of US$2 million from UNITY in common stock.
• Phase I study demonstrated rapid improvement in patients treated with UBX1325.
• UBX1325 showed good tolerability with no treatment-related adverse events.

Negative

• None.

SUZHOU, China, and ROCKVILLE, Md., July 28, 2021 /PRNewswire/ -- Ascentage Pharma (6855.HK), 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. ("UNITY", NASDAQ:UBX), 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 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

 

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SOURCE Ascentage Pharma

FAQ

What is the significance of the US$2 million milestone payment from UNITY Biotechnology for UBX1325?

The milestone payment reflects the progress in clinical development, indicating that UNITY successfully moved from Phase I to Phase IIa trials for UBX1325.

What were the results of the Phase I clinical study for UBX1325?

Patients with advanced diabetic macular edema or wet age-related macular degeneration showed rapid improvement, and the drug was well tolerated without adverse events.

What does the dosing of the first patient in Phase IIa mean for UBX1325?

Dosing the first patient in Phase IIa indicates ongoing advancement in the clinical development of UBX1325, targeting a broader patient population.

What is UBX1325 and what conditions does it target?

UBX1325 is a Bcl-xL inhibitor being developed for treating advanced vascular eye diseases, specifically diabetic macular edema and wet age-related macular degeneration.