Unity takes up option on Ascentage aging drug

A collaboration between California’s Unity Biotech and China’s Ascentage Pharma has yielded a development candidate to treat age-related diseases of the eye.

Unity and Ascentage have been working together since the middle of 2016 on “senolytic drugs,” compounds that can remove aging or senescent cells from the body that are thought to contribute to a range of age-related illnesses. Clearing the cells seems to delay the onset of these disorders, according to animal studies. The collaboration has focused on the Bcl-2 pathway, thought to play a key role in programmed cell death or apoptosis.

The first drug to emerge from that effort is UBX1967, which could have potential in a range of eye disorders including age-related macular degeneration (AMD) as well as diabetic macular edema and diabetic retinopathy, says Unity.

The company's lead drug candidate is UBX0101, an inhibitor of p53-MDM2 interaction which is in early-stage testing for osteoarthritis, and UBX1967 will be its second clinical program.

The multibillion-dollar market for drugs to treat AMD and similar retinal conditions is dominated by biologic anti-VEGF drugs like Lucentis and Eylea, which can slow the progression of the disease but have to be delivered by injection directly into the eye. There could be strong demand for a small-molecule alternative that could be dosed orally or via eye drops.

Other companies company trying to develop alternatives to injectables for retinal diseases include startup Macregen, which has an eye drop-delivered peptide in clinical trials, and PanOptica with oral VEGF inhibitor PAN-90806 in phase 1/2.

Unity’s intention is to start dosing its drugs locally in the first instance to get proof-of-concept, and if successful start to explore systemic dosing that could open up new disease indications.

“We plan to submit our IND application and commence a phase 1 clinical study [of UBX1967] in an ophthalmological indication in the second half of 2019,” says Unity on its website.

Ascentage’s CEO Dajun Yang, M.D., Ph.D., said the company is “pleased that Unity has chosen one of our compounds for IND-enabling studies focused on age-related diseases of the eye.”

“Their decision further validates our industry-leading expertise in the discovery and development of small molecules for complex and difficult-to-target protein-protein interactions including Bcl-2 and other apoptotic pathways,” he added.

The latest compound licensing agreement puts Ascentage in line for an undisclosed upfront payment in Unity stock, as well as cash milestone payments and royalties. Unity completed an $85 million IPO last year to help fund its clinical programs.