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UNITY Biotechnology Announces Completion of UBX1967 License and Advance into IND-Enabling Studies for Age-Related Diseases of the Eye

SAN FRANCISCO, Jan. 03, 2019 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ:UBX], a biotechnology company developing therapeutics to extend human healthspan by slowing, halting or reversing diseases of aging, today announced it has selected UBX1967 as the lead development candidate in the ophthalmology pipeline for advancement into studies to enable an Investigational New Drug (IND) application and executed the compound license agreement for the compound with Ascentage Pharma Group Corp Limited (“Ascentage Pharma”) under a previously agreed compound library agreement. UBX1967 is being evaluated in a range of age-related diseases of the eye, including neovascular age-related macular degeneration, proliferative diabetic retinopathy and diabetic macular edema. UNITY plans to file an IND application for UBX1967 in the second half of 2019.

“UBX1967 represents a novel approach to treating age-related eye diseases, potentially eliminating the source of multiple disease-causing factors,” said Dan Marquess, D. Phil., chief scientific officer at UNITY. “We are excited to move this program into IND-enabling studies with the goal of filing an IND in the second half of 2019 and pursuing multiple age-related eye indications in the clinic.”

About UBX1967
UBX1967, a potent senolytic small molecule inhibitor of particular members of the Bcl-2 family of apoptosis regulatory proteins, targets proteins senescent cells rely on for survival. UNITY entered into a license agreement with Ascentage Pharma granting UNITY the exclusive worldwide development and commercialization rights and non-exclusive manufacturing rights outside of Greater China (China, Hong Kong, Macau and Taiwan) for UBX1967 in all non-oncology indications. Inside Greater China, UNITY is obligated to commercialize UBX1967 through a joint venture with Ascentage Pharma. The UBX1967 License Agreement also grants UNITY the right to continue its preclinical development efforts with respect to another Ascentage Pharma-controlled Bcl-2 inhibitor compound that will serve as a back-up to UBX1967.

About Cellular Senescence and Senolytic Medicines
Cellular senescence is a natural biological state in which a cell permanently halts division. Senescent cells accumulate with age and secrete as many as 100 different biologically active proteins, including pro-inflammatory factors, proteases, pro-fibrotic factors and growth factors that disturb the tissue microenvironment. This collection of secreted proteins is referred to as the SASP. In addition to its effects on tissue function, the SASP contains factors that induce senescence in neighboring cells, setting off a cascade of events that culminates in the formation of the functionally aged and/or diseased tissue that appears to underlie a variety of age-related diseases. UNITY believes that the elimination of senescent cells will remove SASP factors—addressing a root cause of diseases of aging. Senolytic medicines, or treatments designed to selectively remove senescent cells, target the SASP at its source, and may have a more durable impact on certain diseases of aging than current therapies.

About UNITY
UNITY is developing therapeutics to extend healthspan by slowing, halting or reversing diseases of aging. UNITY's initial focus is on creating senolytic medicines to selectively eliminate senescent cells and thereby treat age-related diseases, such as osteoarthritis, eye diseases and pulmonary diseases. More information is available at www.unitybiotechnology.com or follow us on Twitter.

About Ascentage Pharma
Ascentage Pharma is a globally-focused, clinical-stage biopharmaceutical company developing novel small molecule therapies for cancers, hepatitis B and age-related diseases. Based on breakthrough technology from the University of Michigan, the Company’s expertise is in designing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death, in cancers. Ascentage Pharma has built a rich pipeline of seven clinical candidates, including a novel, highly potent Bcl-2/Bcl-xL inhibitor, APG-1252, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors. For more information, please visit www.ascentagepharma.com.

Forward-Looking Statements
This press release contains forward-looking statements, including but not limited to statements related to the role of cellular senescence in diseases of aging, UNITY’s potential to selectively eliminate senescent cells and thereby treat patients with age-related diseases, and UNITY’s ability to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including UNITY’s ongoing pre-clinical studies of UBX1967 to support the filing of an IND application in the second half of 2019. Such forward-looking statements involve substantial risks and uncertainties that could cause UNITY’s research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including UNITY’s early stage of development and its understanding of senescence biology, the clinical trial process, UNITY’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials and pre-clinical studies, and the results of preclinical studies may not be predictive of future results. UNITY undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see UNITY’s most recently filed Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, filed with the Securities and Exchange Commission on November 7, 2018, as well as other documents that may be filed by UNITY from time to time with the Securities and Exchange Commission.


Media & Investors
Austine Graff
707-593-6151
austine.graff@unitybiotechnology.com