Ascentage Pharma Establishes Cooperative R&D Agreement (CRADA) with the National Cancer Institute for Clinical Development of Ascentage Pharma's Drug Compound pelcitoclax

Ascentage Pharma, a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, announced that the company has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of National Institutes of Health, under which they will collaborate on the non-clinical and clinical development of Ascentage Pharma's drug compound pelcitoclax.

Under the terms of the CRADA, Ascentage Pharma and the NCI will collaborate on a series of clinical trials to evaluate the safety and efficacy of pelcitoclax, Ascentage Pharma's dual inhibitor of BCL-2 and BCL-xL proteins, in solid tumors based upon encouraging anti-tumor activity observed in studies conducted by Ascentage Pharma. The NCI may also conduct non-clinical correlative studies that focus on exploring the biologic activity of pelcitoclax, as well as combination studies of the compound with other targeted agents.

As data from the NCI -sponsored studies and other Ascentage-sponsored trials emerge, the NCI and Ascentage will discuss additional studies to support the development of pelcitoclax.

"Our CRADA with the NCI reinforces our commitment to maximize the clinical potential of pelcitoclax in solid tumors and is aligned with our efforts to advance our pipeline," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma.

"This CRADA will combine the scientific expertise of the NCI and Ascentage Pharma, in generating additional clinical data that may highlight pelcitoclax's differentiated clinical profile in multiple different indications and address important patient unmet medical need," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma.

About Pelcitoclax (APG-1252)

Pelcitoclax (APG-1252) is a novel, dual inhibitor of BCL-2 and BCL-xL proteins developed by Ascentage Pharma and was designed using a prodrug strategy that improves its therapeutic index, decreases cell permeability, and reduces platelet toxicity. Pelcitoclax binds to BCL-2 and BCL-xL molecules with high affinity and in preclinical models exhibits potent antileukemic activity.

In a multicenter, open-label, dose escalation, phase I study, the safety, pharmacokinetics, and preliminary efficacy of pelcitoclax were evaluated in patients with metastatic small-cell lung cancer (SCLC) or other solid tumors (ClinicalTrials.gov Identifier: NCT03080311). To overcome treatment resistance, combining BCL-2 inhibitors with other therapies is also a potentially viable clinical strategy. Currently, pelcitoclax is being evaluated in combination with paclitaxel in relapsed or refractory SCLC (ClinicalTrials.gov Identifier: NCT04210037).

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong, S.A.R., China Limited with the stock code: 6855.HK.

Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. The company has built a pipeline of eight clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 40 Phase I/II clinical trials in the US, Australia, Europe, and China. Ascentage Pharma has been designated for multiple Major National R&D Projects, including five Major New Drug Projects, one New Drug Incubator status, four Innovative Drug Programs, and one Major Project for the Prevention and Treatment of Infectious Diseases. HQP1351, the company's core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML), has been granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA. A New Drug Application (NDA) for HQP1351 has been submitted and subsequently granted Priority Review status and a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) in China. To date, Ascentage Pharma has obtained a total of 11 ODDs from the US FDA for 4 of the company's investigational drug candidates.

Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights, and entered into global partnerships with numerous renowned biotechnology and pharmaceutical companies and research institutes such as UNITY Biotechnology, MD Anderson Cancer Center, Mayo Clinic, Dana-Farber Cancer Institute, MSD, and AstraZeneca. The company has built a talented team with global experience in the discovery and development of innovative drugs, and is setting up its world-class commercial manufacturing and Sales & Marketing teams. Ascentage Pharma aims to continuously strengthen its R&D capabilities and accelerate its clinical development programs to fulfil its mission of 'addressing unmet clinical needs in China and around the world' for the benefit of more patients.