Ascentage Pharma to Announce Results from Four Clinical Studies at 2021 ASCO Annual Meeting, with Data of Its Drug Candidates Including Lisaftoclax (APG-2575) to Be Released in Oral Presentations for the First Time

SUZHOU, China and ROCKVILLE, Md., April 20, 2021 /PRNewswire/ -- Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that results from four clinical studies of the company's three apoptosis-targeted drug candidates have been selected for presentations at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. These include two oral presentations: one based on a global Phase I clinical study of the Bcl-2 inhibitor lisaftoclax (APG-2575); and the other based on a global Phase II clinical trial of the MDM2-p53 inhibitor alrizomadlin (APG-115) in combination with the PD-1 checkpoint inhibitor pembrolizumab.

Convening on June 4 to 8, 2021, the ASCO Annual Meeting showcases the most cutting-edge research in clinical oncology and the most advanced cancer therapies, and is the world's most influential and prominent scientific gathering of the clinical oncology community.

"This year marks the fourth consecutive year in which our clinical study results were selected for presentations at the ASCO Annual Meeting, and we are pleased to have an opportunity to share multiple progress from our clinical development programs," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "We are thrilled that the results from two of our clinical studies have been selected for oral presentations at the meeting this year. Through these oral presentations, we will release the data from the Phase I study of lisaftoclax at a prominent scientific event for the first time. This signifies the drug candidate's therapeutic potential and the global research community's strong interest in this novel therapeutic, and shows Ascentage Pharma's capability in the global research and development of apoptosis-targeted cancer therapies. We look forward to sharing detailed results during the meeting. Moving forward, we will strive to accelerate our clinical development programs to hopefully soon provide cancer patients with more treatment options."

At this year's ASCO Annual Meeting, Ascentage Pharma will present results from four clinical studies of the company's three apoptosis-targeted drug candidates as follows:

The novel Bcl-2 inhibitor lisaftoclax (APG-2575)

Lisaftoclax is a novel, orally administered small-molecule Bcl-2‒selective inhibitor being developed by Ascentage Pharma. Lisaftoclax is designed to treat hematologic malignancies and solid tumors by selectively blocking antiapoptotic protein Bcl-2 to restore the normal apoptosis process in cancer cells. Lisaftoclax is the first China-developed Bcl-2 inhibitor entering clinical development in China.

• Selected study: A global Phase I clinical study of lisaftoclax, a novel Bcl-2 inhibitor, in patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) and other hematologic malignancies (HMs)
  Format: Oral Presentation

This global multi-center, single-agent, open-label Phase I clinical study is designed to assess the safety, pharmacokinetics (PK), pharmacodynamic (PD), and efficacy of lisaftoclax, and to determine its maximum tolerated dose (MTD)/recommended Phase II dose (RP2D) in patients with R/R CLL and other HMs.

In the preliminary data released by Ascentage Pharma in December 2020, lisaftoclax has demonstrated an objective response rate (ORR) of 70%, with favorable tolerability and manageable safety profiles in patients with R/R CLL. Detailed updated results will be released in an oral presentation at the ASCO Annual Meeting during June 4 - 8, 2021.

The novel MDM2 inhibitor alrizomadlin (APG-115)

Being developed by Ascentage Pharma, alrizomadlin is an orally administered, selective, small-molecule inhibitor of the MDM2 protein. Alrizomadlin has strong binding affinity to MDM2 and is designed to activate tumor suppression activity of p53 by blocking the MDM2-p53 protein-protein interaction. Alrizomadlin is the first MDM2-p53 inhibitor entering clinical development in China, and is currently being investigated in multiple Phase Ib/II clinical studies in solid tumors and HMs in China, Australia and the US.

• Selected study: A Phase II study of alrizomadlin in combination with pembrolizumab in patients with unresectable or metastatic melanoma or advanced solid tumors that have failed immuno-oncologic drugs
  Format: Oral Presentation

This study is designed to evaluate the efficacy and safety of alrizomadlin in combination with pembrolizumab in patients with unresectable or metastatic melanoma or advanced solid tumors that have failed immuno-oncologic drugs.

The results of this Phase Ib study released at the 2020 ASCO Annual Meeting demonstrated that alrizomadlin in combination with pembrolizumab is well-tolerated, with preliminary antitumor activity in advanced solid tumors.

• Selected study: A Phase I/II trial of alrizomadlin, with or without platinum chemotherapy, in patients with p53 wild-type salivary gland carcinoma
  Format: Poster Presentation

This multi-center, open-label Phase I/II study in the US is designed to evaluate the efficacy of alrizomadlin, with or without platinum chemotherapy, in patients with p53 wild-type salivary gland carcinoma.

The Bcl-2/Bcl-xL inhibitor pelcitoclax (APG-1252)

Pelcitoclax is a novel, highly potent, small molecule drug designed to restore apoptosis through selective inhibition of Bcl-2 and Bcl-xL proteins.

• Selected study: A multi-center Phase Ib/II study of pelcitoclax plus paclitaxel in patients with relapsed/refractory small-cell lung cancer (R/R SCLC)
  Format: Poster Presentation

This multi-center, open-label Phase Ib/II study is designed to evaluate the safety and preliminary efficacy of combination therapy with pelcitoclax plus paclitaxel in patients with R/R SCLC.

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, CHB, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong 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, and China. Olverembatinib (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 olverembatinib has been submitted and subsequently granted Priority Review 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 four of the company's investigational drug candidates.

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SOURCE Ascentage Pharma

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