During the reporting period, Ascentage Pharma announced the updated data of lisaftoclax in Chinese patients with R/R CLL/SLL at the 2022 ASCO Annual Meeting. These data showed an objective response rate (ORR) of 67.4% and favorable tolerability. In terms of safety, most adverse events were manageable, no dose-limiting toxicity (DLT) was observed at the maximum dose of 800mg, and the risk of clinical tumor lysis syndrome (TLS) in patients on daily dose ramp-up was minimal.

Furthermore, Phase I data of lisaftoclax in Chinese patients with relapsed/refractory non-Hodgkin lymphoma (r/r NHL) were released at the 2022 European Hematology Association (EHA) Hybrid Congress. These data showed, lisaftoclax was well tolerated at doses of up to 800 mg/day, without evidence of TLS, and has antitumor activity in a range of relapsed/refractory hematologic malignancies such as CLL/SLL, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and T-cell NHL. In the 11 efficacy evaluable patients with CLL (all of whom were heavily pretreated and had failed prior therapies such as chemoimmunotherapies and Bruton's tyrosine kinase [BTK] inhibitors, and the majority had at least one type of adverse prognostic factors such as 17p deletion/TP53 mutation), there were 8 efficacy evaluable patients in cohorts received 200 mg or higher doses, including 3 complete responses (CRs) and 4 partial responses (PRs), thus demonstrating an ORR of 87.5%. There is a growing body of evidence signifying the global best-in-class potential of lisaftoclax.

While at the 2022 ASCO Annual Meeting, Ascentage Pharma reported the updated clinical data of alrizomadlin (APG-115), a MDM2-p53 inhibitor that is also a key asset in the company's apoptosis-targeted pipeline, in combination with pembrolizumab. These data validated the antitumor efficacy of the combination therapy in patients with immuno-oncologic- (I-O) drug-resistant or recurrent melanoma, including two CRs, an ORR of 11% and a disease control rate (DCR) of 57%. The study also observed promising clinical benefit to patients with malignant peripheral nerve sheath tumor (MPNST), demonstrated by a DCR of 50%. MPNST is a rare pediatric type of sarcoma lacking effective treatment options. These results provide additional evidence validating the synergy and the first-in-class potential of MDM2-p53 inhibitors plus immuno-oncologic drugs.

Also at the 2022 ASCO Annual Meeting, Ascentage Pharma released the first dataset from the Phase I study of the company's novel FAK inhibitor and third-generation ALK/ROS1 TKI, APG-2449, in patients with second-generation TKI-resistant ALK/ROS1+ non-small-cell lung cancer (NSCLC) or mesothelioma. According to these results, 4 of the 14 ALK+ patients resistant to second-generation TKIs achieved PRs, 10 TKI-naïve patients achieved an ORR of 80%, at a DCR of 100%. APG-2449 is the first China-developed third-generation ALK inhibitor. The candidate drug's clinical progress is a manifestation of Ascentage Pharma's R&D capabilities in the field of solid tumors.

Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma, said, "In the first half of 2022, Ascentage Pharma made solid progress in both commercialization and clinical development, successfully navigated the challenging circumstances posted by the COVID-19 pandemic. The rapid and successful commercialization of olverembatinib, the first and only third-generation BCR-ABL inhibitor, in the months after the NDA approval, has led to substantial revenue growth, allowing us to maintain a healthy cash flow that is essential to the company's long-term development.

While forging ahead with the commercialization of olverembatinib in China, we launched a global NPP to offer patient access to olverembatinib in areas where the drug is not yet commercially available, in efforts to meet the unmet medical needs of patients from around the world. The NPP highlights olverembatinib's differentiated clinical value and serves as a very important prelude to the drug's future global launch. To our surprise, we discovered olverembatinib's therapeutic potential as an alternative treatment for COVID-19 infections, and we plan to further evaluate the drug in clinical settings.

Executing on our strategy of global innovation, we presented the latest research data and clinical results of lead assets including olverembatinib, lisaftoclax, alrizomadlin, and APG-2449, at multiple international congresses such as the ASCO, EHA, and AACR annual meetings. These data readouts are indicative of our rich portfolio and promising clinical programs that are steadily approaching the point of fruition.

As a company focused on original pharmaceutical innovation, we will continue to expand the accessibility, advance the indication expansion and global clinical development of olverembatinib, while pressing ahead with the development programs of other investigational assets. We will remain steadfastly committed to global innovation and the mission of addressing unmet clinical needs in China and around the world, to create additional value for our investors and bring much needed novel therapies to our patients as soon as possible."

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a globally focused 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 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 nine 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 50 Phase I/II clinical trials in the US, Australia, Europe, and China. Olverembatinib, the company's core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML), was granted Priority Review status and a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) and is already approved for the indication. In addition, olverembatinib was also granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EU. To date, Ascentage Pharma has obtained a total of 15 ODDs, 2 FTDs, and 2 Rare Pediatric Disease (RPD) designations from the FDA and 1 ODD from the EU for four of the company's investigational drug candidates. Ascentage Pharma has been designated for multiple Major National R&D Projects, including 5 National Major New Drug Discovery and Manufacturing projects, 1 New Drug Incubator status, 4 Innovative Drug Programs, and 1 Major Project for the Prevention and Treatment of Infectious Diseases.

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, Merck, AstraZeneca, and Pfizer. The company has built a talented team with global experience in discovering, developing, launching, and commercializing innovative drugs and is setting up world-class commercial manufacturing and Sales & Marketing teams. One pivotal aim of Ascentage Pharma is to continuously strengthen its R&D capabilities and accelerate its clinical development programs, in order to fulfil its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients.

Forward-Looking Statements

The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, Ascentage Pharma undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

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SOURCE Ascentage Pharma