Suzhou, China and Rockville, Maryland, October 23, 2023 /PRNewswire/ — Ascentage Pharma (6855.HK), a global biopharmaceutical company dedicated to developing new treatments for cancer, chronic hepatitis B (CHB) and age-related diseases, today announced the release of its latest clinical data. Dual Bcl-2/Bcl-xL inhibitor APG-1252 (pelcitoclax) combined with osimertinib in a small oral form for the treatment of patients with EGFR-mutant non-small cell lung cancer (NSCLC) at the 2023 European Society for Medical Oncology (ESMO) Congress.
Pelcitoclax developed by Ascentage Pharma is a potential best-in-class new Bcl-2/Bcl-xL dual inhibitor that can restore cancer cell apoptosis by selectively inhibiting Bcl-2 and Bcl-xL proteins, thereby exerting therapeutic effect. effect. A spectrum of solid tumors and hematologic malignancies.
Clinical data announced at this year’s ESMO Congress showed that Pesitoclax combined with osimertinib has a good therapeutic effect in the treatment of patients with EGFR-mutated NSCLC. The results showed that among 26 patients who had not received EGFR tyrosine kinase inhibitor (TKI) treatment, partial response (PR) was observed in 21 patients, with an objective response rate (ORR) of 80.8%; while in 16 patients with TP53 and Among EGFR-mutated EGFR-TKI-naïve patients, 14 cases of PR were observed, with an ORR of 87.5%.
PhD. Zhai YifanChief Medical Officer, Ascentage Pharma“, said, “There are many challenges in the current treatment of NSCLC. Among them, TP53 and EGFR mutations can significantly affect the prognosis of NSCLC patients, and there is no standard care and treatment for this subtype of NSCLC. At ESMO 2023, we released updated clinical data that continue to demonstrate the encouraging therapeutic potential of pesitoclax plus osimertinib in patients with TP53 and EGFR mutant NSCLC who have not received treatment with EGFR-TKIs.
In early studies, pelcitoclax combined with osimertinib demonstrated clinical potential in the treatment of patients with EGFR-mutated advanced NSCLC who are resistant to EGFR-TKIs. The latest data released this year further enrich the evidence and reveal the clinical potential of combination therapy in patients with third-generation EGFR-TKI resistance.Going forward, we will continue to deliver on our mission to address unmet clinical needs China and accelerate our clinical programs around the world to benefit more patients. “
The key points of the pelcitoclax data announced at the 2023 ESMO Congress are as follows:
Latest study results of Pesitoclax (APG-1252) combined with osimertinib in the treatment of patients with EGFR mutated non-small cell lung cancer (NSCLC)
(Pelcitoclax is an investigational drug and has not been approved for any indication anywhere in the world. )
About Ascentage Pharma
Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company dedicated to developing new treatments for cancer, chronic hepatitis B and age-related diseases.exist October 28, 2019Ascentage Pharmaceuticals is listed on the main board of The Stock Exchange of Hong Kong Limited, 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 established a pipeline of nine clinical candidates, including novel, highly potent Bcl-2 and dual Bcl-2/Bcl-xL inhibitors, as well as candidates targeting the IAP and MDM2-p53 pathways, as well as next-generation tyrosine Acid kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three classes of known key regulators of apoptosis. The company is conducting more than 40 Phase I/II clinical trials in the United States. Australia, Europeand China. Ascentage Pharma has been approved for a number of major national R&D projects, including 5 major new drug projects, 1 new drug incubator, 4 innovative drug projects, and 1 major infectious disease prevention and treatment project.
The company’s core drug candidate for the treatment of drug-resistant chronic myelogenous leukemia (CML) and the company’s first approved product, Olverembatinib, received priority review and breakthrough designation from the National Center for Drug Evaluation (CDE) Therapeutics Approved Medical Products Administration (NMPA). As of now, the drug has been included in the drug catalog. China 2022 National Reimbursement Drug List (NRDL). In addition, olverembatinib has received Orphan Drug Designation (ODD) and Fast Track Designation (FTD) from the US FDA, and Orphan Drug Designation from the EU EMA. As of now, Ascentage Pharma’s four drug candidates have received 16 ODD, 2 FTD, and 2 rare pediatric disease (RPD) designations from the U.S. FDA, as well as 1 orphan drug designation from the EU EMA.
With strong R&D capabilities, Ascentage Pharma owns global intellectual property rights and has established global partnerships with many well-known biotechnology and pharmaceutical companies and research institutions such as UNITY Biotechnology, MD Anderson Cancer Center, Mayo Clinic, and Dana-Farber Cancer Institute. , MSD and AstraZeneca. The company has built a talented team with global experience in innovative drug discovery and development and is building world-class commercial manufacturing and sales and marketing teams. One of Ascentage Pharma’s core goals is to continuously enhance its research and development capabilities and accelerate clinical development plans to fulfill its mission of solving unmet clinical needs. China and around the world, benefiting more patients.
forward-looking statements
The forward-looking statements contained herein relate only to events or information as of the date stated herein. Except as required by law, Ascentage Pharma undertakes no obligation to publicly update or revise any forward-looking statement after the date the statement is made, whether as a result of new information, future events or otherwise, or to reflect unanticipated events that occur. You should read this article in its entirety and understand that our actual future results or performance may differ materially from our expectations. In this article, statements 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 change based on future developments.
Source: Ascentage Pharma
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