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Reside from ASCO 2024 | Ascentage Pharma Releases Up to date Information of FAK/ALK/ROS1 Inhibitor APG-2449 in Sufferers with NSCLC By Investing.com

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SUZHOU, China, and ROCKVILLE, Md., June 1, 2024 /PRNewswire/ — Ascentage Pharma (6855.HK), a worldwide biopharmaceutical firm engaged in creating novel therapies for most cancers, power hepatitis B (CHB), and age-related illnesses, introduced at the moment that it has launched up to date information of its novel drug candidate AGP-2449, a FAK/ALK/ROS1 tyrosine kinase inhibitor (TKI), in sufferers with non-small-cell lung most cancers (NSCLC) in a poster presentation on the sixtieth American Society of Medical Oncology (ASCO) Annual Assembly happening in Chicago, IL. That is the third consecutive 12 months by which medical information from this examine of APG-2449 have been chosen for shows on the ASCO Annual Assembly.

The ASCO Annual Assembly showcases essentially the most cutting-edge analysis in medical oncology and state-of-the-art superior most cancers therapies and is the world’s most influential and outstanding scientific gathering of the medical oncology neighborhood. Presenting medical improvement progress on the ASCO Annual Assembly for the seventh consecutive 12 months, Ascentage had 4 medical research of three of the corporate’s proprietary drug candidates chosen for shows, together with an oral report, at ASCO 2024.

Outcomes offered this 12 months reaffirmed the therapeutic potential of APG-2449 in NSCLC, with information demonstrating preliminary efficacy in sufferers with NSCLC who have been TKI naïve and proof against second-generation ALK TKIs, in addition to early antitumor exercise in mind metastases. Biomarker evaluation confirmed that, in sufferers with NSCLC proof against second-generation ALK TKIs, phosphorylated FAK (pFAK) expression ranges in tumor tissue at baseline and discount in pFAK ranges in peripheral blood mononuclear cells (PBMCs) have been correlated with responses to APG-2449.

“APG-2449 is an effective multitargeted inhibitor that acts on FAK/ALK/ROS1. Compared to the data released at last year’s ASCO Annual Meeting, the latest results presented this year continued to show manageable safety and favorable antitumor activity in patients with NSCLC,” stated Prof. Li Zhang, the principal investigator of this examine from Solar Yat-sen College Most cancers Middle. “We are very encouraged by the preliminary efficacy observed in patients with resistance to second-generation ALK TKIs, as it suggests that multitargeted inhibition on FAK and ALK may offer a new strategy for the management of patients with NSCLC resistant to second-generation ALK TKIs. We hope that Ascentage Pharma will conduct further studies on APG-2449 and allow more patients to benefit from this novel therapeutic agent as soon as possible.”

“These data of APG-2449 in patients with NSCLC revealed a connection between resistance to ALK inhibitors and the FAK pathway, thus suggesting that the multitargeted FAK/ALK/ROS1 TKI APG-2449 may bring renewed hope to patients with NSCLC who are resistant to second-generation ALK inhibitors. This finding is indeed very encouraging,” stated Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. “Remaining committed to the mission of addressing unmet clinical needs in China and around the world, we will press forward with this clinical development program in order to bring a safe and effective new treatment option to patients in need.”

Highlights of those information offered at ASCO 2024 are as follows:

Up to date examine outcomes of novel FAK/ALK/ROS1 inhibitor APG-2449 in sufferers (pts) with non-small-cell lung most cancers (NSCLC) proof against second-generation ALK inhibitors.

Summary#:  3124

Session Developmental Therapeutics”Molecularly Focused Brokers and Tumor Biology

Date and Time:  June 1, 2024, Saturday, 9:00 AM12:00 PM (Central Time)

First Writer:  Yuxiang Ma, MD, PhD, Solar Yat-sen College Most cancers Middle, Guangzhou, Guangdong, China.

Highlights:

Background: ALK inhibitors improve FAK pathway gene expression in ALK+ NSCLC cell strains, with the very best induced expression in drug-tolerant persister cells. This implies that FAK pathway activation is concerned within the mechanism that results in ALK TKI resistance in ALK+ NSCLC. APG-2449 is an orally energetic FAK inhibitor and a third-generation ALK/ROS1 TKI that has proven potent antitumor exercise in preclinical fashions. This poster reviews additional security and efficacy information of APG-2449.

Affected person enrollment and strategies:

  • This examine includes dose-escalation and dose-expansion parts. 1,200 mg each day (QD) was decided because the RP2D. There have been two cohorts within the dose-expansion portion: Cohort 1 included sufferers with NSCLC who have been proof against second-generation ALK TKIs; Cohort 2 included sufferers with NSCLC who have been ALK or ROS1 TKI naïve.
  • As of April 2, 2024, a complete of 144 sufferers with NSCLC, mesothelioma, or ovarian most cancers have been handled with APG-2449 at doses starting from 150 “ 1,500 mg. The median (vary) age of sufferers was 53 (21-78) years, and 53.5% have been feminine.

Efficacy outcomes:

  • The ORRs of APG-2449 in sufferers with ROS1+ and ALK+ TKI-naïve NSCLC (n=36) have been 68.2% (15/22) and 78.6% (11/14), respectively. Of the 22 sufferers with NSCLC proof against second-generation ALK inhibitors and with out targetable bypass gene mutations (e.g., KRAS G12C, BRAF V600E), 10 achieved PRs (10/22; 45.5%). Among the many sufferers handled at RP2D, 12 had mind metastasis at baseline, 9 of whom achieved intracranial PR, leading to an intracranial ORR of 75.0%.
  • Biomarker evaluation discovered that, in sufferers with NSCLC that was proof against second-generation ALK TKIs, responses to APG-2449 have been correlated with pFAK ranges in tumor tissues at baseline and reductions in pFAK ranges in PBMCs.

Security outcomes: A complete of 129 (89.6%) sufferers had therapy‘associated opposed occasions (TRAEs), essentially the most frequent ( ‰¥10%) of which have been elevated serum creatinine (49.3%), improve in alanine aminotransferase (42.4%), improve in aspartate aminotransferase (36.1%); nausea (28.5%); vomiting (23.6%); diarrhea (22.9%); decreased leukocyte depend (22.2%), decreased neutrophil depend (17.4%) and rash (13.2%). In all, 20 (13.9%) TRAEs have been grade ‰¥ 3.

Conclusions: APG-2449 demonstrated preliminary efficacy in sufferers with NSCLC whose illness was TKI naïve and proof against second-generation ALK inhibitors, particularly in mind metastases. Biomarker evaluation confirmed that, in sufferers with NSCLC proof against second-generation ALK TKIs, responses to APG-2449 PFS have been correlated with pFAK ranges in tumor tissues at baseline and reductions in pFAK ranges in PBMCs.

APG-2449 is an investigational drug that has not been authorised in any nation and area.

Appendix: The 4 medical research of Ascentage Pharma’s three drug candidates, together with lisaftoclax, offered at this 12 months’s ASCO Annual Assembly.

Drug Candidates

Summary Title

Summary #

Format

Olverembatinib
(HQP1351)

Up to date efficacy outcomes of
olverembatinib (HQP1351) in sufferers
withtyrosinekinase inhibitor (TKI)-
resistantsuccinatedehydrogenas
e (SDH)-deficientgastrointestinal
stromal tumor (GIST)and
paraganglioma

#11502

Oral
Report

Lisaftoclax
(
APG-2575)

Security and efficacy of lisaftoclax, a
novel BCL-2 inhibitor, together
withazacitidine in sufferers with
treatment-naïve or relapsed
 or refractory acute myeloid leukemia

#6541

Poster
Presentation

Up to date efficacy and security outcomes of
BCL-2 inhibitorlisaftoclax (APG-2575)
alone or combinedwithibrutinibor
rituximab in sufferers (pts)with
Waldenströmmacroglobulinemia
 (WM)

#7078

Poster
Presentation

APG-2449

Up to date examine outcomes of novel
FAK/ALK/ROS1 inhibitor APG-2449 in
sufferers (pts) with non-small-cell lung
most cancers (NSCLC) resistant tosecond-
generationALK inhibitors

#3124

Poster
Presentation

 

About Ascentage Pharma
Ascentage Pharma (6855.HK) is a globally targeted biopharmaceutical firm engaged in creating novel therapies for cancers, power hepatitis B, and age-related illnesses. On October 28, 2019, Ascentage Pharma was listed on the Principal Board of the Inventory Alternate of Hong Kong Restricted with the inventory code 6855.HK.

Ascentage Pharma focuses on creating therapeutics that inhibit protein-protein interactions to revive apoptosis, or programmed cell loss of life. The corporate has constructed a pipeline of 9 medical drug candidates, together with novel, extremely potent Bcl-2, and twin Bcl-2/Bcl-xL inhibitors, in addition to candidates geared toward IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma can also be the one firm on the earth with energetic medical packages concentrating on all three identified courses of key apoptosis regulators. The corporate is conducting greater than 40 Section I/II medical trials, together with 5 international registrational part III research, within the US, Australia, Europe, and China. Ascentage Pharma has been designated for a number of Main Nationwide R&D Tasks, together with 5 Main New Drug Tasks, one New Drug Incubator standing, 4 Modern Drug Packages, and one Main Undertaking for the Prevention and Therapy of Infectious Illnesses.

Olverembatinib, the corporate’s core drug candidate developed for the therapy of drug-resistant power myeloid leukemia (CML) and the corporate’s first authorised product in China, has been granted Precedence Overview Designations and Breakthrough Remedy Designations by the Middle for Drug Analysis (CDE) of China Nationwide Medical Merchandise Administration (NMPA). Up to now, the drug had been included into the China 2022 Nationwide Reimbursement Drug Listing (NRDL). Moreover, olverembatinib has been granted an Orphan Drug Designation (ODD) and a Quick Monitor Designation (FTD) by the US FDA, and an Orphan Designation by the EMA of the EU. Up to now, Ascentage Pharma has obtained a complete of 16 ODDs from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the corporate’s investigational drug candidates.

Leveraging its strong R&D capabilities, Ascentage Pharma has constructed a portfolio of worldwide mental property rights and entered into international partnerships with quite a few famend biotechnology and pharmaceutical corporations and analysis institutes reminiscent of UNITY Biotechnology, MD Anderson Most cancers Middle, Mayo Clinic, Dana-Farber Most cancers Institute, MSD, and AstraZeneca (NASDAQ:). The corporate has constructed a gifted group with international expertise within the discovery and improvement of progressive medication and is establishing its world-class industrial manufacturing and Gross sales & Advertising groups. One pivotal goal of Ascentage Pharma is to repeatedly strengthen its R&D capabilities and speed up its medical improvement packages, so as to fulfil its mission of addressing unmet medical wants in China and all over the world for the advantage of extra sufferers.

Ahead-Wanting Statements
The forward-looking statements made on this article relate solely to the occasions or data as of the date on which the statements are made on this article. Besides as required by regulation, Ascentage Pharma undertakes no obligation to replace or revise publicly any forward-looking statements, whether or not on account of new data, future occasions, or in any other case, after the date on which the statements are made or to replicate the prevalence of unanticipated occasions. It is best to learn this text utterly and with the understanding that our precise future outcomes or efficiency could also be materially completely different from what we count on. On this article, statements of, or references to, our intentions or these of any of our Administrators or our Firm are made as of the date of this text. Any of those intentions might alter in mild of future improvement.

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