Ascentage Pharma To Present Data from Two Clinical Studies at 2025 ASCO Annual Meeting, Including Oral Presentation on Its Key Assets Lisaftoclax and Alrizomadlin
Ascentage Pharma (NASDAQ: AAPG) will present data from two clinical studies at the 2025 ASCO Annual Meeting. The presentations include an oral report on a Phase Ib/II study of lisaftoclax combination regimen for myeloid malignancies and a poster presentation on alrizomadlin for advanced adenoid cystic carcinoma.
The oral presentation will focus on lisaftoclax (APG-2575) combined with azacitidine in patients with treatment-naïve or prior venetoclax-exposed myeloid malignancies. The poster presentation will showcase results from a Phase 2 study of alrizomadlin (APG-115) with or without toripalimab in patients with advanced ACC or other solid tumors.
This marks Ascentage's eighth consecutive year presenting at ASCO, which will be held both online and in-person at McCormick Place, Chicago, from May 30-June 3, 2025.
Ascentage Pharma (NASDAQ: AAPG) presenterà i dati di due studi clinici al Meeting Annuale ASCO 2025. Le presentazioni includono un rapporto orale su uno studio di Fase Ib/II del regime combinato con lisaftoclax per le neoplasie mieloidi e una presentazione poster su alrizomadlin per il carcinoma adenoideo cistico avanzato.
La presentazione orale si concentrerà su lisaftoclax (APG-2575) in combinazione con azacitidina in pazienti con neoplasie mieloidi naïve al trattamento o precedentemente esposti a venetoclax. La presentazione poster mostrerà i risultati di uno studio di Fase 2 su alrizomadlin (APG-115), con o senza toripalimab, in pazienti con ACC avanzato o altri tumori solidi.
Questa sarà l’ottava partecipazione consecutiva di Ascentage ad ASCO, che si terrà sia online che in presenza presso il McCormick Place di Chicago, dal 30 maggio al 3 giugno 2025.
Ascentage Pharma (NASDAQ: AAPG) presentará datos de dos estudios clínicos en la Reunión Anual ASCO 2025. Las presentaciones incluyen un informe oral sobre un estudio de Fase Ib/II del régimen combinado con lisaftoclax para malignidades mieloides y una presentación en póster sobre alrizomadlin para carcinoma adenoide quístico avanzado.
La presentación oral se centrará en lisaftoclax (APG-2575) combinado con azacitidina en pacientes con malignidades mieloides sin tratamiento previo o expuestos anteriormente a venetoclax. La presentación en póster mostrará los resultados de un estudio de Fase 2 de alrizomadlin (APG-115), con o sin toripalimab, en pacientes con carcinoma adenoide quístico avanzado u otros tumores sólidos.
Esta será la octava participación consecutiva de Ascentage en ASCO, que se realizará tanto en línea como presencialmente en McCormick Place, Chicago, del 30 de mayo al 3 de junio de 2025.
Ascentage Pharma (NASDAQ: AAPG)는 2025년 ASCO 연례 회의에서 두 건의 임상 연구 데이터를 발표할 예정입니다. 발표 내용에는 골수성 악성종양에 대한 lisaftoclax 병용 요법의 1b/2상 연구 구두 발표와 진행성 선양낭암에 대한 alrizomadlin 포스터 발표가 포함됩니다.
구두 발표는 치료 경험이 없거나 이전에 venetoclax에 노출된 골수성 악성종양 환자에서 azacitidine과 병용한 lisaftoclax (APG-2575)에 중점을 둡니다. 포스터 발표는 진행성 ACC 또는 기타 고형암 환자를 대상으로 한 alrizomadlin (APG-115)의 단독 또는 toripalimab 병용 2상 연구 결과를 소개합니다.
이번 발표는 Ascentage가 ASCO에 연속으로 8년째 참여하는 것으로, 2025년 5월 30일부터 6월 3일까지 시카고 맥코믹 플레이스에서 온라인과 오프라인으로 동시에 진행됩니다.
Ascentage Pharma (NASDAQ : AAPG) présentera des données issues de deux études cliniques lors du Congrès annuel ASCO 2025. Les présentations incluent un exposé oral sur une étude de phase Ib/II du régime combiné à base de lisaftoclax pour les malignités myéloïdes, ainsi qu’une présentation par poster sur l’alrizomadlin dans le carcinome adénoïde kystique avancé.
L’exposé oral portera sur le lisaftoclax (APG-2575) en association avec l’azacitidine chez des patients atteints de malignités myéloïdes naïfs de traitement ou exposés antérieurement au venetoclax. La présentation par poster mettra en avant les résultats d’une étude de phase 2 sur l’alrizomadlin (APG-115) avec ou sans toripalimab chez des patients atteints d’ACC avancé ou d’autres tumeurs solides.
Il s’agit de la huitième année consécutive qu’Ascentage participe à ASCO, qui se tiendra en ligne et en présentiel au McCormick Place de Chicago, du 30 mai au 3 juin 2025.
Ascentage Pharma (NASDAQ: AAPG) wird auf dem ASCO-Jahrestreffen 2025 Daten aus zwei klinischen Studien präsentieren. Die Präsentationen umfassen einen mündlichen Bericht über eine Phase Ib/II-Studie zum Kombinationstherapie-Regime mit Lisaftoclax bei myeloiden Malignomen sowie eine Posterpräsentation zu Alrizomadlin bei fortgeschrittenem adenoidzystischem Karzinom.
Die mündliche Präsentation konzentriert sich auf Lisaftoclax (APG-2575) in Kombination mit Azacitidin bei Patienten mit unbehandelten oder zuvor mit Venetoclax behandelten myeloiden Malignomen. Die Posterpräsentation zeigt Ergebnisse einer Phase-2-Studie mit Alrizomadlin (APG-115) mit oder ohne Toripalimab bei Patienten mit fortgeschrittenem ACC oder anderen soliden Tumoren.
Dies ist das achte Jahr in Folge, in dem Ascentage auf der ASCO präsentiert, die vom 30. Mai bis 3. Juni 2025 sowohl online als auch vor Ort im McCormick Place in Chicago stattfinden wird.
- Selected for oral presentation at prestigious ASCO Annual Meeting, indicating significant clinical findings
- Eighth consecutive year of presence at ASCO, demonstrating consistent research progress
- Advancing two key drug candidates in multiple cancer indications
- Both drug candidates are still investigational and not approved in the U.S.
- Final trial results and regulatory approval timeline remain uncertain
ROCKVILLE, Md. and SUZHOU, China, April 23, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global biopharmaceutical company engaged in discovering, developing, and commercializing therapies to address global unmet medical needs primarily for hematological malignancies, today announced that results from two clinical studies of the Bcl-2 selective inhibitor lisaftoclax (APG-2575) and the MDM2-p53 inhibitor alrizomadlin (APG-115), two key drug candidates in the company’s apoptosis-targeted pipeline, have been selected for presentations at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. These presentations will include an oral report featuring updated results from a Phase Ib/II study of a lisaftoclax combination regimen in patients with myeloid malignancies.
The ASCO Annual Meeting showcases the most cutting-edge research in clinical oncology and state-of-the-art advanced cancer therapies and is the world’s most influential and prominent scientific gathering of the clinical oncology community, bringing together more than 40,000 oncology professionals from across the globe. This year’s ASCO Annual Meeting will take place both online and in-person at McCormick Place, Chicago, IL, the United States, on May 30–June 3 (local time).
Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said, “We are honored to return to the ASCO Annual Meeting for the eighth consecutive year to present the latest data on our novel assets and highlight the strength of our clinical development and global innovation. We look forward to sharing an oral presentation on a lisaftoclax combination regimen in patients with treatment-naïve or prior venetoclax-exposed myeloid malignancies and a readout on alrizomadlin in patients with advanced adenoid cystic carcinoma or other solid tumors. These presentations reflect our deep focus on advancing global clinical development of our key assets in order to bring more treatment options to patients as soon as possible.”
The clinical studies to be presented at this year’s ASCO Annual Meeting are as follows:
Phase 1b/2 study of lisaftoclax (APG-2575) combined with azacitidine (AZA) in patients (pts) with treatment-naïve (TN) or prior venetoclax (VEN)-exposed myeloid malignancies
- Abstract#: 6505
- Format: Oral Presentation
- Session Title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
- Date and Time: Monday June 2, 2025, 3:00 PM-6:00 PM, Central Time (Tuesday June 3, 2025, 4:00 AM-7:00 AM, Beijing Time)
- Principal Authors: Michael Francis Leahy, MBChB, Royal Perth Hospital, Australia; Shaun Fleming, MBBS(Hons), PhD, The Alfred Hospital & Australian Centre for Blood Diseases, Australia; Patricia Kropf, MD, Novant Health Cancer Institute, United States, et al.
A phase 2 study of novel MDM2 inhibitor alrizomadlin (APG-115) with or without toripalimab in patients (pts) with advanced adenoid cystic carcinoma (ACC) or other solid tumors.
- Abstract#: 6102
- Format: Poster Presentation
- Session Title: Head and Neck Cancer
- Date and Time: Monday June 2, 2025, 9:00 AM-12:00 PM, Central Time (Monday June 2, 2025, 10:00 PM – 1:00 AM the next day, Beijing Time)
- Principal Authors: Ye Guo, MD, Department of Medical Oncology, Shanghai East Hospital, China; Ning Li, MD, Chinese Academy of Medical Sciences Cancer Hospital, China; Xing Zhang, MD, Melanoma and Sarcoma Medical Oncology Unit, Sun Yat-sen University Cancer Center, China; Meiyu Fang, MD, Department of Rare Cancer & Head and Neck Medical Oncology, Cancer Hospital of the University of Chinese Academy of Sciences, China; Shuhang Wang, MD, Chinese Academy of Medical Sciences Cancer Hospital, China, et al.
*Lisaftoclax and alrizomadlin are investigational drugs and are not approved in the U.S.
About Ascentage Pharma
Ascentage Pharma is a global, integrated biopharmaceutical company engaged in discovering, developing, and commercializing therapies to address global unmet medical needs primarily in hematological malignancies. Ascentage Pharma has been listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK since October 2019 and has also been listed on the Nasdaq Global Market under the ticker symbol “AAPG” since January 2025.
The company has built a rich pipeline of innovative drug candidates that includes inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53; and next-generation TKIs that target kinase mutants emergent during cancer treatment. Ascentage Pharma is also the only company in the world with active clinical programs targeting all known key apoptosis regulators.
Olverembatinib, one of the company’s lead assets, is approved in China, with all of its approved indications included in the China National Reimbursement Drug List (NRDL). Meanwhile, a New Drug Application (NDA) for another one of Ascentage Pharmas key drug candidates, the novel Bcl-2 selective inhibitor lisaftoclax (APG-2575), has been accepted and granted a Priority Review designation by the China Center for Drug Evaluation.
To date, Ascentage Pharma has obtained a total of 16 Orphan Drug Designations from the US FDA and 1 Orphan Designation from the European Medicines Agency of the European Union 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 and other relationships with numerous leading biotechnology and pharmaceutical companies such as Takeda, Merck, AstraZeneca, Pfizer and Innovent; and research and development relationships with leading research institutions such as Mayo Clinic, Dana-Farber Cancer Institute, National Cancer Institute (NCI) and the University of Michigan.
The company has built a talented team with a wealth of global experience in the discovery and development of innovative drugs and fully functional 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 fulfill its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients.
Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained in this press release may be forward-looking statements, including statements that express Ascentage Pharma’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition. These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma’s filings with the SEC, including those set forth in the sections titled “Risk factors” and “Special note regarding forward-looking statements and industry data” in its final prospectus for its U.S. initial public offering, filed with the SEC on January 24, 2025 and the Form 20-F filed with the SEC on April 16, 2025, and other filings with the SEC that the Company made or makes from time to time, and with respect to non-U.S. investors only, the sections headed “Forward-looking Statements” and “Risk Factors” in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with The Stock Exchange of Hong Kong Limited it has made or it makes from time to time that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements contained in this presentation do not constitute profit forecast by the Company’s management.
As a result of these factors, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are based on Ascentage Pharma’s current expectations and beliefs concerning future developments and their potential effects and speak only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact Information
Investor Relations:
Hogan Wan, Head of IR and Strategy
Ascentage Pharma
Hogan.Wan@ascentage.com
+86 512 85557777
Stephanie Carrington
ICR Healthcare
Stephanie.Carrington@icrhealthcare.com
(646) 277-1282
Media Relations:
Sean Leous
ICR Healthcare
Sean.Leous@icrhealthcare.com
(646) 866-4012
FAQ
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