On November 14, 2019 Ascentage Pharma (6855.HK), a globally-focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, hepatitis B virus and age-related diseases, reported that the updated preliminary results from a Phase I clinical trial on the company’s novel investigational drug HQP1351 has been accepted for oral presentation at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (Press release, Ascentage Pharma, NOV 14, 2019, View Source [SID1234551340]). Qian Jiang, M.D., who will be presenting, and Xiaojun Huang, M.D. from Peking University People’s Hospital, are the principal investigators of this study. HQP1351 is a third-generation BCR-ABL inhibitor for the treatment of drug-resistant chronic myeloid leukemia (CML).

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Early results from this Phase I study had been accepted for oral presentation at the ASH (Free ASH Whitepaper) Annual Meeting in 2018. Being accepted for oral presentations two years in a row is a strong indication of the interest on HQP1351’s promising efficacy and safety data and updates.

The 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition will be held on December 7–10, 2019, in Orlando, Florida, United States. The ASH (Free ASH Whitepaper) Annual Meeting is the largest gathering of the international hematology field, bringing together the latest and most cutting-edge research and development in hematology.

The oral report will present updated safety and efficacy data from the Chinese Phase I trial of HQP1351. As of May 27, 2019, a total of 101 Chinese patients were enrolled in the study. Trial data have demonstrated that HQP1351 was well tolerated with good and durable anti-tumor activity in TKI-resistant CML patients, including those with the T315I mutation. HQP1351 is Ascentage Pharma’s novel investigational drug with the potential to effectively address the acquired drug resistance commonly associated with the first- and second-generation BCR-ABL inhibitors.

At ASH (Free ASH Whitepaper) 2019, in addition to the oral presentation on HQP1351, Ascentage Pharma will also release data in a poster presentation for a new research on the BCL-2/BCL-xL dual inhibitor APG-1252, which can overcome ibrutinib-resistance conferred by the upregulation of integrin pathway and BCL-xL. APG-1252 is one of the key drug candidates in Ascentage Pharma’s pipeline that focuses on restoring cell apoptosis function and inhibiting cancer growth.

Oral Presentation

Title: An Updated Safety and Efficacy Results of Phase 1 Study of HQP1351, a Novel Third Generation BCR-ABL Tyrosine Kinase Inhibitor (TKI), in Patients with TKI-Resistant Chronic Myeloid Leukemia

Report#: 493
Session: 632
Presenter: Qian Jiang, MD
Time: Sunday, December 8, 4:30 pm (EST)
Location: W308, Orange County Convention Center (OCCC)

Poster Presentation

Title: A Novel BCL-2/BCL-xL Dual Inhibitor Overcomes Ibrutinib-Resistance Conferred By the Upregulation of Integrin Pathway and BCL-xL

Poster#: 2573
Session: 605
Time: Sunday, December 8, 6:00 PM – 8:00 PM (EST)
Location: Hall B, Orange County Convention Center (OCCC)

About HQP1351

HQP1351 is a novel kinase inhibitor developed by Ascentage Pharma. It is an oral third-generation BCR-ABL inhibitor targeting a broad spectrum of BCR-ABL mutants, including those with the T315I mutation, to treat drug-resistant CML patients. A Phase I clinical trial for patients with TKI-resistant CML has been completed and pivotal Phase II clinical trial are ongoing in China. In addition, a Phase I trial in patients with GIST has been initiated in China.

About APG-1252

APG-1252 is a novel, highly potent, small molecule drug designed to restore apoptosis through selective inhibition of the Bcl-2 and Bcl-xL proteins for the treatment of SCLC (small-cell lung cancer), lymphoma and other solid tumors. Ascentage is currently conducting two Phase I dose-escalation trials in patients with advanced cancers in the United States and Australia, and Phase I dose-escalation/expansion trial as a monotherapy in patients with SCLC in China.