Ascentage Pharma Announces Oral Presentation of Novel, Third-Generation BCR-ABL Inhibitor in Myelogenous Leukemia Patients at the 60th American Society of Hematology Annual Meeting

December 3, 2018

SAN DIEGO, CA–December 3, 2018–Ascentage Pharma, a clinical-stage biopharmaceutical company dedicated to the development of novel therapies for the treatment of cancers, hepatitis B and aging-related diseases, today announced data from a Phase 1 clinical study of its novel BCR-ABL inhibitor, HQP1351, in patients with Tyrosine Kinase Inhibitor (TKI)-refractory chronic myelogenous leukemia (CML) at the 60th American Society of Hematology (ASH) Annual Meeting. The data were reviewed in an oral presentation by Principal Investigator Qian Jiang, M.D., Deputy Director of the Institute of Hematology at Peking University People’s Hospital.

“While certain TKIs, such as imatinib, have been effective in some cancer patients, there is an urgent need to address resistance that develops with these therapies,” said Dr. Jiang. “In this Phase 1 study, HQP1351 showed potential results in CML patients resistant to prior TKIs.”

Study Details and Highlights:

  • Patients received treatment in one of eleven dose groups ranging from 1mg to 60mg;
  • As of October 2018, 100 CML patients were enrolled in the study, 86 of which were chronic phase (CP) and 14 accelerated phase (AP);
  • HQP1351 was well-tolerated across all dose groups, with the exception of the 60mg dose group. None of the patients withdrew from the study due to treatment-related adverse effects (TRAEs). Two out of three patients in the 60mg dose group developed dose-limiting toxicity and 50mg was considered to be the maximum tolerated dose;
  • Among evaluable patients, the complete hematologic response (CHR) rate was 96% in CP, and 85% in AP;
  • Among evaluable 66 CP patients, the major cytogenetic response (MCyR) rate was 67%; of note, in those CP patients with T315I mutation, which is highly resistant to almost all TKIs, the MCyR rate was 78%.

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, commented: “HQP1351 shows potential as a third-generation BCR-ABL inhibitor. We have initiated a potential registration-enabling Phase 2 study for patients with TKI-resistant CML for HQP1351 in China and seek to expedite its development, advancing a potential new treatment for patients who have developed resistance to imatinib.”

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. Phase 1 clinical trials for patients with imatinib-resistant CML have been completed and Phase 2 clinical trials have been initiated.

About Ascentage Pharma
Ascentage Pharma is a globally-focused clinical-stage biopharmaceutical company developing novel therapies for cancers, hepatitis B and age-related diseases. Based on breakthrough technology from the University of Michigan, the Company’s expertise is in designing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death, in cancers. Ascentage has built a rich pipeline of seven clinical candidates, including a novel, highly potent Bcl-2/Bcl-xL inhibitor, APG-1252, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors. For more information, please visit www.ascentagepharma.com.