Ascentage Pharma, a renowned clinical-stage biotechnology firm focused on developing new therapies for CHB (chronic hepatitis B), cancers, as well as age-related illnesses, has reportedly announced that outcomes from two Phase II clinical studies of its new BCR-ABL inhibitor, HQP1351, namely olverembatinib, were accepted for an oral presentation at 62nd ASH (American Society of Hematology) Annual Meeting.
Xiaojun Huang, M.D., Peking University People's Hospital, Hematology Department, and Qian Jiang, M.D., who would be presenting the results at the event, are principal investigators of both studies. This would be the 3rd time the company has unveiled updated clinical trial data for HQP1351 at ASH Annual Meeting, with the prior two data releases occurring in 2018 as well as 2019.
The accolade of being accepted for an oral presentation by ASH for three years running signifies that the safety as well as efficacy profiles of HQP1351 are well recognized by the global hematology community. Unlike previous events, the 62nd Annual ASH Meeting would be conducted online, in a virtual format between December 5 and 8, 2020.
This annual event is the biggest gathering of experts in the field of international hematology, and brings together the most cutting-edge and the latest research and development breakthroughs in hematology.
HQP1351, or olverembatinib, is the company’s new third-gen BCR-ABL TKI (tyrosine kinase inhibitor), being developed for effectively treating patients suffering from CML (chronic myeloid leukemia) who are resistant to first- as well as second-gen TKIs.
The updated clinical outcomes that would be unveiled through the ASH oral presentation would come from two separate pivotal Phase II studies of HQP1351 within patients with both T315I-mutant and TKI-resistant CML.
As per reports, Ascentage Pharma has also submitted an NDA for HQP1351, on the basis of results from the two Phase II trials, for treating patients suffering from T315I-mutant CML-AP and CML-CP in China in 2020. The company’s NDA has subsequently been granted a Priority Review status.
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