Le Lézard
Classified in: Health, Science and technology
Subjects: TRI, FDA

Ascentage Pharma to Initiate Phase Ib Study of HQP1351 in Tyrosine Kinase Inhibitors -resistant Chronic Myeloid Leukemia Patients in the US


SUZHOU, China and ROCKVILLE, Md., July 21, 2019 /PRNewswire/ -- Ascentage Pharma, a globally-focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, hepatitis B virus and age-related diseases, today announced that the company was notified by the U.S. Food & Drug Administration (FDA) on the clearance of the Investigational New Drug (IND) application which allows the company to initiate its Phase Ib clinical trial of HQP1351, a novel drug candidate developed by Ascentage Pharma, for the treatment of patients with tyrosine kinase inhibitors (TKI)-resistant chronic myeloid leukemia (CML) in the United States.

Ascentage_Pharma_Logo

HQP1351 is the sixth molecule to receive clearance of IND from the FDA for Ascentage Pharma. The Company submitted data generated from over 100 subjects in the Phase I clinical trial in China to the FDA to support the IND application.

This clinical study is a bridging Phase Ib clinical trial with three dose cohorts (30mg, 40mg and 50mg), which is more efficient than the traditional 3+3 dose-escalation study and is expected to accelerate the progress of this clinical trial. It is designed to evaluate the safety, tolerability, and pharmacokinetic (PK) of HQP1351 in CML patients who are resistant or intolerant to at least second-line TKIs and to confirm the recommended Phase II dose (RP2D). This clinical study will be led by Hagop Kantarjian, M.D., Chair of Department of Leukemia at MD Anderson Cancer Center, and other prominent US research centers and hospitals will also participate.

HQP1351 is designed to address the acquired drug resistance from the treatment using Imatinib. Such resistance is developed in 20-30% of patients treated with the drug develop acquired drug resistance, thus representing a major challenge to the treatment of CML. HQP1351 is an oral, third-generation BCR-ABL TKI targeting a broad spectrum of BCR-ABL mutants, including those with the T315I mutation, to treat drug-resistant CML patients. The agent is currently in pivotal Phase II clinical trial and is the first third-generation BCR-ABL inhibitor targeting drug-resistant CML in China. A New Drug Application (NDA) submission is planned upon the successful completion of the pivotal Phase II clinical studies in China.

As previously announced, the updated data from HQP1351 Phase I study in China was accepted as an oral presentation at the 60th American Society of Hematology (ASH) Annual Meeting last December. The preliminary data showed that HQP1351 was effective in the treatment of first and second generation TKI-resistant CML, especially the highly resistant CML with T315I mutation, with improved safety profile compared to other agents in the same class. This result demonstrates HQP1351's best-in-class potential for treating TKI-resistant CML.

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, commented: "Ascentage Pharma used the clinical data from its HQP1351 Phase1 clinical trial in China to support the US IND application. This FDA agreed Phase Ib clinical trial design could significantly accelerate HQP1351's global clinical development program. Drug-resistant CML represents significant unmet clinical need and we hope that HQP1351 will soon benefit patients worldwide."

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 a pivotal Phase II clinical trial was initiated in China. It also entered a Phase I trial in patients with GIST in China.

About Ascentage Pharma Pharma 
Ascentage Pharma is a globally-focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, hepatitis B virus and age-related diseases. The Company focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. Ascentage Pharma has built a pipeline of eight drug candidates in clinical development, including a novel, highly potent Bcl-2/Bcl-xL inhibitor, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors.

SOURCE Ascentage Pharma


These press releases may also interest you

at 05:17
EQT Infrastructure portfolio company Hector Rail Group to sell its UK subsidiary GB Railfreight, a leading rail freight operator in the United Kingdom, to Infracapital             During EQT's tenure, GB Railfreight has experienced substantial growth...

at 05:06
Archibus, a leading provider of workplace software solutions, today announced the availability of Archibus Cloud, an integrated workplace management system (IWMS) that now makes enterprise-grade SaaS more accessible. This new product aligns...

at 05:05
Market research company Technavio has released new reports on the impact of enterprise applications on the SMEs and BFSI sector. The research firm expects the enterprise resource planning (ERP) software market to register a CAGR of over 9% by 2023....

at 05:05
Keysight Technologies, Inc. , a leading technology company that helps enterprises, service providers and governments accelerate innovation to connect and secure the world, announced two new solutions - the N4891A 400GBASE Forward Error Correction...

at 05:05
September 23, 2019 New report shows how to address the challenges of implementing digital health technology ? a catalyst for achieving Universal Health Coverage (UHC)Philips Chief Medical Officer Jan Kimpen discusses the creation of enabling...

at 05:04
Aptiv and Hyundai Motor Group announced today that they will be forming an autonomous driving joint venture. This partnership brings together one of the industry's most innovative vehicle technology providers and one of the world's largest vehicle...



News published on 21 july 2019 at 19:00 and distributed by: