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.
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.
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SOURCE Ascentage Pharma