On March 4, 2021 Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, reported that the first patient has been successfully enrolled into a Phase 1 clinical trial of APL-106 (uproleselan injection) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) in China (Press release, Apollomics, MAR 4, 2021, View Source [SID1234576050]). In February of this year, the two Phase 1 study sites were initiated.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The Phase 1 clinical trial is a part of the Phase 1 and Phase 3 bridging clinical study of APL-106 in combination with chemotherapy in adults with relapsed or refractory AML. Its principal investigator is Professor Jianxiang Wang of the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College. The primary objective of the Phase 1 is to study the pharmacokinetic (PK) characteristics of APL-106 in Chinese subjects with relapsed or refractory AML and to evaluate the safety and tolerability of APL-106 in combination with chemotherapy.
About APL-106 (uproleselan injection)
APL-106 (uproleselan injection) is an innovative drug discovered and developed by GlycoMimetics. Uproleselan (yoo’ pro le’ sel an) is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells, thereby disrupting the mechanism of leukemic cell resistance within the bone marrow microenvironment. In 2017, the U.S. FDA granted Breakthrough Therapy Designation to uproleselan for the treatment of adults with relapsed or refractory acute myeloid leukemia. Apollomics licensed uproleselan from GlycoMimetics in January 2020. Apollomics has the rights to clinical development, production and commercial sales in the Chinese market (Mainland China, Hong Kong, Macau and Taiwan).
In September 2020, APL-106 received the approval of the National Medical Products Administration (NMPA) through the issuance of the "Clinical Trial Drug Approval Notification". This approval enables the conduct of Phase I and Phase III bridging clinical study of APL-106 in combination with chemotherapy in adults with relapsed or refractory acute myeloid leukemia. In January 2021, APL-106 was also granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the NMPA.
About Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow. It is an aggressive disease that causes the bone marrow to produce immature cells that are unable to carry out their normal function and develop into leukemia cells. In the U.S., there are approximately 20,000 new cases of AML each year, and the 5-year survival rate is 28.7%1. The annual incidence of AML in China in 2019 is approximately 26,9002, and relapsed/refractory AML has an extremely poor prognosis.