Apollomics Doses First Patient in Phase 3 Clinical Trial With APL-106 (Uproleselan Injection) in Chinese Patients With Relapsed/Refractory Acute Myeloid Leukemia
Apollomics Inc. recently announced the first patient has been successfully dosed in a Phase 3 clinical trial of APL-106 (uproleselan injection) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) in China. Apollomics licensed the Greater China rights for uproleselan from GlycoMimetics.
“As our first Phase 3 clinical trial, dosing of the first patient with APL-106 is a major inflection point for Apollomics as we now become a company in late-stage development,” said Guo-Liang Yu, PhD, Co-Founder, Chairman and Chief Executive Officer. “AML is a highly aggressive hematological cancer, and the prognosis of patients with relapsed or refractory disease is extremely poor. APL-106 acts via an innovative mechanism that drives cancer cells out of the bone marrow, making them a prime target to be killed by chemotherapy. This combined treatment approach could have a meaningful impact on the lives of patients living with relapsed or refractory AML.”
The Phase 3 trial with APL-106 is part of the overall development program for Apollomics in China that also includes an ongoing Phase 1 pharmacokinetics (PK) and tolerability study. The Phase 3 clinical trial is a randomized, double-blind, placebo controlled, bridging study that will evaluate the efficacy of uproleselan in combination with chemotherapy, compared to chemotherapy alone, for treating relapsed/refractory AML, in Chinese patients. The trial will enroll approximately 140 adult patients with primary refractory AML or relapsed AML (first or second untreated relapse) and eligible to receive induction chemotherapy.
The primary endpoint for the trial is overall survival. Secondary outcome measures include the rate and duration of remission, and whether uproleselan could reduce the rate of oral mucositis, a chemotherapy-related side effect. Apollomics expects to conduct this study at approximately 20 blood cancer clinical research centers across China. Additional information on the Phase 3 trial can be found on clinicaltrials.gov (NCT05054543)
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. Apollomics licensed uproleselan from GlycoMimetics, and Apollomics has the rights to clinical development, production and commercial sales in the Greater China market (Mainland China, Hong Kong, Macau and Taiwan). The US FDA granted Breakthrough Therapy Designation to uproleselan for the treatment of adults with relapsed or refractory acute myeloid leukemia. APL-106 has also been granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.
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 US, there are approximately 20,000 new cases of AML each year, and the 5-year survival rate is 28.7%. The annual incidence of AML in China in 2019 is approximately 26,900, and relapsed/refractory AML has an extremely poor prognosis.
Apollomics Inc. is an innovative biopharmaceutical company committed to the discovery and development of monotherapies and combination therapies of tumor-targeting and immuno-oncology agents. The company’s product pipeline has several programs at different stages of development, including novel, humanized monoclonal antibodies that restore the body’s immune system to recognize and kill cancer cells, and targeted therapies against uncontrolled growth signaling pathways. Apollomics has operating entities in Foster City, CA, Hangzhou and Shanghai, China. For more information, visit www.apollomicsinc.com.
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