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Apollomics Completes Enrollment in Phase 3 Bridging Study of Uproleselan in Chinese Patients with Relapsed/Refractory Acute Myeloid Leukemia


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FOSTER CITY, Calif., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM) (“Apollomics” or the “Company”), a clinical-stage biopharmaceutical company developing medicines to address difficult-to-treat cancers, today announced the completion of enrollment in its Phase 3 bridging study evaluating uproleselan (APL-106), an investigational, first-in-class E-selectin antagonist, added to a standard chemotherapy regimen for the treatment of adults with relapsed or refractory acute myeloid leukemia (relapsed/refractory AML).

  

This Phase 3 bridging study is being performed in China with Chinese r/r AML patients. A total of 140 adult patients across 20 sites in Greater China with primary refractory AML or relapsed AML (first or second untreated relapse) and eligible to receive induction chemotherapy have been randomized to either uproleselan combined with chemotherapy or placebo plus chemotherapy. Apollomics licensed uproleselan from GlycoMimetics (Nasdaq: GLYC), including the rights to clinical development, production and commercial sales in the Greater China market (Mainland China, Hong Kong, Macau and Taiwan).

  

“Uproleselan, as a potent E-selectin antagonist, is the first in this novel mechanism class to be tested in Phase 3 AML studies, and has the potential to transform the care and positively impact the outcomes of relapsed and refractory AML patients,” said Dr. Jianxiang Wang, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China.

  

“AML is a highly aggressive hematological cancer, and the prognosis of patients with relapsed or refractory disease is extremely poor. AML remains a major unmet medical need in China with an incidence of close to 40,000 patients every year. Drug combinations targeting tumor-intrinsic and microenvironment-extrinsic pathways of chemoresistance may provide improved outcomes in this disease,” said Guo-Liang Yu, Chairman and CEO of Apollomics, Inc. “As a potential first-in-class therapeutic that addresses chemoresistance, uproleselan has the potential to be transformative in patients with AML. I would also like to thank our investigators, staff, as well as our clinical team and CRO partners, for their commitment to completing this important milestone.”

  

The primary endpoint for the Phase 3 bridging study is overall survival. Secondary outcome measures include the rate and duration of remission and whether uproleselan can reduce the rate of oral mucositis, a chemotherapy-related side effect. Additional information on the Phase 3 trial can be found on clinicaltrials.gov (NCT05054543).

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