Policy & Regulation
Apollomics Doses First Patient in Phase 1 Clinical Trial in China of GlycoMimetics' Uproleselan for the Treatment of AML
5 March 2021 - - US-based biopharmaceutical company Apollomics has dosed the first patient in China in a Phase 1 clinical trial of APL-106 (uproleselan injection) for the treatment of adults with relapsed or refractory acute myeloid leukemia, US-based biotechnology company GlycoMimetics (NASDAQ: GLYC) said.

In February of this year, Apollomics initiated two Phase 1 study sites in Greater China.

The Phase 1 clinical trial in China 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 trial is to study the pharmacokinetic 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.

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted inhibitor of E-selectin.

Uproleselan (yoo' pro le' sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy designation from the US FDA the treatment of adult AML patients with relapsed or refractory disease.

In January 2021, it was also granted Breakthrough Therapy Designation by the Center for Drug Evaluation of the NMPA in China.

Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment.

In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed or refractory patients with AML.

In both populations, patients treated with uproleselan together with standard chemotherapy achieved better-than-expected remission rates and overall survival compared to historical controls, which have been derived from results from third-party clinical trials evaluating standard chemotherapy, as well as lower-than-expected induction-related mortality rates.

Treatment in these patient populations was generally well-tolerated, with fewer than expected adverse effects.

Apollomics is a biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies to harness the immune system and target specific molecular pathways to eradicate cancer.

The company's existing pipeline consists of several development-stage assets 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.

GlycoMimetics is a biotechnology company with a focus in hematology-oncology and a pipeline of novel glycomimetic drugs, all designed to address unmet medical needs resulting from diseases in which carbohydrate biology plays a key role.

GlycoMimetics' drug candidate, uproleselan, an E-selectin antagonist, was evaluated in a Phase 1/2 clinical trial as a potential treatment for AML and is being evaluated across a range of patient populations including in a company-sponsored Phase 3 trial in relapsed/refractory AML.

GlycoMimetics has an ongoing Phase 1b clinical trial evaluating GMI-1359, a combined CXCR4 and E-selectin antagonist, also a wholly-owned drug candidate. GlycoMimetics is located in Rockville, MD in the BioHealth Capital Region.

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