On January 7, 2021 Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, and GlycoMimetics (Nasdaq: GLYC), reported APL-106 (uproleselan) has been granted Breakthrough Therapy Designation (BTD) from the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) for the treatment of relapsed/refractory acute myeloid leukemia (AML) (Press release, GlycoMimetics, JAN 7, 2021, View Source [SID1234573625]).
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!
"This Breakthrough Therapy Designation for APL-106 reinforces its potential and is an important regulatory milestone for Apollomics as we prepare to initiate our clinical development work in China for patients suffering from AML," said Guo-Liang Yu, PhD, Co-Founder, Chairman and Chief Executive Officer. "AML is an aggressive disease and relapsed/refractory patients have an extremely poor prognosis. We look forward to initiating our Phase 3 bridging study this year and working with the CDE on a potentially accelerated clinical development program to address this important patient need."
In September 2020, the NMPA CDE granted Investigational New Drug (IND) approval for APL-106 enabling the initiation of a Phase 1 pharmacokinetics (PK) and tolerability study and includes acceptance of a Phase 3 bridging study of APL-106 in combination with chemotherapy in relapsed/refractory AML.
The BTD is part of the revised Drug Registration Regulation that became effective in July 2020 in China. The BTD is designed to expedite the development and review of therapies that are being developed for treatment of serious diseases for which there is no existing treatment or where preliminary evidence indicates significant advantages of the therapy over available treatment options.1
About Uproleselan (APL-106)
Discovered and developed by GlycoMimetics, uproleselan (APL-106) is a late clinical-stage, potentially first-in-class, targeted inhibitor of E-selectin. 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 as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In 2017, the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to uproleselan for treatment of adults with relapsed or refractory AML. Apollomics licensed APL-106 from GlycoMimetics in January 2020 to develop and commercialize APL-106 in Mainland China, Hong Kong, Macau and Taiwan, also known as Greater China.
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 leukemic white blood cells called myeloblasts. In the U.S., there are approximately 20,000 new cases of AML each year and a 5-year survival rate of 28.7%.2 The annual incidence of new cases of AML in China is 21,600, and relapsed/refractory AML has an extremely poor prognosis.3