|
|
|
Foster City, CA & Hangzhou, CH, Mar 4, 2021 - (ACN Newswire) - Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, today announced 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. In February of this year, the two Phase 1 study sites were initiated.
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.
About Apollomics, Inc.
Apollomics, Inc. is an innovative 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. For more information, please visit www.apollomicsinc.com.
1National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) Program 2Source: CIC Report
Contact information of Apollomics: Investor Contact: Wilson W. Cheung Chief Financial Officer Telephone: +1-650-209-4436 Email: wcheung@apollomicsinc.com
Company Contact: Remy Bernarda Telephone: +1-415-203-6386 Email: remy.bernarda@apollomicsinc.com
China Media Contact: Porda Havas International Finance Communications Group Kelly Fung General Manager Telephone: (852) 3150 6763 Email: kelly.fung@pordahavas.com
Phoenix Fung Assistant Vice President Telephone: (852) 3150 6773 Email: phoenix.fung@pordahavas.com
Topic: Clinical Trial Results
Source: Apollomics, Inc.
Sectors: BioTech, Healthcare & Pharm
http://www.acnnewswire.com
From the Asia Corporate News Network
Copyright © 2024 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.
|
|
|
|
|
|
Apollomics, Inc. |
Mar 30, 2023 20:29 HKT/SGT |
Apollomics, a Company Developing Novel Oncology Therapies to Address Difficult-to-Treat Cancers, Announces Closing of Business Combination and Listing on Nasdaq |
July 26, 2022 09:17 HKT/SGT |
Apollomics Inc. Expands Leadership Team with Appointment of Jane Wang, PhD as Chief Scientific Officer |
Jan 12, 2022 09:25 HKT/SGT |
Apollomics Inc. to Host Virtual Investor Events on Wednesday, January 26, 2022 and Thursday, January 27, 2022 |
Jan 4, 2022 10:10 HKT/SGT |
Apollomics Inc. Announces CEO Guo-Liang Yu, PhD Appointed as Chairman of the Board for the BayHelix Group |
Nov 22, 2021 10:40 HKT/SGT |
Apollomics Inc. Doses First Patient in Phase 3 Clinical Trial with APL-106 (Uproleselan Injection) in Chinese Patients with Relapsed/Refractory Acute Myeloid Leukemia |
Oct 1, 2021 10:00 HKT/SGT |
Edison Oncology and Apollomics Announce Treatment of First Patient by EO1001 (APL-122) in a Phase I/IIa Clinical Trial |
Aug 10, 2021 11:53 HKT/SGT |
Apollomics, Inc. Doses First Patient in a Phase I Clinical Trial of APL-102 |
May 20, 2021 13:36 HKT/SGT |
APOLLOMICS INC. ANNOUNCES OFFICIAL OPENING OF SHANGHAI BRANCH |
Mar 9, 2021 10:35 HKT/SGT |
Apollomics, Inc. Appoints Seasoned Healthcare Executive K. Peony Yu, M.D., as Chief Medical Officer |
Feb 12, 2021 13:00 HKT/SGT |
Apollomics, Inc. Licenses a Targeted, Active Checkpoint Control Immunotherapy for Greater China and South Africa |
More news >> |
|
|
|
|