GBI Biomanufacturing Enters into Collaboration with Allterum for Antibody Production in Clinical Trials
Tuesday, October 08, 2024
GBI Biomanufacturing has formed a manufacturing partnership with Allterum Therapeutics to advance Allterum's lead candidate, 4A10, into clinical trials.
The initial focus of Allterum's trial will be on patients with acute lymphoblastic leukaemia (ALL), with plans to expand trials to include other CD127-expressing blood cancers, such as lymphomas and acute myeloid leukaemia.
This monoclonal antibody targets CD127, a receptor found in various cancers.
Allterum’s development of 4A10 is supported by grants from the Cancer Prevention and Research Institute of Texas (CPRIT) and the National Cancer Institute (NCI).
Under this collaboration, GBI will utilise its extensive expertise in manufacturing complex biologics to ensure the high-quality production of 4A10 for Phase 1/2a clinical trials.
The company has received Orphan Drug and Rare Pediatric Disease designations from the FDA for ALL, which will facilitate access to regulatory processes and may qualify 4A10 for a Pediatric Priority Review Voucher.
The successful completion of the Phase 1/2a clinical trials will represent a significant milestone in the development of this promising anti-cancer treatment, addressing critical unmet medical needs.
Source: gbibio.com
