- GBI Biomanufacturing partners with Allterum Therapeutics to manufacture the 4A10 antibody for clinical trials.
- The 4A10 monoclonal antibody targets CD127, a receptor found in multiple cancers.
GBI Biomanufacturing, a contract development and manufacturing organization (CDMO), has entered a partnership with Allterum Therapeutics to produce Allterum’s lead cancer therapy candidate, 4A10. The monoclonal antibody (mAb), which targets CD127, will be manufactured for Phase 1/2a clinical trials. The first trial will focus on treating acute lymphoblastic leukemia (ALL), with further expansion planned for other cancers expressing CD127, including lymphomas and acute myeloid leukemia.
GBI will utilise its expertise in biologics manufacturing to ensure the high-quality production of 4A10. “We are honoured to be chosen by Allterum as their trusted partner on this important project,” said Karl Pinto, Chairman and CEO of GBI. He noted the company’s commitment to providing top-tier development and manufacturing services to support the success of this treatment.
Allterum’s CEO, Atul Varadhachary, expressed optimism about advancing 4A10 into clinical trials, citing GBI’s experience with complex biologics as a key factor in their selection. “4A10 has demonstrated robust preclinical activity, and we look forward to working with GBI to ensure the success of this programme,” Varadhachary said.
The development of 4A10 is supported by grants from the Cancer Prevention and Research Institute of Texas (CPRIT) and the National Cancer Institute (NCI). The antibody has also received Orphan Drug and Rare Pediatric Disease designations from the FDA, potentially qualifying it for a Pediatric Priority Review Voucher.
Overview of outsourcing trends 
