GBI Biomanufacturing and Allterum Therapeutics have announced a strategic partnership to advance Allterum's lead candidate, 4A10, into clinical trials. 4A10 is a monoclonal antibody (mAb) targeting CD127, a receptor expressed by various cancers. The collaboration aims to leverage GBI's manufacturing expertise to produce high-quality 4A10 for Phase 1/2a clinical trials, initially focusing on acute lymphoblastic leukemia (ALL).
Manufacturing and Clinical Trial Focus
Under the partnership, GBI Biomanufacturing will utilize its expertise in manufacturing complex biologics to ensure the production of 4A10 for clinical trials. Allterum's initial trial will enroll patients with acute lymphoblastic leukemia (ALL), with subsequent trials planned for patients with other CD127-expressing hematological malignancies, including lymphomas and acute myeloid leukemia.
Executive Perspectives
"We are honored to be chosen by Allterum as their trusted partner on this important project," said Karl Pinto, Chairman and CEO of GBI. "Our team is dedicated to providing the highest quality development and manufacturing services for drug substance and drug product, ensuring the success of this promising treatment. This collaboration is a testament of our commitment to advancing the field of oncology and making a meaningful difference in the lives of patients."
Atul Varadhachary, Allterum's CEO and Managing Partner at Fannin, added, "4A10 has demonstrated robust preclinical activity across multiple cancers and we are excited about advancing it into clinic. We selected GBI as our manufacturing partner based on their years of experience with complex biologics, and we look forward to working together to ensure our program's success."
4A10 Development and Funding
Allterum's 4A10 development program is supported by grant funding from the Cancer Prevention and Research Institute of Texas (CPRIT), the National Cancer Institute (NCI), and the NCI Experimental Therapeutics Program (NExT). The antibody, invented at the NCI by Scott Durum, PhD, is licensed exclusively to Allterum. Allterum has received Orphan Drug and Rare Pediatric Disease designations for ALL from the FDA, potentially qualifying 4A10 for a Pediatric Priority Review Voucher.
Addressing Unmet Needs in Cancer Treatment
Successful completion of Allterum's Phase 1/2a clinical trials will mark a significant milestone in developing this anti-cancer drug, addressing major unmet medical needs. According to the American Cancer Society, approximately 6,550 new cases of ALL and about 1,330 related deaths are estimated to occur in 2024. 4A10 represents a promising new approach to targeting CD127-expressing cancers and improving patient outcomes.
