GBI Biomanufacturing and Allterum Therapeutics have announced a partnership to manufacture a monoclonal antibody (mAb) therapy to be used in Phase I/II clinical trials for patients with ALL. GBI will manufacture Allterum’s lead candidate 4A10, which targets the CD127 receptor found in various forms of cancer.

ALL is a cancer of the blood and bone marrow that occurs when too many lymphocytes are produced. According to Cancer.org, the American Cancer Society estimates about 6,550 new cases of ALL and about 1,330 related deaths will occur in 2024.

"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.”

Although the initial trial will focus on patients with ALL, subsequent expansion trials are planned for patients with other CD127-expressing malignancies which include lymphomas and acute myeloid leukemia.

“4A10 has demonstrated robust preclinical activity across multiple cancers and we are excited about advancing it into clinic,” said Atul Varadhachary, CEO of Allterum and managing partner at Fannin. “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."

GBI is a mid-sized CDMO based in Plantation, Florida where it manufactures 4A10 using single-use bioreactors. The company began its collaboration plans with Allterum earlier in 2024 and plans to support the developer during the entire clinical trial process and through commercialization.

A spokesperson for GBI told BioProcess Insider that the company has worked on more than 500 projects in the past and has participated in more than 50 investigational new drugs (INDs.) The company is thus well positioned to overcome the manufacturing challenges that mAb manufacturers sometimes face during production such as supply chain and timeline issues and capacity constraints, which can all be problems for large CDMOs. “GBI has skilled scientists, manufacturing, compliance, and regulatory specialists, who have many years of experience.”

The spokesperson added, “GBI is poised to overcome, because we have long partnerships with suppliers over our 30-year history, flexibility and capacity to meet timelines, an excellent project management team, and experienced subject matter experts who have worked in the manufacturing space and have the depth of knowledge to deliver for our clients.”