NEC Bio Therapeutics and AGC Biologics have announced a partnership to advance the production of NECVAX-NEO1, an orally delivered, bacteria-based DNA vaccine designed to target patient-specific tumor neoantigens. This important and promising collaboration aims to enhance the production of personalized cancer treatments by leveraging the biotechnology strengths of both companies.

Advancing Personalized Cancer Treatment

NEC Bio Therapeutics, a Mannheim based German company focused on clinical development of innovative drugs by using proprietary AI, is developing NECVAX-NEO1, a personalized cancer vaccine that uses cutting-edge AI/machine learning technology to target specific tumor neoantigens that are unique to each patient. NECVAX-NEO1 relies on powerful and flexible plug and play bacteria-based platform technology and is convenient for patients due to its oral delivery. Unlike traditional treatments, NECVAX-NEO1 requires tailored manufacturing capacities and is produced by cost-efficient microbial fermentation at a small scale and with a quick turnaround time.

New Phase1/2 clinical trials for NECVAX-NEO1 are slated to begin in cancer patients throughout 2024 and 2025. These trials will play a crucial role in validating the efficacy and safety of this novel treatment, potentially offering new hope to countless individuals battling cancer.

Expert CDMO Collaboration for Global Manufacturing

AGC Biologics is well-equipped to support the current supply chain needs of NECVAX-NEO1, ensuring timely delivery for clinical trials.

As a global Contract Development and Manufacturing Organization (CDMO), AGC Biologics will use its state-of-the-art Heidelberg, Germany facility, a site with almost 40 years of microbial fermentation expertise, to perform a technology knowledge transfer, implementation and qualification of analytical methods, preparation for large scale clinical manufacturing, engineering and batch execution with Good Manufacturing Practices (GMP), and drug product release testing.

"Personalized medicines have the potential to innovate how a treatment can address specific traits of a disease in a patient and give them a better quality of life. That is truly a remarkable endeavor, and the Heidelberg site is proud to have this opportunity to help NEC Bio Therapeutics on its mission of combining AI and machine learning with traditional biologics and personalized care," said Dieter Kramer, General Manager, AGC Biologics Heidelberg. "We are eager to begin work and to collaborate with our new partners on this important journey."

AGC Biologics is the large molecule arm of the AGC Life Science Company, the life science division of AGC Inc. AGC Biologics offers end-to-end services for protein biologics, cell and gene therapies, plasmid DNA and messenger RNA, with operations in Europe, North America, and Japan.

Collaboration Kickoff in Germany

The partnership between NEC Bio Therapeutics and AGC Biologics will commence with a focus on clinical development and GMP-compliant manufacturing in Germany. Both companies have strategically positioned teams in Heidelberg and Mannheim, close to each other, fostering a collaborative environment for advancing this critical initiative.

"We are thrilled to announce our collaboration with AGC Biologics to support the manufacturing of NECVAX-NEO1. This partnership represents a significant milestone in our commitment to delivering high-quality, affordable personalized cancer vaccines to patients. This collaboration underscores our dedication to improving global health outcomes in the oncology field. We look forward to the transformative impact this partnership will have on our operations and, more importantly, on the lives of the patients we serve," said Dr. Heinz Lubenau, CEO, NEC Bio Therapeutics.