NEC Bio Therapeutics and AGC Biologics Announce Collaboration to Manufacture Personalized Cancer Vaccines

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. 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. 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. 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. NEC Bio Therapeutics, established in Manheim, Germany, focuses on the clinical strategy and development, as well as planning and execution of clinical trials in the oncology area. It is a subsidiary of NEC Bio, the biotech arm of NEC Corporation. NEC Bio, a subsidiary of NEC Corporation, is located in the Netherlands and dedicated to the development of innovative biotechnological solutions to tackle some of the most pressing health challenges. NEC Bio's research and development efforts are focused on creating personalized therapies that improve the quality of life for patients worldwide. NEC OncoImmunity in Oslo, Norway, is also a subsidiary of NEC Bio. AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 Team Members worldwide.