AGC Biologics to Manufacture NECVAX-NEO1 at Heidelberg Facility

• NEC Bio Therapeutics and AGC Biologics have announced a collaboration to advance the production of the NECVAX-NEO1 cancer vaccine.

• The partnership will leverage AGC Biologics’ Heidelberg facility for manufacturing and support the upcoming Phase 1/2 clinical trials starting in 2024.

NEC Bio Therapeutics, a German biotechnology firm based in Mannheim, is collaborating with AGC Biologics to enhance the production of NECVAX-NEO1. This vaccine, designed to be delivered orally, targets patient-specific tumor neoantigens using a bacteria-based DNA platform. It aims to offer a personalised approach to cancer treatment through AI and machine learning technologies.

The collaboration will enable AGC Biologics to utilise its Heidelberg, Germany facility, known for its expertise in microbial fermentation, to manage the manufacturing and supply chain needs for NECVAX-NEO1. The facility will handle technology transfer, analytical method implementation, and production under Good Manufacturing Practices (GMP).

New Phase 1/2 clinical trials for NECVAX-NEO1 are set to begin in 2024 and 2025. These trials are critical for assessing the vaccine’s safety and efficacy. Dr. Heinz Lubenau, CEO of NEC Bio Therapeutics, highlighted the partnership’s potential to improve global health outcomes in oncology.

Dieter Kramer, General Manager of AGC Biologics Heidelberg, emphasised the innovative nature of the project, stating, “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.”