AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced a new partnership with Allergy Therapeutics, the fully integrated specialty pharmaceutical company specializing in allergy vaccines. The CDMO has manufactured phase I clinical trial materials for Allergy Therapeutics’ novel virus-like particle (VLP)-based peanut allergy vaccine candidate (“VLP Peanut”), ahead of trial commencement later this year.
Under the terms of the agreement, AGC Biologics is supporting the manufacturing and testing of Allergy Therapeutics’ VLP Peanut vaccine candidate, providing VLP material for Phase I supply. The United States Food & Drug Administration (FDA) recently cleared Allergy Therapeutics Investigational New Drug application (IND), which included data generated in this collaborative effort and granted the VLP Peanut vaccine candidate a clear path to a Phase I product trial in the U.S.
“Allergy Therapeutics is creating a strong vaccine candidate for one of the most common food allergies in the world and we are proud to be helping bring it to this critical phase I trial phase,” said Jean-Baptiste Agnus, Chief Business Officer at AGC Biologics. “This is a shining example of the ability and expertise of our global network to handle some of the most complex products and support our clients advancing through important clinical phases.”
A peanut allergy is one of the most common types of food allergies worldwide, and in the U.S., it is also a leading cause of severe and fatal food-induced anaphylactic reactions. Through this partnership, AGC Biologics will continue to work collaboratively with Allergy Therapeutics to develop the vaccine candidate that has the potential to provide relief for patients that have a critical need.
“This is another key milestone for our VLP Peanut vaccine candidate, and we believe AGC Biologics is a great partner for us as we enter the next stage of bringing this promising immunotherapy to market,” said Manuel Llobet, Chief Executive Officer, Allergy Therapeutics. “We are excited to demonstrate the potential of this vaccine to provide long-term protection and a long-lasting protective immune response.”
AGC Biologics is producing this vaccine material at its state-of-the-art clinical and commercial manufacturing facility in Heidelberg, Germany. The site specializes in Microbial and Plasmid DNA (pDNA) offerings and is one of the company’s central facilities in Europe. The core team at the Heidelberg facility has several decades of experience delivering a wide range of programs, including work with BioNTech to supply COVID-19 vaccine materials.