Polyvac® Peanut CMO appointed
April 23, 2018
Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, today announces it has signed a contract with AGC Biologics (Heidelberg, Germany) to scale up the manufacturing of its Polyvac® Peanut product for use in clinical studies.
Pre-clinical findings using Polyvac® Peanut demonstrated protection against anaphylaxis and induction of protective immunity. It is planned that further development of this product will enable the Group to address the current unmet need. Allergy Therapeutics will now scale-up and validate the manufacturing processes for Polyvac® Peanut as part of the clinical development programme.
Food allergy, and in particular peanut allergy, is a significant and strategically important area for Allergy Therapeutics due to the serious and destabilising effects on the lives of both patients and their families. The global addressable market for therapies to help mitigate these effects is estimated at $8 billion per annum1.
AGC Biologics is a contract manufacturing organisation (CMO) specialising in expression and purification of recombinant therapies. The company has produced batches of cGMP-compliant material for a variety of pharmaceutical and biotech companies with proven operational expertise in the transfer, development, scale-up and validation of cGMP processes and has prior experience in expression of virus like particle constructs.
Manuel Llobet, CEO at Allergy Therapeutics, stated: " The disruption to patients' social and family life as a result of food allergies is significant, and we are committed to addressing these current unmet needs. The Group's peanut vaccine programme complements our current marketed range of ultra-short course vaccines in terms of safety, efficacy and improved patient convenience. We are pleased to start working with AGC Biologics in order to further progress the clinical programme."