Allergy Therapeutics prepares for manufacturing and clinical development of Polyvac ® Peanut allergy product
- Specialist CMO AGC Biologics engaged -
28 February 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."
1 The Journal of Allergy and Clinical Immunology 2016.
For further information, please contact:
+44 (0) 1903 845 820
Manuel Llobet, Chief Executive Officer
Nick Wykeman, Finance Director
+44 (0) 20 7886 2500
Freddy Crossley, Corporate Finance
Tom Salvesen, Corporate Broking
Consilium Strategic Communications
+44 20 3709 5700
Mary-Jane Elliott / Ivar Milligan / Philippa Gardner
Stern Investor Relations
+1 212 362 1200
Notes for editors:
About Allergy Therapeutics
Allergy Therapeutics is an international specialty pharmaceutical group focussed on the treatment and diagnosis of allergic disorders, including immunotherapy vaccines that have the potential to cure disease. The Group sells proprietary and third party products from its subsidiaries in nine major European countries and via distribution agreements in an additional ten countries. Its broad pipeline of products in clinical development include vaccines for grass, tree and house dust mite, and peanut allergy vaccine in pre-clinical development. Adjuvant systems to boost performance of vaccines outside allergy are also in development.
Formed in 1999 out of Smith Kline Beecham, Allergy Therapeutics is headquartered in Worthing, UK with more than 11,000m2 of state-of-the-art MHRA-approved manufacturing facilities and laboratories. The Group, which has achieved double digit compound annual growth since formation, employs c.500 employees and is listed on the London Stock Exchange (AIM:AGY). For more information, please see www.allergytherapeutics.com .
About AGC Biologics
AGC Biologics is a leading global contract development and manufacturing organisation (CDMO), with a strong commitment to deliver the highest standard of service to its clients and partners. AGC Biologics is the product of the convergence and integration of Asahi Glass Company (AGC) Bioscience, Biomeva GmbH, and CMC Biologics. The company currently employs more than 850 employees worldwide. Its extensive network spans three continents, with cGMP-compliant facilities in Seattle, WA; Berkeley, CA; Copenhagen, Denmark; Heidelberg, Germany; Yokohama, Japan; and Chiba, Japan.
AGC Biologics offers deep industry expertise and unique customised services for the scale-up and cGMP manufacture of protein-based therapeutics; from pre-clinical to commercial production, for mammalian and microbial. Its integrated service offerings include cell line development, bioprocess development, formulation, analytical testing, antibody drug development and conjugation, cell banking and storage, and protein expression - including its proprietary CHEF1®Expression System for mammalian production.
Further information can be found at www.agcbio.com
This information is provided by RNS