Allergy Thera. Regulatory News (AGY)

Allergy Therapeutics plc ("Allergy Therapeutics", "ATL" or the "Group"), Saiba AG

("Saiba") and DeepVax GmbH ("DeepVax")

Allergy Therapeutics secures virus-like particle ("VLP") technology platform to broaden vaccine pipeline through licensing agreements with Saiba AG and DeepVax GmbH

- Group to investigate potential of VLP technology in oncology and other immune conditions after encouraging proof of concept findings

- Builds on positive ongoing progress in VLP-based peanut allergy candidate vaccine

- VLP platform to be combined with Allergy Therapeutics' proprietary adjuvant technology

3 September 2020 Allergy Therapeutics plc (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today announces further investment in virus-like particle (VLP) technology for applications beyond the allergy immunotherapy field. Allergy therapeutics (the Group) entered into an exclusive licence agreement with Saiba AG and DeepVax GmbH to use their patented VLP technology platform to develop and commercialise vaccines targeting solid cancer tumours, atopic dermatitis, asthma, and psoriasis.

Allergy Therapeutics has an existing license agreement with Saiba and DeepVax, exclusively licensing their technology for the Group's development of a new VLP vaccine immunotherapy treatment for peanut allergy sufferers. Submission of the clinical trial application for that candidate vaccine is anticipated in 2021 and follows previously published encouraging preclinical results1.

The latest licensing agreement with Saiba and DeepVax includes upfront payments, which are not material in Group terms, plus further milestone payments at key points in clinical development, as well as royalty payments if candidates are commercialised.

The Group believes the use of VLP technology is a novel approach to generating active vaccines against appropriate cytokines, the small proteins that are crucial to cell signalling in the immune pathway for many diseases. Current approaches, including monoclonal antibodies, can have the limitation of a transient effect meaning repeated treatments are required. The Group believes the VLP approach could offer many benefits including sustained efficacy and a much lower cost per patient.

In pursuing this approach, Allergy Therapeutics intends to investigate the potential of combining VLP technology with its adjuvant systems including MCT (microcrystalline tyrosine). Adjuvant technologies are a key element of Allergy Therapeutics' strategy and have the potential to create immunotherapies that act faster, generate a sustained response, and work more efficiently than traditional therapies. Prior studies have already demonstrated the Group's adjuvant technologies have a synergistic effect in certain disease models2.

The Group plans to evaluate these new therapies via initial pre-clinical evaluation and, should these studies be successful, will explore future clinical development and potential partnering opportunities, alongside discussions with regulatory authorities.

Manuel Llobet, CEO at Allergy Therapeutics, stated: "This is a very exciting opportunity for Allergy Therapeutics, enabling us to take the first steps into the broader vaccine field using a technology platform that we are familiar with and already using in our peanut allergy candidate vaccine. While the allergy field remains our core focus, we believe VLP technology has potential across multiple therapies areas where there remains huge unmet need among patients. This is an opportunity to provide significant improvements to current treatment approaches used for a number of solid cancer and immune conditions and a more convenient treatment option for patients, which is the founding principle of our business."

Martin Bachmann, Founder of Saiba and CSO of DeepVax, stated: "This is a very important opportunity and milestone for Saiba and DeepVax. It advances four of our major programs towards clinical status and proof-of-concept. In addition, it reflects an important progression and validation of our CuMVtt-VLP platform." 

This announcement contains inside information for the purposes of Article 7 of Regulatory (EU) No596/2014.

- ENDS -

References

1. Allergy Therapeutics publishes encouraging new data for peanut allergy vaccine candidate in The Journal of Allergy and Clinical Immunology, 29 January 2020, https://ir.q4europe.com/solutions/allergytherapeutics2018tf/3856/newsArticle.aspx?storyid=14586336 

2. Cabral-Miranda et al., Virus-Like Particle (VLP) Plus Microcrystalline Tyrosine (MCT) Adjuvants Enhance Vaccine Efficacy Improving T and B Cell Immunogenicity and Protection against Plasmodium berghei/Vivax. Vaccines 2017, 5, 10; doi:10.3390/vaccines5020010

For further information, please contact:

Allergy Therapeutics

+44 (0) 1903 845 820

Manuel Llobet, Chief Executive Officer

Nick Wykeman, Chief Financial Officer

Saiba AG

+41 (44) 515 4133

Patrik M. Paulus, Executive Chairman

Dr. Gary Jennings, COO

Panmure Gordon

+44 (0) 20 7886 2500

Freddy Crossley, Emma Earl, Corporate Finance

James Stearns, Corporate Broking

Consilium Strategic Communications

+44 20 3709 5700

Mary-Jane Elliott / David Daley / Ashley Tapp / Olivia Manser

allergytherapeutics@consilium-comms.com

Stern Investor Relations, Inc.

+1 212 362 1200

Christina Tartaglia

christina@sternir.com

Notes for editors:

About Allergy Therapeutics

Allergy Therapeutics is an international commercial biotechnology company focussed on the treatment and diagnosis of allergic disorders, including aluminium free 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 over 9% 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 Saiba AG

Saiba AG, headquartered in Pfäffikon (Schwyz) Switzerland, is built on a solid foundation of experience, know-how and intellectual property in vaccine research and development. Its patented VLP technology and core projects help clients to define, explore and develop vaccination strategies for their needs, which include infectious and chronic diseases. Virus-like particles (VLPs) are the most immunogenic recombinant scaffold for display of antigens with strong Proof-of-Concept (PoC) in humans. Saiba AG's proprietary technology has enabled its scientists to generate a vaccine candidate against COVID-19 with preclinical proof of concept, and they have significantly invested in their discovery and clinical capabilities. With the effective control of many infectious diseases in many parts of the world, chronic, often non-communicable diseases have become the single largest cause of death and disability. Treatment of such chronic diseases is expensive and often ineffective. There is a major need for novel treatment modalities such as therapeutic immunization to prevent rather than treat chronic diseases and that are available at affordable costs. For more information, please see www.saiba-biotech.com.