Allergy Thera. Regulatory News (AGY)

Allergy Therapeutics plc

("Allergy Therapeutics" or the "Group")

Allergy Therapeutics Publishes New Data Validating Mode of Action and Unique Adjuvant Properties of its Patented Adjuvant, Microcrystalline Tyrosine (MCT®), in The Journal of Immunology

Novel Findings Further Highlight the Effectiveness of MCT as Alternative to Alum and its Potential Advantage in Allergy-Specific Immunotherapy

WORTHING, United Kingdom, 14 May 2018 - Allergy Therapeutics (AIM:AGY), a leading, fully-integrated commercial biotechnology company specialising in allergy vaccines, today announces that new data from a study investigating immune responses produced by microcrystalline tyrosine (MCT®)-based vaccines as compared with conventional aluminium hydroxide has been published online in The Journal of Immunology. The findings demonstrate that, based on its comparable strength and mechanism of Ag-specific IgG induction and induction of T cell responses, MCT® is a suitable and flexible alternative to aluminium hydroxide as an adjuvant in both allergen-specific immunotherapy and infectious disease applications. The study also demonstrated that MCT®-adjuvanted allergens caused fewer anaphylactic reactions compared with alum-adjuvanted allergens.

"These findings provide evidence of the effectiveness of MCT as an adjuvant, confirming the mechanism of action underlying its ability to induce a robust and sustained immunological response. Additionally, the findings indicated a potentially favourable profile for the use of MCT over alum in allergy-specific vaccines," said Matthias Kramer, M.D., Allergy Therapeutics' International Medical Director and co-author of the paper. "We believe these data highlight the significance of our differentiated proprietary platform technology in the development of our growing suite of cutting-edge, globally marketed ultra-short course allergy vaccines."

This is the first study to report the mechanism of action by which MCT governs the immunologic response after exposure to an antigen and protection against anaphylaxis in an allergic model. The results illustrate upregulation of IgG antibody responses and a higher IgE:IgG ratio in MCT-based immunotherapy compared with Alum-based immunotherapy. A high IgE:IgG ratio has been reported to be a positive predictive marker for allergen immunotherapy in humans.

Further evaluation in this study indicated that MCT facilitates robust adaptive T cell responses with associated IFN-γ (interferon gamma) and TNF-α (tumour necrosis factor alpha), which is in line with previous studies illustrating protective efficacy in influenza and malaria applications1, 2. Meanwhile, studies in a cancer (melanoma) model are underway.

A link to publication is here: www.jimmunol.org/content/200/9/3151

- ENDS -

For further information, please contact:

Allergy Therapeutics

+44 (0) 1903 845 820

Manuel Llobet, Chief Executive Officer

Nick Wykeman, Finance Director

Panmure Gordon

+44 (0) 20 7886 2500

Freddy Crossley, Emma Earl, Corporate Finance

Consilium Strategic Communications

+44 20 3709 5700

Mary-Jane Elliott / Ivar Milligan / Philippa Gardner

allergytherapeutics@consilium-comms.com

Stern Investor Relations

+1 212 362 1200

Christina Tartaglia

Christina@sternir.com 

Notes for editors:

About Microcrystalline Tyrosine (MCT®)

MCT has been developed by the research division of Allergy Therapeutics, Bencard Adjuvant Systems, and comprises the depot in the group's marketed allergen-specific immunotherapy vaccines. MCT® has been designed to provide defined particle size and morphology along with strong antigen binding capacity to enhance its use as a powerful immune system potentiator.

Many existing adjuvants persist long after administration, whereas MCT®, being based upon naturally derived amino acids, is biodegradable with a half-life of ~48 hours. Previous research has illustrated that MCT® is consistently absorbed with antigens and other adjuvants3, a feature that permits the creation of novel adjuvant systems.

MCT has demonstrated enhanced protective immune responses against infectious disease antigens and in a pre-clinical model, MCT® enhanced specific IgG responses and protection2.

References

1 - Heath. M et al., Comparison of a novel microcrystalline tyrosine adjuvant with aluminium hydroxide for enhancing vaccination against seasonal influenza. BMC Infect Dis. 2017 Mar 27;17(1):232

2 - Microcrystalline Tyrosine (MCT®): A Depot Adjuvant in Licensed Allergy Immunotherapy Offers New Opportunities in Malaria. Cabral-Miranda et al., Vaccines 2017, 5, 32.

3 - Bell A.J. et al., The adsorption of allergoids and MPL to MCT® in formulations for use in allergy immunotherapy. J Inorg Bioch 152 (2015) 147 -153.

About Allergy Therapeutics

Allergy Therapeutics is an international commercial biotechnology company focused 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.