Mission Statement
To create a sustainable, fast-growing and profitable global speciality pharmaceutical business with a substantial franchise in the allergy sector by developing innovative, patented, registered therapies for both the treatment and prevention of allergy-related conditions.

NEWS

19th Jul 2018 Proposed placing and subscription to raise up to £10.6 million
13th Jul 2018 Hardman & Co Research
12th Jul 2018 Trading update
25th Jun 2018 Positive data of Pollinex Quattro Grass vaccine
29th May 2018 Positive data with house-dust mite immunotherapy
21st May 2018 Positive top-line results from Grass Ph II study
14th May 2018 Publication of MCT Adjuvant Data
07th Mar 2018 Hardman Research: Clinical development towards submission
07th Mar 2018 Interim Results for the six months ended 31 December 2017


VIDEO/AUDIO
21st May 2018 Allergy Therapeutics on track for phase III grass pollen trial in 2019
September 2017 5 minute pitch
09th May 2016 Allergy Therapeutics boss excited by PQBirch204 Phase II data
08th Mar 2016 Allergy Therapeutics says double-digit revenue growth is sustainable
18th Feb 2016 Allergy Therapeutics hopes to launch "exciting" grass pollen allergy vaccine in 2019
14th Jan 2016 Allergy Therapeutics boss says the firm is outperforming its competitors

EVENTS
27 11 2018 AGM (tentative)
03 10 2018 Shares Investor Evening (London)
26 09 2018 Preliminary Annual Results 2018 Announcement (tentative)


WEBSITES

Allergy Therapeutics' Murray Skinner talks up 'huge market opportunities' for dust mite treatment
14:19 14 Feb 2017

Allergy Therapeutics plc (LON:AGY) chief scientific officer Murray Skinner speaks to Proactive about their phase I clinical study of Acarovac MPL receiving official sign-off in Spain.
A total of 32 patients will receive Acarovac, which will be administered at two different doses. The trial is expected to take 12 months from start to finish.
 
Andrew Scott

http://www.proactiveinvestors.co.uk/companies/stocktube/6911/allergy-therapeutics-murray-skinner-talks-up-huge-market-opportunities-for-dust-mite-treatment-6911.html

Big picture - Why invest in Allergy Therapeutics plc

Allergy Therapeutics plc
("Allergy Therapeutics" or the "Group")
 
Notice of Interim Results
 
9 March 2017 Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, will issue its interim results for the six months ended 31 December 2016 on Wednesday 29 March 2017.
 
Manuel Llobet, Chief Executive Officer, and Nick Wykeman, Finance Director, will hold a presentation and conference call for analysts on the day of results at 9:00am at Panmure Gordon, One New Change, London, EC4M 9AF.
 
Please contact Consilium Strategic Communications for further details.
 
- ENDS -

http://www.moneyam.com/action/news/showArticle?id=5509442

16 March 2017 
Allergy Therapeutics plc

First Patient Recruited in Pivotal Phase III Birch Immunotherapy B301 Study 
 
16 March 2017 Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces the recruitment of the first patient in its Phase III study designed to evaluate the efficacy and safety of its ultra-short course, aluminium-free Pollinex® Quattro Birch immunotherapy to address the cause of symptoms of allergic rhinoconjunctivitis due to birch pollen.
 
The first patient in the B301 Phase III study was recruited in Austria on 15 March. The study is anticipated to run for one year and involve more than 550 patients over 50 sites across Germany, Sweden, Austria and Poland. The primary objective of this study is to evaluate the efficacy of Pollinex® Quattro Birch in birch pollen-induced rhinoconjunctivitis and to enable registration of the product in Germany via the Therapieallergene-Verordnung (TAV) process of the Paul Ehrlich Institut, before anticipated marketing authorisation in 2019.
 
The adopted cumulative dose has been demonstrated to be efficacious in two recent dose range finding studies with respect to reduction of symptoms induced by a conjunctival provocation test (CPT) with no prior safety concerns.
 
Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: "The start of our Phase III trial investigating Pollinex Quattro Birch marks the beginning of a number of trials aimed at strengthening our product portfolio across Europe and helping the 6% of Europeans who test positive to birch allergens. If approved, Pollinex Quattro Birch will be the first MPL adjuvanted ultra-short course aluminium-free vaccine ever approved. Combined with our clinical programme in the US focusing on Pollinex Quattro Grass, we aim to have a comprehensive global modified allergen + MCT® and MPL vaccine package that focuses on delivering convenience, safety, efficacy and enhanced patient compliance."

http://www.moneyam.com/action/news/showArticle?id=5513615

Allergy Therapeutics recruits first patients to its phase III birch trial
07:43 16 Mar 2017

The year-long study over 50 sites in Germany, Sweden, Austria and Poland



Allergy Therapeutics plc (LON:AGY) has recruited the first patients to its phase III trial of people with a sensitivity to birch pollen.

The year-long study over 50 sites in Germany, Sweden, Austria and Poland will recruit 550 patients and assess the efficacy and safety of its ultra-short course treatment Pollinex Quattro.

A successful outcome will pave the way to marketing authorisation in 2019.

"The start of our phase III trial investigating Pollinex Quattro Birch marks the beginning of a number of trials aimed at strengthening our product portfolio across Europe and helping the 6% of Europeans who test positive to birch allergens,” said chief executive Manuel Llobet.

If approved, Pollinex Quattro Birch will be the first MPL enhanced ultra-short course aluminium-free vaccine ever approved.

MPL, or monophosphoryl lipid A, is what’s called an adjuvant that enhances the body’s immune response.

“Combined with our clinical programme in the US focusing on Pollinex Quattro Grass, we aim to have a comprehensive global modified allergen + MCT and MPL vaccine package that focuses on delivering convenience, safety, efficacy and enhanced patient compliance," said Llobet.

Ian Lyall

29 March 2017 
Manuel Llobet, Chief Executive Officer, and Nick Wykeman, Finance Director, will host a meeting and call for analysts to provide an update on the Group, followed by a Q&A session, at 0900 BST today. Dial-in details are: +44 (0) 1452 555566. Conference ID: 75062637. 
 
Allergy Therapeutics plc

 
Interim Results for the six months ended 31 December 2016
 
29 March 2017 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, announces its unaudited interim results for the six months ended 31 December 2016.
 
Highlights (including post period end highlights)
 
Financial highlights

·      Revenue increased by 18% at constant currency to £34.2m (H1 2016: £29.0m)* while reported revenue increased by 39% to £40.4m (H1 2016: £29.0m)

·      R&D expenditure of £3.8m (H1 2016: £6.5m) following a higher level of investment in Phase II trials in H1 2016

·      Strong growth in operating profit pre R&D of 40% as a result of broad investment in the business to £11.1m (H1 2016: £7.9m) and the strength of the euro against sterling

·      Cash balance of £27.8m (H1 2016: £33.2m)
 

Products and pipeline highlights

·      Increased market share in the Group's main European markets to 13% (2016: 12%) against a low to flat market

·      Pollinex franchise continues to expand and shape the market as a more convenient treatment

·      First patient recruited in pivotal Pollinex Quattro Birch Phase III study in Europe

·      US Grass MATA MPL programme proceeding as planned with the safety trial (G104) advancing to a dosing trial in H2 2017

·     CTA approval in Spain for Phase I clinical study investigating the safety and tolerability of Acarovac MPL (monophosphoryl lipid A)

·      Positive proof of concept preclinical trial results announced with Polyvac® Peanut, the Group's peanut allergy vaccine
 
Commenting on the interim results, Manuel Llobet, Chief Executive Officer, said: "In the first half of this year, we delivered an increase of 18% in revenue at constant currency, despite flat or low growth in European markets, driven by the quality of the Group's highly convenient, ultra-short course, aluminium-free therapy enabling us to continue to gain market share. This, linked to the recent announcements on progress with our pipeline projects, illustrates that the approach of investing both in the current business as well as the pipeline is working, paving the way for our long-term strategic international plans for a world-class allergy vaccines portfolio."
 
*Constant currency uses prior year weighted average exchange rates to translate current year foreign currency denominated revenue to give a year on year comparison excluding the effects of foreign exchange movements. See table in financial review for an analysis of revenue.
 

Conference call
Manuel Llobet, Chief Executive Officer, and Nick Wykeman, Finance Director, will host a conference call for analysts at 0900 BST today.

http://www.moneyam.com/action/news/showArticle?id=5521411

Allergy Therapeutics confident of further growth
08:17 29 Mar 2017

Its European markets were largely flat but the company still managed to achieve top-line growth of 18% on a constant currency basis



Allergy vaccines specialist Allergy Therapeutics plc (LON:AGY) continued to gain market share in the second half of 2016.

The group issued half-year results that largely confirmed the numbers in its January trading update.

• Read Allergy Therapeutics' revenues rising across hay fever portfoliot

Revenue rose 39% to £40.4mln from £29.0mln in the second half of 2015, helped by favourable exchange rate movements. Stripping out currency fluctuations, the increase was still an impressive 18%.

The revenue uplift was achieved despite European markets as a whole showing no or very little growth.

Germany, Austria, Spain and The Netherlands contributed the most to top-line growth, Allergy revealed, although all markets saw sales head higher.

In the 12 months to 31 December 2016, market share grew to 13% compared to 12% in the year ended 30 June 2016 in the markets in which the group competes.

The flagship pollen allergy Pollinex franchise continues to expand, while Acarovac Plus, its dust mite allergy treatment, continues to grow well in Spain and has been launched in Austria.

Sales of synbiotics products – products that are a synthesis of prebiotics (substances that encourage the growth of microorganisms) and probiotics (health-giving microorganisms) - have performed well in Italy and Spain.

Profit before tax shot up to £7.2mln from £1.3mln as research & development (R&D) costs declined to £3.82mln from £6.54mln the previous year.

“The board and management team expect that growth in net sales will continue in the second half of the year and have great confidence in the future of the business,” the company said.

“As planned, research and development costs are expected to rise significantly in the second half of the year compared to the first half, reflecting the exciting preparation for the expected start of two major trials (US Grass MATA MPL Phase II and PQ Birch Phase III) as well as investment in infrastructure to progress the important TAV process. Other costs are expected to be similar to H1 2017,” Allergy Therapeutics confirmed.

Broker finnCap, which rates the shares a 'buy' said that apart from a slightly lower than expected first half R&D charge, “which is likely to be timing related”, it will make no change to its full-year forecasts.

“We retain a near term target price of 43p and point to the further upside that Pollinex Quattro (PQ) Grass programme in the US offers investors,” the broker said.



John Harrington

05 April 2017
 
Hardman Research: Progressive development across portfolio

Progressive development across portfolio - AGY is a long-established specialist in the prevention, diagnosis and treatment of allergies.

Pollinex Quattro continues to gain market share despite being available in EU only on a 'Named Patient' basis.

Trials to obtain full approval as a biological have progressed well in EU with the first patient recruited in the pivotal birch pollen allergy vaccine Phase III trial.

US trials are back on-track with a new safety trial underway.

A Phase I study of Acarovac MPL, a 'dust mite allergy' vaccine, has been approved in Spain for 32 patients.

Finally, Polyvac Peanut has completed pre-clinical testing and has potential to significantly disrupt the peanut allergy market.

Please click here for the full report:

http://hardmanandco.com/docs/default-source/company-docs/allergy-therapeutics-documents/agy-interim-results-update-5th-april.pdf

http://www.moneyam.com/action/news/showArticle?id=5526728

Issue of equity in respect of the exercise of warrants and options
 
13 April 2017 Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, announces the issue and allotment of a total number of 673,748 new ordinary shares of 0.1p each in the capital of the Company ("Ordinary Shares") pursuant to the exercise of 353,748 share warrants issued to JSB Partners, LP in 2012 and pursuant to the exercise of 320,000 share options by certain employees.
 
Application has been made to the London Stock Exchange for admission to trading of the new Ordinary Shares on AIM ("Admission"). It is expected that Admission will take place and that dealings in the new Ordinary Shares on AIM will commence at 8.00 a.m. on 18 April 2017. The new Ordinary Shares will, when issued, be credited as fully paid and will rank pari passu in all respects with the existing Ordinary Shares in the capital of the Company, including the right to receive all dividends or other distributions made, paid or declared in respect of such shares after the date of issue of the new Ordinary Shares.
 
Allergy Therapeutics' enlarged issued ordinary share capital immediately following Admission will be 594,117,768 Ordinary Shares with voting rights attached. The Company has no Ordinary Shares in Treasury; therefore the total number of voting rights in Allergy Therapeutics is 594,117,768. This figure may be used by shareholders as the denominator for the calculations by which they will determine whether they are required to notify an interest in, or a change to their interest in, the share capital of the Company under the FCA's Disclosure and Transparency Rules.
 
- ENDS -

http://www.moneyam.com/action/news/showArticle?id=5531505

General interest:

Month of misery in store for hay fever sufferers, say scientists
By Henry Bodkin
15 April 2017

Hay fever sufferers face another month of misery from tree pollen with scientists also predicting an early start to the grass pollen season.

The birch pollen season, which began around 10 days sooner than last year, has left millions experiencing symptoms and now allergy scientists expect the grass pollen season will begin earlier in May than normal.

The late date of the Easter weekend means holidaymakers keen to get outdoors are facing higher levels of pollen in the atmosphere than in previous years, with more trees in leaf.

Birch pollen is currently at peak levels in the South of England and the Midlands, with high readings expected in northern parts of the UK later in the month.

The early onset of the season is thought to have been brought about by the comparatively warm winter and early spring.

The sustained warm temperatures also mean 2017 is likely to be a year when the grass pollen season builds up steadily, rather than beginning suddenly in the final week of May. (More from link below)

Interesting study (Note-AGY sponsored the research):

Virus-Like Particle (VLP) Plus Microcrystalline
Tyrosine (MCT) Adjuvants Enhance Vaccine Efficacy
Improving T and B Cell Immunogenicity and
Protection against Plasmodium berghei/vivax


Published 2nd May 2017

Vaccination is the most effective prophylactic tool against infectious diseases.
Despite continued efforts to control malaria, the disease still generally represents a significant unmet medical need.

Microcrystalline tyrosine (MCT) is a well described depot used in licensed allergy
immunotherapy products and in clinical development. However, its proof of concept in prophylactic vaccines has only recently been explored. MCT has never been used in combination with virus-like particles (VLPs), which are considered to be one of the most potent inducers of cellular and humoral immune responses in mice and humans.

In the current study we assessed the potential ofMCT to serve as an adjuvant in the development of a vaccine againstmalaria either alone or combinedwith VLP using
Plasmodium vivax thrombospondin-related adhesive protein (TRAP) as a target antigen. We chemically coupled PvTRAP to VLPs derived from the cucumber mosaic virus fused to a universal T-cell epitope of the tetanus toxin (CMVtt), formulated with MCT and compared the induced immune responses to PvTRAP formulated in PBS or Alum.

The protective capacity of the various formulations was assessed using Plasmodium berghei expressing PvTRAP. All vaccine formulations using adjuvants and/or VLP
increased humoral immunogenicity for PvTRAP compared to the antigen alone. The most proficient responder was the group of mice immunized with the vaccine formulated with PvTRAP-VLP + MCT.

The VLP-based vaccine formulated in MCT also induced the strongest T cell response and conferred best protection against challenge with recombinant Plasmodium berghei. Thus, the combination of VLP with MCT may take advantage of the properties of each component and appears to be an alternative biodegradable depot adjuvant for development of novel prophylactic vaccines.

http://www.google.co.uk/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0ahUKEwjG47f0v_bTAhUhBcAKHZGrBLAQFggiMAA&url=http%3A%2F%2Fwww.mdpi.com%2F2076-393X%2F5%2F2%2F10%2Fpdf&usg=AFQjCNF9PyTKNj05k19umwAMjX4DdB4Lpw

Information on Micro Crystalline Tyrosine (MCT) can be found from page 7 from the Bencard Adjuvant Systems (a division of Allergy Therapeutics UK) brochure:

http://www.allergytherapeutics.com/media/1238/bencard-adjuvant-systems.pdf

TR-1: NOTIFICATION OF MAJOR INTEREST IN SHARES

BlackRock, Inc. have gone above 5% to 30,368,413 (5.11%)

http://www.moneyam.com/action/news/showArticle?id=5560882

06 June 2017
 Allergy Therapeutics plc
 
Directorate changes
 
6 June 2017 Allergy Therapeutics (AIM:AGY), the fully integrated speciality pharmaceutical company specialising in allergy vaccines, announces the appointment of Dr Tunde Otulana to its Board of Directors as a Non-Executive Director with effect from 6 June 2017.
 
Additionally, Dr Thomas Lander has indicated that he wishes to retire from his position as a Non-Executive Director of the Group with effect from 30 June 2017.
 
Dr Babatunde 'Tunde' Adekunle Otulana, aged 60, brings over 20 years' pharmaceutical industry knowledge and significant executive level experience in clinical development and medical affairs roles. He currently serves as Senior Vice President and Chief Medical Officer at Mallinckrodt Pharmaceuticals where he has responsibility for all global medical functions, and has previously worked for Boehringer Ingelheim Pharmaceutical Inc. as Senior Vice President, Clinical Development and Medical Affairs. He has previously spent over six years working at the US Food and Drug Administration (FDA) as a Medical Officer and Medical Team Leader in the Division of Pulmonary-Allergy Drug Products.
 
Dr Otulana received his medical degree in Nigeria where he also completed hospital residency training. He then moved to Cambridge, UK to complete his Clinical Research Fellowship in Pulmonary Medicine at the Papworth and Addenbrooke's hospitals, University of Cambridge.
 
Peter Jensen, Chairman of Allergy Therapeutics, commented: "We are pleased to welcome Tunde to the Board. He brings a wealth of global experience in clinical and regulatory work, particularly with the FDA in the United States, which will be especially valuable as we continue to execute our global strategy.
 
"I also want to take this opportunity to thank Thomas for his significant contribution and support to the Group during the past five years. Thomas has always given the Board very clear advice on R&D matters and his experience has been hugely valuable. We all wish him well for the future in his retirement."
 
Allergy Therapeutics confirms that there are no further disclosures to be made in relation to Rule 17 of paragraph (g) of Schedule Two of the AIM Rules for Companies in respect of Dr Otulana's appointment.

http://www.moneyam.com/action/news/showArticle?id=5562090

19 June 2017 
Allergy Therapeutics plc
 
Allergy Therapeutics hosts satellite symposium at EAACI 2017
 
~ World-leading experts discuss allergy immunotherapies ~
 
Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces today that a satellite symposium entitled: "The Best Therapies by Design"  was held at the 36th Annual Congress of the European Academy of Allergy and Clinical Immunology (EAACI) in Helsinki, Finland on 18 June 2017, providing an overview of the technologies and strategies involved in designing the best immunotherapies.
 
Chaired by Professor Stephen Durham, four world-leading experts in the field of allergy, pollen, and immunotherapy vaccine delivery, Jörg Kleine-Tebbe, Erika Jensen-Jarolim, Uwe Berger & Tim Higenbottam presented on the strategy, design and considerations involved in creating immunotherapies such as Allergy Therapeutics' flagship product, Pollinex Quattro®.  Uwe Berger and Erika Jensen-Jarolim discussed the importance of highlighting relevant allergens and characterising them sufficiently.  Jörg Kleine-Tebbe discussed why successful immunotherapy requires identification of the optimal dose before Phase III studies are begun, before Tim Higenbottam finished the session describing the results recently gained from the Group's clinical studies.
 
Manuel Llobet, Chief Executive Officer, commented: "We are delighted with our progress in developing the next generation of allergen immunotherapy products. Our latest clinical data on dose-ranging confirms that our unique allergen-specific immunotherapies are formulated to the optimal strength and we believe Allergy Therapeutics has the potential to transform allergy treatment with optimised-dose, well-characterised, aluminium-free products."


Satellite Symposium: "The Best Therapies by Design"

1.   The importance of defining the optimal dose - Jörg Kleine-Tebbe, Allergie und Asthma - Zentrum Westend, Berlin.
2.   Molecular fingerprinting of complex allergoids - Erika Jensen-Jarolim, Institute of Pathophysiology and Allergy Research, Medical University Vienna.
3.   Rationale for broad spectrum grass immunotherapy - Uwe Berger, Medical University of Vienna. Head of Aerobiology & Pollen Information Research Unit.
4.   Defining the plateau of the efficacy for Allergen Specific Immunotherapy - Tim Higenbottam, R&D Director, Allergy Therapeutics.

http://www.moneyam.com/action/news/showArticle?id=5569444

27 June 2017 
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Group")
 
Investor and analyst site visits
 
27 June 2017 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, is hosting a site visit at its corporate headquarters for sell-side analysts today and institutional investors tomorrow.
 
The site visits will be hosted by Manuel Llobet, Chief Executive Officer, Nick Wykeman, Finance Director, and Murray Skinner, Chief Scientific Officer and will include presentations by the Group's key opinion leaders who are world-leading in their fields of expertise, including Professor Lawrence DeBuske, Clinical Professor of Medicine at the George Washington University School of Medicine, and Professor Dr Matthias Kramer, International Medical Director of Allergy Therapeutics.
 
During the visits, attendees will be provided with an update on the Group's market-leading businesses, markets, strategy and pipeline.
 
No inside information will be disclosed. The presentations will be available on the Group's website from 28 June 2017.

http://www.moneyam.com/action/news/showArticle?id=5573994

Link to the presentation mentioned above:

http://www.allergytherapeutics.com/media/1251/investors_slides_jul_2017.pdf

06 July 2017 
Allergy Therapeutics plc
 
Two studies of adjuvants in malaria and influenza vaccines published in peer-reviewed journals
 
~ Publications demonstrate the potential of Allergy Therapeutics' novel adjuvant systems in infectious diseases, further broadening the product pipeline ~

 
6 July 2017 Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, today announces that two preclinical studies carried out through its Bencard Adjuvant Systems division have been published in peer-review journals.
 
The two papers report that the novel depot adjuvant behind Allergy Therapeutics' successful allergy immunotherapy Pollinex® platform, microcrystalline tyrosine (MCT), both alone and in an adjuvant system, have broad applications and elicit high, sustained antibody titres demonstrating enhanced protective efficacy compared to conventional adjuvants including aluminium.
 
Commenting on the recent publications, Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: "These publications underpin the strategy for our Bencard Adjuvant Systems division, which focuses on extending the use of MCT® and VLP in further developing vaccines against unmet needs, and new and emerging infectious diseases that require an effective depot adjuvant."
 
The two publications are:
 
Comparison of a novel microcrystalline tyrosine adjuvant with aluminium hydroxide for enhancing vaccination against seasonal influenza: Heath et al., BMC Infectious Diseases (2017) 17:232
The paper authored by principal scientist Dr Matthew D. Heath & collaborators from Public Health England discusses the use of MCT® in a seasonal influenza vaccine model. The use of MCT® displayed higher binding affinity compared to the conventional depot adjuvant, aluminium, demonstrating the suitability of MCT® as a depot adjuvant in applications outside of allergy immunotherapy. MCT® elicited an immune response (HAI titre) indicative of protection in a pre-clinical model. The data provide evidence of the suitability of using the MCT® platform in an influenza model and address some of the issues associated with weakly stimulating vaccine targets/antigens.
 
Virus-like particle (VLP) plus microcrystalline tyrosine (MCT) adjuvants enhance vaccine efficacy improving T and B cell immunogenicity and protection against plasmodium berghei/vivax: Cabral-Miranda et al., Vaccines (2017) 5;10.
 
This publication authored with The Jenner Institute at the University of Oxford has been published investigating the use of adjuvants MCT and adjuvant system MCT+VLP (AdSys-VCT) in malaria. In a pre-clinical model, malaria antigens conjugated to VLP and formulated in MCT induced highest antibody responses, highest T-cell responses, and offered the best protection against malaria compared with antigens formulated with aluminium. Moreover, the study demonstrated that MCT® alone is able to elicit high and sustained IgG antibody responses that are specific and protective against P.vivax (malaria).

http://www.moneyam.com/action/news/showArticle?id=5580828

Allergy Therapeutics publishes pre-clinical data on malaria and flu vaccines
08:47 06 Jul 2017

The studies were carried out through Allergy’s Bencard Adjuvant Systems division.



Allergy Therapeutics (LON:AGY) has published data in peer-reviewed journals from two preclinical studies analysing its immuno-therapy platform as a potential vaccine against malaria and the flu.

The two papers reported that Allergy’s immunotherapy Pollinex platform, microcrystalline tyrosine (MCT), both alone and in an adjuvant (immune system booster) system, had broad applications and boosted protection compared to conventional adjuvants.

The studies were carried out through Allergy’s Bencard Adjuvant Systems division. 
Manuel Llobet, chief executive, said: "These publications underpin the strategy for our Bencard Adjuvant Systems division, which focuses on extending the use of MCT and VLP (virus-like particle) in further developing vaccines against unmet needs, and new and emerging infectious diseases that require an effective depot adjuvant."

http://www.proactiveinvestors.co.uk/companies/news/180447/allergy-therapeutics-publishes-pre-clinical-data-on-malaria-and-flu-vaccines-180447.html

General interest but still AGY specific:

Filling and capping machine boosts output by 300%
10th July 2017



A Flexicon FMB210L fully automatic vial filling and screw capping machine from Watson-Marlow Fluid Technology Group (WMFTG) has boosted output by 300% at a major pharmaceutical company, dedicated to reducing the impact of allergies on sufferers. The new machine has been set to work producing a sublingual immunotherapy (SLIT) product at a rate of 2,400 vials an hour.

UK-headquartered Allergy Therapeutics produces a wide range of aluminium-free allergy vaccines and diagnostics for customers across Europe and further afield in markets such as Canada, South Korea and Hong Kong. Sales currently stand at circa £50 million a year. The company has a special focus on allergy vaccination – also known as specific immunotherapy or desensitisation therapy – which is a treatment that deals with the underlying cause of allergies and not just the symptoms.

Central to manufacturing operations at Allergy Therapeutics is the ability to fill and cap product vials at throughput rates that match market demand. With this in mind, the company recently sought to enhance its operations in two areas.

“Firstly, we researched the market for robust components (vial and cap) to help progress the filling of our sublingual products,” explains the company’s head of Manufacturing and Technology, Rick Poland. “Secondly, we wanted to invest in an automatic filling and capping machine with faster throughput capacity.”

Having identified suitably robust 10cc vial and screw-cap components, Allergy Therapeutics set about reviewing various filling and capping machine manufacturers against a comprehensive user-requirement specification.

“We specified Flexicon for a number of reasons, but principally because the FMB210L proved to be extremely fit-for-purpose with regard to our particular application,” states Poland. “Furthermore, we’ve had a number of Flexicon machines over the years, so their proven track record was a prime consideration.”

Set up as a dedicated solution, the Flexicon FMB210L is being used to fill 10cc threaded-neck amber diluent vials with a raspberry flavouring, to which an allergen concentrate is added at a second stage before capping. Throughput rates of 2400 vials an hour are being achieved.

Allergy Therapeutics’ sublingual immunotherapy (SLIT) product is used to address the causes of allergic rhinitis (hay fever) against different allergens. It consists of a liquid that sufferers place under the tongue, and is more convenient than a traditional injected therapy in that patients can administer doses themselves at home. The raspberry flavouring is designed to increase the likelihood of sufferers using the therapy.

Automatic filling and capping

The FMB210L is a fully automatic filling and screw-capping system designed for the biopharm, diagnostic and pharmaceutical industries. It can fill volumes from less than 0.2ml to more than 250ml with ±0.5% accuracy to prevent costly overfilling. It also caps to a consistent torque that prevents leaks and over-tightening. The system is modular and easily customisable, and can work with many different liquids, containers and caps.

Only the liquid contacts a single-use fluid path, so changeover from one product to another can be completed in less than 20 minutes without the risk of cross-contamination. Flexicon offers IQ/OQ for the equipment and provides a free validation pack for the fluid path, reducing the time and resources needed.

In this case the FMB210L was equipped with an integrated Laminar Airflow System to maintain a near particle-free environment in the critical zones.

Installed at Allergy Therapeutics in October 2016, the Flexicon machine (and new vial and cap products) have since been validated, successfully passing final regulatory approval. Validation has also been achieved for processing empty vials to which a threaded cap is added. The system is now in full production.

“We worked hand-in-hand with WMFTG against a rigorous user specification, to develop a fit-for-purpose process that would withstand regulatory requirements,” says Poland. “Today, we have a filling and capping machine that offers 300% more output than our previous capability. As we operate in a highly-competitive market, investments of this nature are key to our business.”