Allergy Therapeutics Live Discussion

jamesm 11 Jul 2019

Allergy Therapeutics Trading Update - Video Video from FD Nick Wykeman re: this mornings trading update:

Totally_Wired 01 Jul 2019

In the Media Hardman & Co: Successful legal outcome removes uncertainty AGY is a long-established specialist in the prevention, diagnosis and treatment of allergies. The Pollinex Quattro (PQ) platform, an ultra-short-course subcutaneous allergy immunotherapy (SCIT), continues to gain market share despite its availability in the EU on a ‘named-patient’ (NP) basis only. Several products are in clinical development, with the aim of moving the platform to full registration under the new regulatory framework. AGY has issued a positive trading update highlighting the strong operating performance of the group. Also, it has reached a successful settlement of an ongoing legal dispute with one of its third-party R&D contractors. Please click here for the full report: [link]

Totally_Wired 27 Jun 2019

RNS=Historic 27 June 2019 Allergy Therapeutics plc Successful litigation settlement relating to PQ Grass Phase II Trial 27 June 2019 Allergy Therapeutics plc (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, announces that it has received a $7.6m settlement from Inflamax Research Inc. (“Inflamax”) in relation to legal proceedings about the previously disclosed inconclusive Phase II Grass MATA MPL trial which took place in the USA in 2015-16. Inflamax has also agreed to pay a substantial part of the Group’s legal costs. The clinical trial (G204) used mobile challenge chambers provided by Inflamax and preceded the successful Grass MATA MPL trial (G205) which the Group reported in June 2018. The Group commenced legal proceedings in the English High Court against Inflamax in March 2017 for breach of contract and misrepresentation concerning theG204 Study. Commenting on outcome, Manuel Llobet, CEO of Allergy Therapeutics, said: “ATL has always had full confidence in the Grass MATA MPL product and maintained that the inconclusive results of the G204 study were due to the inadequate procedures in the study. I am pleased that Inflamax have now compensated ATL for a significant proportion of the wasted study costs, as well as agreeing to pay the majority of the legal costs. Allergy Therapeutics aims to maintain the highest standards throughout its business and we are pleased that the matter has now been resolved.” [link]

Totally_Wired 19 Jun 2019

RNS=Historic Allergy Therapeutics plc Board Change Appointment of Mary Tavener as Non-Executive Director 19 June 2019 Allergy Therapeutics plc (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, announces that Mary Tavener will join the Board of Allergy Therapeutics as a Non-Executive Director with immediate effect. Mary will also join the Audit Committee of the Board and will work closely with the current chair Stephen Smith in anticipation of her succeeding Stephen as chair of the committee after the Group publishes its final results for the year ended 30 June 2019 in September. Mary has extensive experience in the healthcare sector, having spent more than 19 years as Chief Financial Officer and Board member of AIM listed Advanced Medical Solutions (“AMS”). At AMS, Mary was responsible for strategy and risk management, finance, operations, regulatory, and legal. During her tenure through to the end of 2018, AMS delivered 15 consecutive years of growth, listed on AIM, and successfully conducted several transformational M&A deals. Mary is aFellow of the Chartered Institute of Management Accountants (FCMA) and a Fellow of the Association of Corporate Treasurers (FCT). Prior to joining AMS, Mary was the Group Financial Controller of BTP plc. Commenting on the appointment, Peter Jensen, Chairman of Allergy Therapeutics, said: “I am delighted to announce Mary’s appointment and welcome her to the Board. Mary has an excellent track record and an impressive breadth of executive experience, and we look forward to the invaluable and trusted perspective she will bring to the Board.” Commenting on her appointment, Mary Tavener said: “Allergy Therapeutics has an excellent growth story since its formation as a small spinout from SmithKline Beecham in 1999. The business today has a broad range of assets in clinical development, a global presence across 23 markets, over 500 employees, and has achieved a 10% CAGR over the last 19 years as well as significant commercial success. I look forward to working with the Board to further develop Allergy’s leading position in the allergen immunotherapy sector.” [link]

Totally_Wired 11 Jun 2019

In the Media There appears to be a new report out: Seasonal Allergic Rhinitis Drug Market Demand Is Increasing (2019-2025)| Featuring Industry Top Players: Allergy Therapeutics Plc, Faes Farma, S.A., Glenmark Pharmaceuticals Ltd The Seasonal Allergic Rhinitis Drug study accurately screens through and validates various information pertaining to this business vertical including the important definitions, product types, and application. The latest report Seasonal Allergic Rhinitis Drug Market discusses everything a business owner needs to know about the Seasonal Allergic Rhinitis Drug market for the forecast period, 2019 to 2025. The document offers an insight into what the target customer’s needs and wants. Industry experts have extracted data from various sources on size, share, growth rate, production volume, production capacity, import and export status, distribution channels and more and have analysed it thoroughly. By properly assessing the competitors and their offerings the study aims at empowering business owners to step ahead. The top players in Seasonal Allergic Rhinitis Drug market are Allergy Therapeutics Plc, Faes Farma, S.A., Glenmark Pharmaceuticals Ltd., Hisamitsu Pharmaceutical Co., Inc., Merck & Co., Inc., Pfizer Inc., Shionogi & Co., Ltd., VentiRx Pharmaceuticals, Inc. [link] [link]

Totally_Wired 11 Jun 2019

Major Shareholders-Updated Well done AGY they have updated their ‘Major Shareholders’ webpage this morning: Share Information The total number of shares issued is 636,168,616 Ordinary Shares of 0.1 pence each. 61.17% of the shares are not in public hands, as at 11 June 2019. Significant Shareholders The following were the significant shareholders as notified to the Company at 11 June 2019: Shareholder name Amount % Holding CFR International SPA & Associated Holding 240,584,571 37.82 Southern Fox Investments 127,238,783 22.69 SkyGem Acquisition Limited (ZQ Capital) 99,054,416 15.60 Invesco 28,618,373 4.50 Director Shareholdings Director name Amount % Holding Manuel Llobet* 3,325,000 0.52 Stephen Smith 775,513 0.12 Peter Jensen 170,000 0.03 Nick Wykeman* 300,000 0.03 Tunde Otulana 50,000 0.01 *Executive Director [link]

Totally_Wired 11 Jun 2019

Major Shareholders-Updated About time AGY updated their ‘Major Shareholders’ webpage, anyway: SkyGem Acquisition Limited have increased from 12.1% to15.6% [link]

Totally_Wired 21 May 2019

In the Media Hardman research report: House dust mite vaccine – clinical progress 21 MAY 2019 / CORPORATE RESEARCH By Dr Dorothea Hill [link]

Totally_Wired 20 May 2019

RNS=Historic 20 May 2019 Allergy Therapeutics plc Allergy Therapeutics announces positive top line results from Phase I clinical study using Acarovac MPL Investigational house dust mite allergy vaccine demonstrates good safety and tolerability profile Patients experienced symptom improvement in response to Nasal Provocation Testing The primary endpoint was the safety and tolerability of 7 injections of Acarovac MPL administered over 6-12 weeks each 1-2 weeks apart. The formulation was well tolerated. The safety profile was satisfactory and the reported adverse events were consistent with what have been observed with similar formulations of allergy vaccines. Secondary endpoints included the effect of treatment on response to nasal provocation test (NPT), immunological parameters including immunoglobulins and patients’ satisfaction with the treatment. A significant improvement from baseline in patients’ total symptom scores following NPT after 12 weeks, and significant increases in immunoglobulin markers and reduction in IL-4 were observed. Patients reported high satisfaction with their treatment measured via the ESPIA questionnaire (Satisfaction Scale for Patients Receiving Allergen Immunotherapy). Acarovac MPL is a subcutaneous immunotherapy product containing Dermatophagoides pteronyssinus and Dermatophagoides farinae allergoids adsorbed to the adjuvant system comprised of MCT® (Microcrystalline Tyrosine) and MPL. [link]

Totally_Wired 14 May 2019

Major Shareholders-Updated Share Information The total number of shares issued is 636,168,616 Ordinary Shares of 0.1 pence each. 61.17% of the shares are not in public hands, as at 25 September 2018. Significant Shareholders The following were the significant shareholders as notified to the Company at 7 November 2018: Shareholder name Amount % Holding CFR International SPA & Associated Holding 240,584,571 37.82 Southern Fox Investments 127,238,783 22.69 Odey Assest Management 43,747,523 6.88 Invesco 28,618,373 4.50 Director Shareholdings Director name Amount % Holding Manuel Llobet* 3,325,000 0.52 Stephen Smith 775,513 0.12 Peter Jensen 170,000 0.03 Nick Wykeman* 300,000 0.03 Tunde Otulana 50,000 0.01 *Executive Director [link]

Totally_Wired 14 May 2019

RNS=Historic A busy 24hrs regarding news flow- Yesterday: 16:35 Price Monitoring Extension 16:41 Second Price Monitoring Extension 18:14 TR1 where BlackRock have gone from a 5.33% holding to Below 5% Today: 71 TR1 where SkyGem are new in with a stake of 12.1% [link]

Pharma_Giles 13 May 2019

PQBirch301 - Outcome It will be interesting see the reason behind the recent rise - wonder whether this is following a further analysis of a study that really shouldn’t have failed?

Totally_Wired 07 May 2019

RNS=Historic 07 May 2019 Allergy Therapeutics plc Allergy Therapeutics Publishes New Research Exploring Potential of its Adjuvant Systems in the Treatment of Cancer in the Journal of ImmunoTherapy of Cancer - Research illustrates broad, novel applications of the Group’s adjuvant systems portfolio beyond allergy indications - 7 May 2019 Allergy Therapeutics plc (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today announces, through its adjuvant research division Bencard Adjuvant Systems, the publication of new research into the Group’s adjuvant system Microcrystalline Tyrosine (MCT®) combined with Virus-Like particles (VLPs). The research, Vaccination with nanoparticles combined with micro-adjuvants protects against cancer (Mohsen M et al.), undertaken by the Group’s adjuvant research division, Bencard Adjuvant Systems and published in the Journal for ImmunoTherapy of Cancer, investigated the protective efficacy of the Group’s adjuvant system against cancer and showed that the combination of MCT and VLPs caused tumour regression in an aggressive melanoma mouse model and initiated a highly protective CD8 T-cell immune response. Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: “Our strategy for growth with our adjuvant division, Bencard Adjuvant Systems, focuses on extending the use of MCT® and VLPs in developing vaccines for unmet needs and disease areas beyond allergy that require an effective depot adjuvant. This ground-breaking work, completed in collaboration with the Jenner Institute at the University of Oxford, supports this strategy and complements the existing work illustrating the potential of our adjuvant systems in disease areas such as influenza and malaria.” About the study: Microcrystalline Tyrosine and Virus-Like Particles in treating cancer The paper was published in conjunction with collaborators from the Jenner Institute, Oxford, UK and University of Bern, Switzerland and describes how the depot effect of MCT allows release of VLP-antigen to reach lymphoid organs efficiently (<72hrs) for optimal priming of T-cells. The induction of strong T-cell responses, in particular cytotoxic T-cells, is key for the generation of an efficacious therapeutic cancer vaccine. The study showed that VLPs rapidly drain into the lymphatic system due to their nano-size. However, formulating the nanoparticles with the micron-sized MCT adjuvant resulted in a local depot for the nanoparticles and a longer exposure time for the immune system. In doing so, the MCT:VLP was similarly potent to other commonly used adjuvants such as the potent B type immunostimulatory CpGs and performed better than Alum in inducing cytotoxic T lymphocytes and tumour protection. MCT has been used in the clinic for decades in allergen-specific desensitisation. The potential shown in this study may therefore readily translate into a clinical setting to optimise the induction of cytotoxic T-cells in humans to drive protection against melanoma. [link]

Totally_Wired 25 Apr 2019

RNS=Historic Allergy Therapeutics plc Regulatory and Trading Update - Successful FDA and Paul Ehrlich Institut meetings on design of Phase III PQ Grass trial, now planned to commence in H2 2020 25 April 2019 Allergy Therapeutics plc (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today announces the outcome of successful discussions with the Paul Ehrlich Institut (PEI) in Germany and the Food and Drug Administration (FDA) in the US regarding the pivotal Phase III PQ Grass trial design. The trial, being planned for the US and Europe, will evaluate the efficacy and safety of the Group’s short course, aluminium-free pre-seasonal immunotherapy in the prevention of the symptoms of allergic rhinoconjunctivitis caused by grass pollen. The Group presented positive results from its Phase II PQ Grass trial to the PEI and FDA and agreement was reached on the dose to progress into Phase III, as well as other essential features of the trial design. Accordingly, in order to finalise the design of the trial and incorporate the latest clinical evidence, the trial is expected to commence in H2 2020, to be aligned with the 2020/2021 allergy season. The Group continues to make good progress with its broad clinical pipeline. A readout of the Phase I Acarovac MPL trial for house dust mite allergies is expected in Q2 2019. Manufacturing scale-up of the Group’s Polyvac Peanut product, which is critical to ensure commercial manufacture in a consistent manner for clinical trials and in GMP conditions, is progressing well. The Phase I first-in-human trial for Polyvac Peanut is now expected in H1 2020 as we complete the pre-clinical work in advance of human dosing next year. The commercial business continues to trade in line with market expectations and gain market share, and the Group remains well-funded to progress its commercial and clinical programme into 2021. As announced in the 6 March 2019 Interim Results, the Group had a cash balance of £31.6m at 31 December 2018. Manuel Llobet, CEO at Allergy Therapeutics, stated: "With the positive outcomes from our meetings with the FDA and Paul Ehrlich Institut, we have agreed design of our Phase III PQ Grass trial, including patient number requirements and statistical measures. "Given the sensitivity of clinical trials in allergic rhinitis to the subjective nature of patient-reported outcomes, it is important that we incorporate any potential learnings from our recent trials into the final trial design for PQ Grass. Given the PQ Grass trial is expected to commence in H2 2020 we are confident that we have time to amend the protocol accordingly if required. This product has the potential to become a much-needed treatment option for the estimated 25-30% of the EU and US populations who are allergic to grass pollen1, and we believe that the PQ Grass trial will enable us to demonstrate the efficacy of this short-course grass pollen immunotherapy. "The potential of our pipeline is illustrated by the expected newsflow from our other clinical portfolio programmes and we look forward to updating the market as these progress." [link]

Totally_Wired 18 Mar 2019

RNS=Historic 18 March 2019 Allergy Therapeutics plc Allergy Therapeutics announces top-line Phase III results from its B301 clinical trial Study primary endpoint not achieved - Highly statistically significant and relevant increase in immune response observed in active group compared to placebo - Clinical development programme to continue after review of the full dataset - Allergy Therapeutics has extensive experience with other approved and commercialized birch products. Since 2010, the investigational product has undergone two successful Phase II trials where a highly statistically significant 32% reduction in allergic symptoms between the active and placebo was observed. The Group will undertake a review of the full trial dataset to understand any cause for the lack of consistency in the clinical outcomes seen between the studies. The B301 trial was a multi-centre, double-blind, placebo-controlled study designed to test the efficacy in birch-pollen induced seasonal allergic rhinitis. The European study took place in Germany, Poland, Austria and Sweden with 582 patients over 59 centres being randomised into active and placebo arms, to evaluate the safety and efficacy measured as a reduction in allergic symptoms as determined by the combined symptom medication score. This announcement contains inside information for the purposes of Article 7 of Regulatory (EU) No596/2014. [link]