Aankondiging • Mar 05
Allergy Therapeutics plc Announces Consistent Biomarker Results Fromits Phase I/IIa PROTECT Trial Allergy Therapeutics plc announces consistent biomarker results fromits Phase I/IIa PROTECT trial, supporting the strong immunomodulating potential of the product. Increasing doses of VLP peanut were associated with a reduction compared to baseline in basophil sensitivity for whole peanut extract and Ara h2. Notably, at the higher dose, the reduction reached 376% (p=0.003) and 489% (p=0.04) for peanut and Ara h2 compared to placebo respectively. The functional assay measuring the main allergen (Ara h2) binding to the effector B-Cells (IgE-Fab) demonstrated a relevant downward dose response, reaching statistical significance for the higher dose of VLP Peanut. Both these positive outcomes in basophil sensitivity and IgE-FAB were associated with a strong dose-response in Ara h2-specific IgG change from baseline when comparing each of the cumulative doses with placebo, reaching statistical significance for all but the lowest dose compared to placebo reaching p=0.0005 for the higher dose. A reduction in wheal diameter was observed 1-month post treatment while placebo wheal diameter slightly increased consistent with the beneficial immunological shift seen across the full panel of efficacy biomarkers. Aankondiging • Jan 29
Allergy Therapeutics plc Announces Board and Executive Appointments Allergy Therapeutics plc at its AGM held on 29 January 2026 appointed Helge Weiner-Trapness as a Executive Director. 30 January 2026- the company announced the appointment of Helge Weiner-Trapness as Chief Strategy Officer. He also joins the Group's Board as an Executive Director. Helge has more than 30 years of experience across leading global investment banks in the US and Asia. He most recently served as Vice Chairman, Global Banking at HSBC Holdings plc (LSE: HSBA; HKG: 0005), one of the world's largest financial organizations which is dual-listed on the London Stock Exchange and the Hong Kong Stock Exchange. He was a Founding Partner of Hong Kong-based Quintus Partners, an independent financial advisory firm offering investment banking, strategic advisory and capital raising, particularly in the US and Asia. Earlier, he held senior roles at Barclays Bank, Asia Pacific Land, J.P. Morgan Securities and Goldman Sachs. In his newly created role as Chief Strategy Officer, Helge will drive Allergy Therapeutics' long-term growth strategy, including corporate development, partnership strategy and portfolio prioritisation as Allergy Therapeutics advances its next-generation pipeline and explores opportunities to deliver on its global ambitions. Allergy Therapeutics also announced that Lawrence Allen Wang will join the Company's Board as an independent Non-Executive Director. Lawrence has more than 20 years' experience across healthcare and investment roles. He currently serves as Chief Financial Officer of Adicon Clinical Laboratories Inc. (HKG: 9860), one of China's leading independent clinical laboratory service providers, where he played a key role in the company's financing and its listing on the Hong Kong Stock Exchange. Prior to Adicon, Lawrence held roles in private equity, asset management and investment banking groups, including positions at Vivo Capital, Primavera Capital, Macquarie Group and Goldman Sachs (Asia). Aankondiging • Jan 19
Allergy Therapeutics plc Provides Earnings Guidance for the Six Months Ended 31 December 2025 Allergy Therapeutics plc provided earnings guidance for the six months ended 31 December 2025. For the period, the group expects revenue to be £36.3 million (2024: £34.0 million), representing growth of 7% on a reported basis,or 3% on a constant currency basis. Overall Group sales for the full year ending 30 June 2026 are expected to exceed those achieved in the year ended 30 June 2025. Aankondiging • Jan 06
Allergy Therapeutics plc, Annual General Meeting, Jan 29, 2026 Allergy Therapeutics plc, Annual General Meeting, Jan 29, 2026. Location: the offices of cooley uk llp, 22 bishopsgate, ec2n 4bq, london United Kingdom Aankondiging • Jul 31
Allergy Therapeutics plc Announces Publication of Three Papers in the Journal Allergy That Strengthens the Evidence Base for Grass MATA MPL Allergen Immunotherapy Allergy Therapeutics announced the publication of three key publications in the journal Allergy supporting the efficacy, safety and quality-of-life effects of Grass MATA MPL, the Group's innovative subcutaneous immunotherapy (SCIT) candidate designed to address the cause of symptoms of allergic rhinoconjunctivitis due to grass pollen. Allergy is the official journal of EAACI with an impact factor of 12.6, the highest-impact journal in the field of allergy and clinical immunology. A Marketing Authorisation Application to the Paul Ehrlich Institut in Germany is currently under review, following the Group's submission in November 2024. Should this result in regulatory approval, commercial launch of the product is anticipated in FY2026. Results from Allergy Therapeutics' G306 Phase III trial, which completed in November 2023, have been published by Zielen et al., showing that Grass MATA MPL met the primary endpoint, demonstrating a highly statistically significant reduction in the Combined Symptom & Medication Score (CSMS) of 20.3% (p=0.0005) compared to placebo over the peak pollen season. Furthermore, a meta-analysis of the two Phase III trials in the Grass MATA MPL programme (G306 and G309) has also been published by Zielenet al., whereby 674 adult subjects with allergic rhinitis and/or rhino-conjunctivitis were included. Furthermore, based on an anchor-based approach using the rhinitis quality-of-life questionnaire, an MCID of 16% and 0.22 points were justified as relative and absolute CSMS differences, respectively. Taken together, these three papers complete the publication cycle for the adult-phase of the clinical programme evaluating Grass MATA MPL. The Group's G308 long-term paediatric study evaluating Grass MATA MPL in a paediatric population is ongoing, and the first cohort of grass allergic patients has completed their first grass pollen season. Furthermore, a Meta-analysis of the two Phase 3 trials in the Grass MATAMPL programme (G306 andG309) has also been published By Zielen et al. whereby 674 adult subjects with allergy rhinitis and/or Rhino-conjunctivis were included. Furthermore, based On an anchor-based approach using The rhinitis quality-of thelife questionnaire, an MCIDof 16% and 0.22points were justified as relative and absoluteCSMS differences, respectively. taken together, these three papers complete The publication cycle for the adult- phase of the clinical programme evaluating grass MATA MPL. The group's G308 long-term pediatric study evaluating Grass MATA MP L in a paediatric population is continue, and the first cohort of Grass MATA MPL has completed their first grass allergy season. Aankondiging • Jul 21
Allergy Therapeutics plc Provides Revenue Guidance for the Second Half and Year Ended 30 June 2025 Allergy Therapeutics plc provided revenue guidance for the second half and year ended 30 June 2025. Revenue for second half is expected to be £21.0 million (second half 2024: £21.6 million), reflecting an earlier than expected impact of the approaching change in the German regulatory landscape, as the end of the TAV transition period is reached in 2026. This is expected to result in unregistered allergy treatments being withdrawn from the market and a shift to fully licensed products.
Revenue for the year ended 30 June 2025 is expected to be broadly flat at £55.0 million (2024: £55.2 million) based on actual foreign currency rates. Aankondiging • Jun 13
Allergy Therapeutics plc Presents Key Scientific Findings from Research Portfolio At European Academy of Allergy and Clinical Immunology Congress Allergy Therapeutics announced that it will share key scientific findings from across its research portfolio at the European Academy of Allergy and Clinical Immunology (EAACI) Congress, taking place until 16 June in Glasgow, United Kingdom. The EAACI Congress is the world's largest scientific conference specialising in the field of allergy and clinical immunology and the flagship meeting of the European Academy of All allergy and Clinical Immunology. The Academy is an association of more than 16,000 clinicians, researchers and allied health professionals from 124 countries, dedicated to improving the health of people affected by allergic diseases. Among its posters being presented, Allergy Therapeutics will share: Preliminary clinical proof of concept for the Group's novel immunomodulating peanut allergy vaccine candidate demonstrated in peanut-allergic patients after three injection days, four weeks apart at two low cumulative doses. The peanut allergy vaccine candidate, currently at the final cohort stage of the first-in-human Phase I/IIa PROTECT trial, shows a benign safety profile in healthy subjects and peanut allergic patients. Moreover, it has demonstrated a strong dose-dependent reduction in skin-prick-test wheal size at low cumulative doses, accompanied by concordant biomarker changes supporting its hypoallergic mode of action in combination with early signs of a potent, clinically meaningful immune response. Aankondiging • Mar 31
Allergy Therapeutics plc Provides Sales Guidance for the Second Half and Full Year of 2025 Allergy Therapeutics plc provided sales guidance for the second half and full year of 2025. In the second half of the financial year,we expect further sales growth when compared to second half of2024 and company expects overall sales for the full year of 2025 to show growth over the corresponding period ended 30 June 2024. Aankondiging • Mar 27
Allergy Therapeutics plc Announces Positive Interim Analysis Data from the Phase I/IIa VLP Peanut PROTECT Trial Allergy Therapeutics plc announced positive interim biomarker efficacy data from its Phase I/IIa VLP Peanut PROTECT trial, demonstrating the first evidence of treatment effect in peanut allergic patients. Interim analysis of the first two cohorts of peanut allergic patients showed that treatment with VLP Peanut resulted in a meaningful dose-dependent reduction in skin sensitivity to peanut allergen, with treated patients in cohort 2 showing a 48% reduction in wheal size after skin-prick test compared to an 8% reduction in those treated with placebo. Additionally, a comparison of the biomarker profile between treatment and placebo points to VLP Peanut driving a reduction in allergic response to the major peanut allergen (Ara h2): A protective dose-dependent inhibition of Ara h2 IgE binding to B cells was observed after treatment with VLP Peanut compared to placebo. This inhibitory effect is indicative of how VLP Peanut induces blocking antibodies that may reduce the pro-allergic response. A trend towards a reduction of both basophil sensitivity and basophil reactivity to Ara h2 was seen, especially for the higher VLP Peanut dose, and an induction of protective specific IgG towards the major peanut allergen Ara h2 was observed compared to placebo. This interim analysis stage involved 12 peanut allergic patients across three treatment groups. The data represents the first demonstration of an immunologic response using a nanoparticle-based approach in peanut allergic patients. Following administration of initial escalating doses, patients underwent comprehensive assessment including skin-prick testing with whole peanut extract and blood sampling to identify key biomarkers of efficacy. As previously communicated, no relevant safety signals have been observed to date. Aankondiging • Jan 28
Allergy Therapeutics plc Provides Earnings Guidance for the Six Months Ended 31 December 2024 and Second Half and for the Full Year Ending on 30 June 2025 Allergy Therapeutics plc provided earnings guidance for the six months ended 31 December 2024 and second half and for the full year ending on 30 June 2025. For the six months, the group expects revenue for the six months ended 31 December 2024 to be £34.0 million (2023: £33.6 million), representing 1% growth on a reported basis, or more than 4% on a constant currency basis.
In the second half of the financial year, sales are expected to continue to grow.
For the Full year ending on 30 June 2025, Overall sales are expected to exceed sales in the corresponding period ended 30 June 2024. Aankondiging • Nov 26
Allergy Therapeutics plc Submits Marketing Authorisation Application for Grass MATA MPL Allergy Therapeutics plc announced that it has submitted a full Marketing Authorisation Application (MAA) to the Paul Ehrlich Institut (PEI) for its Grass MATA MPL subcutaneous immunotherapy (SCIT) candidate designed to address the cause of symptoms of allergic rhinoconjunctivitis due to grass pollen. The application has been submitted under a National procedure in Germany and following completion of standard validation checks by PEI, the Group expects the formal MAA review process to begin shortly. Grass MATA MPL incorporates MicroCrystalline Tyrosine ("MCT") adsorbed allergoids and the innovative adjuvant Monophosphoryl-lipid A ("MPL"). Grass MATA MPL has been developed to modify the allergic response following only six injections prior to the grass allergy season. The full MAA comprises a comprehensive evidence package of quality, safety and clinical efficacy including the Group's pivotal Phase III G306 trial in adults. In that trial, Grass MATA MPL demonstrated a highly statistically significant reduction in the Combined Symptom & Medication Score (CSMS) compared to placebo over the peak pollen season. Aankondiging • Nov 22
Allergy Therapeutics plc, Annual General Meeting, Dec 16, 2024 Allergy Therapeutics plc, Annual General Meeting, Dec 16, 2024. Location: the offices of cooley uk llp, 22 bishopsgate, ec2n 4bq, london United Kingdom Aankondiging • Jul 23
Allergy Therapeutics plc Provides Revenue Guidance for the Second Half and Year Ended 30 June 2024 Allergy Therapeutics plc provided revenue guidance for the second half and year ended 30 June 2024. For the second half, the company expected revenue to have increased by 2% to £21.6 million (second half 2023: £21.2 million).
For the year, the company revenue is expected to be 7% lower at £55.2 million (2023: £59.6 million). Aankondiging • Jun 27
Allergy Therapeutics plc Appoints David Ball as Non- Executive Director and Chair of the Board's Audit and Risk Committee Allergy Therapeutics announced that David Ball will join the Board of Allergy Therapeutics as an independent Non-Executive Director with immediate effect. David is also appointed Chair of the Board's Audit and Risk Committee. David has over 25 years of experience in financial markets, including 15 years as an equity portfolio manager and partner with Tudor Investment Corporation. David is a chartered accountant and holds undergraduate and postgraduate degrees in engineering from Cambridge University. David William Dawson Ball, aged 55, is a director of Argonaute RNA Limited and in the previous five years, David was a director of Brainomix Limited. David does not have an interest in ordinary shares in the Company. Aankondiging • May 08
Allergy Therapeutics plc Provides Further Details from Positive Top Line Results from G306 Phase III Field Study G306 to Evaluate the Efficacy and Safety of Grass MATA MPL Allergy Therapeutics plc provided further detail from the positive top line results from its pivotal Phase III field study G306 to evaluate the efficacy and safety of Grass MATA MPL, the Group's short-course subcutaneous allergen-specific immunotherapy (SCIT) candidate that aims to address the cause of symptoms of allergic rhinoconjunctivitis due to grass pollen. The trial successfully met its primary endpoint as previously announced on 14 November 2023. An evaluation was conducted in both the EU and US to assess the impact of a treatment regimen consisting of six pre-seasonal injections given over a span of 14 weeks. The key findings from this evaluation are as follows: The primary endpoint of the trial, Combined Symptom & Medication Score (CSMS) averaged over the peak pollen season, demonstrated a statistically significant improvement of 20.3% (p=0.00024) for Grass MATA MPL compared to placebo, providing evidence of a substantial reduction in daily symptoms and use of relief medication among participants receiving Grass MATA MPL · A highly statistically significant improvement in the rhinoconjunctivitis quality of life questionnaire (RQLQ) (p=0.0003) was observed during the peak season. The protective biomarker immunoglobulin (IgG4), measured during the grass pollen season, showed a large increase of approximately five-fold after treatment with Grass MATA MPL compared to placebo which achieved high statistical significance (p<0.0001) consistent with data from the earlier G309 exploratory field trial. 555 subjects with allergic conjunctivitis and/or rhinitis were randomised and 528 (95%) completed all six injections of Grass MATA MPL or placebo. Demographics, allergic history and immunoglobulins were generally well-balanced at baseline between the Grass MATA MPL and placebo groups. In total, 278 and 277 patients received Grass MATA MPL and placebo, respectively. As previously communicated, the treatment was well tolerated with no unexpected safety signals. Further exploratory endpoint analyses (including an extensive biomarker evaluation) of the G306 trial are now underway. Full results, including secondary and exploratory endpoints, will be presented at the upcoming European Academy of Allergy & Clinical Immunology conference in June 2024 and submitted for peer-reviewed publication later this year. The Group's preparation for the marketing authorisation application (MAA) is well underway, with a planned submission in fourth quarter 2024. Aankondiging • Apr 03
Allergy Therapeutics Announces Resignation of Mary Tavener as Non-Executive Director Allergy Therapeutics announced that Mary Tavener has resigned as a Non-Executive Director of the Group with immediate effect. Aankondiging • Mar 29
Allergy Therapeutics plc Provides Sales Guidance for the Second Half and Full Year Ending on 30 June 2024 Allergy Therapeutics plc provided sales guidance for the second half and full year ending on 30 June 2024. For the second half of the financial year, sales are expected to be slightly higher than the previous year.For the full year ending on 30 June 2024, sales are expected to be slightly lower than the corresponding period ending 30 June 2023. Aankondiging • Mar 12
Allergy Therapeutics plc Announces Appointment of Shaun Furlong to Board of Directors Allergy Therapeutics plc announced the appointment of Shaun Furlong as an Executive Director of the Company, with effect from 8 March 2024. Shaun was appointed as the Group's Chief Financial Officer (CFO) in August 2023, having previously served as Group Financial Controller since April 2022. He brings significant financial experience, having held senior finance roles within blue-chip companies across multiple sectors, including Legal & General, Hastings Direct, Volution Group and American Express. Shaun is a Fellow of the Institute of Chartered Accountants in England and Wales and holds a PhD in polymer chemistry from the University of Sussex. Shaun Antony Furlong, aged 48, holds an interest in 1,500 ordinary shares in the Company. In the previous five years, Shaun was a director of SAF Management Services Limited. Aankondiging • Feb 10
Allergy Therapeutics plc, Annual General Meeting, Mar 08, 2024 Allergy Therapeutics plc, Annual General Meeting, Mar 08, 2024, at 11:00 Coordinated Universal Time. Location: offices of Cooley (UK) LLP at 22 Bishopsgate London United Kingdom Agenda: To receive the Directors’ report, the consolidated financial statements and the auditors’ report of the Company for the year ended 30 June 2023; to approve the Directors’ remuneration report; to consider directorate reelections; to re-appoint BDO LLP as auditors of the Company to hold office from conclusion of this AGM until the conclusion of the next annual general meeting of the Company at which accounts are laid before the Company; to authorize the Directors to agree the auditors’ remuneration; and to consider other matters. Aankondiging • Dec 13
Allergy Therapeutics plc Provides an Update on the Data Analysis of Its Pivotal G306 Phase III Trial of Grass MATA MPL Allergy Therapeutics plc provided an update on the data analysis of its pivotal G306 Phase III trial of Grass MATA MPL, the Group's short-course subcutaneous allergen-specific immunotherapy (SCIT) candidate that aims to address the cause of symptoms of allergic rhinoconjunctivitis due to grass pollen. As previously communicated, the active treatment group demonstrated a highly statistically significant reduction in Combined Symptom & Medication Score (CSMS) (p0.0024) compared to placebo over the peak pollen season. This allowed the Group to stop the study for success and no second season cohort was required. Further analysis of the dataset shows: Statistical significance was also seen in the eDiary secondary endpoints, including CSMS during the entire grass pollen season, and daily medication and daily symptom scores; A strong, statistically significant induction of the protective biomarker IgG4 was seen during the grass pollen season between active and placebo (p 0.0001); There was a statistically significant overall improvement in the quality-of-life score, according to the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) (p 0.0003); No unexpected safety events were observed with Grass MATA MPL 27,600 SU. The large dataset, including primary and secondary endpoints, is being collated for use in regulatory discussions on the route to market authorisation application. The Group is pleased that the secondary endpoints strongly align, and all data analysed demonstrates the beneficial effect of the Grass MATA MPL 27.,600 SU product. The first scientific advice meeting with regulators is anticipated to occur in late First Quarter 2024, where discussions will lay out a pathway forward to permit progression to the marketing authorisation application process. Aankondiging • Nov 14
Allergy Therapeutics plc Announces Interim Top Line Results from its Pivotal G306 Phase III Trial of Grass MATA MPL Allergy Therapeutics plc announced interim top line results from its pivotal G306 Phase III trial of Grass MATA MPL, the Group's short-course subcutaneous allergen-specific immunotherapy (SCIT) candidate that aims to address the cause of symptoms of allergic rhinoconjunctivitis due to grass pollen. The adaptive G306 study design, endorsed by regulators, allowed an interim analysis to determine whether a 2nd cohort would be required. The trial met its primary endpoint demonstrating statistically significant superiority of Grass MATA MPL compared to placebo (p =0.0024, one-sided) in the CSMS during the peak pollen season, and the study was stopped for success. Top line analysis is expected to be available in mid-December. This will include treatment effect data and secondary endpoint analysis. The G306 trial was a multi-centre, randomised, parallel group, double-blind, placebo-controlled clinical trial to evaluate the efficacy of Grass MATA MPL 27600 SU in subjects with grass pollen induced seasonal allergic rhinitis and/or rhinoconjunctivitis based on symptoms and medications. The trial was conducted in the US and Europe at 89 sites. Preparation for a clinical trial application for the Group's G308 paediatric study is currently underway to meet the previously communicated requirements of the German regulatory framework (Therapy Allergen Ordinance) as well as the approved Paediatric Investigation Plan (PIP). Aankondiging • Oct 14
Allergy Therapeutics plc has completed a Follow-on Equity Offering in the amount of £6.891025 million. Allergy Therapeutics plc has completed a Follow-on Equity Offering in the amount of £6.891025 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 689,102,532
Price\Range: £0.01
Transaction Features: Regulation S; Rights Offering Aankondiging • Sep 26
Allergy Therapeutics plc Announces the Completion of Dosing of Healthy Volunteers in the First Two Cohorts in the Phase I Protect Trial of Its Novel Virus-Like Particle (Vlp)-Based Peanut Allergy Vaccine Candidate Allergy Therapeutics plc announces the completion of dosing of healthy volunteers in the first two cohorts in the Phase I PROTECT trial ("PROTECT trial") of its novel virus-like particle (VLP)-based peanut allergy vaccine candidate ("VLP Peanut"). Dosing of the subsequent cohorts will begin now that the approval from the external safety review committee (SRC) has been received. Additionally, after the successful skin-prick testing phase completed in April 2023, the SRC approved the commencement of subcutaneous dose escalation in peanut allergic subjects, marking the start of the early proof of concept phase of the PROTECT trial. This pivotal stage of the PROTECT trial is expected to begin imminently. The full results from the trial are expected in 2024. The PROTECT trial is being conducted in both healthy volunteers and peanut allergic patients and consists of two parts: Part A:Open-label study of four cohorts of healthy subjects (Group A1) who undergo subcutaneous dosing with ascending concentrations of VLP Peanut. Peanut allergic subjects (Group A2) underwent skin prick tests performed with ascending concentrations of the vaccine candidate (completed April 2023). Part B:Double-blind, placebo-controlled Part B enrolling peanut allergic patients who receive ascending doses of the vaccine candidate administered subcutaneously. The PROTECT trial builds on the findings from the VLP001 study, which took place at Imperial College London. This ex-vivo biomarker study revealed that VLP Peanut significantly reduced certain allergic responses compared to the major allergen Ara h2, indicating a promising safety profile with reduced potential to induce allergic reactions. Aankondiging • Jul 11
Allergy Therapeutics plc Announces Executive Changes Allergy Therapeutics plc announced the promotion of Shaun Furlong to Chief Financial Officer with effect from 11 August, when the current interim CFO, Martin Hopcroft, will leave the Company. Shaun brings significant financial experience in both technical and commercial roles. He joined Allergy Therapeutics as Group Financial Controller and a member of the Group's senior management team in April 2022. He previously held senior finance roles within blue-chip companies across multiple sectors, including Legal & General, Hastings Direct, Volution Group and American Express. He is a Fellow of the Institute of Chartered Accountants in England and Wales, and holds a PhD in polymer chemistry from the University of Sussex. Aankondiging • Jun 20
Allergy Therapeutics plc Provides Sales Guidance for the Second Half Year to 30 June 2023 and Full Year to 30 June 2024 Allergy Therapeutics plc provides sales guidance for the second half year to 30 June 2023 and full year to 30 June 2024. The Group expects sales for the second half year to 30 June 2023 to continue at a slightly improved trend when compared with the trend seen for the first half of the year, with correspondingly lower gross margins.As a result of the manufacturing capacity that needs to be allocated to clinical batches, sales for the financial year to 30 June 2024 are expected to be slightly lower than the comparable period, with consequently reduced gross margins, while overheads before R&D and exceptional are expected to be similar. Aankondiging • Jan 20
Allergy Therapeutics plc Provides Revenue Guidance for the Six Months Ended 31 December 2022 Allergy Therapeutics plc provided revenue guidance for the six months ended 31 December 2022. For the period, the company expects revenue to be £39.9 million (2021: £48.7 million) representing a reduction of 18% compared to last year. Aankondiging • Jan 14
Allergy Therapeutics plc, Annual General Meeting, Feb 07, 2023 Allergy Therapeutics plc, Annual General Meeting, Feb 07, 2023, at 09:30 Coordinated Universal Time. Location: The Ardington Hotel, Steyne Gardens Worthing, West Sussex BN11 3DZ West Sussex United Kingdom Aankondiging • Sep 14
Allergy Therapeutics plc Announces the Secondary Endpoint Results from an Ex-Vivo Biomarker Study Vlp001 Allergy Therapeutics plc announced the secondary endpoint results from an ex-vivo biomarker study VLP001 which evaluated the Group's novel virus-like particle (VLP) based peanut allergy vaccine candidate ("VLP Peanut"). The secondary endpoint results demonstrated a reduced IgE binding capacity to B cells of VLP Peanut suggesting a promising safety profile with reduced potency to induce allergic reactions. Further, the results provide a strong indication for the products' efficacy potential, promoting a class switch from the allergic Th2 pathway to the more tolerogenic Th1 pathway; Lower ability to elicit Th2 and Tfh (T follicular helper) cells; Strong ability to promote IFN- ? and Th1 cells; Promotion of selected regulatory B cell subsets. Previously announced primary endpoint data demonstrated a significant 24-fold reduction in basophil activation and histamine release compared to exposure to the major allergen Ara h2, these results provide strong confidence in the beneficial immunologic mode of action of VLP Peanut. The VLP001 study took place at Imperial College London and evaluated the Group's short-course VLP Peanut vaccine candidate. In combination with the primary outcome data, these secondary endpoint results are encouraging and provide strong support for the human translation of the pre-clinical results and strong confidence in the data to be generated in the planned Phase I PROTECT study. The data also provide important information to establish the starting dose for PROTECT, which is expected to commence in First Quarter 2022. Aankondiging • Jul 15
Allergy Therapeutics plc Provides Earnings Guidance for the Year 2021 Allergy Therapeutics plc provided earnings guidance for the year 2021. The Group expects revenue to be £84.3 million (2020: £78.2 million) representing 8% annual growth on a reported basis and 6% on a constant currency basis, reflective of a strong performance in challenging market conditions. Aankondiging • Jun 25
Allergy Therapeutics plc Provides Earnings Guidance for the Full Year O 2021 Allergy Therapeutics plc provided earnings guidance for the full year o 2021. The Group expects operating profit for the full year 2021 to be well ahead of market expectations, with robust sales growth helped by the Euro exchange rate, reflective of a strong Group performance in challenging market conditions. Aankondiging • Jan 05
Allergy Therapeutics Announces an Ex-Vivo Biomarker Study of Blood Samples from Peanut Allergy Patients Has Begun At Imperial College London Allergy Therapeutics announced that an ex-vivo biomarker study of blood samples from peanut allergy patients has begun at Imperial College London. The study aims to evaluate the Group's novel virus like particle (VLP) based peanut allergy vaccine candidate, to confirm its hypoallergic potential and its potent immune response. The study at Imperial College London, using human samples and an extensive set of functional and molecular biomarkers, will provide Allergy Therapeutics with important information to establish the starting dose for its first-in-human Phase I study. The data will also act as an early clinical predictor of efficacy of the VLP platform and support the acceptance of the Investigational New Drug (IND) application and a successful Phase I trial outcome. The submission of an IND application to the United States Food and Drug Administration (FDA) for that study is expected in 2021. The company’s peanut allergy vaccine programme is supported by a strong preclinical research package, providing pre-clinical proof of concept for sustained immunity and protection against peanut anaphylaxis after a single vaccination. Importantly, in contrast to current treatment approaches such as desensitisation via oral administration or transdermal patches, which require daily dosing over several years, it is anticipated that the Group's next-generation VLP-based peanut vaccine candidate will use only 3 injections to induce sustained protection. The potential of an effective short-course peanut allergy vaccine represents a significant opportunity in the $8 billion worldwide food allergy market1. Prevalence of peanut allergy in Western countries is on the rise and currently ranges from 1.4-3% of children2 and, in the US, peanut allergy affects an estimated 1.2% of the overall US population3 with 1 in 4 children with a peanut allergy requiring a hospital visit each year4. In parallel with the peanut allergy human biomarker study, a broader research project with Imperial College London has also commenced, focussing on the selection, measurement and analysis of pre-clinical and clinical biomarkers for allergen immunotherapy products across Allergy Therapeutics' portfolio. Clinical trials in the allergy immunotherapy area often pose challenges with interpretation as they rely on subjective non-validated endpoints. There is therefore an opportunity to explore alternative, more objective measures of success and develop a greater understanding of the underlying science in this important area. Under this collaboration agreement, researchers will examine samples from the Group's ongoing Grass MATA MPL exploratory field study (G309), and the pre-clinical and clinical development programme for the Group's VLP-based peanut allergy vaccine candidate. Changes in an extensive set of established and innovative biomarkers will be analysed at baseline and throughout treatment with each of the allergen immunotherapies.