Apitope to attend the JP Morgan 38th Annual Healthcare Conference 13-16 January 2020 in San Francisco, CA, USA

Apitope’s Antigen specific immunotherapy for Graves’ disease features in the October 2019 edition of the British Thyroid Foundation Newsletter

Apitope’s Antigen specific immunotherapy for Graves’ disease  features in the October 2019 edition of the British Thyroid Foundation Newsletter (BTF) and the article is also available on the BTF website by following this link: https://www.btf-thyroid.org/research-news-graves-disease

Apitope announces that the first in human clinical trial for the treatment of Graves’ disease has been published as a ‘Success Story’ by the European Commission

HASSELT, Belgium, and CHEPSTOW, UK, 13 September 19 – Apitope, a clinical stage biotech company developing potential first-in-class antigen-specific immunotherapies targeting autoimmune diseases, today announces that the first in human clinical trial for the treatment of Graves’ disease funded by the European Union (DAVIAD) has been published as a “Success Story” on the European Union website. The article entitled ‘ New treatment on the horizon for Graves’ disease’ can be viewed in the following link:

https://ec.europa.eu/research/infocentre/article_en.cfm?artid=50625

Apitope Announces Publication of Data in International Peer-Reviewed Journal Thyroid on Graves’ disease Therapy

HASSELT, Belgium, and CHEPSTOW, UK, 20 June 19 – Apitope, a clinical stage biotech company developing potential first-in-class antigen-specific immunotherapies targeting autoimmune diseases, today announces publication of its clinical Graves’ disease data in Thyroid, one of the leading peer-reviewed thyroid disease related medical journals.

The publication entitled: Antigen-Specific Immunotherapy with Thyrotropin Receptor Peptides in Graves’ Hyperthyroidism: A Phase I Study , reports the results from a first in human clinical study to assess the safety, tolerability and efficacy of Apitope’s antigen-specific immunotherapy, ATX-GD-59, in patients with Graves’ disease.

The open-label trial reported in the paper was conducted in patients with mild to moderate Graves’ disease. These preliminary data suggest that ATX-GD-59 is a safe and well-tolerated treatment. The improvement in free thyroid function in 70% of subjects receiving the medication suggests potential efficacy as a novel treatment for Graves’ hyperthyroidism.
Hayley French, CEO of Apitope, said: “We are delighted that these data have been published in Thyroid, a peer-reviewed journal for thyroid related diseases. For people suffering from Graves’, the project’s progress has finally created hope that the underlying disease can be treated and, for the first time in over 70 years, an innovative disease modifying treatment could be on the horizon”.

https://www.liebertpub.com/doi/full/10.1089/thy.2019.0036

Apitope Announces Management Changes

Keith Martin to retire as CEO, continue as Non-Executive DirectorHayley French appointed COO and interim CEO
HASSELT, Belgium, and CHEPSTOW, UK, 24 October 2018 – Apitope, a clinical stage biotech company developing potential first-in-class antigen-specific immunotherapies targeting autoimmune diseases, today announces that Chief Executive Officer (CEO) Dr Keith Martin has decided to retire from the CEO role after 12 years at the helm of Apitope. He will remain on the Apitope Board as a non-executive director. Dr Hayley French will move to Chief Operations Officer (COO) and act as interim CEO of Apitope until a permanent replacement is in place. Dr French will join the Board of Directors effective immediately.

Dr French brings over 25 years of experience in the pharmaceutical and biotechnology industry, most recently as Chief Business Officer & General Counsel of Apitope and prior to this she spent three years at Novartis where she worked on all global deals and collaborations in the respiratory division. She has been with Apitope since November 2010 and has over twenty years’ experience of negotiating licences and collaborations and managing alliances in the life sciences sector.

Stéphane Verdood, Chairman of the Board of Directors of Apitope, commented: “Keith’s contribution to Apitope’s growth during his 12-year tenure has been immeasurable. Under his strategic leadership Apitope has grown to be a clinical stage biotech with multiple programmes in development for diseases with high unmet needs. On behalf of the Board we would like to thank Keith for his contribution to Apitope and we are delighted he will stay on the Board as a Non-executive Director.

“I am very pleased that Hayley has agreed to take on the role of COO and interim CEO to ensure the smooth running of the company. She has played a major role in Apitope’s growth and success over the past eight years and the Board is confident in her expertise and experience in progressing Apitope’s growth and maximising the potential of its clinical programmes.”

Dr Keith Martin said: “It has been an honour to have led Apitope and the transformation of the company from a University of Bristol spin-out to a clinical stage company with a strong clinical pipeline. I am proud of our achievements to date and I look forward to supporting the growth and development of Apitope as a Board member.”

Dr Hayley French, newly appointed interim CEO of Apitope, added: ” With efficacy demonstrated in two diseases, Apitope has a robust clinical pipeline of first-in-class antigen-specific immunotherapies for the treatment of autoimmune diseases. Apitope’s ATX-MS-1467 is a potential game changer in the treatment of multiple sclerosis and ATX-GD-59 appears to be the first disease-modifying treatment for Graves’ disease in over 60 years. I look forward to maximising the potential of these important new treatments and lead the Company through its next phase of growth.”

Prior to joining Apitope, Dr French spent three years at Novartis and prior to this worked in the Life Sciences Group of Bird & Bird, London, specialising in advising pharmaceutical and biotech companies. Prior to joining Bird & Bird, she was Head of Commercial Legal Affairs at the Centre for Applied Microbiology and Research (CAMR) in Salisbury, UK. Dr French started her career at University College London Ventures where she was responsible for the development, management and commercialisation of technologies in the life sciences sector. She is past president of the Licensing Executives Society Britain & Ireland, and chair of the Licensing Executives Society International (LESI) life sciences committee.

Dr French teaches on the LESI Intellectual Asset Management courses and is a regular speaker on IP licensing and negotiation. She has a B.Sc. in Microbiology from the University of Liverpool, as well as a PhD in Microbiology and a M.Sc. in intellectual property from the University of London and is a certified licensing professional (CLP).

Apitope Announces Publication of Graves’ Disease Data in International Peer-Reviewed Journal, Endocrinology

HASSELT, Belgium, and CHEPSTOW, UK, 14 August 2018 – Apitope, a clinical stage biotech company developing potential first-in-class antigen-specific immunotherapies targeting autoimmune diseases, today announces publication of its pre-clinical Graves’ disease data in Endocrinology, one of the leading peer-reviewed endocrinology medical journals.

The publication entitled: Immunotherapy with apitopes® blocks the immune response to thyroid stimulating hormone receptor in HLA-DR transgenic mice , reports the results from a series of studies to identify peptides that can be used to treat the abnormal immune response to TSHR (thyroid stimulating hormone receptor) in Graves’ disease patients and can be found here.

The study showed that a mixture of two immunodominant apitopes® was sufficient to suppress both the abnormal T cell and antibody response to TSHR in HLA-DR transgenic mice. Tolerance induction was not disrupted by current drug treatments for Graves’ disease. The paper concluded antigen-specific immunotherapy with apitopes® from TSHR is a suitable approach for the treatment of Graves’ disease.

Dr Keith Martin, CEO of Apitope, said: “It is very encouraging to have these findings by our talented team of scientists published in Endocrinology, one of the most highly-regarded journals in the field. The data shows that immunotherapy with apitopes® is a suitable approach to be investigated for the treatment of Graves’ disease and demonstrate the potential to be the first disease-modifying treatment, as well as the first innovative therapy for Graves’ disease in more than 60 years.”

Prof David Wraith, CSO of Apitope, said: “I am excited to see these data published because it provides further evidence of the broad applicability of the Apitope platform to identify peptide apitopes® to treat a wide range of autoimmune diseases. The initial clinical data announced earlier this year confirmed the potential for the apitopes® reported in this publication to make a significant impact in the treatment of Graves’ disease.”

Apitope announces positive results with novel treatment for Graves’ disease

Phase I data show early efficacy in the majority of patients and a very favourable safety profile

HASSELT, Belgium, and CHEPSTOW, UK, 16 April 2018 – Apitope, a clinical stage biotech company developing potential first-in-class antigen-specific immunotherapies targeting autoimmune diseases (including multiple sclerosis (MS), Graves’ disease and uveitis), today announced positive results from the Phase I first in man clinical trial of its product candidate, ATX-GD-59, in development for the treatment of Graves’ disease.

Graves’ disease is one of the most common autoimmune diseases with approximately 10 million patients across Europe and the US and yet there have been no innovative treatments in more than 60 years. With Graves’ disease, the immune system mistakenly attacks the thyroid gland and causes it to become overactive. Symptoms can include an enlargement of the thyroid gland, swelling of the neck, localised abnormalities of skin, tremors, heat intolerance and sweating, significant weight loss, osteoporosis, atrial fibrillation and ocular changes in patients. Each year 20-30 out of every 100,000 people are newly diagnosed with Graves’ disease. The ratio of women versus men diagnosed with Graves’ disease is 6:1 and around 2% of all women will develop Graves’ disease during their lifetime.

Dr Simon Pearce, Professor of Endocrinology, Newcastle University, and Chief Investigator for the trial commenting on the results said: “It is very exciting to see these promising Phase I results where ATX-GD-59 has shown both an encouraging safety and tolerability profile as well as efficacy. With current first-line treatments having a high failure rate, and the second-line treatments being either invasive surgery or radioiodine, ATX-GD-59 demonstrates the potential to address the high medical need for a new, safe and effective treatment for the neglected field of those suffering from Graves’ disease.”

The Phase I clinical study met the primary endpoint to assess the safety and tolerability of ATX-GD-59 in 12 patients with Graves’ disease. The majority of the per protocol subjects were either euthyroid, the clinical objective of therapy, or close to being euthyroid by the end of treatment; the effect was maintained during the 3 months follow up off therapy. Importantly, TSHR antibody levels were also reduced with close correlations between percentage decreases in antibody and thyroid hormone levels in line with the mechanism of action.

Dr Keith Martin, Chief Executive Officer of Apitope, commented: “We’re highly encouraged by these data as they provide further evidence that our Apitope® platform identifies safe and effective treatments for autoimmune diseases. These findings are important for Graves’ disease patients in providing a potential new treatment paradigm aimed at the cause of the disease not just the symptoms. We will continue to progress the development of ATX-GD-59 as a treatment for Graves’ disease and are currently preparing to initiate a Phase II study in the first quarter of 2019.”

The investigational product was administered intradermally (ID) every two weeks over a period of 18 weeks in male and female patients that were not otherwise being treated with anti-thyroid therapy. Following a titration period of 25, 50, 100, 400 and 800 μg in the initial eight weeks of treatment, a dose of 800 μg was administered fortnightly for an additional 10 weeks, comparable to the regime followed in the successful ATX-MS-1467 multiple sclerosis (MS) trials.

Apitope Announces Publication of Data in International Peer-Reviewed Journal Neurology on Novel Multiple Sclerosis Therapy

HASSELT, Belgium, and CHEPSTOW, UK, 19 March 2018 – Apitope, a clinical stage biotech company developing potential first-in-class antigen-specific immunotherapies targeting autoimmune diseases, today announced publication of data on it multiple sclerosis treatment in Neurology, the official journal of the American Academy of Neurology and one of the world’s most widely read and highly cited peer-reviewed neurology medical journals.

The publication entitled: Effects of ATX-MS-1467 immunotherapy over 16 weeks in relapsing multiple sclerosis1 , outlines results from two clinical studies to assess the safety, tolerability and efficacy of Apitope’s antigen-specific immunotherapy, ATX-MS-1467, in patients with relapsing multiple sclerosis.

The two open-label trials reported in the paper were conducted in patients with relapsing multiple sclerosis using different treatment protocols to induce tolerance. Both studies demonstrated an highly favourable safety profile with zero treatment related serious adverse events and showed a significant decrease in both new lesions and lesion volume, as well as a significant improvement in cognition. No changes in EDSS and MSFC scores from baseline to the end of treatment were observed although there was a strong trend for improvement in MSFC (p=0.054). The paper concluded that relatively slow ATX-MS-1467 titration and a longer full-dose intra-dermal treatment period is associated with reduction in gadolinium enhancing lesions and a sustained effect post-treatment and that further trials of ATX-MS-1467 are warranted.

Keith Martin, CEO of Apitope, said: “We are delighted that these data have been published in Neurology, a premier peer-reviewed journal for clinical neurologists. ATX-MS-1467 is the first potential therapeutic for multiple sclerosis that has the potential to combine high efficacy with an excellent, and thereby differentiating, safety profile.”

Dr Jeremy Chataway, Lead author and Consultant Neurologist National Hospital for Neurology and Neurosurgery and Reader in Neurology, University College London, said: “Apitope’s antigen-specific immunotherapy approach, to reinstate tolerance to the protein causing the disease, represents a major conceptual shift away from most current and emerging immunomodulatory therapies for multiple sclerosis. The results from a phase 1b and phase 2a study outlined in the Neurology publication, further support ATX-MS-1467 as a potentially effective and well-tolerated new therapy.”
 

1 Neurology. 2018 Mar 13;90(11):e955-e962. doi: 10.1212/WNL.0000000000005118. Epub 2018 Feb

Apitope announces positive ATX-MS-1467 phase IIa data in relapsing Multiple Sclerosis

Hasselt, Belgium and Chepstow, UK: 21 February 2017 − Apitope, the drug discovery and development company focused on treating the underlying cause of autoimmune diseases, announces positive results from the Phase IIa clinical study of its lead product candidate, ATX-MS-1467, for the treatment of patients with multiple sclerosis.

The Phase IIa, open-label, one arm study evaluated the effects of ATX-MS-1467 in 19 patients with relapsing multiple sclerosis. The investigational product was administered intradermally (ID) every 2 weeks for 20 weeks. Following a dose titration of 50 and 200 μg in the initial 4 weeks of treatment a dose of 800μg was administered fortnightly for a further of 16 weeks.

There were statistically significant reductions in total and new T1 Gadolinium enhancing lesions measured using MRI during treatment as well as a significant reduction in the volume of T1 Gadolinium enhancing lesions. The data also showed a strong trend towards improvement in the Multiple Sclerosis Functional Composite (MSFC) score that is used clinically as an indicator of improvement in disability. There were no treatment related serious adverse events and the adverse event profile was mild.

Dr Keith Martin, Chief Executive Officer of Apitope, commented: “We are delighted with these positive results that confirm both clinical findings in our Phase Ib trial as well as preclinical results showing significant decreases in MRI detected lesions and disability in a standard multiple sclerosis model. We will continue to progress the development of ATX-MS-1467 as a treatment for multiple sclerosis and are currently preparing for a Phase IIb placebo controlled study to demonstrate clinical efficacy.”

Dr Jeremy Chataway, Consultant Neurologist, National Hospital for Neurology and Neurosurgery, London, commenting on the results said: “Having been the Chief Investigator on the previous Phase Ib study, it is pleasing to see these promising confirmatory Phase IIa results where ATX-MS-1467 has shown both an encouraging efficacy and an excellent safety and tolerability profile. While these patients were only treated for 20 weeks, results in a Phase IIb study with a longer treatment period will be interesting.”

The compound had previously completed a Phase I clinical study in six patients with secondary progressive multiple sclerosis (SPMS) and a second Phase I study in 43 relapsing multiple sclerosis patients, assessing safety and biological parameters. The latest results support the further development of ATX-MS-1467 in multiple sclerosis.