Apitope to present at 1st Antigen-Specific Immune Tolerance Europe Conference

Apitope to present at 1st Antigen-Specific Immune Tolerance Europe Conference

HASSELT, Belgium, and CHEPSTOW, UK, 10 December 2018 – Apitope, a clinical stage biotech company developing potential first-in-class antigen-specific immunotherapies targeting autoimmune diseases, announces that Non-Executive Director Dr Keith Martin and Chief Scientific Officer Prof David Wraith are scheduled to attend and present at the Antigen-Specific Immune Tolerance Europe 2018 conference being held in London on 10th-12th December. The conference will be held at Park Plaza Victoria.

Dr Martin and Dr Wraith’s presentation details are below.

11th December 2018

Presentation: Antigen-Specific Immunotherapy of Autoimmune Diseases
Time: 09:00am
Presenter: David Wraith

The presentation is part of the session on ‘Harnessing Tregs to Induce Antigen-Specific Immune Tolerance’.

12th December 2018

Panel Discussion: Improving Pre-Clinical Predictability of Antigen-Specific Immune Tolerance Therapies
Time: 10:30am

Dr Keith Martin to join panel discussion along with Timm Jessen, Topas Therapeutics and Pieter Rottiers, ActoBio Therapeutics. The panel is part of the session on ‘Overcoming Translational Challenges of Antigen-Specific Immune Tolerance Therapies into the Clinic’.

Presentation: Antigen Specific Immunotherapy with Apitopes® from Concept to Clinic”
Time: 11:30am
Presenter: Dr Keith Martin

The presentation is part of the session on ‘Optimizing Clinical Development & Paving the Future of Antigen-Specific Immune Tolerance Therapies’.

Antigen-Specific Immune Tolerance Europe 2018 is the first European centric, dedicated platform that brings key decision makers together to successfully translate ground breaking science into a novel class of therapies to treat autoimmunity. The Conference will be will be dedicated to determining novel antigen identification, validation of preclinical models and ultimately the effective clinical translation of this research clinical setting.

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.

Apitope Featured in the Report: 60 Years of Immunology

Hasselt, Belgium and Chepstow, UK: 15 November 2016 − Apitope, the clinical stage company focused on treating the underlying cause of autoimmune diseases, is pleased to announce that Apitope is featured in the 60 Years of Immunology report by the British Society for Immunology (BSI).

In the report, Professor David Wraith, Founder & Chief Scientific Officer of Apitope, discusses the importance of moving away from non-specific immunosuppressive drugs that make patients susceptible to infections as well as cancers and instead help the immune system correct itself using antigen specific immunotherapy.

The BSI is one of Europe’s largest and oldest societies and is dedicated to supporting immunology and immunologists. It was founded 60 years ago in 1956 by a small group of hard working, visionary immunologists, who wanted to come together to share ideas and encourage the study of immunology. With over 3,000 members, the society’s mission is to promote excellence in immunological research, scholarship and clinical practice in order to improve human and animal health. The BSI publishes the journals, Immunology and Clinical & Experimental Immunology.

Dr Keith Martin, CEO of Apitope, commented: “It is a great honour to be included the BSI’s report highlighting the key advances in immunology including the use of antigen specific therapy pioneered by our CSO, Professor David Wraith, to celebrate the Society’s 60 years. Apitope has built an exciting portfolio of product candidates with two programmes in the clinic; one for multiple sclerosis and another for Graves’ disease whilst a peptide therapy for Factor VIII inhibitor patients is being prepared for initiation of clinical trials. We have a pipeline of seven programmes in clinical and preclinical development for the treatment of multiple sclerosis, Graves’ disease, Factor VIII intolerance and uveitis. These have the potential to be uniquely disease-modifying therapies.”

Apitope Announces Enrolment of First Patient in Phase I Trial of ATX-GD-59 for the Treatment of Graves’ Disease

Hasselt, Belgium and Chepstow, UK: 26th October 2016 − Apitope, the drug discovery and development company focused on treating the underlying cause of autoimmune diseases, today announces that the first patient has been enrolled in the Phase I clinical trial of its novel peptide therapy, ATX-GD-59, for the treatment of Graves’ disease.

Apitope’s ATX-GD-59 has the potential to treat and prevent the production of stimulating antibodies against TSHR (thyroid stimulating hormone receptor) that lead to Graves’ disease. The Phase I trial will recruit up to 30 patients and is designed to assess the safety and initial efficacy of the product.

Dr Simon Pearce, Professor of Endocrinology, Newcastle University, and Chief Investigator for the trial commented: “This is the first new therapy for Graves’ disease to be tested in over 50 years and is a significant step forward in the development of the drug. We are very pleased to be leading the first clinical trial of ATX-GD-59 which has significant potential to treat the underlying cause of this condition for the first time.”

Dr Keith Martin, CEO of Apitope, said: “Graves’ disease is an autoimmune disorder that impacts over 5 Million people worldwide. There is no cure and the current treatment options available for patients have limited efficacy. Apitope is developing innovative products based on therapeutic peptides to treat a range of life-threatening autoimmune diseases, including rare conditions. We are delighted to progress the development of these innovative peptides which have the potential to treat Graves’ disease patients.”

Graves’ Disease is the most common auto-immune disorder with prevalence rates of approximately 0.2% in Europe and 0.5% in the US (>2.4 million in EU and 2.6 million in the US); far outreaching the numbers of rheumatoid arthritis or type 1 diabetes patients. It is more common in women than men. This autoimmune endocrine disorder is linked to the thyroid gland and the overproduction of the thyroid hormones thyroxine (T4) and triiodothyronine (T3) caused by auto-antibodies. It can lead to high risk of long-term cardiovascular morbidity and mortality.

About 30-50% of patients also suffer from Graves’ orbitopathy characterized by a protrusion of one or both eyes caused by the auto-antibody driven inflammation in extraocular eye muscles, connective and adipose tissue. Without treatment, it can lead to visual impairments and even blindness in a significant proportion (3-5%) of patients. It is therefore considered as a serious unmet need confirmed by The European Group on Graves’ orbitopathy (EUGOGO). Paediatric Graves’ disease is also recognised as an important unmet need with low levels of response.

Approximately 50% of patients fail the current first line therapy. This provides a real opportunity for Apitope’s immunotherapy. In particular, early intervention may prevent moderate-to-severe or sight- threatening Graves’ orbitopathy from occurring or significantly ameliorate the symptoms without the need to suppress the whole immune system. This would greatly improve the health-related quality of life of the patients.

Apitope regains global rights to its novel treatment for multiple sclerosis from Merck KGaA, Darmstadt, Germany.

Chepstow, UK and Hasselt, Belgium: October 17 2016 − Apitope is a drug discovery and development company focused on highly selective therapies that reinstate immune tolerance and thereby treat the underlying cause of autoimmune, as well as allergic diseases. Today Apitope announces it has regained global rights to its compound, ATX-MS-1467, a potentially disease-modifying therapy for the treatment of Multiple Sclerosis (MS). Under the agreement with Merck KGaA, Darmstadt, Germany, Apitope will regain all rights and clinical data associated with its compound ATX-MS-1467, which just completed a Phase II clinical trial.

Dr Keith Martin, CEO of Apitope, commented: “We believe ATX-MS-1467 has enormous potential for treating MS patients. We are pleased to be regaining the rights to the compound, as well as the clinical data. This will provide us with greater flexibility and control in the clinical development of ATX-MS-1467. We are now able to pursue new business collaborations to enable the further development of this promising treatment. We appreciate the efforts made by the Merck KGaA, Darmstadt, Germany -team members in advancing this programme to date.”

ATX-MS-1467 has successfully completed a Phase I clinical trial in six patients with secondary progressive MS (SPMS) and a second Phase I trial in 43 relapsing MS patients, assessing safety as well as biological parameters. Examination of the MRI results (new gadolinium- and total gadolinium-enhancing [Gd+] lesions) demonstrated a decrease of 78% in the number of Gd+ brain lesions in patients with relapsing MS treated with intradermal injection of ATX-MS-1467.

Enrolment in a Phase IIa clinical trial of ATX-MS-1467 in Relapsing Multiple Sclerosis was completed in mid-2015, and the outcome of the study is expected Q4 2016.

The terms of the agreement are not disclosed.