Immune Regulation presents new data on ‘1104 at the American Thoracic Society (ATS) Annual International Conference

Immune Regulation Limited (‘Immune Regulation’ or the ‘Company’) a biopharmaceutical company developing “first in class” immune-resetting therapies for asthma and other inflammatory diseases, publically presented exciting preclinical data on IRL201104 (formerly PIN201104 or ‘1104) for the first time at the annual American Thoracic Society (ATS) International Conference in Dallas, Texas, held on 17th-22nd May.

The ATS Annual Conference is one of the leading pulmonary care (including allergy/immunology) events of the year attracting over 14,000 leading healthcare professionals from around the world.

The data was presented as part of the session titled, “Mechanisms for Airway Hyperresponsiveness: From Cell to Organism”. This is the first public presentation of data from two key preclinical studies. The data shows the activity of ‘1104 in reducing the levels of key inflammatory cells following challenge with two different allergens, and the longer-term immune resetting effects of ‘1104 upon allergen rechallenge with no drug present, due to its short pharmacokinetic half life (10 mins). A copy of the presentation abstract is included below.

In the first study, mice were sensitized to the allergen, ovalbumin (OVA), and treated with ‘1104 during sensitization or following OVA challenge. Allergen rechallenge was performed 10 days after the last ‘1104 treatment. Inflammatory cells were measured 24 hours after initial OVA challenge and after rechallenge. ‘1104 significantly inhibited eosinophil recruitment to the lung 24 hours after sensitization and 10 days after the last treatment on rechallenge.

In the second study, mice were sensitized to house dust mite (HDM) allergen. After two weeks either a single dose of ‘1104 or a control was administered, prior to a first HDM challenge. 14 days later, inflammatory cell recruitment and cytokine release were measured four hours after a second challenge with HDM. Following this HDM rechallenge, ‘1104 markedly reduced levels of three key inflammatory cells, eosinophils, neutrophils and lymphocytes. ‘1104 also reduced levels of pro-inflammatory cytokines (IL-4, IL-5 and IL-13). In contrast, fluticasone, montelukast or anti-IL-5 (other than reduced eosinophils for the anti-IL5) had no significant effect at this time point.

The presentation concluded that ‘1104 significantly inhibited the recruitment of inflammatory cells to the lung in two models of allergic inflammation. The very short exposure time of IRL201104, the prolonged nature of inhibition of cell recruitment, and the reduction in Th-2 cytokines, all suggest that ‘1104’s effects are novel and likely due to a resetting of immune homeostasis.

Richard Nagle, CEO of Immune Regulation commented,
“We are very pleased to release these data to the medical community, confirming our vision for ‘1104 as a short acting molecule, which can potentially have long term effects by resetting the immune system to a normal regulatory state in allergy and asthma. On behalf of Immune Regulation, I would like to thank our academic and industry collaborators who were responsible for performing these studies”.

PIN201104, A Peptide Derived from Mycobacterium Tuberculosis Chaperonin 60.1 Shows Prolonged Modulation of Allergic Inflammation in Murine Lungs

Authors
C. P. Page, D. Federici-Canova, A. Lightfoot, N. Cooper, C. Burgess, Y. Riffo-Vasquez; Sackler Institute of Pulmonary Pharmacology, King’s College London, London, United Kingdom, Immune Regulation Ltd. Stevenage, United Kingdom.

Abstract
Introduction: Epidemiological data suggests that M. tuberculosis (mTB) infection prevents asthma development. Chaperonin 60.1 (Cpn60.1), a protein secreted by mTB to dampen down the host immune response while in a latent state in the lung, inhibits allergic pulmonary inflammation and bronchial hyperresponsiveness in a murine model (Riffo-Vasquez, Y et al. AJRCMB, 47(2):245, 2012). We have investigated the effect of PIN201104, a synthetic, low molecular weight, short PK half-life (blood T1/2, 10min after i.v administration) molecule derived from Cpn60.1 in murine models of allergic lung inflammation. Methods: OVA model: Mice were sensitised with ovalbumin (OVA) and from day 14 were challenged with OVA (3%) once daily for 3 days. PIN201104 (20 ng/kg, i.v.) was given either, 5 min before each sensitization (G1), or before each OVA challenge (G2). Bronchoalveolar lavage (BAL) was performed at 24 h after the third OVA challenge or 10 days later upon re-challenge, when no further treatment with PIN201104 was given. HDM model: Mice were sensitised with house dust mite (HDM 25μg) intra-nasally for three weeks. Two weeks after the final sensitization animals were challenged with HDM (i.n. 100μg). PIN201104 (2μg/kg i.n.) or controls were administered prior to HDM challenge. Fourteen days later, mice were re-challenged with HDM and BAL samples were taken. Results: OVA model: PIN201104 markedly inhibited eosinophil recruitment to the lung 24h after challenge, when given either during sensitisation or before each challenge, (OVA: 42.7 ± 12.4 vs PIN201104 G1: 7.8 + 2.2, PIN201104 G2: 13.7 + 6.1 x 10 /ml, (P<0.05), and also when re-challenged 10 days after the 3 PIN21104 treatment (OVA: 18.4 ± 12.4 vs PIN201104 G1: 5.7 + 1.1, PIN201104 G2: 6.4 + 3 x 10 /ml, P<0.001) HDM model: 4hrs after re-challenge, PIN201104 (i.n.) markedly reduced BAL eosinophils (84±5%), neutrophils (67±4%) and lymphocytes (52±12%), 14 days after a single administration (P<0.05). Moreover, it also reduced levels of Th-2 cytokines (IL-4, IL-5, IL-13) in the BAL at the same time point. In contrast, fluticasone, montelukast or anti-IL-5 (other than reduced eosinophils) had no significant effect at this time point Conclusion: PIN201104 significantly inhibits the recruitment of inflammatory cells to the lung in two models of allergic inflammation. The very short exposure time of PIN201104, the prolonged nature of inhibition of cell recruitment, and the reduction in Th-2 cytokines, suggests that its effects are novel, and likely to be through a resetting of immune homeostasis. Thanks to GSK for performing the HDM model.

Enquiries
Immune Regulation
Richard Nagle, CEO
+44 (0)7809 525267
info@immuneregulation.com

Instinctif Partners
Melanie Toyne-Sewell / Rozi Morris
+44 (0)20 7457 2020

About Immune Regulation Limited
Immune Regulation is a clinical stage biotech company, pioneering new technologies for resetting the immune system, developing novel, first-in-class therapies for inflammatory and immunological diseases. These therapies reset the immune system from a pro-inflammatory to a regulatory state to induce long-term disease remission in patients with allergic and immune mediated diseases, without the negative effects of chronic current therapies.

Lead drug candidates, IRL201805 (‘1805) and IRL201104 (‘1104) have successfully completed Phase 1/2a and Phase 1 studies, respectively. Both molecules have demonstrated a durable regulation of the immune system for a significant time period after a single dose and both appear to have very clean safety profiles. They appear to modulate key cells of the immune system that control the inflammatory response, with a long duration of action following a single dose (‘1805, up to 12 weeks; ‘1104, up to 14 days) despite their short pharmacokinetic half-lives. Furthermore, despite regulating the immune system they do not appear to suppress host defence, having shown no impact to date on the body’s ability to fight infection. Rather, they are immunomodulators: they appear to reset the immune response with the potential for inducing long-term disease remission.

22 May 2019

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Glen Giovanetti

Non-Executive Director

Glen Giovanetti has more than 35 years of experience in strategy and operational leadership in the life science industry as well as in financial governance, risk and reporting as EY’s Global Biotechnology Sector Leader and Life Sciences Sector Leader. He currently serves on the Board of Directors of Life Science Cares, Teon Therapeutics and XW Pharma.

Marla S. Persky

Non-Executive Director

Marla S. Persky currently serves as the chief executive officer and president of WOMN LLC. She has more than 25 years of international senior business and legal experience in the pharmaceutical industry having held numerous business and legal positions at Boehringer Ingelheim and Baxter International. She currently serves on the Boards of Directors of Xeris Pharmaceuticals, YGEIA Consulting Group, Primary Stages, World Neighbors and A Better Chance in Ridgefield.

Dora Rau

Senior Vice President, Quality

Dora Rau brings 25 years of experience in development and commercial operations for drugs, biologics, devices and combination products to the team. She has held numerous executive-level quality positions, with expertise in building quality systems and in leading teams to attain successful regulatory authority inspection outcomes and product approvals.

Jonathan Gold

Chief Financial Officer

Over the last 25 years, Jonathan Gold has been an institutional venture capitalist, a public fund manager, a founder, an operating executive, and a board member for companies across sectors including life sciences. In those roles, he was active in the development, financing and mergers and acquisitions for numerous public and private companies.

Team Members

Michael Albisser

Non-Executive Director​

Michael is a partner of Metellus, a Zurich and London-based venture capital firm investing in technology and life sciences with ground-breaking potential. Having more than 25 years of experience in the finance area he is responsible for finance, tax, and deal structures. He serves on the board of various venture-backed companies.

Dr. Isaac Cheng, m.d.

Non-Executive Director

Dr. Isaac Cheng is currently an investment professional at Morningside, a venture capital and private equity institution based in Boston USA, and Shanghai China. Dr. Cheng focuses primarily on biopharmaceutical and healthcare investments. He has served on numerous public and private company boards.

Peter Greenleaf

Chairman

Peter Greenleaf currently serves as the chief executive officer (CEO) and member of the Board of Directors of Aurinia, (NASDAQ: AUPH / TSX: AUP), an autoimmune therapeutics company. He has held several other CEO and chairman roles. He is also currently a member of the Board of Directors of Antares Pharmaceuticals, Inc. (NASDAQ: ATRS) and Chairman of the Board of Directors of Biodelivery Sciences International, Inc. (NASDAQ: BDSI).

Marylyn Rigby

VP of Marketing and Investor Relations

Marylyn Rigby is an experienced pharmaceutical, biotech, and drug delivery professional. In addition to her expertise in marketing, public and investor relations, she has a successful track record with business development, licensing, public and private equity financing, strategy and other key corporate functions.

Nancy Vinh

VP of Clinical Operations

Nancy Vinh brings over 20 years of experience in managing early and late phase, international clinical trials for drugs, biologics, cell therapy and combination products across a wide range of therapeutic areas to the team. She has served as head of clinical operations and led registrational and label expansion trials execution.

Team Members

Dr. Clare Burgess

Chief Development Officer

Dr. Clare Burgess has 24 years of experience in clinical drug development as a pharmacologist and has worked across a wide range of therapeutic areas within the pharmaceutical industry. She has held multiple leadership roles and has led multidisciplinary teams across the world.

Jeff Myers, m.d., ph.d

Chief Medical Officer

Jeff Myers, M.D., Ph.D., has 20 years of experience in medical affairs, regulatory and clinical development within the biopharmaceutical industry, with focuses on cardiovascular, pulmonary, oncology, and inflammatory diseases.

Before entering the industry, he practiced as a congenital cardiac surgeon and served as the chief of pediatric cardiac surgery at Massachusetts General Hospital and as Associate Professor of Surgery at Harvard Medical School.

Team Members

Dr. Roly Foulkes

Chief Scientific Officer

A true drug discoverer, Dr. Roly Foulkes has 25 years of experience building and delivering innovative therapeutic portfolios within the immunology and inflammatory disease space. He has a strong record advising small and medium sized immunology biopharma companies in developing competitive therapeutic strategies and bringing new innovative molecules to the clinic.

Team Members

Jones w (woody) Bryan, ph.d.

Chief Business Officer

Jones (Woody) Bryan, Ph.D., brings almost 30 years of experience in the healthcare industry to the team, having led successful business development operations in both private and public pharma and biotech companies.

Team Members

Perry Calias, ph.d.

Chief Operating Officer

Perry Calias, Ph.D., brings over 25 years of experience in pre-clinical and clinical development, CMC and global regulatory submissions across the drug and device sectors of healthcare. He has held numerous executive positions leading clinical and non-clinical operations, with a strong focus on diseases of the central nervous system and rare diseases.

Team Members

Jonathan Rigby, mba

Group Chief Executive Officer

As employee #1 of Revolo Biotherapeutics in the US, Jonathan Rigby has led the company through substantial and rapid growth. He brings three decades of experience creating value and opportunities for companies in the pharmaceutical, biotech and drug delivery technology industry.

Team Members
  • Carrie Vincent: Director, HR & Senior Executive Administration
  • Dr. Jones W. (Woody) Bryan: Chief Business Officer
  • Dr. Roly Foulkes: Chief Scientific Officer
  • Jonathan Gold: Chief Financial Officer
  • Jeff Myers, MD: Chief Medical Officer
  • Marylyn Rigby: VP Marketing & Investor Relations
  • Dr. Perry Calias: Chief Operating Officer