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Immune Regulation Ltd receives notice of allowance for new U.S. patent for its novel protein with anti-inflammatory properties

Patent provides long term composition of matter protection

(London UK, 08 September 2020) Immune Regulation Ltd, a US and UK based clinical stage biotechnology company, today announced that it has received a notice of allowance from the U.S. Patent and Trademark Office (USPTO) for a new patent covering IRL201805 (‘1805). ‘1805 is a first-in-class compound derived from the endogenous immuno-regulatory protein Binding Immunoglobulin Protein (BiP) and is in development to treat rheumatoid arthritis and other inflammatory and autoimmune diseases. The new patent provides Immune Regulation with additional intellectual property protection covering the composition of matter of ‘1805.

This new ‘1805 patent significantly strengthens Immune Regulation’s intellectual property portfolio,” said Jonathan Rigby, Group CEO of Immune Regulation. “We will continue to prosecute patent applications for both of our first-in-class immune resetting drug candidates ‘1805 and ‘1104.”

Previously reported data from a Phase 1/2A dose range finding study in patients with active rheumatoid arthritis who had failed one or more standard therapies, ‘1805 given intravenously as a single dose, showed a good tolerability profile, with no drug-related toxicities. Clinical responses and remissions of disease was achieved in some patients, which correlated to early reductions in a number of inflammatory biomarkers, in those patients that had been given ‘1805. The activity of ‘1805 appeared to be long lasting, with effects on biomarkers and clinical changes still evident at the cessation of the 12-week clinical trial. The clinical responses were associated with an induction of Treg cells. This study represents early proof of concept for ‘1805 as a safe and effective immunomodulating treatment for rheumatoid arthritis.

A Phase 2 clinical study with ‘1805 is currently being planned in adult patients with moderate to severe rheumatoid arthritis to further assess remission rates and longevity of action.

 

For further enquiries 

Immune Regulation Ltd
Jonathan Rigby, Group CEO
+1 510 589 3268
jonathan.rigby@immuneregulation.com

 

 

About Immune Regulation

Immune Regulation Limited is a US and UK based clinical stage biotechnology company, pioneering new technologies for regulating and resetting the immune system and developing novel first-in-class therapies for inflammatory and immunological diseases.

Immune Regulation’s first-in-class immune resetting therapies have demonstrated unique efficacy and safety in pre-clinical and human studies without suppressing the immune system. These therapies exhibit short pharmacokinetic activity but reset the immune system from a pro-inflammatory to a regulatory state to induce disease remission in patients with allergic and immune mediated diseases, without the negative effects of chronic current therapies.

At Immune Regulation our aim is to develop novel, safe and effective therapies that reset the immune system, transforming the lives of patients with inflammatory and immunological diseases.

About IRL201805

Immune Regulation’s IRL201805 (‘1805) is a first-in-class compound derived from the endogenous immuno-regulatory protein (Binding Immunoglobulin Protein, BiP). ‘1805 has demonstrated long duration of activity and disease remission with a good tolerability profile in a phase 1/2A study in patients with rheumatoid arthritis who have failed previous therapies.https://immuneregulation.com/science

Forward-Looking Statements

This announcement includes forward-looking statements, being statements made in the announcement that are not historical fact. Forward-looking statements can generally be identified by the use of words including “anticipate”, “may”, “believe”, “estimate”, “intend”, “expect” and words of similar meaning.  Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause the Company’s actual results, performance or achievements to be materially different from the results, performance or achievements contemplated by the forward-looking statements in this announcement.  The forward-looking statements speak only to the date of this announcement. Neither the Company, nor any shareholder, affiliate, employee, adviser or representative of the Company shall be under any obligation to, and all of those persons expressly disclaim any obligation to, update or revise the forward-looking statements contained in this announcement.

08 September 2020

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David Southwell

Chairman

In addition to his role as Chairman of Revolo, David Southwell serves on the Board of Directors for Rocket Pharmaceuticals and PTC Therapeutics. David is the former CEO of TScan Therapeutics. Before that, he served as President and CEO of Inotek Pharmaceuticals until its merger with Rocket Pharmaceuticals in 2018. David has held other senior leadership roles and Board of Director positions at companies including Human Genome Sciences, Sepracor, Spero Therapeutics, inVentiv Health, and THL Credit.

Kari Brown, M.D.

Chief Medical Officer

Kari Brown, a board-certified allergist and immunologist, brings 10 years of experience in clinical treatment deployment, development and strategy to Revolo. In her various roles, Kari has played an integral part in advancing pipelines across allergy and immunology disease indications.

Femi Oluboyede

Vice President, Technical Operations, CMC

Femi Oluboyede has over 20 years of experience within the bio-pharma industry, with a proven track record of achieving strategic corporate objectives. Through his roles, Femi has excelled in fostering alignment across functional teams, including Process Development, Tech-transfers, cGMP Manufacturing in Biologics, Small molecules, Proteins and Synthetic Peptides. He has succeeded in delivering investigational products and providing support across different phases of clinical trials.

Tunde Otulana, M.D.

Non-Executive Director

Tunde is currently the Chief Medical Officer of Veloxis Pharmaceuticals in North Carolina, USA since August 2020. Prior to Veloxis he was Senior Vice President and Chief Medical Officer at Mallinckrodt Pharmaceuticals. His career, which spans about 30 years in industry, government and academia, includes leadership roles at Boehringer Ingelheim Pharmaceutical Inc. and the US Food and Drug Administration (“FDA”). Tunde is a physician trained in Pulmonary and Critical Care Medicine.

Beth Alley

Senior Vice President, Regulatory Affairs and Pipeline Planning

Beth Alley has over 20 years of experience within the biopharmaceutical industry in regulatory affairs, commercial strategy, and medical writing throughout all phases of drug development. Her primary areas of focus have been in development of biologics for treatment of autoimmune, inflammatory, and infectious diseases.

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

Non-Executive Director

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

SVP 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

SVP 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.

President & Chief Executive 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

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