Opsona Therapeutics Ltd.
This article was originally published in Start Up
Executive Summary
Opsona Therapeutics is focusing on Toll-like receptors, which control the activity of regulatory T cells, signaling the presence of infection and triggering the inflammatory immune response. The company will identify key preclinical candidates (either in-house or licensed-in) and take them to development points of value before partnering. The Trinity College spin-out has struck its first two deals: with Wyeth Pharmaceuticals and with Phylogica.
Toll-like receptors for immune-mediated disorders
Institute of Molecular Medicine
Trinity Centre for Health Sciences
St. James' Hospital
Dublin 8, Ireland
Phone: +353 1 896 8499
Fax: +353 1 896 8501
Web Site: www.opsona.com
Contact: Mark Heffernan, PhD, CEO
Industry Segment: Specialty Pharmaceuticals
Business: Development of novel anti-inflammatories
Founded: 2003
Founders: Mark Heffernan; Kingston Mills, PhD (Trinity College Dublin); Dermot Kelleher, MD, PhD (Trinity College Dublin); Luke O’Neill, PhD (Trinity College Dublin)
Employees: 19
Financing: €6.25 million ($8.4 million)
Investors: Inventages Venture Capital; Seroba BioVentures; Genentech Inc.; Enterprise Ireland
Board of Directors: Mark Heffernan; Cormac Kilty, PhD (Biotrin Holdings Ltd.); Seamus O’Hara (Seroba BioVentures Ltd. and the Irish BioScience Venture Capital Fund); Kingston Mills; John Obijeski, PhD; Robert Schier, PhD (Inventages Venture Capital)
Scientific Advisory Board: Mark Heffernan; Andy Gearing, PhD (Biocomm); Kingston Mills; Dermot Kelleher; Luke O’Neill; Christopher Locher, PhD (Chairman, VP of preclinical development)
Irish biotech Opsona Therapeutics Ltd. is a 2004 spinout from Trinity College (Dublin) and is based in the St James’ Hospital campus there. The company was founded by Trinity professors Kingston Mills, Dermot Kelleher, and Luke O’Neill. It is their first start-up, but all have strong links with the biopharma industry, as well as a pedigree of peer-reviewed research. The company’s focus is on modulating the immune system to prevent inflammation and autoimmune disease, and its name is derived from the Greek word that means "to prepare food," describing how the immune response prepares foreign material before it is "eaten" by white blood cells.
What makes Opsona different from the other early-stage R&D companies in the crowded anti-inflammatory space is its focus on Toll-like receptors or TLRs. TLRs alert the immune system, signaling the presence of infection and triggering the inflammatory immune response. They can control the immune response by controlling the activity of regulatory T cells, the cells that can damp down effector T cell activity and reduce the immune response. Suppressing Toll-like receptors or amplifying regulatory T cells could prevent inflammation, and increasing activity could enhance the immune response and aid the efficiency of cancer immunotherapy.
"Immune-related therapies are a very competitive area of the market--however, we occupy a niche by being focused on the inhibition of Toll-like receptors, and are likely to have the competitive advantage of being first-in-class. By turning off cytokines, our drugs are applicable in a number of diseases," explains co-founder and CEO Mark Heffernan.
Opsona’s founders have a strong background in immunology and related areas. Professor O’Neill is head of biochemistry at Trinity College, and he is a world authority on Toll-like receptors, immune system signaling, and innate immunity. He has filed patents surrounding a number of key proteins in the innate immune cascade. Professor Mills is a Science Foundation Ireland Principal Investigator, Professor of Experimental Immunology and Fellow, with expertise in regulatory T cells and adaptive immunity, and he was awarded the Royal Irish Academy Medal for Biochemistry in 2004. Professor Kelleher is head of medicine and consultant gastroenterologist at St. James’ Hospital, working in immunology and cell biology of the GI tract. He has experience in multinational clinical trials, and he also serves on the board for Irish biotech Deerac Fluidics, which specializes in nanofluidics. He was made a Fellow of the American Gastroenterological Association (AGA) in 2007. Opsona has 10 patent families, including in-house IP and patents licensed from Trinity.
The idea behind Opsona grew from Mark Heffernan’s search for new opportunities. He was previously in senior management at Australian companies Metabolic Pharmaceuticals Ltd. and Antisense Therapeutics Ltd., and he was involved in the Antisense flotation. Interested in their background and technologies, Heffernan sought out the three immunologists and suggested the concept of the start-up.
During 2004, Heffernan prepared business plans in preparation for the Series A funding of €6.25 million in January 2005 from Inventages Venture Capital (Bahamas) and Seroba BioVentures (Ireland) with co-investors Genentech Inc. and Enterprise Ireland. International business development company Biocomm helped structure the company and its programs. Opsona will seek a Series B round of financing in late 2007 or early 2008, and it expects the return of existing financiers as well as additional European and US investors.
The money from the Series A financing was earmarked for the development of OPN 101 and OPN 201, large protein immunomodulators with activity directly on T regulatory cells. OPN 101 has both therapeutic and prophylactic potential for the treatment and prevention for autoimmune and inflammatory diseases, with OPN 201 as a follow-on molecule.
However, the development of these compounds may be overtaken by an undisclosed series of new molecules, which will be announced during the second half of 2007. This will take the company’s pipeline from its broader focus on protein targets for OPN 101 and 201 to more TLR-specific approaches, including biologics, peptides, and small molecules. Opsona will select its first clinical candidate from this series with clinical trials beginning late 2008 or early 2009.
Opsona is also working on biologics to Toll-like receptors, which may have potential in rheumatoid arthritis, atherosclerosis, heart disease, and ischemia. To further extend its pipeline, the company is currently evaluating candidates to license in, focusing on gastrointestinal inflammation, oncology, and inflammatory diseases.
The company’s business strategy is to identify key preclinical products (either in-house or licensed-in) in Toll-like receptor or regulatory T cell receptor fields, take them to development points of value, as early as target development or as late as clinical trials, and find companies to partner, either as licensees or collaborators.
As part of this process, in February 2006, Opsona announced its first major licensing agreement, with Wyeth Pharmaceuticals , focused on Toll-like receptor targets that arose from technology developed at Trinity by Luke O’Neill, through funding originally received by Science Foundation Ireland. The two companies are developing screens and evaluating protein targets to discover new chemical entities and biologics for the treatment of autoimmune and inflammatory diseases. Opsona will also be undertaking a target discovery program that may lead to the generation of new targets in the Toll-like receptor pathways. It will receive up-front and milestone payments from Wyeth, as well as R&D funding and royalties on any product sales. Opsona will also have the option to develop drugs derived from the collaboration for the treatment of topical indications," says Heffernan. "This collaboration is a key milestone for Opsona and provides validation of the science around the TLRs."
This was followed by an agreement with the Australian company Phylogica Ltd., setting up a drug discovery collaboration using Phylogica’s Phylomer peptide libraries to discover new drugs for targeting inflammatory diseases including asthma, autoimmune diseases, and atopic dermatitis, based on Toll-like receptors and signaling pathways in T regulatory cells. Opsona will license and develop the relevant Phylomer compounds, and Phylogica will share in the revenue stream. "We are very pleased to be working with a key player in drug discovery such as Phylogica, whose skills complement our development capabilities," Heffernan said. Opsona also aims to have a third partner by the end of 2007, based on ongoing discussions
There are a number of companies working in similar areas as Opsona, which the company regards as much potential collaborators as competitors. Other companies working specifically with Toll-like receptors include Eisai Co. Ltd., Idera Pharmaceuticals Inc, Coley Pharmaceutical Group Inc., Dynavax Technologies Corp. and Anadys Pharmaceuticals Inc.
Opsona's challenge will be to prove its technology and face the competition that will increase as the area becomes better known. Mark Heffernan has confidence in Opsona and is pleased with its progress to date. "It has grown beyond our expectations," Heffernan says. "We have a pipeline targeting primarily autoimmune disorders, and our board and staff include world experts in the field. If Toll-like receptors continue to be a hot area in the industry, Opsona could become a key acquisition target."–Suzanne Elvidge