Opsona Therapeutics Ltd. to present results on Tomaralimab study at the 60th Annual Meeting of the American Society of Hematology (ASH)

Opsona Therapeutics Ltd (‘Opsona’), today announces that it will give an oral presentation on results from its ongoing prospective, open label Phase I/II study being conducted with Tomaralimab (OPN-305), its novel proprietary humanized IgG4 monoclonal antibody (MAb) against Toll-Like Receptor 2 (TLR2), in second and third-line lower (Low and intermediate-1) risk myelodysplastic syndrome (MDS). The presentation will take place on Dec 03rd 2018 at the 60th Annual Meeting of the American Society of Hematology (ASH) in San Diego.

The study in transfusion-dependent patients with lower risk MDS who have failed hypomethylating agents is ongoing in collaboration with the MD Anderson Cancer Center in Houston, Moffitt Cancer Center in Florida, Weill Cornell in New York and Montefiore in the Bronx USA.

The lead principal investigator Professor Guillermo Garcia-Manero will present the data at ASH and commenting on today’s announcement said “Tomaralimab therapy presents a potential safe and efficacious therapeutic option for heavily pre-treated low risk patients that have failed HMA therapy.”

Myelodysplastic syndromes are a complex and heterogeneous group of bone marrow failure disorders characterized by ineffective hematopoiesis and poor prognosis. Transfusion dependent patients who have failed on HMA have a worse prognosis in terms of survival. The best standard of care for patients in the USA who have failed on HMA is repeated red blood cell transfusions which are associated with reduced Quality of Life outcomes.

There is an urgent need for the development of novel therapies in the treatment of MDS in patients who have exhausted other therapies and which can eliminate the need for red blood cell transfusions, delay progression, improve patient survival and overall quality of life.

Details of the presentation are as follows:

TITLE: A Clinical Study of Tomaralimab (OPN-305), a Toll-like Receptor 2 (TLR-2) Antibody, in Heavily Pre-Treated Transfusion Dependent Patients with Lower Risk Myelodysplastic Syndromes (MDS) That Have Received and Failed on Prior Hypomethylating Agent (HMA) Therapy

Session Name: 637. Myelodysplastic Syndromes—Clinical Studies: Prognosis and Prediction

Session Date: Monday, December 3, 2018

Session Time: 2:45 PM - 4:15 PM

Presentation Time: 4:00 PM

Room: Manchester Grand Hyatt San Diego, Grand Hall A

First publication of the abstract will be in the ASH online meeting program on November 1, 2018, at 9 a.m. EDT.

About Opsona Therapeutics

Opsona is a leading immunology drug development company, focused on novel therapeutic approaches to key targets of the innate immune system associated with a wide range of major human diseases, including cancer, autoimmune and other inflammatory diseases. The company was founded in 2004 by three world-renowned immunologists at Trinity College, Dublin. Opsona has a strong international investor consortium including: Amgen Ventures, BB Biotech Ventures, EMBL Ventures, Enterprise Ireland, Fountain Healthcare Partners, Inventages Venture Capital, Novartis Venture Fund, Omnes Capital, Roche Venture Fund, Seroba Life Sciences, Shire and Sunstone Capital.

Contacts

Opsona Therapeutics

Mary Reilly (COO)

+ 353 16770223

mreilly@opsona.com

Opsona Therapeutics Ltd. announces preliminary results from ongoing study in second line lower risk MDS recently presented at the 58th Annual ASH Meeting

Dublin, Ireland – Opsona Therapeutics Ltd (‘Opsona’), the innate immune drug development company focused on novel therapeutic approaches to treat oncology, autoimmune and other inflammatory diseases, today announces the preliminary results from its ongoing prospective, open label Phase I/II study being conducted with OPN-305 in second-line lower (Low and intermediate-1) risk myelodysplastic syndrome (MDS) which created interest when presented recently at the 58th Annual Meeting of the American Society of Hematology (ASH) in San Diego by Prof Garcia-Manero from the MD Anderson Cancer Center.

OPN-305 is a novel proprietary humanized IgG4 monoclonal antibody (MAb) against Toll-Like Receptor 2 (TLR2), a key target within the innate immune system. Opsona has recently received orphan drug designation from the United States Food and Drug Administration for MDS.
The study in patients with lower risk, red cell transfusion dependent, MDS who have failed hypomethylating agents (HMA) ± an erythropoiesis stimulating agent is ongoing in collaboration with MD Anderson Cancer Center in Houston USA with additional sites now being added in the USA.

As of December 2016, 24 eligible patients have been enrolled, 11 at 5 mg dose and 13 at 10 mg/kg. A total of 15 (75%) patients are evaluable for response. Hematological improvement has been seen in 53% (8/15) with 3 (20%) patients achieving transfusion independence and of these 2/5 (40%) were receiving 10 mg/kg while on OPN-305 monotherapy. 12 patients remain on study.
Median age was 72 years (range 42-87). Nine (43 %) patients were classified as Low risk and 15 (63%) as Intermediate-1 risk by IPSS. Thirteen patients (61%) had diploid cytogenetics, 8 (38%) RAEB,5 (23%) RCMD, 3 (14%) RA, 2 (10%) RARS, and 1 (4%) 5q-, RCMD-RS, CMML.

The median number of prior HMA therapies was 2 (range 1-4) with a median duration of prior therapies from time of diagnosis to enrollment of 22.7 months (range 6.3-56.1). The median number of OPN-305 cycles administered is 5 (2-22) with 5 of 9 (55.5%) patients having received azacitidine add-back after 16 weeks of OPN-305 monotherapy. A total of 5 (29%) patients developed AEs related to OPN-305 all grade 1 with gastrointestinal disorders being the most
frequent (23.5%). At this point, no significant drug related toxicity or unexpected infectious complications have been seen and combination with azacitidine has been well tolerated.

To date three (20%) patients were taken off study due to progression to AML and 4 (27%) due to no response all at the 5 mg/kg dose. There is no evidence of treatment related anti-drug antibodies or statistically significant dynamic changes in cytokines in any of the patients.

Myelodysplastic syndromes are a complex and heterogeneous group of bone marrow failure disorders characterized by ineffective hematopoiesis and poor prognosis. There is an urgent need for the development of well tolerated, novel therapies in the treatment of MDS which can delay progression, improve patient survival and quality of life and reduce the social and economic burden of transfusion dependence.

Commenting on today’s announcement Mary Reilly VP Pharmaceutical Development & Operations said “OPN-305 data emerging in this heavily pre-treated group of patients is very encouraging, the unmet need for a safe and tolerable product for this patient population is significant and we are happy to be in collaboration with the MD Anderson Cancer Center one of the leading clinical center’s in this hematological area”

For further information, please contact:
Mary Reilly (VP Pharmaceutical Development and Operations) or Martin Welschof (CEO), telephone: + 353 16770223, e-mail: mreilly@opsona.com, mwelschof@opsona.com

About Opsona Therapeutics
Opsona is a leading immunology drug development company, focused on novel therapeutic approaches to key targets of the innate immune system associated with a wide range of major human diseases, including cancer, autoimmune and other inflammatory diseases. The company was founded in 2004 by three world-renowned immunologists at Trinity College, Dublin. Opsona has a strong international investor consortium including: Amgen Ventures, BB Biotech Ventures, EMBL Ventures, Enterprise Ireland, Fountain Healthcare Partners, Inventages Venture Capital, Novartis Venture Fund, Omnes Capital, Roche Venture Fund, Seroba Life Sciences, Shire and Sunstone Capital

Opsona Therapeutics Ltd. to present preliminary results from ongoing study in second line lower risk myelodysplastic syndrome at the 58th Annual Meeting of the American Society of Hematology (ASH)

Dublin, Ireland – Opsona Therapeutics Ltd (‘Opsona’), the innate immune drug development company focused on novel therapeutic approaches to treat oncology, autoimmune and other inflammatory diseases, today announces that it will present preliminary results from its ongoing prospective, open label Phase I/II study being conducted with OPN-305 in second-line lower (Low and intermediate-1) risk myelodysplastic syndrome (MDS). The presentation will take place on Saturday, 3 December at the 58th Annual Meeting of the American Society of Hematology (ASH) in San Diego.

Myelodysplastic syndromes are a complex and heterogeneous group of bone marrow failure disorders characterized by ineffective hematopoiesis and poor prognosis. There is an urgent need for the development of novel therapies in the treatment of MDS which can delay progression, improve patient survival and quality of life, and which have fewer adverse effects. Opsona has recently received orphan drug designation (ODD) from the United States Food and Drug

Administration for MDS.

OPN-305 is a novel proprietary humanized IgG4 monoclonal antibody (MAb) against Toll-Like Receptor 2 (TLR2), a key target within the innate immune system.

The study in patients with lower risk MDS who have failed hypomethylating agents is ongoing in collaboration with MD Anderson Cancer Center in Houston USA with additional sites now being added in the USA. The lead principal investigator Professor Guillermo Garcia-Manero will present the preliminary data at ASH and commenting on today’s announcement said “Inhibition of TLR2 with OPN-305 is safe and is currently demonstrating strong clinical activity in patients with lower risk MDS after hypomethylating agent therapy”

Details of the presentation are as follows:

A Clinical Study of OPN-305, a Toll-like receptor 2 (TLR-2) antibody, in patients with Lower Risk Myelodysplastic Syndromes (MDS) that have received prior Hypomethylating Agent (HMA) Therapy

Abstract # 227
Session Name: 637. Myelodysplastic Syndromes—Clinical Studies: Lower Risk MDS Clinical Studies
Session Date: Saturday, December 3, 2016
Session Time: 4:00 PM - 5:30 PM
Presentation Time: 5:00 PM Room: Manchester Grand Hyatt San Diego, Grand Hall C

The ASH abstract is now online can be accessed here:
https://ash.confex.com/ash/2016/webprogram/Paper97931.html


For further information, please contact:

Mary Reilly (VP Pharmaceutical Development and Operations) or Martin Welschof (CEO), telephone: + 353 16770223, e-mail: mreilly@opsona.com, mwelschof@opsona.com

About Opsona Therapeutics

Opsona is a leading immunology drug development company, focused on novel therapeutic approaches to key targets of the innate immune system associated with a wide range of major human diseases, including cancer, autoimmune and other inflammatory diseases. The company was founded in 2004 by three world-renowned immunologists at Trinity College, Dublin. Opsona has a strong international investor consortium including: Amgen Ventures, BB Biotech Ventures, EMBL Ventures, Enterprise Ireland, Fountain Healthcare Partners, Inventages Venture Capital, Novartis Venture Fund, Omnes Capital, Roche Venture Fund, Seroba Life Sciences, Shire and Sunstone Capital

Opsona Therapeutics Ltd. receives orphan designation for myelodysplastic syndrome (MDS) with OPN-305, a first-in-class monoclonal antibody that blocks Toll-Like Receptor 2

Dublin, Ireland – Opsona Therapeutics Ltd (‘Opsona’), the innate immune drug and development company focused on novel therapeutic approaches to treat oncology, autoimmune and other inflammatory diseases, today announced that it has received orphan drug designation (ODD) from United States Food and Drug Administration for myelodysplastic syndromes (MDS).

Myelodysplastic syndromes are a complex and heterogeneous group of bone marrow failure disorders characterized by ineffective hematopoiesis, and poor prognosis. There is an urgent need for the development of novel therapies in the treatment of MDS which can delay progression, improve patient survival and quality of life, and which have fewer adverse effects.

OPN-305 is a novel proprietary humanized IgG4 monoclonal antibody (MAb) against Toll-Like Receptor 2 (TLR2), a key target within the innate immune system.

Evaluation of OPN-305 in MDS is the first of a range of oncology indications that the company is exploring with its leading drug in development, OPN-305. A study in patients with lower risk MDS who have failed hypomethylating agents is ongoing in collaboration with MD Anderson Cancer Center in Houston USA. Opsona believes that OPN-305 has the potential to be first and best-in-class while also providing a novel treatment option for a wide variety of oncology, autoimmune and other inflammatory diseases.

Commenting on today’s announcement, Mary Reilly, VP Pharmaceutical Development and Operations at Opsona Therapeutics, said: “We are pleased to receive FDA Orphan Drug Designation for OPN-305 in MDS. This is an important regulatory milestone for the company and a significant step forward in our clinical development of OPN-305 targeting this rare disease associated with an unmet medical need for safe and effective therapeutics."

 

For further information, please contact:

Mary Reilly (VP Pharmaceutical Development and Operations) or Martin Welschof (CEO), telephone: + 353 16770223, e-mail: MReilly@opsona.com, mwelschof@opsona.com
Or
Jim Devlin, FTI Consulting, e. jim.devlin@fticonsulting.com ; d. +353 (0)1 6633600; m. +353 (0)87 2631057
 

About Opsona Therapeutics

Opsona is a leading immunology drug development company, focused on novel therapeutic approaches to key targets of the innate immune system associated with a wide range of major human diseases, including cancer, autoimmune and other inflammatory diseases. The company was founded in 2004 by three world-renowned immunologists at Trinity College, Dublin. Opsona has a strong international investor consortium including: Amgen Ventures, BB Biotech Ventures, EMBL Ventures, Enterprise Ireland, Fountain Healthcare Partners, Inventages Venture Capital, Novartis Venture Fund, Omnes Capital, Roche Venture Fund, Seroba Life Sciences, Shire and Sunstone Capital

Opsona Therapeutics Ltd. commences Part B of phase II study of Blocking Toll-Like Receptor 2 in Extended Criteria Donor renal transplant recipients at high risk of Early Graft Dysfunction

Dublin, Ireland – Opsona Therapeutics Ltd (‘Opsona’), the innate immune drug development company focused on novel therapeutic approaches to treat autoimmune inflammatory diseases and oncology, today announced the continuation of its double-blind renal transplant study by the initiation of Part B of its adaptive phase II clinical trial in Extended Criteria Donors (ECD) renal transplant recipients at high risk of early graft dysfunction with its lead drug candidate OPN-305.

Based on the completion of Part A of this double blind study, OPN-305 was well tolerated and deemed to be safe by the data and safety monitoring board across all dose groups with no evidence of increased risk of infection in these highly immuno-suppressed patients.

The company is proceeding with Part B in a modified patient population evaluating ECD-only recipients. ECD kidneys make up the largest pool of the cadaveric donor population. Currently up to 45% of ECD kidneys are discarded resulting in a significant deficit in supply versus demand. OPN-305 has the opportunity to turn borderline non-transplantable organs into viable kidneys and functioning grafts resulting in fewer ECD discards, driving an overall increase in the number of deceased donor transplants.

Commenting on today’s announcement, Mary Reilly VP Pharmaceutical Development & Operations said: “We are excited about the initiation of Part B and hope that we can demonstrate an effect of TLR2 blockade on reducing early graft dysfunction in this patient population which is a significant unmet medical need.

Opsona remains committed to further development of OPN-305 and believe that OPN-305 has the potential to be first and best-in-class while also providing a novel treatment option for a wide variety of autoimmune, inflammatory and oncology diseases.”

For further information please contact:

Mary Reilly (VP Pharmaceutical Development and Operations) or Martin Welschof (CEO), telephone: + 353 16770223, e-mail: MReilly@opsona.com, mwelschof@opsona.com

About Opsona Therapeutics

Opsona is a leading immunology drug development company, focused on novel therapeutic approaches to key targets of the innate immune system associated with a wide range of major human diseases, including autoimmune and inflammatory diseases, solid organ transplantation, cancer, diabetes, Alzheimer's disease and others. The company was founded in 2004 by three world-renowned immunologists at Trinity College in Dublin. Opsona have a strong international investor consortium including:

• Amgen Ventures (www.amgen.com/partners/amgen_ventures)

• Baxter Ventures (www.baxter.com/about_baxter/scientific_excellence/baxter_ventures)

• BB Biotech Ventures (www.bbbiotechventures.com)

• EMBL Ventures (www.embl-ventures.com)

• Enterprise Ireland (www.enterprise-ireland.com)

• Fountain Healthcare Partners (www.fh-partners.com)

• GenenFund (www.gene.com)

• Inventages Venture Capital (www.inventages.com)

• Novartis Venture Fund (www.nvfund.com)

• Omnes Capital (www.omnescapital.com)

• Roche Venture Fund (www.venturefund.roche.com)

• Seroba Kernel Life Sciences (www.seroba-kernel.com)

• Sunstone Capital (www.sunstone.eu)

Opsona Therapeutics Ltd. Patent issued in USA covering an antibody directed against Toll-like Receptor-2 (TLR-2) and the use and development thereof

Dublin, Ireland – Opsona Therapeutics Ltd (‘Opsona’), the innate immune drug development company focused on novel therapeutic approaches to treat autoimmune, inflammatory diseases and oncology, today announced that the US Patent Office has issued US Patent 8,623,353, which covers an antibody directed against Toll-like Receptor-2 (TLR-2) and the use and development thereof.

TLR-2 plays an important role in the induction and progression of a number of non-pathogen associated inflammatory conditions including ischaemia reperfusion injury (delayed graft function in renal transplantation, myocardial infarct), certain cancer, autoimmune diseases, diabetes, Alzheimer's disease and atherosclerosis.

TLR-2 is one of the key structures of the innate immune system and is part of the first line defense against microbial organisms. Upon stimulation it induces and propagates inflammation. TLR-2 is activated through so called external danger signals (microbial cell wall components) as well as through so called internal danger signals resulting from tissue injury.

This patent describes a cross-reactive antibody which specifically blocks mammalian TLR-2 and further provides for a pharmaceutical composition for the treatment of various inflammatory conditions. The recently issued patent is assigned to the Technische Universitat Munchen (TUM) and Amgen Inc., and is exclusively licensed by Opsona Therapeutics.

Commenting on today's announcement, Mary Reilly VP Pharmaceutical Development and Operations of Opsona Therapeutics said, "The issuance of this patent is an important milestone in the development of Opsona's TLR2 intellectual property portfolio and will facilitate market exclusivity for the use of OPN-305 in the ever expanding area of TLR2 mediated diseases."

Using the TUM/Amgen license, Opsona has developed a clinical anti-TLR-2 antibody candidate, termed ‘OPN-305'. OPN-305 is a humanised IgG4 monoclonal antibody (mAb) antagonizing TLR-2 and is under development as a treatment for the prevention of Early Graft Dysfunction following renal transplantation and Myelodysplastic Syndromes (MDS), in addition to other therapeutic indications.

A three-part multi-center, double blinded and placebo controlled Phase II clinical study to evaluate the safety, tolerability and efficacy of OPN-305 in renal transplant patients at high risk of Early Graft Dysfunction as the first clinical target indication for the development of OPN-305 was initiated in April 2013 and is currently ongoing.

An open label Phase I/II study to assess the safety and efficacy of cycles of intravenously infused doses of OPN-305 in second-line lower (low and intermediate-1) risk MDS, a form of blood cancer, as the second clinical target indication for OPN-305 was initiated in January 2015.

For further information please contact:

Mary Reilly (VP Pharmaceutical Development and Operations) or Martin Welschof (CEO), telephone: + 353 16770223, e-mail: MReilly@opsona.com, mwelschof@opsona.com

About Opsona Therapeutics

Opsona is a leading immunology drug development company, focused on novel therapeutic approaches to key targets of the innate immune system associated with a wide range of major human diseases, including autoimmune and inflammatory diseases, solid organ transplantation, cancer, diabetes, Alzheimer's disease and others. The company was founded in 2004 by three world-renowned immunologists at Trinity College in Dublin. Opsona have a strong international investor consortium including:

• Amgen Ventures (www.amgen.com/partners/amgen_ventures)

• Baxter Ventures (www.baxter.com/about_baxter/scientific_excellence/baxter_ventures)

• BB Biotech Ventures (www.bbbiotechventures.com)

• EMBL Ventures (www.embl-ventures.com)

• Enterprise Ireland (www.enterprise-ireland.com)

• Fountain Healthcare Partners (www.fh-partners.com)

Opsona Therapeutics Ltd. initiates Phase I/II study in a First-in Class Monoclonal Antibody that blocks Toll-Like Receptor 2

Opsona Therapeutics Ltd. initiates a prospective open label Phase I/II study in second-line lower (Low and intermediate-1) risk myelodysplastic syndrome (MDS) with OPN-305, a First-in Class Monoclonal Antibody that blocks Toll-Like Receptor 2

Dublin – Opsona Therapeutics Ltd (‘Opsona’), the innate immune drug development company focused on novel therapeutic approaches to treat autoimmune, inflammatory diseases and oncology, announces that it has initiated a phase I/II clinical trial in second-line lower (Low and intermediate-1) risk myelodysplastic syndrome (MDS) patients with its lead drug candidate, OPN-305.

The lead principal investigator Professor Guillermo Garcia-Manero, who was closely involved in the preliminary work on the potential benefit of TLR2 antagonism in MDS, will conduct the trial at MD Anderson Cancer Center, Houston, USA, one of the premier cancer centres in the world.

Myelodysplastic syndromes (MDS) are a complex group of bone marrow failure disorders characterized by ineffective hematopoiesis, and poor prognosis. There is an urgent need for the development of novel therapies in the treatment of MDS which can delay progression, improve patient survival and which have fewer adverse effects.

OPN-305 is a novel proprietary humanized IgG4 monoclonal antibody (MAb) against the Toll-Like Receptor 2 (TLR2), a target within the innate immune system. Evaluation of OPN-305 in MDS will be the first of a range of oncology indications that the company plans to explore and this will be the first multiple dosing trial with OPN-305 in patients.

OPN-305 is also under development in a large multi-center phase II clinical trial as a treatment in the prevention of delayed graft function (DGF) following renal transplantation. OPN-305 has orphan status in the EU and USA for solid organ transplantation.

Opsona believes that OPN-305 has the potential to provide novel treatment options for a wide variety of autoimmune, inflammatory and oncology diseases.

Professor Guillermo Garcia Manero commented: “Data from our laboratory has indicated that TLR2 is commonly overexpressed in MDS and that alterations in innate immune signalling are a potential therapeutic target in MDS. We are very excited about using OPN-305 in patients with MDS.”

Commenting on today’s announcement, Mary Reilly, VP Pharmaceutical Development and Operations of Opsona Therapeutics said: “We are privileged to be working with world class leaders from MD Anderson, one of the premier cancer center‘s in the world. We are continuing to develop and explore the potential of OPN-305 in bringing a much needed novel therapy option to MDS patients”

For further information please contact:

Mary Reilly (VP Pharmaceutical Development and Operations) or Martin Welschof (CEO), telephone: + 353 16770223, e-mail: mreilly@opsona.com, mwelschof@opsona.com

For media enquiries, please contact:

Jim Devlin or Aoife Kelly at FTI Consulting, t. 01 6633600; e. jim.devlin@fticonsulting.com or aoife.kelly@fticonsulting.com

About Opsona Therapeutics

Opsona is a leading immunology drug development company, focused on novel therapeutic approaches to key targets of the innate immune system associated with a wide range of major human diseases, including autoimmune and inflammatory diseases, solid organ transplantation, cancer, diabetes, Alzheimer's disease and others. The company was founded in 2004 by three world-renowned immunologists at Trinity College in Dublin. Opsona have a strong international investor consortium including:

• Amgen Ventures (www.amgen.com/partners/amgen_ventures)

• Baxter Ventures (www.baxter.com/about_baxter/scientific_excellence/baxter_ventures)

• BB Biotech Ventures (www.bbbiotechventures.com)

• EMBL Ventures (www.embl-ventures.com)

• Enterprise Ireland (www.enterprise-ireland.com)

• Fountain Healthcare Partners (www.fh-partners.com)

• GenenFund (www.gene.com)

• Inventages Venture Capital (www.inventages.com)

• Novartis Venture Fund (www.venturefund.novartis.com)

• Omnes Capital (www.omnescapital.com)

• Roche Venture Fund (www.venturefund.roche.com)

• Seroba Kernel Life Sciences (www.seroba-kernel.com)

• Sunstone Capital (www.sunstone.eu)

Opsona Therapeutics Limited raises an additional €3 million (USD 4 million) from Omnes Capital in Series C extension, resulting in a total financing round of € 36 million (USD 48.6 million)

Opsona Therapeutics Limited (Opsona), the innate immune drug development company, today announced that it has raised an additional €3 million (US $4 million) in a second closing of its previously announced Series C equity financing from new investor Omnes Capital. The extension brings the total raised by Opsona in this Series C financing to €36 million (US $48.6 million). On April 25th, 2013, Opsona raised €33 million (US $43 million) from Novartis Venture Fund, Fountain Healthcare Partners, Roche Venture Fund, Seroba-Kernel Life Sciences, BB Biotech Ventures, Sunstone Capital, Baxter Ventures, Amgen Ventures and EMBL Ventures.

The company will use the proceeds of this Series C financing to supplement funding a three-part multi-centered, double blinded and placebo controlled clinical study to evaluate the safety, tolerability and efficacy of its lead product OPN-305 in renal transplant patients at high risk of Delayed Graft Function (DGF) as the first clinical indication for the development of OPN-305. The clinical study has already commenced with successful recruitment of patients underway. Opsona's lead product is a humanized monoclonal IgG4 antibody targeting Toll-like-receptor-2 (TLR2) and has demonstrated activity in a number of animal models and was recently tested successfully in a phase I clinical trial in healthy volunteers and in a pilot cohort of renal transplant recipients.

Dr. Martin Welschof, CEO of Opsona, commented: “I am delighted Omnes Capital is joining the exceptional Series C consortium of venture captial and corporate venture firms. The second closing of our Series C with Omnes Capital further validates the great medical and commercial potential of our drug candidate OPN-305.” Dr. Bruno Montanari, Life Sciences Director, Omnes Capital, added: “I am looking forward to progressing Opsona’s lead product OPN-305 through the well-designed Phase II efficacy study to prevent delayed graft function (DGF) in renal transplantation, an indication with major unmet medical need and attractive commercial potential. In addition, I am interested in exploring the full potential of OPN-305 in additional disease indications.”

-ends-

About Opsona Therapeutics

Opsona is a leading immunology drug development company, focused on novel therapeutic approaches to key targets of the innate immune system associated with a wide range of major human diseases, including autoimmune and inflammatory diseases, transplant rejection, cancer, diabetes, Alzheimer's disease and atherosclerosis. The company was founded in 2004 by three world-renowned immunologists at Trinity College in Dublin. The company was awarded a EUR 6 million non-dilutive grant by the European Union for clinical development of its anti-TLR2 antibody in solid organ transplantation including renal transplantation and the program has recently obtained EMA and FDA orphan drug status. Additional indications are currently explored.

Further information is available at http://www.opsona.com/. About Omnes Capital (formerly Crédit Agricole Private Equity)

Omnes Capital is a major player in private equity, with a commitment to financing SMEs. With €1.8 billion in assets under management, Omnes capital provides companies with the capital needed to finance their growth and with key expertise in a number of areas: Mid and Small Cap Buyout & Growth Capital, Venture Capital in technology and life sciences, Renewable Energy, Mezzanine, Secondary Funds of Funds, Co-Investment. Omnes Capital, formerly Crédit Agricole Private Equity, was a subsidiary of Crédit Agricole until March 2012 when the company gained its independence. Omnes Capital is a signatory to the United Nations Principles for Responsible Investment (PRI).

Further information is available at http://www.omnescapital.com/.

For further information please contact:

Martin Welschof (CEO) - mwelschof@opsona.com or + 353 1 6770223

Martine Sessin-Caracci - martine.sessincaracci@omnescapital.com or +33 1 80 48 79 15

Caroline Babouillard (Shan) - caroline.babouillard@shan.fr or +33 1 44 50 58 72

Opsona Therapeutics Ltd. Initiates a Phase II Study with OPN-305

Opsona Therapeutics Ltd. Initiates a Phase II Study with OPN-305, a First-in Class Monoclonal Antibody that Blocks Toll-Like Receptor 2, in Renal Transplant Patients at High Risk of Delayed Graft Function

DUBLIN, May 07, 2013.  Opsona Therapeutics Ltd ('Opsona'), the innate immune drug development company focused on novel therapeutic approaches to treat autoimmune and inflammatory diseases, today announced that it has initiated a phase II clinical trial in renal transplant patients at high risk of delayed graft function with its lead drug candidate OPN-305.

OPN-305 has already been administered to a number of transplant patients at high risk of delayed graft function (DGF) as part of a Pilot study before initiation of this multi-centre, randomized, double-blind, placebo-controlled, parallel group, sequential adaptive phase II trial. This pilot clearly demonstrated that 100% receptor occupancy of TLR2 on circulating monocytes was achievable and durable for the period of ischemia/reperfusion risk. It provided evidence that there was up-regulation of TLR2 in patients and provided the range of doses to be tested versus placebo in the double-blind trial. OPN-305 was well tolerated with no related adverse events. The phase II study which is expected to enrol 278 patients is an adaptive design powered to show a 15-20% absolute benefit of OPN-305 over placebo in reducing the incidence of DGF.

OPN-305 is a novel proprietary humanized IgG4 monoclonal antibody (MAb) against Toll-Like Receptor 2 (TLR2), a target within the innate immune system, and is under development as a treatment for the prevention of DGF following renal transplantation. OPN-305 has orphan status in the EU and USA for solid organ transplantation. Other therapeutic indications are being explored in addition.

Opsona has identified the prevention of DGF following renal transplantation as the first clinical indication for the development of OPN-305. Delayed Graft Function is a serious complication that can increase the risk of organ rejection in the immediate post-operative period of kidney transplants and can range from 45-60% in high risk donor kidneys. Opsona believes that OPN-305 has the potential to be first and best in class in the prevention of DGF and will also provide a novel treatment option for a much wider variety of human diseases, including acute kidney injury, transplantation of other organs, cancer, cardiovascular disease and others.

Commenting on today's announcement, Mary Reilly VP Pharmaceutical Development and Operations of Opsona Therapeutics said, "It's exciting to see cutting-edge science offering the prospect of a real breakthrough in life expectancy and quality post transplantation. OPN-305 was granted 'orphan' status for solid organ transplantation, in recognition of its rarity and the fact that there are no other comparable treatments being developed. OPN-305 could be a potential first and best in class candidate to reduce this complication. Developing a novel product for an unmet clinical need and working with world class global key opinion leaders in the transplant community is highly motivating and gives all the project partners a sense of urgency about this collaboration."

Dr. Robert Miller Chief Medical Officer of Opsona commented, "This study represents a real opportunity to improve early graft function in patients offered kidneys from older donors and enlarging the pool of potential organs for patients with end-stage renal disease. We are very pleased with the enthusiasm of the transplant community who have readily agreed to participate in this process."

About Opsona Therapeutics

Opsona is a leading immunology drug development company, focused on novel therapeutic approaches to key targets of the innate immune system associated with a wide range of major human diseases, including autoimmune and inflammatory diseases, solid organ transplantation, cancer, diabetes, Alzheimer's disease and others. The company was founded in 2004 by three world-renowned immunologists at Trinity College in Dublin. Opsona's lead product, a fully humanized monoclonal IgG4 antibody (OPN-305) targeting Toll-like-receptor-2 (TLR2) has demonstrated activity in a number of preclinical models and has been tested in healthy volunteers and recently in a Pilot study in transplant patients. Opsona was awarded EUR5.9 million from the European Commission in 2010 to lead a European framework 7 (FP7) consortium of research and clinical groups (termed MABSOT*) to advance OPN-305 through clinical development. Opsona has recently completed a EUR33 million Series C financing round with an international investor consortium including Novartis Venture Fund, Fountain Healthcare Partners, Roche Venture Fund, Seroba Kernel Life Sciences, BB Biotech Ventures, Sunstone Capital, Baxter Ventures, Amgen Ventures and EMBL Ventures.

Note

*Monoclonal antibody solid organ transplantation

Opsona Therapeutics Limited raises €33 million (US$43 million) oversubscribed Series C equity financing to advance clinical development of its lead product OPN-305

April 29th, 2013, Dublin, Ireland – Opsona Therapeutics Limited (‘Opsona’), the innate immune drug development company, today announced that it has raised €33 million (US$43 million) in an oversubscribed Series C financing. The participants in this Series C financing include existing investors, Novartis Venture Fund, Fountain Healthcare Partners, Roche Venture Fund and Seroba Kernel Life Sciences. The new investors joining the consortium are BB Biotech Ventures, Sunstone Capital, Baxter Ventures, Amgen Ventures, and EMBL Ventures. BB Biotech Ventures and Novartis Venture Fund led the Series C financing round. BB Biotech Ventures, Sunstone Capital and Baxter Ventures will be joining the board of directors.

Opsona is developing new treatments for inflammatory diseases and will use the proceeds to conduct a two-part multi-centered, double blinded and placebo controlled clinical study to evaluate the safety, tolerability and efficacy of its lead product OPN-305 in renal transplant patients at high risk of Delayed Graft Function (DGF). This is the first clinical indication for OPN-305, a fully human monoclonal IgG4 antibody targeting Toll-like-receptor-2 (TLR2). Opsona recently completed a successful Phase I clinical trial in healthy human volunteers and has also demonstrated activity in preclinical animal models and ex-vivo studies. This first-in-class inhibitor of TLR2 has the advantage of inhibiting multiple cytokines leading to the pathogenesis of the complex inflammatory response in various diseases (ischemia/reperfusion injuries, rheumatoid arthritis, diabetes, lupus, nephritis and various cancers) and has therefore a potentially broad application potential.

Dr. Martin Welschof, CEO of Opsona, commented: “The innate immune system represents a new frontier in targeting inflammatory diseases, and the quality of venture and corporate investors in this funding round is a demonstration of Opsona's expertise and capabilities in this highly promising field. With their repeat investment, our existing investors have clearly indicated their long-term commitment to Opsona, while the new investment from BB Biotech Ventures, Sunstone Capital, Baxter Ventures, Amgen Ventures and EMBL Ventures is a further endorsement of Opsona’s future potential.”

Dr. Martin Muenchbach, Managing Director at BB Biotech Ventures, added: “We are delighted to be working with Opsona Therapeutics and the other investors. We are excited to further advance Opsona’s lead product OPN-305 into a well-designed Phase II efficacy study to improve post-operative complications in renal transplantation, an indication with major unmet medical need and attractive commercial potential. This high-quality study with clinically meaningful endpoints will also be of relevance for a subsequent Phase III registration study.”

-ends-

For further information please contact:

Martin Welschof (CEO), telephone: + 35316770223, e-mail: mwelschof@opsona.com

About Opsona Therapeutics

Opsona is a leading immunology drug development company, focused on novel therapeutic approaches to key targets of the innate immune system associated with a wide range of major human diseases, including autoimmune and inflammatory diseases, transplant rejection, cancer, diabetes, Alzheimer's disease and atherosclerosis. The company was founded in 2004 by three world-renowned immunologists at Trinity College in Dublin. Opsona's lead product, a fully human monoclonal IgG4 antibody (OPN-305) targeting Toll-like-receptor-2 (TLR2) has demonstrated activity in a number of animal models and was recently tested in a Phase 1 clinical trial in healthy volunteers. The company has initiated a two-part multi-centered, double blinded and placebo controlled clinical study to evaluate the safety, tolerability and efficacy of OPN 305 in renal transplant patients at high risk of Delayed Graft Function (DGF) as the first clinical target indication for the development of OPN-305. The company was awarded a EUR 5.9 million non-dilutive grant by the European Union for clinical development of its anti-TLR2 antibody in solid organ transplantation including renal transplantation and the program has recently obtained EMA and FDA orphan drug status. Additional indications are currently being explored.

Further information is available at http://www.opsona.com/.

Opsona Therapeutics announces the issuance of new patent from the European Patent Office (EPO) covering the development and use of an antibody directed against Toll-like Receptor TLR-2

April 17th, 2012, Dublin, Ireland - Opsona Therapeutics, the innate immune drug development company, today announced that the European Patent Office has issued EP Patent 1,664,118 which covers an antibody directed against Toll-like Receptor-2 (TLR-2) and the use and development thereof.

TLR-2 plays an important role in the induction and progression of a number of non-pathogen associated inflammatory conditions including ischemia reperfusion injury (delayed graft function in renal transplantation, myocardial infarct), certain cancer, autoimmune diseases, diabetes, Alzheimer's disease and atherosclerosis.

TLR-2 is one of the key structures of the innate immune system and is part of the first line defense against microbial organisms. Upon stimulation it induces and propagates inflammation. TLR-2 is activated through so called external danger signals (microbial cell wall components) as well as through so called internal danger signals resulting from tissue injury.

This patent describes a cross reactive antibody which specifically blocks mammalian TLR-2 and further provides for a pharmaceutical composition for the treatment of various inflammatory conditions. The recently issued patent is assigned to the Technische Universitat Munchen (TUM) and Amgen Inc, and is exclusively licensed by Opsona Therapeutics.

Using the TUM/Amgen license, Opsona has developed a clinical anti-TLR-2 antibody candidate, termed ‘OPN-305'. OPN-305 is a humanised IgG4 monoclonal antibody (MAb) antagonizing TLR-2 and is under development as a treatment for the prevention of Delayed Graft Function (DGF) following renal transplantation, in addition to other therapeutic indications.

Opsona has successfully conducted a phase 1 clinical trial in healthy volunteers with its lead drug candidate OPN-305. This is the first-in-human study with OPN-305 and also represents the first clinical study for an anti-TLR-2 drug candidate.

Following successful completion of the phase 1 trial, the company plans to conduct a two-part multi-centered, double blinded and placebo controlled clinical study to evaluate the safety, tolerability and efficacy of OPN-305 in renal transplant patients at high risk of Delayed Graft Function (DGF) as the first clinical target indication for the development of OPN-305 to be initiated in 2012.

Commenting on today's announcement, Mary Reilly VP Pharmaceutical Development and Operations of Opsona Therapeutics said, "The issuance of this patent is an important milestone in the development of Opsona's TLR2 intellectual property portfolio and will facilitate market exclusivity for the use of OPN-305 in the ever expanding area of TLR2 mediated diseases."

About Opsona Therapeutics

Opsona is a leading immunology drug development company, focused on novel therapeutic approaches to key targets of the innate immune system associated with a wide range of major human diseases, including autoimmune and inflammatory diseases, transplant rejection, cancer, diabetes, Alzheimer's disease and atherosclerosis. The company was founded in 2004 by three world-renowned immunologists at Trinity College in Dublin. Opsona's lead product, a fully human monoclonal IgG4 antibody (OPN-305) targeting Toll-like-receptor-2 (TLR-2) has demonstrated activity in a number of animal models and was recently tested in a phase 1 clinical trial in healthy volunteers. Following successful completion of the phase 1 trial, the company plans to conduct a two-part multi-centered, double blinded and placebo controlled clinical study to evaluate the safety, tolerability and efficacy of OPN 305 in renal transplant patients at high risk of Delayed Graft Function (DGF) as the first clinical target indication for the development of OPN-305 to be initiated in 2012. In May 2009 the company announced the completion of a € 21.3 million equity funding with an international investor consortium including: Inventages Venture Capital, Novartis Venture Fund, Roche Venture Fund, Seroba Kernel Life Sciences, Fountain Healthcare Partners and Enterprise Ireland. Further information is available at http://www.opsona.com/.

For further information please contact:

Martin Welschof (CEO)
Telephone: + 35316770223
E-mail: mwelschof@opsona.com

Opsona Therapeutics announces initiation of a Phase 1 clinical trial with its lead drug

DUBLIN, Ireland -- Opsona Therapeutics, a biotechnology company focused on novel therapeutic approaches to treat autoimmune and inflammatory diseases today announced that it has initiated a phase 1 clinical trial in healthy volunteers with its lead drug candidate OPN-305. This is a first-in-human study with OPN-305.

OPN-305 is a humanised IgG4 monoclonal antibody (MAb) against Toll-Like Receptor 2 (TLR2), a target within the innate immune system, and is under development as a treatment for the prevention of Delayed Graft Function (DGF) following renal transplantation, in addition to other therapeutic indications.

Opsona has identified the prevention of Delayed Graft Function (DGF) following renal transplantation as its likely first target clinical indication for the development of OPN-305. Delayed Graft Function is a serious complication that can increase the risk of organ rejection in the immediate post-operative period of kidney transplants. Opsona believes that OPN-305 has the potential to provide a novel treatment option for a much wider variety of human diseases, including acute kidney injury, cancer, cardiovascular disease and others. Commenting on today's announcement, Mary Reilly VP Pharmaceutical Development and Operations of Opsona Therapeutics said, "We are very excited to enter the clinic with this drug candidate having managed its progression over the past few years through the development cycle."

Also commenting on today's announcement, Bernd R. Seizinger, M.D., Ph.D., Executive Chairman of Opsona Therapeutics said," OPN-305 is a first-in-class antibody against Toll-like- Receptor 2, one of the most promising novel drug targets in the innate immune system. TLR-2 has been linked to an increasing number of major human diseases, including autoimmune diseases, renal ischemia, myocardial infarction, stroke and cancer. This phase 1 study will provide the basis to explore the broad medical and commercial viability and opportunity of OPN- 305 in a variety of indications with unmet medical needs."

The phase 1 study is a single centre, prospective, randomised, double blind, placebo-controlled, sequential, dose escalating phase I study to assess the safety and tolerability, pharmacokinetics and pharmacodynamics of intraveneously infused single doses of OPN-305 in healthy subjects.

Opsona was recently awarded €5.9 million from the European Commission to lead a European framework 7 (FP7) consortium of research and clinical groups (termed MABSOT*) to advance this clinical trial. Following successful completion of the phase 1 trial, the Company plans to conduct a prospective randomized placebo-controlled phase 2 trials in the prevention of DGF to be initiated in 2012.

Dr. Leon Hooftman Appointed Chief Medical Officer As Opsona Therapeutics Transitions Into The Clinic

-    Prof. Luke O’Neill extends role to become Chief Scientific Officer

-    Ms. Mary Reilly assumes broader role as VP Pharmaceutical Development and Operations

06 May, 2011 – DUBLIN, Ireland - Opsona Therapeutics, a drug development company focused on novel therapeutic and preventative approaches to autoimmune and inflammatory diseases, today announced that Leon Hooftman, M.D., has joined the company as Chief Medical Officer, with responsibility for leading the company’s clinical development initiatives.  Dr. Hooftman who will be based at Opsona Therapeutics’ headquarters in Dublin will be a member of the company’s Executive Management Team.

Commenting on Dr. Hooftman’s 18 years of experience in the industry, Bernd R. Seizinger, M.D., Ph.D., Executive Chairman said, “During his successful career Dr. Hooftman has provided extensive clinical development leadership in a variety of therapeutic areas including transplantation and oncology, designing and overseeing numerous multi-center clinical trials.  His credibility and experience as a leading clinical scientist will be invaluable as we move OPN-305, our first-in-class monoclonal antibody against Toll-like-Receptor-2 into clinical development this year.”

Leon Hooftman, M.D., joins Opsona Therapeutics following a high-profile career in clinical development where he was most recently Chief Medical Officer at Chroma Therapeutics (UK).  Previously, Leon was Head of Clinical Development at Celltech (U.K.); Director of Clinical Science for Oncology and Immunology and prior to that International Medical Manager in Immunology at Hoffmann La-Roche.  Dr. Hooftman also served as the Senior Clinical Research Physician at Syntex, U.K.

Dr. Hooftman obtained his medical degree at University of Utrecht (Netherlands) and underwent specialist training in transplantation surgery at Addenbrooke’s Hospital in Cambridge, U.K.

To further strengthen the Executive Management team, one of the Company’s founding scientists and Directors, Professor Luke O’Neill, a world-renowned leader in innate immunity and Professor at Trinity College in Dublin will assume the additional role of Chief Scientific Officer at Opsona.  

Opsona’s VP of Pharmaceutical Development, Ms Mary Reilly, will assume a broader role within the company as Vice President of Pharmaceutical Development and Operations.  Together with the Company’s CFO David Hurley, Dr. Hooftman, Prof. O’Neill and Ms. Reilly will constitute the Company’s Executive Management Team, reporting to Dr. Bernd Seizinger.

Opsona Therapeutics Executive Chairman, Dr. Bernd Seizinger, went on to say, “as Opsona looks forward to an exciting new chapter in its corporate evolution, we have aligned a highly experienced team of senior professionals who will help us to further solidify our position as an international leader in the development of a new generation of therapeutics targeting the innate immune system.” 

For further information: Niamh Lyons for Opsona Therapeutics - +353 1 6633602

European Commission Awards Eur 5.9m To Opsona Therapeutics For Clinical Development Of Lead Drug Candidate Opn-305

-    Trans-European Consortium to start clinical development of OPN-305this year

-    Clinical trials to target solid organ transplantation

06 May,  2011-- DUBLIN, Ireland -- Opsona Therapeutics, a drug development company focused on novel therapeutic approaches to treat autoimmune and inflammatory diseases today announced that it has been awarded€5.9 million from the European Commission to lead a European framework 7 (FP7) consortium of research and clinical groups (termed MABSOT*) in the advancement of clinical trials for its lead drug candidate OPN-305 in solid organ transplantation.  A phase 1 trial in healthy volunteers is due to start this summer. 

Commenting on today’s announcement, Bernd R. Seizinger, M.D., Ph.D., Executive Chairman of Opsona Therapeutics said, “We are very excited to have the opportunity to coordinate this important trans-European consortium.  Improvement of graft function, specifically in renal transplantation, continues to be an area of unmet medical need, requiring truly innovative therapeutic approaches such as OPN-305.”

The specific focus of the Consortium will be the development of OPN-305 as a therapeutic agent for the prevention of Delayed Graft Function (DGF), a serious complication of the immediate postoperative period in renal transplantation.  OPN-305 is a monoclonal antibody inhibitor of Toll-like-receptor-2 (TLR-2). Data generated by Opsona, its collaborators and independent scientists has provided solid scientific evidence for a link between TLR-2 and DGF. The consequences of DGF can be prolonged hospitalisation of patients, additional invasive procedures and transplant rejection.   There is currently no specific therapeutic treatment for DGF.  Following successful completion of the Phase 1 trial this year, the consortium plans to conduct a prospective randomized placebo-controlled Phase 2 trial in the prevention of DGF to be initiated in 2012. 

Dr. Seizinger went on to comment on the broader potential of OPN-305, “Since OPN-305 targets TLR-2, a key component of innate immunity, this first-in-class antibody against TLR-2 may have even greater medical and commercial potential for the novel treatment of a broad range of human diseases including cancer and cardiovascular disease.”

The Monoclonal Antibody Solid Organ Transplantation (MABSOT)* consortium which has been partially funded by the European Commission Seventh Framework Program (FP7) consists ofKings College London (UK),  Katholieke Universiteit Leuven (Belgium),  Fundacio Privada Institut D'Investigacio Biomedica De Bellvitge (Spain), Academisch Ziekenhuis Groningen (Netherlands), Institut Klinické a Experimentální Medicin(Czech Republic), University of Newcastle Upon Tyne (UK), Euram Ltd (UK) and Almac Diagnostics Ltd (UK), together with Opsona Therapeutics Ltd. (Ireland).

“We are proud, particularly as a Small/Medium Enterprise, to lead and coordinate this important collaborative effort which brings together many outstanding scientists, transplant surgeons and medical opinion leaders in the field of immunology and transplantation from across Europe” said Mary Reilly, VP Pharmaceutical Development and Operations, and MABSOT coordinator with the European Commission. 

Further information on the objectives of the MABSOT consortium can be found on the projects website, www.mabsot.eu.

For further information: Niamh Lyons for Opsona Therapeutics - +353 1 6633602

Opsona Therapeutics Appoints Chairman Dr. Bernd R. Seizinger As Executive Chairman; Dr. Mark Heffernan Resigns As Ceo But Remains As Non-Executive Director

06 May, 2011 – DUBLIN, Ireland - Opsona Therapeutics, a drug development company focused on novel therapeutic approaches to target autoimmune and inflammatory diseases today announced that its Board of Directors has appointed Chairman Bernd Seizinger M.D., Ph.D., as Executive Chairman, following the resignation of founding CEO Mark Heffernan, Ph.D.  Dr. Heffernan who has stepped down for personal reasons to return to Australia is joining Opsona’s Board of Directors as a Non-Executive Director of the Board. 

A CEO search committee has been formed.  The committee is led by Dr. Seizinger who also has assumed additional oversight responsibilities of the Company’s operations during this period of transition.

Speaking about Dr. Heffernan’s departure, Dr Seizinger said, “As our founding CEO, Mark, in his seven years with the company has established Opsona as one of Europe’s leading early-stage biotech companies. He successfully managed the company through a number of fundraisings, built collaborations and partnerships with some of the best in the business and ultimately led the company to the door of clinical development.  As we move into our next stage of corporate evolution we are happy that Mark will maintain his association with Opsona as a Non-Executive Director.”

"Opsona has gained considerable product and financial momentum and is evolving into a clinical development company capable of translating key scientific discoveries on the innate immune system into novel therapeutics.   Our roadmap for the year includes moving into Phase I clinical trials with our first-in-class antibody OPN-305 targeting Toll-like-receptor 2 (TLR2).  TLR2 has

been associated with a variety of human diseases including complications in solid organ transplantation, cancer, cardiovascular disease, as well asautoimmune-  and inflammatory diseases.  This is a pivotal and exciting time for the Company," continuedDr. Seizinger.

For more information – Niamh Lyons for Opsona Therapeutics - +353 1 6633602

About Opsona Therapeutics

Opsona is a drug development company, focused on novel therapeutic approaches to key targets of the innate immune systemassociated with a wide range of major human diseases, including autoimmune and inflammatory diseases, transplant rejection, cancer, diabetes, Alzheimer’s disease and atherosclerosis. The company was founded in 2004 by three world-renowned immunologists at Trinity College in Dublin.  Opsona has two lead programs that modulate the innate immune system, including biologics and small molecules.  Opsona’s lead product, a fully humanized monoclonal antibody (OPN-305) against Toll-like-receptor-2 (TLR-2) has demonstratedactivityin a number of animal models and will start clinical trials in 2011 Opsona has also signed significant partnering and collaborative deals, with Pharmaceutical companiessuch asPfizer (USA). Headquartered in Dublin, Opsona most recently completed a €21.3m financing round with an international investor consortium including: Inventages Venture Capital, Novartis Venture Fund,  Roche Venture Fund, Seroba-Kernel Life Sciences, Fountain Healthcare Partnersand Enterprise Ireland.  www.opsona.com

Opsona Therapheutics Closes €18M Funding

• Novartis Venture Fund, Fountain Healthcare Partners, Inventages Venture Capital and Seroba Kernel Life Sciences invests in Opsona Therapeutics Series B Financing
• Proceeds will Advance Lead Compound Targeting Inflammatory Diseases into Clinical Development
• Opsona opens facility in Switzerland to complement Dublin team

DUBLIN, Ireland, 18 February 2009 - Opsona Therapeutics, a biotechnology company focused on novel therapeutic and preventative approaches to autoimmune and inflammatory diseases, today announced the completion of an €18M ($23M) Series B financing round which will enable it to expand both at an operational and clinical level. Novartis Venture Fund, Fountain Healthcare Partners, Inventages Venture Capital and Seroba Kernel Life Sciences all participated in the funding.

Proceeds will support the advancement of Opsona‘s clinical trials targeting inflammatory diseases, such as rheumatoid arthritis, lupus and transplantation. As a part of the financing, Opsona Therapeutics also announced the addition of Florent Gros, managing director at Novartis Venture Fund, and Dr. Manus Rogan, managing partner at Fountain Healthcare Partners, to the Board of Directors. Opsona expects to make a number of other key appointments in the corporate and clinical areas in the coming months.

Commenting on the announcement, Dr Mark Heffernan, Chief Executive Officer of Opsona Therapeutics, said: "Completion of this financing represents a significant milestone in the transition of Opsona into a product-focused company delivering key clinical development milestones. With the endorsement of our existing and new investors, including the Novartis Venture Fund, Fountain Healthcare Partners and Seroba Kernel Life Sciences. Opsona is positioned to deliver on proof of concept studies in patients by targeting inflammatory diseases through the innate immune system, with our ultimate aim being to uncover innovative therapies that combat diseases with significant unmet medical need.”

Opsona is developing biopharmaceutical and small molecule products which modulate the innate immune system, which is the key trigger in the inflammation cascade in many autoimmune and inflammatory diseases. Opsona’s lead product, a fully humanised monoclonal antibody (OPN-305) to a key toll-like receptor (TLR) target, has demonstrated efficacy in a number of animal models and will start pivotal clinical trials in 2010.

Florent Gros, managing director, Novartis Venture Fund added, "We are delighted to be working with Opsona Therapeutics and the other investors to assist Opsona in progressing the company’s highly innovative technology and approaches towards the clinic. The innate immune system represents a new frontier in targeting inflammatory diseases, and the caliber of the investors in this funding round is a demonstration of Opsona’s expertise and capabilities in this highly promising field."

Opsona has also announced the opening of a new facility in Switzerland. The Swiss laboratory will carry out pivotal assay development and biochemical work for new projects and therapeutics recently acquired by Opsona to expand its pipeline of immunomodulators. The expertise that it intends to grow in Switzerland will complement the existing team and activity in Dublin.

Dr Cormac Kilty, Chairman of Opsona and past Chairman of the Irish Bioindustry Association explains “This is major achievement for any biotechnology company in the current economic climate. Opsona’s R&D shows that emerging Irish companies can reach international recognition in biotechnology.” 

About Opsona Therapeutics

Opsona is a drug development company, focused on novel therapeutic and preventative approaches to autoimmune and inflammatory diseases. The company was founded in 2004 with three of Trinity College Dublin’s respected Immunologists (Professors Luke O’Neill, Kingston Mills and Dermot Kelleher). The company is specifically interested in drugs which modulate the innate immune system and its signalling, specifically Toll-Like Receptors (TLR). Opsona has a pipeline of therapeutics in advanced pre-clinical development which modulate the innate immune system, including biologics and small molecules. The company has signed some significant partnering and collaborative deals, such as with Wyeth (USA). The company is based in Dublin and also has laboratories in Lausanne, Switzerland. www.opsona.com