Opsona Therapeutics will be participating in the upcoming BIO Investor Forum, and will be giving a presentation on their work in the autoimmune/inflammatory diseases and oncology space (among other indications). To learn more about their company, please read one of our final company snapshots below.
What is your company’s lead product or technology?
Opsona’s lead product OPN-305 is a fully humanized monoclonal IgG4 antibody targeting Toll-like-receptor-2 (TLR2), which is in clinical development as a treatment for the prevention of Delayed Graft Function (DGF) following renal transplantation.
OPN-305 has demonstrated activity in a number of preclinical models and has been successfully tested in a Phase I clinical trial in healthy volunteers and recently in a Pilot study in transplant patients. 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 phase II trial. OPN-305 was well tolerated with no related adverse events.
In April 2013 we have initiated a two-part multi-centred, 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 Delayed Graft Function (DGF) as the first clinical indication for the development of OPN-305.
How does your company go about differentiating itself from the competition?
Opsona was founded in 2004 by three world-renowned immunologists at Trinity College in Dublin. Based on the pioneering scientific work from Trinity, we are focusing 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.
We have identified the prevention of Delayed Graft Function (DGF) following renal transplantation as the first clinical indication for the development of OPN-305. DGF is a serious complication in the immediate post-operative period of kidney transplants and can range from 45-60% in high risk donor kidneys. DGF is associated with a higher incidence of acute kidney rejection and other negative outcomes for transplant patients. We believe 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.
OPN-305 has orphan status in EU and USA for solid organ transplantation.
What are the short-term and long-term priorities for your company?
Our top priority is our clinical development program for renal transplant patients at a high risk of Delayed Graft Function (DGF). The phase II study which is expected to enroll 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.
Long term we want to identify additional clinical indications and we are currently focusing on specific cancers.
Tell us something about your company that investors might not know.
In addition to OPN-305, we have a second program targeting the Nlpr3-Inflammasome, strategically complementing our pipeline of innate immune modulators. Pathologies such as gouty arthritis, Muckle-Wells syndrome or CINCA/NOMID have been shown to be dependent on Inflammasome activity. We have developed cell based assays for high trough put screening and small molecule inhibitors have been identified.
Since our main focus is the OPN-305 program, we are looking for a development partner for the Nlpr3-Inflammasome program.
Opsona Therapeutics’s presentation is scheduled for Tuesday, October 8th at 11:00am in the Presidio Room. For the full line-up of presentation companies and panels, please download our Program Schedule.
*Company snapshots are meant to be previews of presentations given at BIO events by way of answering set questions. BIO does not substantiate or validate any claims mentioned in company snapshots or presentations.