Date: 2016-12-20
Type of information: Presentation of results at a congress
phase: 1-2
Announcement: presentation of results at the 58th American Society of Hematology (ASH) Annual Meeting
Company: Opsona Therapeutics (Ireland)
Product: OPN-305
Action
mechanism: monoclonal antibody. OPN-305 is a novel proprietary humanized IgG4 monoclonal antibody (MAb) against Toll-Like Receptor 2 (TLR2), a target within the innate immune system. 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.
Disease: second-line lower (Low and intermediate-1) risk myelodysplastic syndrome
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: The dose-confirming part of this study, comprising at least 10 patients is designed as a single center, prospective, single arm, open label in patients who have failed or are unresponsive to Azacitidine (AZA) or Decitabine (they may also have additionally failed an Erythropoiesis Stimulating Agent (ESA) followed by a dose expansion part with an additional 30 patients; the objective of the whole study being to assess the safety, efficacy, pharmacokinetics and pharmacodynamics of intravenously infused multiple doses of OPN-305 in low and intermediate-1 risk myelodysplastic syndrome (Second line Lower risk MDS). (NCT02363491)
Latest
news: * On December 20 2016, Opsona Therapeutics announced the preliminary results from its ongoing open label Phase I/II study being conducted with OPN-305 in secondline lower (Low and intermediate-1) risk myelodysplastic syndrome (MDS). The results have been presented 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. 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. * On January 26, 2015, Opsona Therapeutics, an innate immune drug development company focused on novel therapeutic approaches to treat autoimmune, inflammatory diseases and oncology, announced 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. 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.
