On November 13, 2024 Opna Bio, a clinical-stage biopharmaceutical company focused on the discovery and development of novel oncology therapeutics, reported that two abstracts have been accepted for poster presentations at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, taking place Dec 7-10, 2024 in San Diego (Press release, Opna Bio, NOV 13, 2024, View Source [SID1234648311]). The presentations will highlight data from Opna’s lead clinical programs, OPN-2853 and OPN-6602.

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The data presentations will include an interim analysis of the ongoing Phase 1 study of OPN-2853, a bromodomain and extra-terminal motif (BET) inhibitor being tested in combination with ruxolitinib, a Janus kinase 1/2 (JAK1/2) inhibitor, in patients with myelofibrosis who are no longer responding to ruxolitinib alone. The study is testing the hypothesis that a continuous daily dosing regimen of oral agents will reduce disease burden. This investigator-initiated study is led by Professor Adam Mead at the University of Oxford through a collaboration with Cancer Research UK (CRUK) and is run through the Cancer Research UK Clinical Trials Unit at the University of Birmingham. As of February 2024, 16 patients have been enrolled at different dose levels. Encouraging levels of spleen reduction, with minimal toxicities and adverse events, have been observed thus far.

A second presentation features preclinical data with OPN-6602, an oral, small molecule inhibitor of the E1A binding protein (EP300) and CREB-binding protein (CBP) currently being tested in a Phase 1 trial in multiple myeloma (MM). In human-derived MM models, OPN-6602 suppresses tumor growth, while downregulating key MM driving genes, with synergistic effects observed in combination with dexamethasone, pomalidomide and mezigdomide.

"We are excited about the upcoming data disclosures at ASH (Free ASH Whitepaper). Both OPN-2853 and OPN-6602 were intentionally designed to have a high C-max and short half-life. This distinct pharmacokinetic profile allows for continuous daily dosing that potentially results in a lower incidence of toxicities and improved efficacy," said Gideon Bollag, PhD, chief scientific officer of Opna Bio.

Investigator-sponsored study
Title: "PROMise Trial: Interim analysis of PROMise, a clinical study combining the BET inhibitor OPN-2853 with ruxolitinib in patients with advanced myelofibrosis experiencing an inadequate response to ruxolitinib"
Publication Number: 3186
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II
Date and Time: December 8th, 6-8 PM
Presenter: Adam Mead, PhD, Professor of Haematology, Radcliffe Department of Medicine, CRUK Senior Cancer Research Fellow

Opna-sponsored research
Title: "OPN-6602, an Orally Bioavailable EP300/CBP Bromodomain Inhibitor, Targets Multiple Myeloma Through Suppression of IRF4 and MYC"
Publication Number: 1908
Session Name: 651. Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational: Poster I
Date and Time: December 7th, 5:30 – 7:30 PM
Presenter: Bernice Matusow, MS, Director, Preclinical Development, Opna Bio