First subject treated in Opna Bio’s Phase I multiple myeloma trial

The study is expected to include up to 130 subjects with relapsed or refractory multiple myeloma. Image credit: Nemes Laszlo / Shutterstock.

Swiss biopharmaceutical company Opna Bio has administered a dose to the first subjects in a Phase I clinical trial of OPN-6602, an EP300/CBP bromodomain inhibitor for the treatment of multiple myeloma.

The aim of the study is to enroll up to 130 subjects with relapsed or refractory multiple myeloma at various study sites in the United States.

The first dose was administered at the START Center for Cancer Research in Grand Rapids, Michigan.

The open-label study will evaluate the safety, tolerability, pharmacokinetics and early antitumor activity of OPN-6602 both as a stand-alone treatment and in combination with dexamethasone.

It is planned to enroll 90 patients in a dose escalation phase and a further 40 in a dose expansion phase.

The study is expected to be completed in the second half of 2026.

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OPN-6602 is an oral small molecule designed to inhibit E1A binding protein (EP300) and CREB binding protein (CBP), both of which are involved in the regulation of genes that promote myeloma cell growth.

The active ingredient has shown a significant antitumor effect in preclinical tests: when used alone, there was a reduction in tumor growth of 71% and when used in combination treatments, there was an inhibition of over 100%.

Opna Bio CEO Reinaldo Diaz said: “We are excited to begin clinical testing of OPN-6602, which has demonstrated potent anti-tumor activity in models of multiple myeloma as well as other cancers.”

Founded in 1998, Opna Bio focuses on the discovery and development of therapies for various types of cancer.

The company's diverse pipeline includes a program targeting Fragile X Mental Retardation Protein (FMRP) and other promising oncology compounds.

In November 2022, Opna Bio secured $38 million in a Series A funding round led by Longitude Capital and Northpond Ventures with participation from Menlo Ventures.

The company used these proceeds to develop Fragile X Mental Retardation Protein (FMRP) inhibitors for the treatment of cancer and to acquire a broad portfolio of clinical and preclinical oncology activities from Plexxikon.