Opna Bio Initiates Phase I Trial of OPN-6602 for Multiple Myeloma
Key Insights
Opna Bio (search) has dosed the first subject in a Phase I clinical trial of OPN-6602, an EP300/CBP (search) bromodomain inhibitor, for relapsed or refractory multiple myeloma (search).
The open-label trial will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of OPN-6602 as a monotherapy and in combination with dexamethasone.
The Phase I trial aims to enroll up to 130 patients across multiple sites in the US, with completion expected in the second half of 2026.
Opna Bio (search), a Swiss biopharmaceutical company, has commenced a Phase I clinical trial of OPN-6602, a novel EP300/CBP (search) bromodomain inhibitor, for the treatment of multiple myeloma (search). The first patient was dosed at The START Center for Cancer Research in Grand Rapids, Michigan. This open-label study is designed to evaluate the safety, tolerability, pharmacokinetics, and early anti-tumor activity of OPN-6602, both as a monotherapy and in combination with dexamethasone, offering a potential new treatment avenue for patients with relapsed or refractory disease.
Trial Design and Objectives
The Phase I trial intends to enroll up to 130 patients with relapsed or refractory multiple myeloma (search) across various trial sites in the US. The trial is structured into two phases: a dose-escalation phase involving 90 patients and a dose-expansion phase with an additional 40 patients. The primary objectives include assessing the safety and tolerability of OPN-6602, while secondary endpoints will focus on evaluating its pharmacokinetics and early anti-tumor activity. The study is anticipated to be completed in the second half of 2026.
OPN-6602: Mechanism of Action
OPN-6602 is an orally available small molecule designed to inhibit E1A binding protein (EP300) and CREB-binding protein (CBP). These proteins are involved in the regulation of genes that promote the growth of myeloma cells. By inhibiting EP300 and CBP, OPN-6602 aims to disrupt the signaling pathways that drive myeloma cell proliferation and survival.
Preclinical Efficacy
Preclinical studies have demonstrated that OPN-6602 exhibits significant anti-tumor effects. As a single agent, OPN-6602 led to a 71% reduction in tumor growth. When used in combination treatments, it resulted in more than 100% tumor growth inhibition, highlighting its potential as a therapeutic agent for multiple myeloma (search).
Executive Perspective
"We are pleased to initiate clinical testing of OPN-6602, which has shown potent anti-tumour activity in multiple myeloma (search) models as well as other cancers," said Reinaldo Diaz, CEO of Opna Bio (search). This statement underscores the company's confidence in the potential of OPN-6602 to address unmet needs in multiple myeloma treatment.
Opna Bio's Pipeline and Funding
Founded in 1998, Opna Bio (search) is dedicated to the discovery and development of therapies for various forms of cancer. The company's pipeline includes a program targeting the fragile-X mental retardation protein (search) (FMRP) and other oncology assets. In November 2022, Opna Bio secured $38 million in a Series A funding round, which has supported the development of FMRP inhibitors for cancer and a portfolio of clinical and preclinical oncology activities.