iOmx Therapeutics Starts Phase Ib with OMX-0407

iOmx Therapeutics AG, a clinical-stage biopharmaceutical company based in Germany, has announced the successful completion of the dose escalation phase of its Phase Ia/Ib clinical trial for OMX-0407. This trial is investigating the potential of OMX-0407, a first-in-class spectrum-selective salt-inducible kinase (SIK) inhibitor, in patients with advanced solid tumors. This achievement marks a significant milestone in the drug's development and opens the door for further trials in kidney cancer and angiosarcoma.

Dr. Murray Yule, Chief Medical Officer at iOmx, expressed optimism about OMX-0407, stating that the completion of the dose escalation phase is a critical step forward. He is eager to observe the drug's effects on larger patient populations suffering from kidney cancer and angiosarcoma.

The dose escalation phase involved 20 patients and demonstrated that OMX-0407 is both safe and well-tolerated. Importantly, the study also showed signs of anti-cancer activity within this heavily pretreated group, which included patients who had previously undergone multiple chemotherapy treatments. Notably, one patient experienced a durable complete response, with all tumor lesions disappearing. Additionally, biomarker analyses confirmed significant pharmacological activity in circulating blood cells.

Dr. Hannes Loferer, Chief Operations Officer at iOmx, emphasized the importance of generating efficacy data in the upcoming dose expansion phase. The first two indications, kidney cancer and angiosarcoma, were selected based on their high potential for objective response to OMX-0407, as observed in the initial phase and preclinical data.

The expansion phase will be conducted at major oncology centers specializing in kidney cancer and angiosarcoma. The aim is to further assess the single-agent activity and safety profile of OMX-0407 at the recommended dose established during the dose escalation phase. The study will enroll up to 86 patients with previously treated renal cell carcinoma and angiosarcoma. The primary endpoint is the objective response rate, with secondary objectives including the duration of response and patient survival.

Dr. Apollon Papadimitriou, Chief Executive Officer of iOmx, highlighted the importance of initiating the Phase Ib segment of the OMX-0407 trial. He noted that the dose escalation data, which included a long-lasting complete response in a patient with high medical needs, is very promising. The company is optimistic about the potential of OMX-0407 to provide a meaningful, differentiated therapy for patients who have not responded to current cancer treatments. Topline clinical proof-of-concept data is expected by early 2026.

OMX-0407 is an orally available, first-in-class spectrum-selective kinase inhibitor. It targets key oncology-relevant tyrosine kinases and SIKs, directly interfering with tumor cell proliferation through modulation of tyrosine kinase signaling. Additionally, OMX-0407 enhances tumor cell apoptosis in response to death receptor ligands like tumor necrosis factor, thereby reshaping the tumor microenvironment.

iOmx Therapeutics leverages deep insights into tumor and myeloid biology, along with its proprietary iOTarg™ target screening platform, to develop novel treatments for prevalent solid tumor indications. The company focuses on developing drugs with single-agent activity, aiming to create new backbone therapies in a modality-open fashion. iOmx's comprehensive drug discovery and development expertise positions it to significantly impact the future of cancer therapy. The company's lead program, OMX-0407, is currently in a Phase Ia/Ib clinical trial for multiple solid tumors. Another program, IOMX-0675, a LILRB1&2 cross-specific antibody, is on track for clinical trial application submission in the fourth quarter of 2024.

iOmx is supported by international venture capital investors, including Athos, Sofinnova Partners, Wellington Partners, MIG Capital, and M Ventures. The company is headquartered in Martinsried/Munich, Germany.