iOmx Therapeutics Receives Regulatory Approval of Clinical Trial Application for IOMX-0675
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EQS-News: iOmx Therapeutics AG
/ Key word(s): Regulatory Approval
iOmx Therapeutics Receives Regulatory Approval of
Martinsried / Munich, Germany, April 15, 2025 – iOmx Therapeutics AG (iOmx), a clinical-stage biopharmaceutical company translating unexplored immune evasion biology into a growing pipeline of biomarker-enabled drug programs, today announced that the Spanish Agency of Medicines and Medicinal Products (AEMPS) has approved the Clinical Trial Application (CTA) for IOMX-0675, a LILRB1/LILRB2 cross-specific antibody designed to reverse immune suppression in solid tumors. The phase I/IIa clinical trial will consist of a dose escalation stage plus expansion cohorts at different dose levels and aims to assess the safety, tolerability and preliminary efficacy of IOMX‑0675 in monotherapy and in combination with an immune checkpoint inhibitor across multiple solid tumor indications. “We are excited to reach this important step in the development of IOMX‑0675, our second clinical-stage asset. This milestone underscores our dedication to delivering innovative treatments for patients with cancers that have shown resistance to existing therapies,” said Apollon Papadimitriou, Ph.D., Chief Executive Officer of iOmx. “IOMX‑0675 is designed to restore both innate and adaptive anti-tumoral immune responses, exemplifying our strategy of developing therapies with single-agent activity and multi-modal mechanisms of action.” Tiantom (Dom) Jarutat, MD, Chief Medical Officer of iOmx, added “IOMX‑0675 exhibits highly differentiated functional characteristics and tackles a target class with evolving clinical validation. Based on its unique mode-of-action and robust preclinical data, we are convinced that IOMX‑0675 will be effective in multiple solid tumor indications, including colorectal, non-small cell lung, and gastric cancers.” IOMX-0675 is a fully human, dual-targeting antibody designed to selectively block LILRB1 and LILRB2, two key immunosuppressive receptors expressed on myeloid and lymphoid cells. With its highly differentiated binding profile, it spares LILRA1 and LILRA3, the two closely related immune-activating receptor family members, and restores both innate and adaptive anti-tumor immunity. Preclinical data have demonstrated its ability to repolarize the tumor microenvironment, activating T cells and macrophages and leading to immune-mediated tumor killing. In both in vitro and in vivo models, IOMX‑0675 has shown superior efficacy compared to other single‑targeting or dual‑targeting antibodies, supporting its potential as a best‑in‑class therapeutic candidate. About iOmx Therapeutics iOmx Therapeutics (www.iomx.com) is a clinical-stage company that harnesses deep tumor and myeloid biology insights to generate novel treatments for the most prevalent solid tumor indications. The company is translating unexplored immune evasion biology into a growing pipeline of biomarker-enabled drug programs. Focused on developing drugs with single agent activity, iOmx is creating potential new backbone therapies in a modality‑open fashion. By applying its comprehensive drug discovery & development expertise iOmx is committed to shaping the future of cancer therapy. The company’s lead program, OMX‑0407, is a proprietary first-in-class spectrum-selective kinase inhibitor targeting key oncology-relevant tyrosine kinases and salt-inducible kinases (SIKs) and is currently being investigated in a Phase Ib clinical trial in multiple solid tumors. The second program, IOMX‑0675, a highly differentiated, LILRB1&2 cross‑specific antibody is ready to advance into clinical development following its recent CTA approval. iOmx is backed by international venture capital investors, such as Athos, Sofinnova Partners, Wellington Partners, MIG Capital, M Ventures and Arvantis Social Foundation Impact Investment. The Company is based in Martinsried/Munich, Germany. Media contact
15.04.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group. |
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