OMX-0407 / iOmx Therap - LARVOL DELTA

OMX-0407: A novel spectrum-selective small molecule kinase inhibitor in advanced/metastatic solid tumors. (ASCO 2025) - P1/2 | "OMX-0407 has been well tolerated at pharmacologically and therapeutically active dose levels. One very durable response has been observed in an angiosarcoma patient at a low dose level. The phase Ib expansion part at the recommended phase II dose is currently recruiting patients with angiosarcoma and clear cell renal cell carcinoma."

Metastases • Angiosarcoma • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Fatigue • Genito-urinary Cancer • Immunology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Non-melanoma Skin Cancer • Oncology • Sarcoma • Solid Tumor

Pharmacodynamic biomarker modulation by OMX-0407, a novel, spectrum-selective kinase inhibitor for the treatment of angiosarcoma and renal cell carcinoma (AACR 2025) - P1/2 | "As of 30th of October 2024, 24 patients have received continuous treatment with OMX-0407 administered orally in 28-day cycles in a dose escalation study at dose levels of 10, 30, 60, 90, 100, and 140 mg twice daily (BID). Treatment was well tolerated with the main safety finding being gastro-intestinal adverse reactions. One patient with secondary radiation-induced angiosarcoma achieved a complete response at doses of up to 60 mg BID, which remains ongoing at 14 months.PhosFlow analysis confirmed OMX-0407 effects on the phosphorylation of SFKs in PBMCs at doses of 60mg and above."

Biomarker • PK/PD data • Angiosarcoma • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Sarcoma • Solid Tumor

OMX-0407 - A spectrum selective kinase inhibitor shows preclinical efficacy in RCC as well as sarcomas (AACR 2025) - P1/2 | "Clinical data from a patient, diagnosed with secondary radiation-induced AS, resistant to prior lines of chemotherapy, demonstrated that OMX-0407 was well tolerated and achieved a complete response at doses of up to 60 mg twice daily, which remains ongoing at 14 month.These findings support OMX-0407 as a promising first-in-class therapeutic candidate for the treatment of AS and RCC, with a dual mechanism combining direct anti-tumor effects with repolarization of an immunosuppressive tumor microenvironment. As of September 2024, Ph1b expansion cohorts of the first-in-human trial (NCT05826600) were initiated for patients with unresectable or metastatic AS or clear cell RCC."

Preclinical • Angiosarcoma • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Sarcoma • Solid Tumor

OMX-0407 A NOVEL SPECTRUM-SELECTIVE SMALL MOLECULE KINASE INHIBITOR IS ACTIVE IN THE TREATMENT OF ANGIOSARCOMA (CTOS 2024) - P1/2 | "The patient had received previous chemotherapy with paclitaxel and doxorubicin. OMX-0407 is a promising new agent for the treatment of angiosarcoma. OMX-0407 is a promising new agent for the treatment of angiosarcoma. A Phase II study of OMX-0407 in patients who have received at least one previous line of treatment for unresectable angiosarcoma will open for recruitment in the third quarter of 2024. The clinical trial is registered as NCT05826600."

Angiosarcoma • Non-melanoma Skin Cancer • Oncology • Sarcoma • Solid Tumor

OMX-0407 a spectrum selective kinase inhibitor shows preclinical and clinical efficacy in Angiosarcoma, an indication of high unmet medical need (EORTC-NCI-AACR 2024) - P1/2 | "These findings are in line with clinical data from a patient, diagnosed with an angiosarcoma, resistant to previous lines of chemotherapy, where treatment with OMX-0407 was well tolerated and led to a complete and durable response in the ongoing Phase I trial (NCT05826600). Exceptional preclinical and clinical anti-tumor efficacy in monotherapy supports the expansion of the ongoing Phase I trial of this promising agent to angiosarcoma and other indications including renal cell carcinoma."

Preclinical • Angiosarcoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Sarcoma • Solid Tumor

iOmx Therapeutics Initiates Phase Ib with OMX-0407 (GlobeNewswire) - "iOmx Therapeutics AG...announced successful completion of the dose escalation segment of the Phase Ia/Ib clinical trial (NCT05826600) investigating OMX-0407, a first-in-class, spectrum-selective SIK (salt-inducible kinase) inhibitor, in patients with advanced solid tumors and opening of the expansion phase in kidney cancer and angiosarcoma...Topline data from the 20-patient dose escalation segment showed that OMX-0407 monotherapy was safe and well-tolerated. Evidence of anti-cancer activity was observed in this heavily pretreated population of patients, suffering from a variety of solid tumors...one patient who was resistant to multiple previous chemotherapies achieved a durable complete response (CR) with disappearance of all tumor lesions. Furthermore, biomarker analyses showed evidence of substantial pharmacological activity in circulating blood cells...'expect to report topline clinical proof-of-concept data by early 2026.'"

P1/2 data • Trial status • Angiosarcoma • Renal Cell Carcinoma

A Study of OMX-0407 in Patients With Previously Treated Solid Tumours That Can't be Removed Surgically (clinicaltrials.gov) - P1/2 | N=158 | Recruiting | Sponsor: iOmx Therapeutics AG | Phase classification: P1 ➔ P1/2 | N=30 ➔ 158 | Trial completion date: May 2025 ➔ Apr 2026 | Trial primary completion date: Aug 2024 ➔ Mar 2026

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Salt-inducible kinase inhibitor OMX-0407 drives cell-cycle arrest in vitro and in vivo: An in-depth MoA analysis by phospho-proteomics (AACR 2024) - P1 | "Combination with Axitinib, a selective orally available inhibitor of vascular endothelial growth factor receptor 2, significantly enhanced anti-tumor efficacy and pharmacodynamic inhibition of cell growth as well as angiogenesis. These data further strengthen the potential of OMX-0407 in the treatment of RCC as well as other indications.In summary, OMX-0407 is a novel spectrum selective kinase inhibitor, currently under evaluation in a clinical Phase I trial (NCT05826600). OMX-0407 demonstrates strong anti-tumor efficacy in monotherapy in selected sensitive indications through a dual-pronged MoA, by modulating the tumor microenvironment and exerting direct anti-tumor activity in solid tumor indications with high unmet medical need."

Preclinical • Genito-urinary Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

iOmx Therapeutics to present new data on lead programs and I/O target screening platform at AACR 2024 (GlobeNewswire) - "iOmx Therapeutics AG...announces that it will present new data on its lead I/O drug candidates...at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2024....An in-depth mode of action analysis demonstrated that spectrum selective kinase inhibitor OMX-0407 drives cell-cycle arrest in vitro and in vivo....OMX-0407 also potentiates tumor cell apoptosis in response to death receptor ligands including tumor necrosis factor through salt inducible kinase signaling. With this dual mode of action, OMX-0407 has shown striking single-agent efficacy in multiple pre-clinical tumor models."

Preclinical • Oncology

Development of a gene signature to predict the anti-tumor response of the salt-inducible kinase (SIK) inhibitor OMX-0407 (SITC 2023) - P1 | "Conclusions In summary, by screening sensitive and non-sensitive tumor cell lines and PDX models, we identified a response-prediction biomarker signature, which will contribute to the future development of OMX-0407 in specific indications and which will be assessed for its potential to select patients highly responsive to OMX-0407 therapy in clinical studies. The gene signature will be evaluated as part of the ongoing first-in-human study OMX-0407–101 (NCT05826600)."

Gene Signature • IO biomarker • Oncology

Development of a predictive biomarker signature for the highly potent SIK3 inhibitor OMX-0407 (AACR 2023) - "By screening sensitive and non-sensitive tumor cell lines and PDX models, we identified a response-prediction biomarker signature. In upcoming clinical studies, this predictive biomarker signature will be evaluated for it’s potential to enrich for patients highly responsive to OMX-0407 therapy."

Biomarker • IO biomarker • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • AMPK

A Study of OMX-0407 in Patients With Previously Treated Solid Tumours That Can't be Removed Surgically (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: iOmx Therapeutics AG

New P1 trial • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer

iOmx doses first patient in pivotal phase 1 study (PharmaTimes) - "iOmx Therapeutics...has announced that the first individual has been dosed in its phase 1 clinical trial researching its OMX-0407 candidate. The therapy is a first-in-class oral salt-inducible kinase (SIK) inhibitor. The trial is an open-label, single-arm, multi-location phase 1 clinical trial studying the tolerability and safety of the treatment as monotherapy among patients with previously treated unresectable solid tumours. At present, the study has been approved by regulators in Belgium and Spain."

Trial status • Oncology • Solid Tumor

iOmx Therapeutics to Present Target Discovery Platform Myeloid iOTarg and New Data on SIK Checkpoint Inhibitor OMX-0407 at AACR 2023 (GlobeNewswire) - "iOmx Therapeutics AG...announced that its high-throughput target discovery platform, myeloid iOTargTM, will be highlighted in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023. Further, the company will present new data on its lead product candidate, OMX-0407, in a poster presentation at the conference, which will take place from April 14 to 19 in Orlando, Florida....'We will present new data on the predictive biomarker signature for this candidate, which will be evaluated during our clinical development strategy'."

Biomarker • Oncology

OMX-0407, a highly potent SIK3 inhibitor, sensitizes tumor cells to cell death and eradicates tumors in combination with PD-1 inhibition (AACR 2022) - "In summary, OMX-0407, a first-in-class oral SIK3 inhibitor, demonstrates potent monotherapy efficacy in a pro-inflammatory tumor setting by reshaping the immune compartment and accelerating tumor cell death. The ability of OMX-0407 to remodel an immunosuppressed TME in a generally cold tumor setting, harbors great clinical potential for OMX-0407 combination therapy with anti-PD-1/PD-L1 immune checkpoint blockade, specifically in patients with high unmet medical need who are resistant to current immune checkpoint inhibitor monotherapy."

Combination therapy • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • HDAC4

iOmx to Present New Pre-Clinical Data on SIK3 Checkpoint Inhibitor OMX-0407 at AACR 2022 (GlobeNewswire) - "iOmx Therapeutics AG (iOmx)...announced the presentation of new preclinical data for its lead program IMT-07 with product candidate OMX-0407, a first-in-class oral SIK3 inhibitor. The data will be presented in a poster session at the American Association for Cancer Research (AACR) Annual Meeting 2022 being held in New Orleans, Louisiana, from April 8 -13, 2022...'We are working at full steam to prepare the first-in-human trial with OMX-0407 and plan to enter the clinic in patients with advanced cancer later this year'."

New trial • Preclinical • Oncology • Solid Tumor

OMX-0407, a highly potent SIK3 inhibitor, sensitizes tumor cells to apoptosis and eradicates tumors in combination with PD-1 inhibition (SITC 2021) - "Conclusions In summary, OMX-0407, a first-in-class oral SIK3 inhibitor, demonstrates potent monotherapy efficacy in a pro-inflammatory tumor setting by reshaping the immune compartment and sensitizing tumor cells to death receptor-mediated apoptosis. The ability of OMX-0407 to remodel an immunosuppressed TME in a generally cold tumor setting, harbors great clinical potential for OMX-0407 combination therapy with anti-PD-1/PD-L1 immune checkpoint blockade, specifically in patients with high unmet medical need who are resistant to current immune checkpoint inhibitor monotherapy."

Combination therapy • IO biomarker • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • AMPK

iOmx refuels with $75M+ on its search for immune checkpoint targets on tumor cells (Endpoints News) - “iOmx unveiled the €65 million Series B round on Tuesday morning, roughly five years after emerging from stealth. The new cash will help the startup put its first candidate, an SIK3 kinase inhibitor called IMT-07, in the clinic late next year for solid tumors. Right behind that program is an IGSF11-targeting antibody to treat PD-1/PD-L1-resistant tumors, which is also in the lead optimization stage, according to iOmx’s website.”

Commercial • Oncology • Solid Tumor