OMTX705 / Oncomatryx, InxMed - LARVOL DELTA

OMTX705: A dual-mechanism ADC targeting FAP-positive CAFs, to overcome chemo and immunotherapy resistance in solid tumors (AACR 2025) - "Higher anti-tumoral effect was evidenced over both classical chemotherapy and modern immunotherapy drugs, as a single agent or in combination therapies with Gemcitabine/Abraxane or immune checkpoint inhibitors. The second mechanism involves immune cell infiltration within the tumor microenvironment, further strengthening its therapeutic potential. This dual effect, combined with a favorable safety profile, positions OMTX705 as a promising candidate among cancer therapeutics, targeting the stroma in solid tumors and enhancing antitumor immune responses."

IO biomarker • Breast Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer • FAP

First-in-human phase 1 dose escalation trial of OMTX705, a novel anti-fibroblast activation protein (FAP) antibody drug conjugate (ADC), in monotherapy and in combination with pembrolizumab in patients with solid tumors. (ASCO 2025) - P1 | "Clinical Trial Registration Number: NCT05547321 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Combination therapy • Monotherapy • P1 data • Oncology • Solid Tumor

ONCOMATRYX Raises €25 Million to Foster OMTX705 Clinical Trials (Businesswire) - "ONCOMATRYX, a biopharmaceutical company developing novel ADCs against the tumor microenvironment, has successfully raised €25 million, to fund Phase Ib-II clinical trials of OMTX705, a first-in-class ADC targeting FAP. The funding round was led by the company’s existing investors and included a €10 million strategic investment from Centro para el Desarrollo Tecnológico y la Innovación. This endorsement highlights the confidence in ONCOMATRYX pioneering ADCs to treat metastatic solid tumors."

Financing • Solid Tumor

Oncomatryx acquires Tube Pharmaceuticals GmbH to consolidate its pioneering pipeline of ADCs targeting the tumor microenvironment (Businesswire) - "Oncomatryx has acquired Tube Pharmaceuticals GmbH, the developer of the Cytolysin toxic payload...The multimillion €uros transaction is a strategic decision by Oncomatryx that will foster its leadership in the field of ADCs targeting the tumor microenvironment. It culminates a decade-long alliance between Oncomatryx and Tube that has already rendered clinical-stage ADCs targeting the Tumor Microenvironment. Oncomatryx's pioneering drug OMTX705, which incorporates the cytolysin toxic payload developed by Tube, is a first-in-class antibody-drug conjugate targeting cancer-associated fibroblasts....A FIH multiple expansion cohort clinical trial targeting metastatic solid tumors is ongoing in seven hospitals in Spain and USA."

M&A • Oncology • Solid Tumor

InxMed Receives Approval to Initiate Phase I Clinical Trial in China for OMTX705, a First-in-Class FAP-Targeting ADC (PRNewswire) - "InxMed...announced today the first-in-class ADC OMTX705 has obtained the IND (Investigational New Drug) approval from China National Medical Products Administration (NMPA) recently. OMTX705 is a novel antibody–drug conjugate (ADC) molecule targeting fibroblast-activating protein α (FAPα)."

New P1 trial • Oncology • Solid Tumor

Efficacy and Safety Study of OMTX705, Monotherapy and Pembrolizumab-combined, in Subjects With Advanced Solid Tumors. (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: Oncomatryx Biopharma S.L. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Monotherapy • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Efficacy and Safety Study of OMTX705, Monotherapy and Pembrolizumab-combined, in Subjects With Advanced Solid Tumors. (clinicaltrials.gov) - P1 | N=120 | Not yet recruiting | Sponsor: Oncomatryx Biopharma S.L.

Combination therapy • Monotherapy • New P1 trial • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Oncomatryx Announces FDA and AEMPS IND Clearance for OMTX705, a First-in-class Tumor Microenvironment-targeted ADC, to Treat Advanced Solid Tumors (Businesswire) - "After 15 years of pioneering R&D efforts in the tumor microenvironment, Oncomatryx announces that the FDA and the Spanish Drug Agency (AEMPS) have cleared its investigational new drug (IND) application for OMTX705, a First-in-Class antibody-drug conjugate (ADC) targeting the tumor microenvironment....OMTX705 has already shown unbeatable safety in non-human primates and tumor regression in murine models of pancreatic, breast, lung and gastric cancer....OMTX705 phase I clinical trial will be run in seven hospitals in USA and Spain."

IND • New P1 trial • Breast Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Thoracic Cancer

OMTX705, a Novel FAP-Targeting ADC demonstrates Activity in Chemotherapy and PD1-Resistant Solid Tumors Models. (PubMed, Clin Cancer Res) - "These data suggest that FAP-targeting with OMTX705 represents a novel and potent strategy for cancer treatment including tumors resistant to immunotherapy and support its clinical development."

Journal • CD8 • PD-1 • PRF1

Tumour stroma targeting and modulation by OMTX705 ADC, a novel and potent immunotherapeutic treatment of solid tumours (ESMO 2019) - "OMTX705 alone induces tumor shrinkage, and full regression with Pembrolizumab, through highly specific, CAF-dependent and long-lasting modulation of tumor stroma. This novel mechanism of action makes OMTX705 a potent and innovative strategy for NSCL cancer treatment. Considering FAP is expressed in a wide array of carcinomas, OMTX705 represents a highly promising and well-tolerated candidate to treat solid tumors with low response to anti-PD1 immunotherapies."

IO Biomarker • PD(L)-1 Biomarker