OMTX705 / Oncomatryx, InxMed - LARVOL DELTA

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 | "OMTX705 is a novel anti-FAP ADC with excellent safety profile. The combination with PEM showed disease control in some heavily pretreated PDAC, MSS CRC and NSCLC. Changes in immune infiltrates and cytokines suggest that OMTX705 may revert CAF-mediated immunosuppression."

Clinical • Combination therapy • Monotherapy • P1 data • Anemia • Colorectal Cancer • Hepatology • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Sarcoma • Solid Tumor • CAFs • CD8 • FAP • NCAM1

TFS HealthScience Expands Collaboration with Oncomatryx for Phase Ib Trial of OMTX705 for Pancreatic Cancer (PRNewswire) - "TFS will support a newly initiated Phase Ib clinical trial evaluating OMTX705—an anti-fibroblast activation protein antibody-drug conjugate (FAP-ADC)— in patients with advanced or metastatic pancreatic adenocarcinoma. The trial will be conducted across sites in Spain and the United States....This Phase Ib study builds on an earlier collaboration between TFS and Oncomatryx during a Phase I trial evaluating OMTX705 as a monotherapy and in combination with pembrolizumab in patients with advanced solid tumors."

Trial status • Pancreatic Ductal Adenocarcinoma

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

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