OMTX705 / Oncomatryx, InxMed - LARVOL DELTA

HanchorBio Tests Broader Ambitions for HCB101 Through InxMed Partnership (PRNewswire) - "Under the MOU, the two companies will conduct preclinical and translational research evaluating HCB101 in combination with InxMed's investigational assets, including IN10018/ifebemtinib, a FAK inhibitor, and OMTX705....HanchorBio has been developing the asset with gastric cancer as an important clinical anchor....InxMed brings a complementary profile. Its lead asset, IN10018/ifebemtinib, has advanced into late-stage clinical development, including a Phase III trial in China for platinum-resistant recurrent ovarian cancer....The collaboration gives HanchorBio a way to test whether HCB101's macrophage-centered immune activation can be paired with drugs targeting the tumor's physical and biological defenses, including fibrosis, stromal barriers, and immune exclusion."

Licensing / partnership • Platinum resistant • Gastric Cancer • Ovarian Cancer

Preclinical Evaluation of the FAP-Targeted Immunoconjugate OMTX705 Reveals Stromal-Mediated Bystander Activity in Sarcoma Patient-Derived Xenografts (EACR 2026) - "Our findings demonstrate that OMTX705 exerts robust antitumor activity in sarcoma PDX models through both direct tumor cell targeting and stromal-mediated bystander mechanisms. Importantly, therapeutic efficacy in RMS with FAP (-) tumor cells highlights the relevance of stromal FAP expression as a predictive biomarker. These results support a patient selection strategy integrating both tumoral and stromal FAP assessment and provide a strong rationale for clinical development of OMTX705 in sarcoma."

Preclinical • Stroma • Leiomyosarcoma • Rhabdomyosarcoma • Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma • CAFs • FAP

Mechanistic drivers of FAP-targeted ADC performance (AACR 2026) - "In these patients, CAF disruption, much lower FAP expression and higher CD8⁺ and CD4+ cell infiltration was detected in tumor areas co-localizing with the OMTX705 payload signal, providing evidence that OMTX705 enhances local immune activation and supports an antitumor immune response.Overall, these findings reveal both cytotoxic and immunomodulatory functions for FAP-targeted ADCs within the TME and provide molecular mechanistic insights into their bystander effect, emphasizing how differences in linker-payload chemistry critically determine efficacy, durability of response, immune engagement, and tolerability. This study highlights OMTX705 potential as a safer FAP-targeted ADC with long-lasting effect and underlines the importance of biology-driven linker-payload engineering for next-generation stroma-directed ADC anticancer therapies."

ADC • Oncology • CAFs • CD4 • CD8 • FAP

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."

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

OMTX705-005: Phase 1b/2 Trial of OMTX705, an Anti-Fibroblast Activation Protein Antibody-Drug Conjugate, in Combination with Carboplatin, Pemetrexed and Tislelizumab in Patients with Advanced/Metastatic Non-squamous Non-Small Cell Lung Cancer (clinicaltrialsregister.eu) - P1/2 | N=88 | Not yet recruiting | Sponsor: Oncomatryx Biopharma S.L.

New P1/2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • PD-L1

OMTX705-006 Phase 1b (clinicaltrialsregister.eu) - P1 | N=54 | Recruiting | Sponsor: Oncomatryx Biopharma S.A.

New P1 trial • Oncology • Pancreatic Cancer

Clinical Trial of OMTX705 in Combination With Gemcitabine/Nab-Paclitaxel and Tislelizumab in Patients With Advanced/Metastatic Pancreatic Adenocarcinoma (clinicaltrials.gov) - P1 | N=69 | Recruiting | Sponsor: Oncomatryx Biopharma S.L.

New P1 trial • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • CA 19-9 • KRAS

Efficacy and Safety Study of OMTX705, Monotherapy and Anti-PD-1-combined, in Subjects With Advanced Solid Tumors. (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: Oncomatryx Biopharma S.L. | Trial completion date: Oct 2024 ➔ Dec 2027 | Trial primary completion date: Oct 2024 ➔ Dec 2027

Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Cancer-associated fibroblast biomarkers to unravel the mechanism of action and tentative patient stratification for OMTX705, a CAF-targeted antibody-drug conjugate (ESMO 2025) - "The increase of cytotoxic T-cell tumor infiltration together with the reduction of immunosuppressive cytokines, would enable pembrolizumab to develop anti-tumor activity in patients who do not respond to immunotherapy. Ongoing trials are aimed at validating periostin as a relevant biomarker for OMTX705 patient stratification and monitoring."

Biomarker • Clinical • IO biomarker • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • CAFs • CD8 • CDH2 • FAP • POSTN

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

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