First-in-human evaluation of a peptide targeting the TSP-1/CD47 matrix checkpoint
- International study coordinated at Gustave Roussy, with clinical sites in France and Belgium
- Initial safety and biomarker data expected in 2027
- Study designed to guide dose selection and seek initial clinical proof-of-concept
Reims, France, 12 November 2026 - Apmonia Therapeutics (“Apmonia”), a clinical-stage biotechnology company developing peptide therapeutics targeting the tumor microenvironment, today announced that the first patient has been treated with TAX2 at Gustave Roussy in APM-CT001, the first-in-human Phase 1/2a study of TAX2 (AP-01) in patients with advanced solid tumors.
Targeting tumor immune suppression
TAX2 is a first-in-class cyclic peptide that binds to thrombospondin-1 (TSP-1), an extracellular matrix protein in the tumor microenvironment, to selectively inhibit its interaction with CD47. This interaction acts as a “matrix checkpoint”: an immune-suppressive signal from the extracellular matrix implicated in T-cell exhaustion. By acting on TSP-1 rather than blocking CD47 itself, TAX2 is designed to preserve antitumor T-cell function and inhibit tumor angiogenesis while sparing CD47/SIRPα signaling.
“Treating the first patient marks Apmonia’s transition into clinical development,” said Albin Jeanne, PhD, Chief Executive Officer of Apmonia Therapeutics. “The next clinical results will guide dose selection and the next stages of development. We aim to build a clinical foundation for TAX2 as a monotherapy and in future combinations, while advancing discussions with potential strategic partners.”
Clinical evaluation in advanced solid tumors
Sponsored by Apmonia and coordinated by Prof. Alexandra Leary, MD, PhD, at Gustave Roussy, APM-CT001 is a multicenter, open-label study conducted in France and Belgium. It evaluates once-weekly intravenous TAX2 monotherapy in patients with advanced or metastatic ovarian, colorectal or pancreatic cancer, or metastatic melanoma, who have exhausted standard treatment options.
At Gustave Roussy, Prof. Alexandra Leary and Dr. Kaïssa Ouali are study investigators, working with the Drug Development Department (DITEP), headed by Prof. Christophe Massard. Other participating investigators include Dr. Philippe Cassier (Centre Léon Bérard), Dr. Nuria Kotecki (Institut Jules Bordet) and Prof. Sylvie Rottey (UZ Gent).
The study comprises Phase 1 dose escalation to assess safety, tolerability and pharmacokinetics, followed by a Phase 2a expansion to explore antitumor activity and seek initial clinical proof-of-concept. Among the solid tumors being investigated, TAX2’s evaluation in ovarian cancer builds on translational research with Gustave Roussy.
The study’s biomarker program will investigate TAX2’s effects on tumor immunity and angiogenesis, seeking pharmacodynamic evidence of TSP-1/CD47 pathway modulation in patients. These findings, together with safety and preliminary clinical activity data, will inform dose selection and guide subsequent development.
“The translational research conducted with Apmonia provides a strong rationale for investigating TAX2, particularly in ovarian cancer,” said Prof. Alexandra Leary, MD, PhD, coordinating investigator of the study at Gustave Roussy. “This study will allow us to assess its safety and explore whether targeting TSP-1/CD47 can translate into biological and clinical activity in patients. It is an important step toward evaluating a differentiated treatment approach for cancers with limited therapeutic options.”
Trial registrations: NCT07688148; EU CT 2025-521164-36-00.
Scientific evidence supporting clinical development
Apmonia’s clinical development of TAX2 builds on its preclinical and translational research program. Work conducted with Gustave Roussy and published in Molecular Cancer (2024) demonstrated TAX2 activity in an ovarian cancer mouse model following PARP inhibitor treatment. The program’s non-clinical pharmacology, pharmacokinetic and safety data were published in Toxicology and Applied Pharmacology (2026).
Independent research from the laboratory of Prof. Taha Merghoub and Jedd Wolchok at Weill Cornell Medicine, internationally recognized leaders in cancer immunology and immunotherapy, provides further support for TAX2. Published in Nature Immunology (2025), their work showed that TAX2 preserved antitumor T-cell function and enhanced anti-PD-1 activity in preclinical models.
About Apmonia Therapeutics
Apmonia Therapeutics is a clinical-stage biotechnology company developing first-in-class peptide therapeutics designed to reprogram the tumor microenvironment. Its lead program, TAX2, is a cyclic peptide designed to selectively modulate the TSP-1/CD47 axis and restore antitumor immunity through a differentiated mechanism of action.
Apmonia’s proprietary extracellular matrix (ECM)-targeting discovery platform combines advanced molecular modeling, AI-driven peptide design and expertise in ECM biology to generate additional therapeutic candidates.
Contacts
- Investor and partnering inquiries - Albin Jeanne, PhD, CEO
a.jeanne@apmonia-therapeutics.com - Press - Acorelis Agency, Gilles Petitot
+33 6 20 27 65 94 | gilles.petitot@acorelis.com - Apmonia Therapeutics
contact@apmonia-therapeutics.com
