AP-01 / Apmonia Therap - LARVOL DELTA

TAX2, a First-in-Class Orthosteric Inhibitor of the TSP-1/CD47 Matrix Checkpoint: Preclinical Efficacy and Translational Strategy for Phase 1 Evaluation (ESMO 2026) - No abstract available

P1 data • Preclinical • Oncology

Selective targeting of TSP1/CD47: an innovative approach to modulate thrombosis without altering hemostasis (ISTH 2026) - "Interestingly, the combination of TAX2 with tirofiban, an antagonist of the α IIb β 3 integrin, achieved an inhibition comparable to that obtained with higher doses of tirofiban. Its favorable safety profile, along with potential combination with existing antiplatelet drugs, paves the way for novel strategies in thrombosis management with reduced bleeding risk. DOI*10.1016/j.rpth.2026.105574"

Cardiovascular • Hematological Disorders • Myocardial Infarction • Thrombosis • CD36 • SCARB1

APM-CT001: A First-in-human Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-tumour Activity of TAX2 in Patients With Relapsed/Refractory Advanced/Metastatic Solid Tumours (clinicaltrials.gov) - P1/2 | N=48 | Not yet recruiting | Sponsor: Apmonia Therapeutics

First-in-human • New P1/2 trial • Colorectal Cancer • Melanoma • Oncology • Ovarian Cancer • Solid Tumor

Non-clinical pharmacology, pharmacokinetics, and safety evaluation of TAX2, a first-in-class peptide targeting the TSP-1/CD47 matricellular axis. (PubMed, Toxicol Appl Pharmacol) - "TAX2 was well tolerated at doses up to 400 mg/kg in rats and 100 mg/kg in dogs, with no hematological or systemic toxicity, and exposures exceeding the projected clinical range. Overall, these findings establish a translational non-clinical framework for TAX2 as a first-in-class TSP-1/CD47 antagonist with cross-species-reactivity and a favorable pharmacokinetic and safety profile2."

Journal • PK/PD data • Hematological Disorders • Oncology • SIRPA

APM-CT001: A phase 1/2a, first-in-human, open-label, dose-escalating study with a safety expansion cohort to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumour activity of TAX2 in patients with relapsed/refractory advanced/metastatic solid tumours (clinicaltrialsregister.eu) - P1/2 | N=48 | Not yet recruiting | Sponsor: Apmonia Therapeutics

First-in-human • New P1/2 trial • Colorectal Cancer • Cutaneous Melanoma • Melanoma • Oncology • Ovarian Cancer • Pancreatic Cancer • Refractory Ovarian Cancer • Solid Tumor

Remodeling the Tumor Microenvironment through TSP-1/CD47 Antagonization: Non-Clinical Characterization of the TAX2 drug candidate (EACR 2025) - "TAX2 peptide, a first-in-class TSP-1/CD47 antagonist, is being developed as an injectable product for the treatment of cancers. These non-clinical data support this concept and TAX2 is now expected to enter in Phase 1/2a clinical trial in advanced solid tumors."

Biomarker • Clinical • Tumor microenvironment • Oncology • Ovarian Cancer • Solid Tumor • SIRPA

The CD47/TSP-1 axis: a promising avenue for ovarian cancer treatment and biomarker research. (PubMed, Mol Cancer) - "Our study thus (1) proposes a CD47-based stratification of patients who may be most likely to benefit from postoperative immunotherapy, and (2) suggests that TAX2 is a potential alternative therapy for patients relapsing on PARP inhibitors."

Biomarker • IO biomarker • Journal • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • CD47 • CD8

Targeting the CD47/TSP-1 axis: A promising strategy for patients with ovarian cancer (OC) that relapses on PARP inhibitors (PARPi). (ASCO 2024) - P2 | "To assess the efficacy of TAX2 and/or PARPi (olaparib) treatment, we used ID8 cells harboring Trp53 -/- and Brca2 -/- mutations, as a pertinent syngeneic representation of intraperitoneal high-grade serous TP53 and BRCA2 mutated OC. Our findings propose TAX2 as a promising strategy for patients relapsing on PARP inhibitors. TAX2 displayed a selective biodistribution pattern in mice, concentrating at tumor sites. Our study showcased that while TAX2 alone exhibited significant but modest activity in PARPi-naive mice, its efficacy significantly increased post-PARPi exposure, irrespective of PARPi duration."

Clinical • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • BRCA2 • SIRPA