A disruptive hypoxia activated prodrug for the treatment of resistant cancers: an AI-driven approach

Project Information

TUMAGNOSTIC

Grant agreement ID: 190158311

DOI

10.3030/190158311

Project closed

EC signature date 21 December 2023

Start date 1 January 2024

End date 31 December 2025

Funded under

• The European Innovation Council (EIC)

Total cost

€ 3 517 905,00

EU contribution

€ 2 462 533,50

Coordinated by

CONVERT PHARMACEUTICALS
Belgium

Periodic Reporting for period 2 - TUMAGNOSTIC (A disruptive hypoxia activated prodrug for the treatment of resistant cancers: an AI-driven approach)

Reporting period: 2025-01-01 to 2025-12-31

Summary of the context and overall objectives of the project

Convert Pharmaceuticals SA (Convert) is a drug development company dedicated to leveraging tumour hypoxia for therapeutic advantage. Its leading candidate, CP-506, is a hypoxia-activated prodrug (HAP) that becomes active within tumours, exhibiting low toxicity. In addition to drug development, Convert specializes in biomarker innovation for precision medicine. The company is conducting a Phase I-IIa clinical trial for CP-506 (TUMAGNOSTIC) and holds intellectual property (IP) for another HAP that has been tested in Phase I and II trials.
The primary goal of TUMAGNOSTIC is to carry out an early-stage (Phase I and IIa), first-in-human clinical trial of CP-506. The trial is designed as an open-label, uncontrolled, multicenter, multiple-dose study. It has already been approved by regulatory authorities in the Netherlands and Belgium (CTD). The trial's main objective is to evaluate safety and tolerability of CP-506, both as a standalone treatment and in combination with other therapies, such as immune checkpoint inhibitors or carboplatin. Secondary objectives include characterizing the pharmacodynamics and pharmacokinetics of CP-506 and determining its preliminary efficacy.
The trial is conducted in three modules, each consisting of two parts: (A) accelerated dose escalation and (B) an expansion cohort. The project aims to advance CP-506 from Technology Readiness Level (TRL) 5 to TRL 6 by completing Phase I clinical trials and laying the groundwork for TRL 7, which corresponds to the completion of Phase II clinical trials.
Convert employs an innovative tumour-agnostic strategy for this project, integrating AI-driven biomarkers to identify patients most likely to respond positively. This approach seeks to maximize treatment efficacy and minimize side effects, addressing challenges associated with previous HAPs.
A robust business development strategy will ensure that the project’s outcomes are effectively translated into further commercial development.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Clinical Progress: The clinical activities have continued to progress steadily. Two additional clinical sites—Erasmus UMC+ (Netherlands) and Institut Jules Bordet (Belgium)—have officially joined the study, expanding the project’s clinical footprint. In addition, regulatory approval has been obtained from competent authorities in Spain, paving the way for further site activation. Patient recruitment has accelerated, and dose escalation is well advanced, with several dose levels already reached. The accumulated data continue to confirm a favourable safety profile and encouraging pharmacokinetic results, consolidating the clinical relevance of the ongoing phase.
Manufacturing and Production:
On the production side, the manufacturing of the new drug product batch is actively progressing, ensuring sufficient supply for the continuation and completion of the study. These manufacturing activities follow the completion of the previous batch of drug substance and contribute to securing material for subsequent clinical phases.
Imaging and Analysis: The imaging work package has continued to support the clinical study through the standardized imaging procedures previously established. Biomarker analyses are being performed in parallel with patient inclusion, allowing real-time correlation of imaging and biological data as the study advances. These ongoing evaluations are strengthening the understanding of the therapeutic mechanism and optimizing the data integration pipeline for future analyses.
Intellectual Property and Pipeline Development: The project has maintained its momentum in reinforcing the intellectual property portfolio and expanding its drug development pipeline. The acquisition of intellectual property rights over an additional HAP compound continues to enhance Convert’s asset base, adding strategic value and potential for future research and clinical translation.
Industry Partnerships: The project team has continue to proactively establish connections within the pharmaceutical industry. Contacts with potential partners in the pharma industry are developing further, which could lead to valuable collaborations, funding opportunities, or eventual commercialization pathways.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The clinical study has now successfully scaled up, with six additional patients enrolled, providing a broader and more robust data set to evaluate the safety and pharmacokinetics of CP-506.
The project continues to apply a biomarker-driven patient selection strategy, monitoring markers associated with tumour hypoxia and homologous recombination repair defects. This approach remains critical to identifying patients most likely to respond to treatment, thereby improving clinical efficacy and supporting the development of a precision medicine framework for future application.
In parallel, progress has also been made on the financial and strategic fronts, with the attraction of additional capital advancing well. This will enable the continuation and expansion of the clinical development programme, including future studies to evaluate CP-506 both as a monotherapy and in combination with standard-of-care treatments. These combined achievements consolidate the project’s contribution to the development of a novel, mechanism-based cancer therapy and set the groundwork for its further clinical and commercial translation.