Investor Relations Captor Therapeutics ®
Conclusion of service contracts for Phase I clinical trials for the CT-01 project with ICON Clinical Research Limited
Current report no. 46/2023
Date of drafting: 13 October 2023.
Subject: Conclusion of service contracts for Phase I clinical trials for the CT-01 project with ICON Clinical Research Limited
Legal basis: Article 17(1) MAR - confidential information.
The Management Board of Captor Therapuetics S.A., based in Wrocław, Poland (the "Company"), announces that on 13 October 2023, the Company has entered into the following agreements with ICON Clinical Research Limited ("ICON") to conduct Phase I clinical trials for Project CT-01 (discovery and development of a drug candidate for the treatment of hepatocellular carcinoma for the elimination of cancer stem cells by induced degradation of an oncogenic transcription factor):
- Start-Up Agreement for the initial services required to prepare the study protocol and enter into a full-scale contract for a Phase I, open-label, dose-escalation and dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CT-01 in patients with intermediate or advanced hepatocellular carcinoma with an estimated fee and cost budget of €275,000; and
- Master Service Agreement, the purpose of which is to establish the terms and conditions of the collaboration between the Company and ICON regarding the provision by ICON of the full range of services related to the Phase I clinical trial concerning CT-01 under which, once the full range of services required for Phase I of this clinical trial has been established, a detailed Statement of Work will be concluded.
The Company estimates that the costs associated with the services envisaged in 1 and 2 above will amount to approximately EUR 8 million, with the above budget subject to change depending on the final defined scope of work.
The Company notes that the commencement of Phase I clinical trials of CT-01 is one of the objectives indicated in "Company Strategy. Next Steps 2023-2025", which the Company announced in current report 7/2023 on 6 March 2023.
ICON is a world leading clinical research company with over 30 years of experience in conducting clinical trials to support drug development. Over the past five years, ICON has participated in more than 800 oncology and hematologic malignancy clinical studies.