Date prepared: June 13, 2023
Abbreviated name of the issuer: CELON PHARMA S.A.
Subject: Celon Pharma S.A.’s project on clinical development of the innovative CPL110 inhibitor in FGFR-dependant solid tumors will receive co-funding
Legal basis: Article 17 (1) of the Market Abuse Regulation (MAR) – inside information.
Content of the report:
The Management Board of Celon Pharma S.A. (“Company”) wishes to announce that on June 13, 2023 it received information that the Company’s application for co-funding of its project (“Project”) entitled “Clinical development of the innovative CPL110 inhibitor in FGFR-dependant solid tumors” (“Rozwój kliniczny innowacyjnego inhibitora CPL110 w nowotworach litych FGFR zależnych”) (“Project”), submitted to the competition announced by the Medical Research Agency (ABM) for the development of targeted medicine based on nucleic acids and small molecule compounds (ABM/2022/6) was granted co-funding.
The total cost of the project was estimated at approx. PLN 39.8 million and the co-funding amounts to approx. PLN 19.3 million. Project completion date: December 31, 2027
The project encompasses R&D, primary and industrial research, as well as development works, including conducting the phase II clinical trial – obtaining co-funding will allow for financing the currently implemented clinical development of CPL110 under the phase II after the year 2023.
The main aim of the Project is the clinical development of the innovative FGFR 1-3 - CPL110 (CPL304110) inhibitor in the phase IIA and IIB trial in patients with FGFR-dependant solid tumors and verification of biomarkers for patient stratification on clinical material. The clinical trial will verify the therapeutic dose and clinical indication for treatment, moreover a biomarker analysis scheme will be developed and validated thanks to the received clinical data.
The indicated therapeutic area is extremely important, as cancers are still the second most common causes of death in Poland and despite the constant advancement of medicine and targeted therapies in cancers, there is still a huge unmet therapeutic need in this area.
A significant share of these cancers are neoplasms with aberrations in the FGFR gene, which account for approx. 24% in non-small cell lung cancer, approx. 15% in gastric cancer, 10-20% in gall bladder cancer and 5-60% in bladder cancer, depending on the type of the investigated genetic change. Due to that fact, therapies targeted at FGFR-dependant tumors, in combination with personalized medicine, i.e., at selecting patients for treatment based on the presence of characteristic biomarker changes constitute a particularity appealing therapeutic target. However, due to the large diversity of genetic changes in tumors and the complexity of the carcinogenesis process and developing resistance during therapy, it is especially important to investigate the mechanism of action of the drug as comprehensively as possible and identify additional biomarkers that will allow for the best selection of patients for treatment.
Transfer of funds for the implementation of the Project is possible following the signing of a co-funding agreement within 30 working days from the date on which the information on the competition results was communicated to the Company. The Company will announce the conclusion of the co-funding agreement in a separate current report.