Philogen S.p.A., a clinical-stage biotechnology company, announced that France's National Agency for the Safety of Medicines and Health Products (ANSM) has authorized the company to run a phase II study of Nidlegy in patients affected by different non-melanoma skin cancer indications. A favourable opinion about the study had already been obtained by one of the country's ethic committees (Comité de Protection des Personnes Sud-Est III) in January 2022.

Patients affected by basal cell carcinoma (BCC), cutaneous squamous cell carcinoma (cSCC), merkel cell carcinoma, keratoacanthoma, tumoural cutaneous T-cell lymphoma, Kaposi's sarcoma or adnexal tumours of the skin, for whom available alternatives have already been exhausted or who are no candidates to such alternative approaches will be eligible for the clinical study.

Nidlegy, the combination of the two active principles bifikafusp alfa (L19IL2) and onfekafusp alfa (L19TNF), has already shown promising results in the intralesional treatment of patients with advanced melanoma and in BCC and cSCC in an ongoing phase II study. The durable responses, excellent safety profile and favourable cosmetic outcome of injected lesions have encouraged the investigation of efficacy and safety of Nidlegy in injectable lesions of numerous non-melanoma skin cancer indications, which are underserved by alternatives presently available.

Prof. Dario Neri, co-founder and president of the Scientific Advisory Board of Philogen said: "We are delighted to start this clinical Phase II study in non-melanoma skin cancers in France under the leadership of Prof. Jean-Jacques Grob, a world-class expert in this group of tumors and to explore the potential of Nidlegy in patients for whom existing therapeutic alternatives are not or no longer practicable."

Philogen is a Swiss-Italian clinical-stage company, listed on the Italian stock exchange, engaged in the discovery and development of novel pharmaceutical and biopharmaceutical products.