Philogen S.p.A., a privately-owned biotechnology company, is pleased to announce that the Swiss national competent authority Swissmedic issued the authorization to run a clinical phase II study in patients with locally advanced, not metastatic nonmelanoma skin cancer. A favourable opinion about the study has now also been obtained by EKOS (Ethics Committee of Eastern Switzerland).

Patients enrolled in the clinical study will be treated with intralesional injections of Nidlegy. Nidlegy, the combination of the two active principles bifikafusp alfa (L19IL2) and onfekafusp alfa (L19TNF), has already shown promising results in the intralesional neoadjuvant treatment of patients with resectable Stage III melanoma in two phase III clinical trials. The durable responses, the excellent safety profile and the favorable cosmetic outcome of injected melanoma lesions have reinforced the investigation of efficacy and safety of NidlegyTM in injectable, locally advanced and not metastatic lesions of basal cell carcinoma or cutaneous squamous cell carcinoma.

"We are delighted to start the clinical phase II study in Switzerland and to explore the potential of NidlegyTM in patients with locally advanced, not metastatic nonmelanoma skin cancer," commented Prof. Dario Neri, co-founder and President of the Scientific Advisory Board of Philogen.

Philogen is a Swiss-Italian clinical-stage company engaged in the discovery and development of novel pharmaceutical and biopharmaceutical products. Philogen's strategy is to deliver bioactive agents, for example, cytokines or drugs, to the site of disease using antibodies and other ligands that specifically and efficiently target stromal antigens. This technology has generated a strong proprietary pipeline of clinical-stage products and preclinical compounds in an array of disease indications. Philogen is headquartered in Siena, Italy, and has research activities at its subsidiary company Philochem in Zürich, Switzerland. Philogen is independently owned and has signed agreements with several major pharmaceutical companies.