On June 1, 2023 Philogen S.p.A., a clinical-stage biotechnology company focused on the development of innovative medicines based on tumor-targeting antibodies and small molecule ligands, reported that it has entered into a Clinical Trial Collaboration and Supply Agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA) (Press release, Philogen, JUN 1, 2023, View Source [SID1234632352]). Under the terms of the supply agreement, MSD provides their anti-PD-1 therapy, KEYTRUDA (pembrolizumab), to be evaluated in combination with Philogen’s immunocytokines L19IL2, L19TNF, and Nidlegy in a randomized Phase II clinical trial. The study provides an opportunity to explore the combination of immunocytokines and PD-1 blockade in stage III and IV unresectable melanoma patients who failed prior checkpoint inhibitor therapies.
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Nidlegy is also investigated in two Phase III randomized clinical trials for the treatment of stage III B/C melanoma in Europe and in the United States, as well as in two Phase II clinical trials in High-Risk Basal Cell Carcinoma and other non-melanoma skin cancers.
Dario Neri, CEO and CSO of Philogen, commented: "KEYTRUDA has shown impressive response rates and long-term benefits for a substantial number of patients with advanced melanoma. However, only a minor proportion of patients who fail checkpoint inhibitors typically benefit from a subsequent re-challenge with single-agent PD-1 blockade. Clinical experience with intralesional recombinant IL2 has shown encouraging response rates when combined with systemic anti-PD-1 antibodies in advanced melanoma patients who progressed on or are resistant to checkpoint inhibitors. This provides a strong rationale to combine Nidlegy (L19IL2 + L19TNF) with KEYTRUDA in this setting, and we are pleased to partner with MSD, a global leader in immuno-oncology, to explore this opportunity."
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Nidlegy is a registered trademark of Philogen S.p.A. of La Lizza 7, 53100 Siena, ITALY