Darleukin/fibromun

Sun Pharmaceutical has signed a global licensing agreement with Philogen for commercializing Philogen’s specialty product, Fibromun (L19TNF). Fibromun, an innovative anti-cancer immunotherapy, is being investigated in registration trials by Philogen for the treatment of soft tissue sarcoma and glioblastoma. Under the terms of the agreement, Sun Pharma will have the exclusive worldwide rights to commercialise Fibromun. Philogen will complete the ongoing pivotal clinical trials for the product, pursue Marketing Authorization with regulatory authorities, and manufacture commercial supplies. Sun Pharma will be responsible for commercialization activities. The two partner companies will share post-commercialization economics in about 45 (Philogen):55 (Sun Pharma) ratio. Other financial terms were not disclosed. Dilip Shanghvi, Chairman and Managing Director of Sun Pharma, said, “Fibromun’s progress through development has been quite encouraging and it has potential to be an important option for treatment of soft-tissue sarcomas and other cancers with significant unmet medical needs. This partnership expands our clinical pipeline into oncology in alignment with our current portfolio in skin cancers. We keenly look forward to providing this treatment option globally in due course of time.” Dr. Dario Neri, CEO and CSO of Philogen commented, “We are pleased to extend our collaboration with Sun Pharma, a leading global pharmaceutical company, from our existing partnership on Nidlegy™ to Fibromun. This collaboration will focus on the global commercialization of Fibromun, a new immunotherapy that has the potential to serve patients with soft tissue sarcoma and certain malignant forms of brain tumors (e.g., glioblastoma), for which limited therapeutic alternatives exist. Our group has published data reflecting the promising therapeutic activity of Fibromun in glioblastoma, inducing long-lasting anti-tumor responses in a subset of patients. We have also announced that an independent monitoring board has evaluated the safety and efficacy data of the pre-planned interim analysis of our Phase III clinical trial in soft tissue sarcoma and recommended continuing the study as planned by the protocol. Given these promising developments, both companies are committed to the development and commercialization of Fibromun, making it widely available to patients who may benefit from it.” Previously, the two companies announced that they entered into an exclusive distribution, license, and supply agreement for commercializing the specialty product Nidlegy in Europe, Australia and New Zealand. The first Marketing Authorization Application for Nidlegy has been submitted to European Medicines Agency (EMA) for the treatment of locally advanced, fully resectable melanoma in the neoadjuvant setting.

A total of 256 patients were enrolled across 22 clinical centres in Germany, Italy, France and Poland. Credit: Gorodenkoff / Shutterstock. The European Medicines Agency (EMA) has validated Philogen and Sun Pharmaceutical’s marketing authorisation application (MAA) for Nidlegy, a treatment for melanoma. Nidlegy is an investigational treatment for neoadjuvant (before surgical procedure) locally advanced fully resectable melanoma. The application, submitted on 4 June 2024, is based on data from the Phase III PIVOTAL study and a Phase II trial. The international, multicentre, randomised, comparator-controlled, parallel-group PIVOTAL trial assessed the efficacy and safety of Nidlegy as a neoadjuvant treatment in melanoma patients with locally advanced, fully resectable cutaneous, subcutaneous or nodal metastases accessible to intratumoural injection. A total of 256 patients were enrolled across 22 clinical centres in Italy, Germany, France and Poland. See Also: CAN-3110 by Candel Therapeutics for High-Grade Glioma: Likelihood of Approval ICTCAR-028 by Innovative Cellular Therapeutics for Hematological Tumor: Likelihood of Approval Results from the PIVOTAL trial showed that Nidlegy reduced the relapse or mortality risk by 41% versus the control arm, with a significant improvement in median recurrence-free survival and distant metastasis-free survival (DMFS). Nidlegy’s safety profile was characterised by mostly low-grade, local adverse events. No grade 3 or grade 4 immune-related adverse events or drug-related deaths were recorded. Nidlegy is a biopharmaceutical product of Philogen, designed to treat skin cancer through intralesional administration of two active ingredients, L19IL2 and L19TNF. These ingredients are pro-inflammatory cytokines with potent anti-tumour activity. Nidlegy is also being investigated in additional Phase III trials for locally advanced melanoma and Phase II trials for high-risk basal cell carcinoma and other non-melanoma skin cancers. Philogen CEO and chief scientific officer Dario Neri stated: “The validation of the dossier by the EMA represents the first important milestone for the MAA review process.” “Our group is committed to working with EMA throughout the review process to make Nidlegy available to patients in need.”