Darleukin/fibromun

Sun Pharmaceutical Industries Ltd. and Philogen have announced the successful completion of patient enrollment in the Phase III FIBROSARC trial for Soft Tissue Sarcoma (STS). All ongoing Fibromun trials remain on track with their expected timelines. Dario Neri, CEO of Philogen, commented, "We are highly encouraged by the progress of Fibromun’s pivotal trials in both Soft Tissue Sarcoma and Glioblastoma. In October 2024, the program entered a strategic commercial partnership with Sun Pharma, a leading multinational pharmaceutical company. The Soft Tissue Sarcoma trials are proceeding as planned across Europe and the United States. Key readouts from our most advanced studies—Phase III FIBROSARC and Phase II FLASH—are anticipated between March and June 2025. These results represent critical milestones for Philogen, as Fibromun has the potential to become our second product to successfully complete multinational clinical trials with registration potential. We are also seeing faster-than-expected patient enrollment in the Glioblastoma trials. The Phase II GLIOSTAR trial, originally projected to complete enrollment by December 2025, is now expected to conclude recruitment in Q2 2025. Philogen remains committed to advancing innovative therapies and delivering meaningful outcomes for patients worldwide.” Dilip Shanghvi, Chairman and Managing Director of Sun Pharma, said, “We look forward to the Fibromun readouts over the next few months. Fibromun has the potential as a valuable treatment option for soft-tissue sarcomas and other cancers with high unmet medical needs. The candidate aligns well with our current portfolio in skin cancers.” Philogen has entered an Exclusive Distribution, License, and Supply Agreement with Sun Pharma for commercializing Fibromun globally, which strengthens their ongoing collaboration on Nidlegy™ in Europe, Australia and New Zealand.

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.