Philogen completes patient enrollment of Phase III FIBROSARC trial in soft tissue sarcom

New Delhi: Sun Pharmaceutical Industries Limited and Philogen, an Italian-Swiss biotech company, have announced the successful completion of patient enrollment in the Phase III FIBROSARC trial for Soft Tissue Sarcoma (STS). All ongoing Fibromun trials are expected remain on track with their expected timelines.

Fibromun is a biopharmaceutical product, proprietary to Philogen, studied for the treatment of advanced soft tissue sarcoma and glioblastoma. It consists of the L19 antibody genetically fused to Tumor Necrosis Factor (TNF). L19 binds selectively to the Extra Domain B of Fibronectin, a protein expressed in tumors (and other diseases) but absent in most healthy adult tissues.

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.”

Neri added: “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.