Mumbai-based Sun Pharmaceutical Industries and Swiss-Italian biotech firm Philogen S.p.A have entered into a global licensing agreement for commercialising 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 Authorisation with regulatory authorities, and manufacture commercial supplies.

Sun Pharma will be responsible for commercialisation activities. The two partner companies will share post-commercialisation economics in about 45(Philogen):55(Sun Pharma) ratio. Other financial terms were not disclosed.

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 Tumour Necrosis Factor (TNF). L19 binds selectively to the Extra Domain B of Fibronectin, a protein expressed in tumours (and other diseases) but absent in most healthy adult tissues. TNF is a cytotoxic cytokine with anti-tumour activity that is preferentially localised by the L19 antibody to neoplastic masses. L19TNF is administered via intravenous infusion.

Late-stage clinical trials with registration potential are on-going in soft tissue sarcoma and glioblastoma. The product has pan-tumoural potential and could be explored for the therapy of other cancer types (e.g., lung, breast, colon, prostate cancers).