Genenta Science receives Orphan Drug Designation from EC for Temferon

Genenta Science announced that the European Commission has granted Orphan Drug Designation to Temferon for the treatment of glioma. Glioblastoma Multiforme is the first clinical indication of Temferon. GBM is the most common malignant primary brain tumor and the most aggressive diffuse glioma, with unmethylated MGMT promoter status identified in approximately 60% of the GBM population. Temferon is Genenta’s product at the most advanced stage of development and consists of the patient’s own stem progenitor cells modified with Genenta’s platform to express interferon alpha within solid tumors. IFNa is a well-known immunomodulatory protein that has been used in the clinic for decades for the treatment of a variety of cancers, but with limited current use because of the systemic toxicity. Genenta’s platform is designed to avoid systemic toxicity and selectively deliver therapeutic activity within the solid tumor. From pre-clinical experiments, it has been observed that Temferon breaks tumor-induced tolerance, thus allowing the immune system to recognize the tumor and mount a durable immune response.