OSE Immunotherapeutics SA (ISIN: FR0012127173) (Mnemo: OSE) (Paris: OSE), a biotech company dedicated to developing first-in-class assets in immuno-oncology and immuno-inflammation, revealed on Wednesday that the Spanish Drug Agency (Agencia Espanola de Medicamentos y Productos Sanitarios, AEMPS) has made a new early access programme available for Tedopi, through a Special Situation Authorization in the treatment of advanced or metastatic non-small cell lung (NSCLC) after immune checkpoint inhibitor (ICI) failure.

The company said that this Special Situation Authorization, which is intended to provide early access to medicines for patients with a severe or rare disease with high unmet need and for which no authorised therapeutic alternatives available, is based on the positive clinical data from the initial phase 3 trial of Tedopi (ATALANTE-1) in third line treatment and the high unmet need for advanced NSCLC patients.

According to OSE Immunotherapeutics, Tedopi is the first cancer vaccine to show positive and clinically meaningful efficacy results with significant gain in survival associated with a better safety and quality of life profile in advanced NSCLC patients. This is administered in monotherapy versus active comparator (chemotherapy-based standard of care), in third line with secondary resistance to immune checkpoint inhibitor (ICI).

Following the earlier nominative compassionate use programme for patients that were included in the phase 3 ATALANTE-1 trial, the Health Authorities in Spain are now expecting applications for the early access to Tedopi through an unlimited Special Situation programme.