NEW YORK – Nouscom said on Thursday that it has gotten the go-ahead from Spanish regulators to begin a Phase Ib trial evaluating its bespoke cancer vaccine NOUS-PEV as a first-line treatment for locally advanced melanoma and non-small cell lung cancer.
The trial, which the Spanish National Agency of Medicines and Medical Devices has now approved, will evaluate the safety, feasibility, and preliminary efficacy of NOUS-PEV combined with pembrolizumab (Merck's Keytruda). It will enroll 28 patients whose cancers express PD-L1 in more than 50 percent of tumor cells and will take place at sites across Spain and other European countries.
The personalized vaccine, which the Basel, Switzerland-based company says has tripled the efficacy of anti-PD-1 and anti-PD-L1 checkpoint inhibitors in preclinical, proof-of-concept studies, is designed to target up to 60 unique neoantigens expressed on a patient's tumor. The manufacturing process that Nouscom has developed allows the company to assemble patient-specific doses that include all of the neoantigens in one vaccine vector. According to Nouscom, the treatment also resulted in CD8-positive and CD4-positive, neoantigen-specific T-cell responses following vaccination, suggesting anti-tumor activity.
The company believes the vaccine could ultimately be used to treat "any cancer indication where a tumor biopsy is available that is suitable for next-generation sequencing," but it is beginning with melanoma and NSCLC due to the high frequency of somatic mutations in these tumor types.