NEW YORK – Nouscom is planning to advance its neoantigen immunotherapy vaccine NOUS-209 into a potentially registration-enabling trial for cancer interception in patients with Lynch syndrome after positive meetings with the US Food and Drug Administration and an upcoming data readout.
Nouscom said it has completed Type B and Type C meetings with the FDA, which has given the firm a clear path forward to a potentially registrational Phase II/III trial of NOUS-209.
NOUS-209 is an off-the-shelf immunotherapy cancer vaccine targeting frameshift peptide (FSP) neoantigens. It encodes 209 unique FSP neoantigens that occur across multiple microsatellite instability tumor types to train immune cells to recognize and attack cancerous and precancerous cells before tumors can develop.
The firm is currently studying NOUS-209 in a Phase Ib/II trial as a cancer interception strategy for patients with Lynch syndrome, an inherited genetic disorder that confers a high risk of developing certain cancers. Nouscom plans to report data at the American Association for Cancer Research's annual meeting next month from 37 evaluable patients with Lynch syndrome enrolled in the study. The results showed that NOUS-209 induced neoantigen-specific T-cell responses in all patients.
Nouscom, based in Basel, Switzerland, is studying the treatment both as a preventive strategy in Lynch syndrome carriers and as a cancer treatment in combination with Merck's Keytruda (pembrolizumab) in patients with mismatch repair deficient or high microsatellite instability unresectable or metastatic gastric, gastro-esophageal junction, and colorectal cancers.