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# FDA OKs Treos Bio IND for Colorectal Cancer Vaccine
- URL: https://www.fdaweb.com/fda-oks-treos-bio-ind-for-colorectal-cancer-vaccine/
- Published: 2018-01-24T12:00:00.000Z
- Updated: 2026-09-14T23:16:53.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5140584

FDA has approved a Treos Bio IND for PolyPEPI 1018 to allow a Phase 1 study to proceed with the investigational precision cancer vaccine for patients with metastatic colorectal cancer (mCRC). The study will be conducted at Mayo Clinic in Rochester, Minnesota and University of Pisa in Italy.

It will investigate the safety, tolerability, and immunogenicity of a single dose of PolyPEPI1018 CRC Vaccine as an add-on treatment to the standard-of-care maintenance therapy in patients with metastatic colorectal cancer. Vaccine induced effector and memory T cell responses will be determined by bioassays and the correlation with the predicted T cell responses will be assessed in each study subject, according to the company.

Treos Bio says the vaccine contains six synthetic polypeptides that are “precisely selected to induce T cell responses against 12 epitopes from seven cancer testis antigens (CTAs) most frequently expressed in colorectal cancers. These polypeptides are optimized with the PEPI biomarker to induce robust and lasting CRC specific T cell responses.”