Treos Bio has activated its clinical trial site at the Mayo Clinic in Rochester, Minnesota to carry out a Phase I trial of PolyPEPI 1018 vaccine to treat patients with metastatic colorectal cancer (mCRC).
Mayo Clinic is the only site in the US that will conduct the trial, which is designed to evaluate the safety, tolerability, and immunogenicity of PolyPEPI 1018 as an add-on treatment to the standard-of-care maintenance therapy inmCRC.
Under the trial, vaccine induced T cell immune responses and tumour-infiltrating lymphocytes will be identified by bioassays, and the correlation with the predicted T cell immune responses will be analysed.
The trial will enrol ten adult patients aged between 18 and 75 who have experienced either a partial response or stable disease during first‑line treatment with a systemic chemotherapy regimen and one biological therapy regimen.
Treos Bio executive chairman Dr Menghis Bairu said: “While progress has been made in treating colorectal cancer and improving outcomes, metastatic colorectal cancer is today the second leading cause of cancer death in the US.
“There is an urgent need for new therapeutic options.”
The PolyPEPI 1018 is a precision cancer vaccine to be developed for mCRC.
The colorectal cancer (CRC) vaccine features six synthetic peptides that are selected to induce T cell responses against 12 epitopes from seven cancer testis antigens (CTAs) most frequently expressed in colorectal cancers.
Treos Bio chief medical officer Franco Lori said: “Treos has long worked to understand how to stimulate the human immune system to destroy tumour cells without attacking healthy cells.
“As the pieces are now in place to begin enrolling patients in this first-in-man clinical trial of our off-the-shelf, precision cancer vaccine, it moves us one step closer to addressing an unmet need of patients and combating this deadly disease.”
According to GLOBOCAN, colorectal cancer is the third most common cancer across the globe, representing 9.7% of all cancers apart from non-melanoma skin cancers with around 700,000 deaths in 2012 worldwide.