The start of the trial follows approval by the U.S. Food and Drug Administration of investigational new drug (IND) status for PolyPEPI 1018. The study will be conducted at the Mayo Clinic in Rochester, Minnesota, in the U.S., and at the University of Pisa, in Italy.
Researchers will test the vaccine’s safety and tolerability, as well as the overall reaction of patients’ immune systems. Participants will receive a single dose of PolyPEPI 1018 CRC vaccine in addition to standard-of-care maintenance therapy.
“Our goal is to address the needs of metastatic colorectal cancer patients, who today face a grim prognosis with an urgent need for new therapeutic options,” Menghis Bairu, MD, Treos Bio’s executive chairman, said in a press release. “This is an important milestone achieved by the Treos team.”
Based on the company’s proprietary databases and algorithms, Treos has developed a precision therapeutic cancer vaccine technology that includes PolyPEPI Companion Diagnostics, which can predict whether a treatment will be effective in a particular patient. The technology identifies specific biomarkers that can be targeted with great efficiency to promote cancer cell death without damaging healthy cells.
Treos has completed preclinical development of targeted vaccines for several cancers, including colorectal cancer, breast cancer, lung cancer, ovarian cancer, glioma, melanoma, and leukemia. The PolyPEPI 1018 CRC vaccine contains six synthetic proteins that induce long-lasting T-cell responses against seven biomarkers commonly present in CRC cells.
“We have spent years studying the mechanism [of] how to stimulate the human immune system to destroy tumor cells but not attack healthy cells. We have analyzed [a] large amount of genetic and clinical data from patients and developed proprietary algorithms to precisely identify the epitopes that stimulate immune responses in human subjects,” said Franco Lori, Treos Bio’s chief medical officer. “We are one step closer to [inducing] tumor specific immune responses in patients who cannot benefit from current immunotherapies.”
PolyPEPI Companion Diagnostics uses computer analysis to predict the benefit-risk profile of each vaccine according to a patient’s immune response, minimizing safety issues and improving the chances of anti-cancer responses, the company said.
“Treos’ IND is based on the qualification of novel predictive models of the therapeutic effects of cancer vaccines in human subjects,” said Julianna Lisziewicz, PhD, founder and chief scientific officer of Treos Bio. “Our proprietary biomarkers not only support the development of companion diagnostics but also decreases the risk and time of cancer vaccine development.”