Friday, September 30, 2022


Biotechnology News Magazine

FDA Clearance of IND Application for PolyPEPI1018 Immunotherapy for the RX of Metastatic Colorectal Cancer

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PolyPEPI1018 Immunotherapy

PolyPEPI1018, Treos’ lead product candidate, is an off-the-shelf immunotherapy in clinical development for the treatment of metastatic colorectal cancer, co-developed with a candidate companion diagnostic. The therapy is in development as add-on to first-line maintenance therapy and to third-line treatment. PolyPEPI1018 has been developed using Treos’ proprietary PASCal computational tool to identify Personal EPItopes (PEPIs) that are likely to induce antigen-specific T Cell responses in a patient.

Today Treos Bio Limited (“Treos”), a clinical stage biotechnology company using data science and proprietary biomarkers to develop both precision off-the-shelf and personalized peptide immunotherapies for cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for PolyPEPI1018, the Company’s lead product candidate, as an add-on to third-line chemotherapy (TAS-102) for the treatment of patients with late-stage metastatic colorectal cancer (mCRC).

“The acceptance of this IND for mCRC marks another milestone in the advancement of our lead cancer immunotherapy program, PolyPEPI1018,” said Dr. Christopher C. Gallen, M.D., Ph.D., Chief Executive Officer of Treos. “The treatment landscape for patients in this late-stage setting is dire, as many face scarce alternatives following long chemotherapy regimens. We believe our product candidate, designed with 12 computationally selected HLA Class I and II epitopes most frequently presented in mCRC tumors, has the potential to demonstrate improved anti-tumor activity for this growing patient population.”

OBERTO 201 is a single arm, open label, investigator-initiated Phase 1b trial evaluating 15 patients with metastatic colorectal cancer who are beginning a third-line treatment of the oral chemotherapy TAS-102. The first dose will be administered on day 17 after initiation of third-line therapy. The primary endpoint of the study is safety and secondary endpoints are progression-free survival as well as other measures of anti-tumor activity and immunologic response.

The trial is funded by a grant awarded to Mayo Clinic in Minnesota (awardee) and to Treos (sub-awardee) by the U.S. Department of Defense Congressionally Directed Medical Research Program.

About Colorectal Cancer

Colorectal cancer (CRC) is the third most common cancer and cause of death in the United States and the third leading cause of cancer-related deaths worldwide. Microsatellite stable (MSS) CRC accounts for 85 percent of CRC cases and almost all cases of mCRC. There are approximately 1.4 million people living with colorectal cancer in the United States. Current treatments for CRC include surgery and chemotherapy in early stages of disease and chemotherapy, biologics and targeted therapies in later stages.


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