CoImmune, Inc. announced that the FDA approved its investigational new drug application (IND) for CMN-001 (formerly known as AGS-003), allowing for the company to begin a Phase 2b clinical trial in patients with advanced metastatic renal cell carcinoma (mRCC).
CMN-001 is a dendritic cell-based immunotherapy custom matched to each patient’s particular disease. The rationale for the design of the randomized Phase 2b trial comes from a retrospective analysis of a prior clinical trial with CMN-001 involving more than 90 randomized subjects, where a strong synergy was observed with one of the approved drugs for treatment of mRCC.
This phase 2B trial will recruit primarily poor risk mRCC patients. The clinical trial is being led by principle investigator Dr. Christopher G. Wood, Professor and Vice Chairman in the Department of Urology at the University of Texas MD Anderson Cancer Center in Houston, Texas. Five clinical centers will participate in the trial, with the first patient anticipated to receive treatment in Q2 2020.
Korean bio companies SCM Life Science and Genexine teamed up to acquire US-based Argos Therapeutics in February of 2019. Argos Therapeutics, a cancer vaccine developer, was subsequently renamed CoImmune and operates as an independent entity in the US.
CMN-001 is a dendritic cell-based, individualized immunotherapy that captures both mutated and variant antigens that are unique to each patient’s tumor, specifically designed to induce an immune response targeting the patient’s particular tumor antigens.
About Kidney Cancer
Kidney cancer is one of the 10 most common cancers in the United States with 90% being attributed to renal cell carcinoma. Death attributed to renal cell carcinoma accounted for 2% of all cancer deaths or approximately 14,000 persons in 2016. Men are diagnosed with renal cell carcinoma at almost twice the rate of women, and there is a greater prevalence in black men. Most cases are diagnosed between 60 and 70 years of age.Source: CoImmune