CoImmune, Inc. Announces FDA Approval of its IND Application to Conduct a Phase 2b Clinical Trial with CMN-001 in Advanced RCC Patients
DURHAM, N.C., Feb. 19, 2020 (GLOBE NEWSWIRE) — CoImmune, Inc. announced today that the FDA approved its investigational new drug application (IND) and that it is cleared to move forward with a Phase 2b clinical trial in advanced metastatic renal cell carcinoma (mRCC).
CMN-001, formerly known as AGS-003, 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. CoImmune scientists have discovered the molecular basis of the observed synergy and filed a patent application on this new mechanism of action for the combination therapy in January 2020.
This 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. “Even with the latest and best available therapies, there is room for improvement in survival outcomes for high-risk mRCC patients. There is a good scientific rationale for conducting this Phase 2b trial and, if successful, CMN-001 may provide a further advance in the treatment of these patients,” stated Dr. Wood. CoImmune intends to initiate five clinical centers of excellence to participate in the trial and expects to treat the first patient in Q2 2020.
“We are very excited to be in a position to initiate the clinical trial with our lead product, CMN-001, just one year after starting up CoImmune,” said Dr. Charles Nicolette, chief executive officer of CoImmune. He added “Our prior clinical data and our new understanding of the mechanism of action of CMN-001 gives us confidence that we can reproduce the positive clinical signal previously observed.”
About CoImmune, Inc.
CoImmune specializes in the development of personalized immuno-oncology therapies including its lead candidate, CMN-001, for the treatment of metastatic renal cell carcinoma. 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. CoImmune is also developing a clinical stage off-the-shelf CAR-T-like therapy for the treatment of acute lymphoblastic leukemia (ALL) in adult and pediatric patients.
For more information visit www.coimmune.com