Shares of nano-cap biopharma Curis, Inc. CRIS are on a strong two-day run that has lifted the equity from penny stock territory.
What Happened: The Lexington, Massachusetts-based company, which focuses on developing innovative therapies for treating cancer, said the FDA has cleared its investigational new drug application for its CI-8993 asset.
CI-8993 is a monoclonal anti-VISTA antibody. It acts by blocking VISTA, which plays a key role in suppressing T-cell activity when activated.
Blocking VISTA reduces the suppression of T-cells and anti-tumor immune function, according to Curis.
Monotherapy with anti-VISTA therapy may help in treating cancers such as mesothelioma, triple negative breast cancer, non-small cell lung cancer and gynecologic malignancies, which the company said are highly driven by VISTA.
In other cancers, the company sees anti-VISTA therapy as being more effective as part of a combination approach.
What's Next: Curis said it plans to initiate a Phase 1a/1b study of CI-8993 in the second half of 2020.
The study is planned as a multi-center, open-label dose escalation study of CI-8993 in about 50 patients with relapsed/refractory solid tumors. The goal of the study is to identify the recommended dose and schedule.
"The clearance of our IND is an important step for the advancement of VISTA therapies, as CI-8993 becomes the first anti-VISTA antibody in development to enter clinical testing," Curis CEO James Dentzer said in a statement.
CRIS Price Action: At last check, Curis shares were skyrocketing 131.15% to $2.82.
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