Curis, Inc. (NASDAQ:CRIS) Announces CI-8993 IND Approval By The Food And Drug Administration

Curis, Inc. (NASDAQ:CRIS) recently announced that it received the Food and Drug Administration’s (FDA) approval of an Investigational New Drug (IND) application that it submitted for CI-8993.

CI-8993 is a developmental monoclonal anti-VISTA antibody that Curis has been developing for cancer treatment. The IND approval marks a significant milestone for the company, which deals with the development of innovative and effective cancer treatment. The approval will also allow Curis to commence its Phase 1a/1b study of the treatment within the second half of 2020.

“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,” stated Curis CEO James Dentzer.

The CEO pointed out that VISTA has a significant contribution to suppressing T-Cell activity, especially when activated. He also added that pre-clinical studies have demonstrated that blocking VISTA reduces the likelihood of T-Cells being suppressed. The approach also plays a critical role in the process because it facilitates the reactivation of the mechanism that prevents the formation of tumors.

Mr. Dentzer stated that his company’s research team is eager to take advantage of their extensive VISTA experience to create the first of its kind anti-VISTA antibody treatment. This approach may prove to be very effective in combatting cancers that have high VISTA levels. Some cancers include non-small cell lung cancer, triple-negative breast cancer, mesothelioma, and gynecologic malignancies.

Anti-VISTA therapy might provide a superior alternative to cancer treatment

Anti-VISTA therapy might even be more effective against other types of cancers, especially when combined with other types of cancer treatments. This is because VISTA does not depend or is not tied to other immune checkpoints such as CTLA4 and PD1.

Past studies demonstrated that VISTA expression increases 5 times as a compensation mechanism when anti-PD1 and anti-CTLA4 treatments are administered. This means that the use of those treatments might prove more effective when anti-VISTA mechanisms are deployed since they will prevent the compensation mechanism from coming into play.

Curis will conduct the Phase 1a/1b CI-8993 study as an open-label dose-escalation study. It will evaluate patients that have relapsed solid tumors, and about 50 patients will be part of the study.