Why the FDA Is Pushing Curis Stock So Much Higher

Curis Inc. (NASDAQ: CRIS) shares jumped on Wednesday after the company announced that the U.S. Food and Drug Administration (FDA) had cleared its Investigational New Drug (IND) application for CI-8993, the first-in-class monoclonal anti-VISTA antibody.

VISTA is a novel negative checkpoint ligand that is homologous to PD-1/PD-L1 and suppresses T cell activation. So anti-VISTA therapy helps to increase the count of T-cells, which in turn fight different cancers.

Certain cancers, such as mesothelioma, triple-negative breast cancer, non-small cell lung cancer and gynecologic malignancies, are known to be highly driven by VISTA. These cancers may be amenable to monotherapy treatment with anti-VISTA therapy.

In other cancers, anti-VISTA therapy may be more effective as part of a combination approach.

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Curis plans to initiate a Phase 1a/1b study of CI-8993 in the second half of 2020.

James Dentzer, president and CEO of Curis, commented:

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. When activated, VISTA plays a critical role in suppressing T cell activity. Conversely, it has been shown in preclinical studies that blocking VISTA reduces the suppression of T cells and reactivates anti-tumor immune function. We are eager to leverage our extensive experience with VISTA and pioneer this first-in-class anti-VISTA antibody program.

Curis stock traded about 71% to $2.09 on Wednesday, in a 52-week range of $0.62 to $2.90.

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