Why the FDA Is Pushing Curis Stock So Much Higher

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By Chris Lange Published
Why the FDA Is Pushing Curis Stock So Much Higher

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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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About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics. Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications. A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.

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