Company Update (NASDAQ:CRIS): Curis, Inc. Announces FDA Acceptance of Investigational New Drug Application for CA-170

Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for CA-170.  CA-170 is a first-in-class orally available small molecule that has been designed to target and inhibit the immune checkpoints, Programmed Death Ligand-1 (PD-L1) and V-domain Immunoglobulin Suppressor of T-cell Activation (VISTA).

“The acceptance of CA-170’s IND by the FDA marks an important milestone in the advancement of immuno-oncology therapy,” said Ali Fattaey, Ph.D., Curis’s president and CEO. “The last few years have seen the successful development and commercial launch of multiple checkpoint inhibitors to treat a broad range of human cancers.  However, all checkpoint inhibitors developed thus far have been monoclonal antibodies, with similar pharmacokinetic properties, and can only be administered by IV infusion.  Today, the FDA has cleared us to test the first small molecule checkpoint inhibitor, CA-170, that will be taken orally by cancer patients.  We envision that the pharmacokinetic properties of a small molecule will likely provide an advantage in dosing flexibility of a checkpoint inhibitor, either as a monotherapy or in combination with other cancer treatment regimens.  We believe that, if successful, CA-170 can provide a compelling treatment alternative for patients and physicians.”

CA-170 is an orally available, small molecule designed to selectively target and inhibit both PD-L1 and VISTA checkpoint regulators of immune activation. Preclinical data have demonstrated that CA-170 can induce effective proliferation and cytokine production by T cells in culture that are specifically suppressed by PD-L1 or VISTA. In addition, CA-170 demonstrated in vivo anti-tumor activity similar to anti-PD-1 or anti-VISTA antibodies in multiple mouse tumor models and appeared safe to administer based on toxicology studies. (Original Source)

Shares of Curis closed yesterday at $1.75, up $0.05 or 2.94%. CRIS has a 1-year high of $3.75 and a 1-year low of $1.25. The stock’s 50-day moving average is $1.88 and its 200-day moving average is $1.99.

On the ratings front, Curis has been the subject of a number of recent research reports. In a report issued on May 19, FBR analyst Christopher James reiterated a Buy rating on CRIS. Separately, on May 5, Cowen’s Boris Peaker assigned a Buy rating to the stock .

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Christopher James and Boris Peaker have a total average return of -10.8% and 11.3% respectively. James has a success rate of 38.1% and is ranked #3778 out of 3891 analysts, while Peaker has a success rate of 45.5% and is ranked #261.

Curis, Inc. is a biotechnology company, which is focused on the development and commercialization of innovative drug candidates for the treatment of human cancers. Its pipeline includes is CUDC-907, an orally-available, small molecule inhibitor of histone deacetylase, or HDAC, and phosphatidylinositol-3-kinase, or PI3K enzymes. The company conducts research programs both internally and through strategic collaborations. Curis was founded on February 14, 2000 and is headquartered in Lexington, MA.

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