Biotechnology company Curis Inc. (CRIS:NASDAQ), which concentrates its efforts on developing innovative therapeutics for treating cancer, today announced that "the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CI-8993, the first-in-class monoclonal anti-VISTA antibody. Curis plans to initiate a Phase 1a/1b study of CI-8993 in the second half of 2020."
The company's President and CEO James Dentzer 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."
The firm mentioned that certain cancers may be amenable to monotherapy treatment with anti-VISTA therapy. Curis stated that several of these cancers are known to be highly driven by VISTA including mesothelioma, triple negative breast cancer, non-small cell lung cancer and gynecologic malignancies. The company noted that with some other types of cancers, anti-VISTA therapy may be more effective as part of a combination therapy approach.
The company advised that it expects to commence a multi-center Phase 1a/1b dose escalation study of CI-8993 in patients with relapsed/refractory solid tumors in H2/20. The trial will enroll about 50 patients with the objective of determining recommended dosage levels.
The firm explained that "VISTA is a novel negative checkpoint ligand that is homologous to PD-1/PD-L1 and suppresses T cell activation and that it relieves negative regulation by hematopoietic cells and enhances protective anti-tumor immunity, and is highly expressed on myeloid cells and T cells."
Curis Inc. is a biotechnology company based in Lexington, Mass., that is engaged in developing therapeutics to treat cancer. The company is engaged in a collaboration with ImmuNext for development of CI-8993, a monoclonal anti-VISTA antibody. Curis indicated that it is also collaborating with Genentech, a member of the Roche Group, for commercializing Erivedge® for use in treatment of advanced basal cell carcinoma.
Curis began the day with a market capitalization of around $44.6 million with approximately 36.6 million shares outstanding. CRIS shares opened nearly 80% higher today at $2.19 (+$0.97, +79.51%) over yesterday's $1.22 closing price and reached a new 52-week high price this morning of $3.59. The stock has traded today between $1.88 to $3.59 per share and is currently trading at $2.87 (+$1.65, +135.24%).
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