Curis, Inc. (NASDAQ:CRIS) is a drug development company focused on innovative pathway drug technologies and targeted small-molecule drug candidates for cancer. The company has a pipeline of several small-molecule drugs, partnered and unpartnered. Vismodegib, brand-name, Erivedge, is their first-in-class hedgehog inhibitor approved by the FDA in early 2012 for advanced basal cell cancer. Under development in partnership with Genentech-Roche (OTCQX:RHHBY) Erivedge is also being clinically tested in several other indications including pancreatic cancer.
On June 19, 2012, the American Association for Cancer Research held a pancreatic cancer conference in which data from a small clinical trial was released. The data showed 10 of 20 evaluable patients were alive without progression after 3 months when Erivedge was combined with gemcitabine. According to the release, "some patients actually progressed with vismodegib alone, but then had a major response when gemcitabine was added to the treatment." Also, 28% of the patients in the study (N=5) had partial responses (tumor shrinkage), 5 other patients had stable disease, resulting in a 3 month progression free survival of 50%.
Investigators in the study showed that those patients who responded best to the drug combination had higher levels of sonic hedgehog expression prior to the treatment. This is important for future combination studies with Erivedge because investigators will be able to determine which patients will be best responders to the drug.
Daniel Von Hoff, MD, of the Mayo Clinic stated, "the response rate in this study is very high." Generally, the response rate in this patient population would only be around 5-10% with gemcitabine alone. In this study, when Erivedge was added to gemcitabine, the response rate was 25%, "which is beyond what one would have expected," said Von Hoff.
Further studies combining Erivedge, gemcitabine, and Celgene's Abraxane in pancreatic cancer should have results later in 2012. I believe combining Abraxane will further the results in the previous study. Should such results show greater improvement, I believe it will greatly enhance the potential of Erivedge in indications other than their current label for advanced basal cell cancer.
At current levels, I believe CRIS is extremely undervalued. Should Erivedge make a break-through in an indication such as pancreatic cancer, it could potentially add another $1 billion to future revenues for Erivedge of which Curis is entitled to royalties. Erivedge revenues are already predicted to be >$1 billion for their current approved label in advanced basal cell carcinoma, and further development in operable basal cell carcinoma could potentially double that number as well.
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Disclosure: I am long CRIS.