FDA accepts ACT Biotech's ACTB1003 IND

ACT Biotech Inc., a privately held biotechnology company developing a portfolio of oral kinase inhibitors as anti-cancer drugs, today announced the acceptance of the Investigational New Drug (IND) application for ACTB1003 by the US Food and Drug Administration (FDA). The company has now assembled a complete preclinical package, including manufacturing and toxicology studies, allowing ACTB1003 to enter a clinical trial.

ACTB1003 is a novel oral kinase inhibitor that targets cancer cells through multiple modes of action. ACTB1003 inhibits cancer cell growth by targeting the FGF receptor family, which are mutated in a number of human cancer types. ACTB1003 also directly induces apoptosis by targeting the RSK and S6K kinases in the PI3K pathway, all at low nanomolar concentrations.

"Based on many advanced pre-clinical studies and favorable toxicology results, we see ACTB1003 as the first in the next generation of targeted anti-cancer drugs. ACTB1003 has the ability to hit cancer cells via multiple therapeutic modalities and the potential to treat patients according to the genetic profiles of their tumors. Therefore, this drug candidate has a profile that is unmatched in the industry," said Ali Fattaey, Ph.D., Chief Operating Officer and Chief Scientific Officer of ACT Biotech.

Wolf D. Busse, Chief Executive Officer and President of ACT Biotech said, “We are excited that ACTB1003 has reached this important milestone. In the first half of 2010, we will determine whether we will enter into Phase 1 clinical trials on our own or with a partner. Along with Telatinib, which is currently in Phase 2 trials, ACTB1003 will be our second drug in the clinic and we are eager to continue advancing our portfolio of oral kinase inhibitors.”