The company announced that the FDA has cleared its IND application for ATRC-101 and that it can begin its Phase 1b clinical trial.
Atreca (NASDAQ:BCEL) has announced that the US Food and Drug Administration has cleared its investigational new drug application.
As quoted in the press release:
Atreca expects to initiate a first-in-human Phase 1b clinical trial of ATRC-101 in patients with solid tumors in early 2020.
“The FDA’s clearance of our IND application for ATRC-101 is a significant milestone for Atreca and validates the ability of our differentiated drug discovery platform to generate novel clinical candidates against cancer,” said John Orwin, Chief Executive Officer. “We believe that ATRC-101, with both its unique target and mechanism of action, represents an exciting approach in oncology, and we look forward to the initiation of our Phase 1b clinical trial in early 2020.”
The Phase 1b trial will be an open-label, dose escalation, monotherapy trial with an adaptive 3+3 design and will enroll patients with a variety of solid tumor cancers, including ovarian, non-small cell lung, colorectal, breast and acral melanoma. The antigenic target of ATRC-101, a ribonucleoprotein complex, is expressed on over 50% of patient samples for each of these tumor types. Major objectives for the trial are to characterize the safety of ATRC-101 and determine a recommended dose for future studies. The trial will also evaluate potential biomarkers and the initial clinical activity of ATRC-101.