Atreca: FDA Clears Investigational New Drug Application for ATRC-101

First IND clearance of a clinical candidate derived from Atreca’s differentiated drug discovery platform

 Phase 1b clinical trial in patients with solid tumors to begin in early 2020

Atreca, Inc. (Atreca) (NASDAQ: BCEL), a biotechnology company focused on the development of novel cancer therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application. 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.

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