Atreca Announces FDA Clearance of 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
“The FDA’s clearance of our IND application for ATRC-101 is a significant milestone for
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.
ATRC-101 is a monoclonal antibody derived from an antibody identified using Atreca’s discovery platform. ATRC-101 functions through Driver Antigen Engagement, a novel mechanism of action in oncology. This mechanism involves systemic delivery of an antibody that has been shown in preclinical models to engage the innate immune system, cause remodeling of the tumor microenvironment and drive T-cell mediated destruction of tumor cells.
Atreca is a biopharmaceutical company developing novel antibody-based cancer immunotherapeutics generated by its differentiated discovery platform. Atreca’s platform allows access to an unexplored landscape in oncology through the identification of unique antibody-target pairs generated by the human immune system during an active immune response against tumor. These antibodies provide the basis for first-in-class therapeutic candidates, such as ATRC-101, with the potential to address unmet need in large groups of cancer patients. The company expects to commence a Phase 1b study evaluating ATRC-101, its lead product candidate, in multiple solid tumor cancers in early 2020. For more information on
This release contains forward-looking statements regarding our strategy and future plans, including statements regarding the development of ATRC-101 and our clinical and regulatory plans, and the timing thereof. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “will”, “expect,” “believe,” “potential,” “continue,” and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the initiation, timing, progress and results of our research and development programs, preclinical studies, any clinical trials and Investigational New Drug application and other regulatory submissions, and other matters that are described in our prospectus, dated
Source: Atreca, Inc.