Atreca Announces First Patient Dosed in Phase 1b Clinical Trial of ATRC-101 in Patients with Select Solid Tumors
SOUTH SAN FRANCISCO, Calif., Feb. 13, 2020 (GLOBE NEWSWIRE) -- Atreca, Inc. (Atreca) (NASDAQ: BCEL), a biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, today announced that the first patient has been dosed in a Phase 1b first-in-human clinical trial evaluating ATRC-101 in patients with select solid tumor cancers. ATRC-101, a monoclonal antibody derived from a human antibody identified in a cancer patient via Atreca’s drug discovery platform, targets a ribonucleoprotein (RNP) complex and is believed to function through Driver Antigen Engagement, a novel mechanism of action in oncology.
“Dosing of the first patient in our Phase 1b study of ATRC-101 is an important milestone marking our transition to a clinical-stage company,” said John Orwin, Chief Executive Officer. “ATRC-101 has demonstrated potent single-agent anti-tumor activity in multiple preclinical solid tumor models and we believe, through both its novel target and mechanism of action, that this antibody represents an exciting potential new approach in oncology. We look forward to reporting initial data from this study in the second half of 2020.”
The Phase 1b open-label, dose escalation, monotherapy trial with an adaptive 3+3 design will enroll patients with colorectal, ovarian, non-small cell lung and breast cancers and acral melanoma. Over 50% of tumor tissue samples evaluated by Atreca in each of these cancer types were positive for the antigenic target of ATRC-101, an RNP complex. Major objectives of 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 initial signals of clinical activity of ATRC-101. Upon confirmation of safety, Atreca plans to test ATRC-101 further as a single agent and in combination with checkpoint inhibitors and select chemotherapeutics.
For more information about the clinical trial design please visit www.clinicaltrials.gov (NCT04244552).
About ATRC-101ATRC-101 is a monoclonal antibody derived from an antibody identified using Atreca’s discovery platform. ATRC-101 is believed to function 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 has identified the target of ATRC-101 as a ribonucleoprotein (RNP) complex. Underlining the rationale for human testing, ATRC-101 has demonstrated robust anti-tumor activity as a single agent in multiple preclinical syngeneic tumor models, including one model in which PD-1 checkpoint inhibitors typically display limited activity. Further, ATRC-101 has been shown to react in vitro with a majority of human ovarian, non-small cell lung, colorectal, breast cancers and acral melanoma samples from multiple patients.
About Atreca, Inc. 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 lead product candidate ATRC-101. A Phase 1b study evaluating ATRC-101 in multiple solid tumor cancers is currently enrolling patients. For more information on Atreca, please visit www.atreca.com.
Forward-Looking Statements 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”, “believe,” “potential,” “plans,” 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 June 19, 2019, as filed with the Securities and Exchange Commission (SEC) pursuant to Rule 424(b) under the Securities Act of 1933, as amended, and in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, which are available on the SEC’s website at www.sec.gov, including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.
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Source: Atreca, Inc.