Atreca Announces FDA Clearance of Investigational New Drug Application for ATRC-101
04 December 2019 - 12:00AM
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.
About ATRC-101ATRC-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 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 cancer 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
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 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”, “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 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.
ContactsAtreca, Inc. Herb Cross Chief Financial
Officer info@atreca.com Investors: Alex Gray, 650-779-9251, ext.
251 agray@atreca.com Media:Sheryl Seapy,
213-262-9390sseapy@w2ogroup.com
Source: Atreca, Inc.
Atreca (NASDAQ:BCEL)
Historical Stock Chart
From Sep 2024 to Oct 2024
Atreca (NASDAQ:BCEL)
Historical Stock Chart
From Oct 2023 to Oct 2024