Atreca Announces First Patient Dosed in Phase 1b Clinical Trial of ATRC-101 in Patients with Select Solid Tumors
14 2월 2020 - 6:30AM
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.
ContactsAtreca, Inc. Herb Cross Chief Financial
Officer info@atreca.com
Investors: Alex Gray, 650-779-9251 agray@atreca.com
Media:Sheryl Seapy, 213-262-9390sseapy@w2ogroup.com
Source: Atreca, Inc.
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