Atreca Presents Data from Ongoing Phase 1b Study of ATRC-101 in Patients with Select Advanced Solid Tumors during Oral Abstract Session at the ASCO 2023 Annual Meeting
05 June 2023 - 10:00PM
Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage
biotechnology company focused on developing novel therapeutics
generated through a unique discovery platform based on
interrogation of the active human immune response, announced that
Dr. Bartosz Chmielowski, Health Sciences Clinical Professor of
Medicine in the Division of Hematology-Oncology at the University
of California Los Angeles, presented safety and efficacy data from
the ongoing Phase 1b study of ATRC-101 in patients with select
advanced solid tumors cancer during an oral abstract session on
Sunday, June 4 at the American Society of Clinical Oncology (ASCO)
2023 Annual Meeting. The presentation provided a summary of
clinical data collected as of a February 17, 2023, data cut-off
date.
“We are pleased to be able to present these results in an oral
presentation at ASCO, which validate the potential of our discovery
platform and its ability to identify promising therapeutic
antibodies against novel tumor targets,” said Dr. Philippe Bishop,
Chief Medical Officer of Atreca. “We are continuing to enroll
subjects in both the Q3W monotherapy and combination therapy
cohorts at the 30 mg/kg dose level, with a focus on the recruitment
of H-score high participants across tumor types. The additional
data we generate in the coming months will be important in
informing our go/no-go decisions for indication-specific Phase 2
development expected later this year.”
- As of the data cut-off date of February 17, 71 participants had
been dosed in the trial and evaluated for safety, with 62
participants receiving either the 3, 10 or 30 mg/kg dose including
42 participants receiving ATRC-101 monotherapy every 3 weeks (Q3W),
11 receiving ATRC-101 monotherapy every 2 weeks (Q2W), and 9
receiving a combination of ATRC-101 and pembrolizumab. Participants
enrolled in the study had received a median of five prior lines of
treatment.
- ATRC-101 has been generally well-tolerated. Treatment emergent
adverse events of Grade ≥3 occurred in 27 (38%) participants and
were deemed related to ATRC-101 in 2 (3%). None led to treatment
discontinuation or dose reduction due to ATRC-101.
- Atreca continued to observe that high target expression (as
defined by an H-score ≥50) discriminates for anti-tumor activity in
the 3, 10 and 30 mg/kg dose cohorts.
- Among the 17 participants with a high target expression at
screening treated with monotherapy at the higher dose levels,
disease control was observed in 59% (10 of 17 patients) including 9
(53%) patients with stable disease (SD) and one (6%) patient with a
partial response (PR).
- With combination patients included (n=24), disease control was
observed in 14 (58%) including 12 (50%) SD, 1 (4%) PR and 1 (4%)
CR.
- Longer progression-free survival was observed in patients with
high target expression treated in the 3, 10 and 30 mg/kg dose
cohorts.
- A hazard ratio of 0.47 was observed in a Kaplan Meier analysis
of monotherapy patients treated at the higher dose levels separated
by H-score (n=41)
- A hazard ratio of 0.40 was observed in the Kaplan Meier
analysis of combination therapy patients separated by H-score
(n=49).
“These data continue to support ATRC-101’s observed safety and
tolerability profile, and the correlation between longer
progression-free survival and high target expression,” added Dr.
Bartosz Chmielowski, Professor of Medicine at the University of
California Los Angeles. “More importantly, ATRC-101 demonstrated
durable disease control among heavily pre-treated patients across a
range of tumor types. Based on these data, I believe ATRC-101 has
the potential address a significant unmet need in multiple tumor
types as a part of a range of potential therapeutic combinations
with established regimens, including checkpoint inhibitors.”
About Atreca, Inc.
Atreca is a biopharmaceutical company developing novel
antibody-based 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 tumors. These antibodies
provide the basis for first-in-class therapeutic candidates, such
as our 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 within the
meaning of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements include without limitation those
regarding our strategy and future plans, including statements
regarding the continuing safety and tolerability of ATRC-101 in our
ongoing Phase 1b trial, enrollment of patients in our Phase 1b
clinical trial of ATRC-101, our belief that our ATRC-101 results
validate the potential of our discovery platform and its ability to
identify promising therapeutic antibodies against novel tumor
targets, our plan to make go/no-go decisions by the end of 2023 for
potential Phase 2 development of ATRC-101, the development of
ATRC-101 and our clinical and regulatory plans, and the timing
thereof, data read-outs and the timing thereof, including the
reporting of updated data from the monotherapy and pembrolizumab
combination arms of our Phase 1b clinical trial of ATRC-101, the
continuing correlation between longer progression-free survival and
high target expression in our Phase 1b clinical trial of ATRC-101,
and the potential of ATRC-101 to address a significant unmet need
in multiple tumor types as a part of a range of potential
therapeutic combinations with established regimens, including
checkpoint inhibitors. 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 “continue,”
“will,” “expect,” “advance,” “target,” “belief,” 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, clinical
trials, regulatory submissions, and other matters that are
described in our most recent Annual Report on Form 10-K and
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission (SEC) and 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.
Contacts
Atreca, Inc.Herb CrossChief Financial Officerinfo@atreca.com
Investors:Alex Gray, 650-779-9251agray@atreca.com
Media:Julia Fuller, 858-692-2001Julia@fordhutmanmedia.com
Atreca (NASDAQ:BCEL)
Historical Stock Chart
From Mar 2024 to Apr 2024
Atreca (NASDAQ:BCEL)
Historical Stock Chart
From Apr 2023 to Apr 2024