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, today announced
initial data from the dose escalation portion of its ongoing Phase
1b trial evaluating ATRC-101 in select solid tumor types that
displayed greater than 50% target expression in preclinical
studies.
"We are pleased to present initial summary data from our
first-in-human study of ATRC-101,” said Jonathan Benjamin, M.D.,
Ph.D., Sr. Vice President, Clinical Research. "We are very
encouraged by the results observed thus far in a relatively small
set of heavily pre-treated participants. ATRC-101, which targets a
novel tumor antigen and acts via a novel MOA in oncology, was
well-tolerated at all doses evaluated in the study with no
dose-limiting toxicities observed. Furthermore, disease control is
associated with ATRC-101 target expression, and the preliminary
biomarker analysis is consistent with the proposed MOA for
ATRC-101. We anticipate reporting additional data from monotherapy
dose expansion cohorts in the Phase 1b trial and from combination
cohorts evaluating ATRC-101 with pembrolizumab in 2022, and
initiating additional combination cohorts evaluating ATRC-101 with
chemotherapy later this year.”
“ATRC-101 represents a new approach in cancer research,” said
Dr. John Powderly, M.D., Founder and President of the Carolina
BioOncology Institute. “While these data are from a limited number
of treatment-refractory patients, I was pleased to see that
ATRC-101 was well-tolerated and appears to have an informative
biomarker. I look forward to continue investigating the potential
of ATRC-101 in cancer patients.”
ATRC-101 Phase 1b Study Design
The Phase 1b trial is a first-in-human, open-label study of
ATRC-101 in patients with select solid tumor cancers, utilizing a
3+3 design for the dose escalation portion. Enrollment is limited
to patients with tumor types reactive to ATRC-101 in more than 50%
of historical patient samples evaluated preclinically, which
includes non-small cell lung, breast, ovarian, and colorectal
cancer, as well as acral melanoma. The objectives of the study are
to characterize safety, determine a maximum tolerated or
recommended dose for expansion, measure initial clinical activity,
and characterize potential biomarkers of activity in tumors,
plasma, and peripheral blood mononuclear cells (PBMC).
Initial Study Results
A total of 26 participants had been dosed in the trial as of the
data cut-off date of July 16th, including 24 participants treated
at five once-every-21-day (q21d) dose levels, 0.3 mg/kg (n = 3), 1
mg/kg (n = 3), 3 mg/kg (n = 9), 10 mg/kg (n = 6), and 30 mg/kg (n =
3), and two participants treated at one once-every-14-day (q14d)
dose level, 1 mg/kg (n = 2). Tumor types enrolled in the q21d
cohorts were colorectal (n = 13), ovarian (n = 5), breast (n = 3),
non-small cell lung (n = 2) and acral melanoma (n = 1).
Participants enrolled in the study had received a median of five
prior lines of treatment. Of the 26 participants dosed, 24
participants treated with any dose of ATRC-101 were evaluable for
safety, 19 for PK, 20 for clinical response, and 18 participants
for target expression.
Pharmacokinetics (PK)
The peak concentration of ATRC-101 was dose proportional and
minimal accumulation was observed following multiple doses.
ATRC-101’s half-life was 10.5 days and was relatively consistent
across all dose levels.
Safety
ATRC-101 was generally well-tolerated, with no dose-limiting
toxicities at doses ≤30 mg/kg. Thirty-three percent of participants
(n = 8) had at least one grade ≥ 3 adverse event (AE). Respiratory
failure (n = 2) and sepsis (n = 2) were the only grade ≥ 3 AEs
observed in more than one participant, and the one grade 4
treatment-emergent AE observed was a case of acute respiratory
failure. The most common treatment-related AEs were fatigue (n = 5,
21%), nausea (n = 4, 17%), and tumor pain (n = 4, 17%).
Disease Efficacy Observations
Eight of the 20 participants (40%) evaluable prior to the data
cut-off in this analysis experienced stable disease (SD) as their
best RECIST response, including four with tumor reduction observed.
The remaining 12 participants had progressive disease as their best
RECIST response. Disease control observed in the study was
associated with target expression, as 3 of 6 (50%) of participants
with evaluable response assessments and baseline tumor H-scores ≥50
achieved SD, compared with 1 of 9 (11%) evaluable participants with
an H-score <50.
Biomarkers
Preliminary biomarker evaluation supports the proposed MOA of
ATRC-101 initially proposed from preclinical studies. Expansion of
peripheral blood CD8+ T cells was observed at day 8 following
dosing with ATRC-101 among participants with evaluable baseline
tumor biopsies and tumor H-scores ≥50. Preliminary observations of
serum cytokines appeared consistent with the proposed MOA of innate
immune system activation leading to an adaptive immune response
against tumor.
Next Steps
Phase 1b monotherapy dose expansion is ongoing at 30 mg/kg, a
combination study evaluating ATRC-101 with pembrolizumab is active
and another combination study with pegylated liposomal doxorubicin
is expected to begin enrolling patients in 4Q21. Atreca expects to
report additional monotherapy data by mid-2022, pembrolizumab
combination data in mid-2022 and chemotherapy combination data in
late 2022. Supported by data from the dose escalation portion of
the trial, Atreca is developing a diagnostic to select patients
based on target expression.
"We are very pleased with the results of the Phase 1b study
presented today and look forward to the continued clinical
development of ATRC-101 as both a monotherapy and in combination
studies,” said John Orwin, Chief Executive Officer of Atreca.
"ATRC-101 is the first anti-cancer agent discovered via Atreca’s
platform to be tested in humans, and we believe that the activity
observed in the trial provides a strong rationale for further
investigation. Furthermore, we believe that these data provide
validation for the ability of our discovery platform to identify
novel, druggable tumor targets shared across groups of patients. We
would like to thank all of the patients who enrolled, their
families, and their caregivers for participating in this
study.”
ATRC-101 Conference Call and Webcast
Information
Atreca will host a conference call/webcast today at 8:00 a.m.
ET. The live webcast, including slides, can be accessed through the
Events & Presentations section of the Company's website at
https://ir.atreca.com/news-and-events/event-calendar. To access the
conference call, please dial (800) 373-6606 (United States) or
(409) 937-8918 (international) and reference the conference ID
2386207. An archived replay of the webcast will be available on the
Company's website for 90 days following the live event.
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, in preclinical
models, engages the innate immune system to 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
tumor-specific ribonucleoprotein (RNP) complex. 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. Atreca
initiated a Phase 1b first-in-human study of ATRC-101 in
participants with select solid tumor cancers in early 2020.
Clinical trials to evaluate ATRC-101 in combination with a PD-1
inhibitor and in combination with chemotherapy are planned for
2021, as well as in monotherapy dose expansion cohorts in the
ongoing Phase 1b trial.
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 participants.
For more information on Atreca, please visit www.atreca.com.
Forward-Looking StatementsStatements contained
in this press release regarding matters that are not historical
facts are “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995. These
forward-looking statements include, but are not limited to,
statements about our plans, objectives, representations and
contentions and typically are identified by use of terms such as
"continued," "anticipate," "potential," "expect," "believe,"
"planned," and similar words, although some forward-looking
statements are expressed differently. These statements include
those related to our strategy and future plans, including
statements regarding the development of ATRC-101 and our
preclinical, clinical and regulatory plans and the timing thereof,
the availability and timing of data from monotherapy dose expansion
cohorts in the Phase 1b trial and from combination cohorts
evaluating ATRC-101 with pembrolizumab and with pegylated liposomal
doxorubicin, initiating additional combination cohorts evaluating
ATRC-101 with chemotherapy, trends consistent with the proposed MOA
of innate immune system activation, and our development of a
diagnostic to select patients based on target expression. 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
filings with the Securities and Exchange Commission (SEC) and
available on the SEC’s website at www.sec.gov, including in the
“Risk Factors” and “Management’s Discussion and Analysis of
Financial Condition and Results of Operations” sections of our most
recently filed annual report on Form 10-K and quarterly report on
Form 10-Q. Investors are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
of this press 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.comInvestors:Alex Gray,
650-779-9251agray@atreca.com
Media:Sheryl Seapy, 213-262-9390sseapy@w2ogroup.com
Source: Atreca, Inc.
Atreca (NASDAQ:BCEL)
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