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
a licensing agreement with Zymeworks Inc. (Zymeworks) (NYSE: ZYME)
to utilize their ZymeLink™ technology to develop novel
antibody-drug conjugates (ADCs) and declared ATRC-301, an ADC
targeting a novel epitope on EphA2, as the Company’s next clinical
candidate. Atreca management will discuss the agreement, ATRC-301,
and its earlier stage pipeline programs during today’s R&D Day
beginning at 4:15pm EDT.
"We are pleased to be hosting our first R&D Day and
providing an update on our preclinical pipeline in oncology,” said
John Orwin, Chief Executive Officer of Atreca. “We are particularly
excited to announce our next clinical candidate, ATRC-301, an ADC
of an Atreca-discovered antibody targeting EphA2 conjugated using
Zymeworks’ proprietary ZymeLink™ platform. Our new agreement with
Zymeworks enables us to develop up to three potential ADC products
using their technology. Taken together, today’s announcements
demonstrate the productivity of our discovery platform and research
organization, as well as the potential value of our preclinical
programs. Given this productivity and the resulting expansion of
our pipeline of oncology programs, we are targeting one additional
Investigational New Drug (IND) application per year beginning with
ATRC-301 in the second half of 2023.”
Zymeworks Agreement
As part of the licensing agreement with Zymeworks, Atreca’s
novel antibodies will be conjugated using ZymeLink™, Zymeworks’
suite of proprietary cytotoxins, linkers, and conjugation
technologies. The agreement includes a two-year research term for
Atreca to evaluate antibodies as ADC’s using ZymeLink™ with the
option for a third year, during which Atreca can acquire up to
three commercial licenses to develop three unique ADC programs.
Work between the two companies has been ongoing since late
2020.
ZymeLink™ is a next-generation drug conjugate platform that
provides a suite of proprietary auristatin-based or
hemiasterlin-based cytotoxins, complete with stable, cleavable
linkers. Antibodies conjugated using the ZymeLink™ platform have
IgG1-like PK & exposure, have demonstrated tolerability and
support a wide therapeutic window.
“Zymeworks has developed a leading next-generation ADC
technology, and we are pleased to announce a licensing agreement to
utilize their ZymeLink™ platform for our initial ADC programs,”
said Tito A. Serafini, Ph.D., Chief Strategy Officer of Atreca. “A
substantial fraction of the tumor-binding antibodies that we
discover from patients are active in ADC assays, and we view this
as a potentially high-value area for further investment and
development.”
ATRC-301
ATRC-301, Atreca’s next clinical candidate, is an ADC that
selectively targets a novel, membrane-proximal epitope on
erythropoietin-producing hepatocellular receptor A2 (EphA2). EphA2
is a validated and potentially high value target that is widely
expressed across several types of cancer, with 12 tumor types
displaying prevalence of the target epitope of 50% or greater in
human tumor samples evaluated. ATRC-301 has demonstrated potent,
dose-dependent in vivo tumor regression in mice with no significant
toxicity signals yet observed in rats after single doses of up to
and including 30mg/kg. Atreca has initiated IND-enabling studies,
including a non-human primate toxicology study for which data are
expected in 2H22, and anticipates submitting an IND application for
ATRC-301 in 2H23. Atreca also has lead stage CD3-engager targeting
EphA2 in development.
Other Preclinical Programs
Atreca is advancing multiple additional lead-stage programs in
oncology, including ADC leads APN-497444 and APN–959038,
CD3-engager lead APN-346958, and IL-15 superagonist (SA) conjugate
lead APN-541885. Each program is based on an antibody identified
via Atreca’s discovery platform from an active human immune
response antibody, and upon further evaluation displayed strong and
tumor-selective immunoreactivity against targets present on
multiple tumor types across groups of patient samples. In their
weaponized formats, each lead has demonstrated anti-tumor activity
in in vivo preclinical studies. The targets bound by the antibodies
vary in class and include both novel epitopes of known cancer
targets as well as entirely novel target antigens in oncology.
R&D Day Webcast and Conference Call
Details
The live R&D Day webcast, including accompanying 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
event by telephone, please dial (800) 373-6606 (United States) or
(409) 937-8918 (international) and reference the conference ID
3490903. An archived replay of the webcast will be available on the
Company's website following the live event.
About Atreca, Inc.
Atreca is a clinical-stage 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.
About Zymeworks Inc.
Zymeworks is a clinical-stage biopharmaceutical company
dedicated to the discovery, development and commercialization of
next-generation multifunctional biotherapeutics. Zymeworks’ suite
of therapeutic platforms and its fully integrated drug development
engine enable precise engineering of highly differentiated product
candidates. Zymeworks’ lead clinical candidate, zanidatamab, is a
novel Azymetric™ HER2-targeted bispecific antibody currently being
evaluated in multiple Phase 1, Phase 2, and pivotal clinical trials
globally as a targeted treatment option for patients with solid
tumors that express HER2. Zymeworks’ second clinical candidate,
ZW49, is a novel bispecific HER2‑targeted antibody-drug conjugate
currently in Phase 1 clinical development and combines the unique
design and antibody framework of zanidatamab with Zymeworks’
proprietary ZymeLink™ linker and cytotoxin. Zymeworks is also
advancing a deep preclinical pipeline in oncology (including
immuno-oncology agents) and other therapeutic areas. In addition,
its therapeutic platforms are being leveraged through strategic
partnerships with global biopharmaceutical companies. For more
information on our ongoing clinical trials visit
www.zymeworksclinicaltrials.com. For additional information about
Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on
Twitter.
Forward-Looking Statements
This press release contains forward-looking statements regarding
our strategy and future plans, including statements regarding our
plans for utilizing ZymeLinkTM technology with the agreement with
Zymeworks, our plans to utilize the ZymeLinkTM platform in
connection with ATRC-301, the development of ATRC-301 and our
preclinical and clinical plans, specifically, plans to present
results of IND-enabling studies for ATRC-301 in the second half of
2022 and our ability to submit an IND application for ATRC-301 in
the second half of 2023, including the timing thereof, the safety
and potential efficacy of our clinical candidates, including
ATRC-301, ATRC-101 and our anti-SARS-CoV-2 antibody discoveries,
our ability to identify potentially valuable therapeutic antibodies
through our discovery platform and collaborations with
third-parties, the productivity and expansion of our pipeline of
oncology programs, including ADC leads APN-497444 and APN-959038,
CD3-engager lead APN-346958, and IL-15 SA conjugate lead
APN-541885, our ability to continue to develop new clinical
candidates for IND applications and our ability to submit one such
application per year, plans to present new information on our EphA2
program and other pipeline assets, the results of our clinical
trials and studies and other developing data, plans regarding the
evaluation of clinical data, reports of monotherapy data and
combination data and other data read-outs, enrollment objectives,
our ability to obtain sufficient clinical enrollment, reports of
clinical enrollment updates, and our ability to fund current
operations and develop and commercialize our current or potential
future product candidates. 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
“potential,” “believe,” “target,” “will,” “demonstrate” "expect,"
“anticipate” 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 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 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:Julia Fuller, 858-692-2001julia@fordhutmanmedia.com
Source: Atreca, Inc.
Atreca (NASDAQ:BCEL)
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