Atreca, Inc. (Nasdaq: BCEL), BeiGene, Ltd. (Nasdaq: BGNE; HKEX:
06160), and IGM Biosciences, Inc. (Nasdaq: IGMS), today announced
their plans to collaborate to help address the COVID-19 pandemic.
The companies will leverage their combined technology and expertise
in an effort to discover, develop, and manufacture novel IgM and
IgA antibodies targeting SARS-CoV-2 for the potential treatment of
COVID-19. Given the urgency of the global COVID-19 pandemic, the
parties have agreed to begin work immediately and plan to finalize
financial details and other terms in the future.
Immunoglobulin M (IgM) and immunoglobulin A (IgA) are classes of
antibodies naturally produced by the human immune system and are
differentiated from immunoglobulin G (IgG) antibodies in part by
their greater number of binding domains (IgM: 10, IgA: 4, IgG: 2).
IGM Biosciences engineers IgM and IgA antibodies with greater
binding power per antibody, relative to comparable IgG antibodies.
This greater binding power could potentially result in better
activity against a broader range of variants of the virus which
causes COVID-19, as compared to traditional IgG antibodies. IgA and
IgM antibodies also have the inherent property of active transport
from the blood stream to mucosal surfaces, such as in the lung,
which may provide a therapeutic advantage for respiratory diseases
such as COVID-19.
The alliance will utilize Atreca’s proprietary discovery
platform to generate the sequences of antibodies made by particular
B cells found in blood obtained from acutely infected COVID-19
patients. IGM’s technology platform will then be leveraged in an
effort to develop and manufacture engineered IgM and IgA
therapeutic antibodies from the identified sequences.
BeiGene has agreed to provide global clinical development
support by leveraging its more than 1,100-person global development
team across China, the United States, Europe, and Australia,
including leading global regulatory interactions for any potential
drug candidate that is developed. BeiGene is a leader in global
clinical development with 26 potentially registration-enabling
trials ongoing and over 60 studies enrolling patients in more than
35 countries. Its large, global clinical development team is
focused on high-quality, efficient drug development optimized for
global regulatory submissions.
Atreca and IGM have entered into a Material Transfer and
Collaboration Agreement to enable the parties to begin working
together immediately. Atreca, IGM, and BeiGene plan to discuss
further terms and arrangements in the future. If research,
manufacturing, and regulatory activities proceed very well, then
the companies believe that an antibody may be ready to begin
clinical testing in the first half of 2021.
“Atreca has a history of successfully generating potent,
neutralizing antibodies against a number of infectious disease
pathogens, and we are proud to join BeiGene and IGM in working to
identify a potential therapy to help address this unprecedented
international health crisis,” said John Orwin, Chief Executive
Officer of Atreca. “We believe our discovery platform is uniquely
positioned to rapidly isolate a broad range of relevant antibody
sequences from COVID-19 patients that can then be used to create
potentially effective targeted therapies. We have begun processing
samples obtained from acutely infected COVID-19 patients and are
focused on analyzing single plasmablast B cells isolated from these
samples to identify antibodies targeting potentially novel epitopes
that may be missed by other approaches that rely on a specific
viral protein to select B cells.”
“Helping patients is core to our mission, and we believe IGM may
be the only company in the world that is currently positioned to
produce IgM and IgA antibodies with high yield and high quality,”
said Fred Schwarzer, Chief Executive Officer of IGM Biosciences.
“As such, we feel that we have a responsibility to explore the
utility of these antibodies in COVID-19 patients. We believe that
IgM and IgA antibodies created from sequences identified with
Atreca’s platform may produce better binding, cross-reactivity,
neutralization, and mucosal transport than the corresponding IgG
antibodies. These characteristics, plus IGM’s ability to
efficiently manufacture IgM and IgA antibodies, gives us confidence
in the collaboration and hope that we may develop a product that
will be of significant benefit to public health.”
“While the COVID-19 pandemic has presented new challenges to the
biotechnology and pharmaceutical industries, equally notable is the
desire for international scientific collaboration and cooperation,”
said John V. Oyler, Co-Founder, Chief Executive Officer, and
Chairman of BeiGene. “We are grateful for the opportunity to
lend our global clinical development resources to this
critical cause, with both Atreca and IGM to leverage their
innovative discovery and development platforms in an effort to
combat COVID-19.”
Atreca’s proprietary discovery platform, including its Immune
Repertoire Capture® (IRC™) technology, generates bias- and
error-corrected, natively paired heavy and light chain sequences of
the antibodies expressed by single plasmablast B cells isolated
from patient blood samples, enabling analyses of patient antibody
repertoires generated in an active immune response in a target
agnostic fashion, and permitting selection of antibody sequences
for immediate gene synthesis and expression. IGM’s proprietary
platform expands upon the inherent characteristics of IgM and IgA
antibodies and enables the rapid development of engineered
therapeutics. IGM’s technology allows it to create IgM and IgA
antibodies with higher affinity and avidity than naturally
occurring IgM and IgA antibodies, and the company has also overcome
the historical difficulties in recombinantly expressing and
manufacturing IgM and IgA antibodies.
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 tumor. 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 BeiGeneBeiGene is a global,
commercial-stage biotechnology company focused on discovering,
developing, manufacturing, and commercializing innovative medicines
to improve treatment outcomes and access for patients worldwide.
Our 3,500+ employees in China, the United States, Australia, and
Europe are committed to expediting the development of a diverse
pipeline of novel therapeutics for cancer. BeiGene currently
markets two internally-discovered oncology products: BTK inhibitor
BRUKINSA™ (zanubrutinib) in the United States, and anti-PD-1
antibody tislelizumab in China. BeiGene also markets or plans to
market in China additional oncology products licensed from Amgen
Inc., Celgene Logistics Sàrl, a Bristol Myers Squibb (BMS) company,
and EUSA Pharma. To learn more about BeiGene, please visit
www.beigene.com.
About IGM Biosciences, Inc. Headquartered in
Mountain View, California, IGM Biosciences is a clinical-stage
biotechnology company focused on creating and developing engineered
IgM antibodies. Since 2010, IGM Biosciences has worked to overcome
the manufacturing and protein engineering hurdles that have limited
the therapeutic use of IgM antibodies. Through its efforts, IGM
Biosciences has created a proprietary IgM technology platform for
the development of IgM antibodies for those clinical indications
where their inherent properties may provide advantages as compared
to IgG antibodies.
Atreca Forward-Looking StatementsThis release
contains forward-looking statements regarding Atreca’s strategy and
future plans, including statements regarding the anticipated
isolation of relevant antibody sequences from COVID-19 patients
using Atreca’s proprietary discovery platform, the development of
ATRC-101 and Atreca’s 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 “plan,” “will,” “believe,”
“may,” “future,” “potential” and similar words, although some
forward-looking statements are expressed differently. Atreca’s
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 its 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 Atreca’s
Annual Report on Form 10-K for the fiscal year ended December 31,
2019 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 Atreca undertakes no
obligation to update any forward-looking statement in this press
release, except as required by law.
BeiGene Forward-Looking StatementsThis press
release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 and other
federal securities laws, including statements regarding BeiGene’s
plans to work together with Atreca and IGM in the development of a
novel IgM or IgA antibody targeting SARS-CoV-2 for the potential
treatment of COVID-19, the services to be provided by BeiGene, and
the parties’ efforts to finalize further terms and arrangements in
the future. Actual results may differ materially from those
indicated in the forward-looking statements as a result of various
important factors, including the ability of Atreca, BeiGene and IGM
to discover, develop and manufacture a novel IgM or IgA antibody
targeting SARS-CoV-2 for the treatment of COVID-19; the risk that
Atreca, BeiGene or IGM decide not to pursue the collaboration or
that the parties are unable to agree to further terms and
arrangements for the collaboration in the future; the risk that the
potential benefits of the collaboration do not materialize or do
not outweigh the costs; BeiGene's ability to demonstrate the
efficacy and safety of its drug candidates; the clinical results
for its drug candidates, which may not support further development
or marketing approval; actions of regulatory agencies, which may
affect the initiation, timing and progress of clinical trials and
marketing approval; BeiGene's ability to achieve commercial success
for its marketed products and drug candidates, if approved;
BeiGene's ability to obtain and maintain protection of intellectual
property for its technology and drugs; BeiGene's reliance on third
parties to conduct drug development, manufacturing and other
services; BeiGene's limited operating history and BeiGene's ability
to obtain additional funding for operations and to complete the
development and commercialization of its drug candidates; and the
impact of the COVID-19 pandemic on BeiGene’s clinical development,
commercial and other operations, as well as those risks more fully
discussed in the section entitled "Risk Factors" in BeiGene's most
recent annual report on Form 10-K, as well as discussions of
potential risks, uncertainties, and other important factors in
BeiGene's subsequent filings with the U.S. Securities and Exchange
Commission. All information in this press release is as of the date
of this press release, and BeiGene undertakes no duty to update
such information unless required by law.
IGM Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements. These statements include, but are not limited to,
statements relating to the contemplated collaboration among IGM,
Atreca and BeiGene; the possible nature and scope of any such
collaboration; the capabilities of IGM’s technology platform, both
generally and specifically with respect to development, testing and
manufacture of antibodies targeted at COVID- 19; the potential
safety and efficacy of such antibodies; and the capabilities of
Atreca and BeiGene.
Such statements are subject to numerous important risks and
uncertainties that may cause actual events or results to differ
materially, including, but not limited to, the risks that: IGM,
Atreca and/or Beigene ultimately decide to not pursue the
collaboration; IGM, Atreca and BeiGene do not reach agreement on
the definitive terms and conditions of such collaboration; one or
more of IGM, Atreca, BeiGene decide to leave the collaboration;
antibodies with the desired characteristics cannot be isolated from
the COVID-19 patient samples obtained by Atreca; any
antibodies developed are not safe and effective in treating COVID -
19; such antibodies are not safer and/or more effective than
alternatives to treating or otherwise addressing COVID – 19; IGM is
not able to successfully manufacture such antibodies; any
preclinical studies and clinical trials do not proceed
successfully; all necessary regulatory approvals cannot be
obtained; the potential benefits of the collaboration and these
efforts do not outweigh their costs; the collaboration and related
efforts are delayed or disrupted by the COVID-19 pandemic
itself or by governmental responses to the pandemic; and
other risks and uncertainties, including those more fully described
in IGM’s filings with the Securities and Exchange Commission
(“SEC”), including IGM’s Annual Report on Form 10-K filed with the
SEC on March 26, 2020 and in IGM’s future reports to be filed with
the SEC. Any forward-looking statements contained in this
press release speak only as of the date hereof, and IGM
specifically disclaims any obligation to update any forward-looking
statement, except as required by law.
Atreca Contact:
Herb CrossChief Financial Officerinfo@atreca.com
Atreca Investor Contact:
Alex Gray+1 650-779-9251agray@atreca.com
Atreca Media Contact:
Sheryl Seapy +1 213-262-9390sseapy@w2ogroup.com
BeiGene Investor Contact:
Craig West+1 857-302-5189ir@beigene.com
BeiGene Media Contact:
Liza Heapes or Vivian Ni+1 857-302-5663 or +1
857-302-7596media@beigene.com
IGM Biosciences Contact:
Argot Partners David Pitts+1
212-600-1902igmbio@argotpartners.com
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