Intellia Therapeutics and Kyverna Therapeutics Announce Collaboration to Develop Next-Generation Allogeneic T-Cell Therapy for Autoimmune Diseases
05 Janvier 2022 - 1:30PM
Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage
genome editing company focused on developing curative therapeutics
leveraging CRISPR-based technologies, and Kyverna Therapeutics, a
cell therapy company engineering a new class of therapies for
autoimmune and inflammatory diseases, today announced a licensing
and collaboration agreement for the development of an allogeneic
CD19 chimeric antigen receptor (CAR) T-cell therapy for the
treatment of a variety of B cell-mediated autoimmune diseases.
As part of the agreement, Intellia granted Kyverna rights to use
its proprietary ex vivo CRISPR/Cas9-based allogeneic platform for
the development of KYV-201, a next-generation CD19 CAR T-cell
investigational candidate for the treatment of select autoimmune
diseases. In exchange, Intellia received an equity stake in Kyverna
and made an additional investment in Kyverna. Kyverna will lead and
fund preclinical and clinical development for KYV-201. Intellia
will be eligible to receive certain development and commercial
milestone payments, as well as low-to-mid-single-digit royalties on
potential future sales. Intellia may also exercise an option to
lead U.S. commercialization for KYV-201 under a co-development and
co-commercialization agreement. If Intellia chooses to co-develop
and co-commercialize KYV-201, it will pay an opt-in fee and share
in 50 percent of development costs and future sales revenue from
commercializing KYV-201 in the U.S. Kyverna retains all rights
outside of the U.S., and Intellia will receive
low-to-mid-single-digit royalties on net sales generated outside of
the U.S.
“Intellia has built a novel CRISPR/Cas9-based allogeneic
platform with the goal of developing safer and more effective
therapies for a host of diseases. We are excited to license our
allogeneic cell engineering platform to Kyverna, for the
development of a new autoimmune disease therapeutic product for
patients,” said Intellia President and Chief Executive Officer John
Leonard, M.D. “Today’s announcement is another example of our
strategy to fully leverage the power of our genome editing
technology to address diseases that are inadequately treated with
existing medicines. While our core focus remains on advancing
therapies within our own research and clinical pipeline, we
recognize that our proprietary technology can have additional
impact when we strategically partner with others who possess
complementary capabilities.”
Preclinically, CD19-targeted CAR T-cell therapies have
demonstrated striking efficacy through deep B-cell depletion in
disease models in both blood and tissues in disease models,
supporting the promise of a transformative therapy for patients
living with B-cell driven autoimmune diseases.1 Through an
announced agreement with the National Institutes of Health (NIH),
Kyverna is the exclusive worldwide licensee of a novel
clinical-stage anti-CD19 CAR T construct for use in both autologous
and allogeneic CAR T-cell therapies to address autoimmune diseases.
Designed to improve the tolerability profile of conventional CD19
CAR Ts, this construct combines a fully human anti-CD19 CAR with
costimulatory domains engineered to minimize cytokine release and
to improve clinical tolerability,2 as observed in a Phase 1/2
clinical study conducted by the NIH in 20 patients with B-cell
malignancies. Recognizing the favorable characteristics as highly
desirable for the treatment of autoimmune diseases, Kyverna,
through its collaboration with Intellia, plans to develop the
construct in the CRISPR/Cas9-engineered allogeneic CD19 CAR T
KYV-201 for use in B-cell mediated autoimmune diseases.
“The partnership with Intellia will allow us to develop our
next-generation fully human CD19 CAR T construct in an allogeneic
setting. The improved tolerability profile observed in the NIH
trial for this construct, combined with the off-the-shelf
allogeneic approach enabled by Intellia’s CRISPR/Cas9 technology,
holds great promise for patients with autoimmunity,” said Kyverna
President and Chief Executive Officer Dominic Borie, M.D., Ph.D.
“We believe that these two points, together with the anticipated
transformative efficacy, may enable outpatient administration and
support access for patients with B cell-driven autoimmune
diseases.”
About Intellia TherapeuticsIntellia
Therapeutics, a leading clinical-stage genome editing company, is
developing novel, potentially curative therapeutics using
CRISPR-based technologies. To fully realize the transformative
potential of CRISPR-based technologies, Intellia is pursuing two
primary approaches. The company’s in vivo programs use
intravenously administered CRISPR as the therapy, in which
proprietary delivery technology enables highly precise editing of
disease-causing genes directly within specific target tissues.
Intellia’s ex vivo programs use CRISPR to create the therapy by
using engineered human cells to treat cancer and autoimmune
diseases. Intellia’s deep scientific, technical and clinical
development experience, along with its robust intellectual property
portfolio, have enabled the company to take a leadership role in
harnessing the full potential of genome editing to create new
classes of genetic medicine. Learn more at intelliatx.com. Follow
us on Twitter @intelliatweets.
About Kyverna TherapeuticsKyverna Therapeutics
is a cell therapy company engineering a new class of therapies for
autoimmune and inflammatory diseases. The Kyverna therapeutic
platform combines advanced T-cell engineering and synthetic biology
technologies to suppress or eliminate the autoreactive immune cells
at the origin of autoimmune and inflammatory diseases. In addition
to developing next-generation chimeric antigen receptor T-cell (CAR
T) therapies in both autologous and allogeneic settings, Kyverna is
creating synReg T cells, a synthetic version of Regulatory T cells
(Tregs), powerful natural immune cells that control immune
homeostasis through multiple immunosuppressive mechanisms. By
offering more than one mechanism for taming autoimmunity, Kyverna
is positioned to transform how autoimmune diseases are treated. For
more information, please visit https://kyvernatx.com.
Intellia Forward-Looking StatementsThis press
release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995, as amended,
including, without limitation, express or implied statements
regarding Intellia’s beliefs and expectations regarding: its
strategy, business plans and focus; its ability to quickly and
efficiently realize the scope and potential of its genome editing
technology; its ability to maintain, expand and maximize its
intellectual property portfolio and pipeline as well as accelerate
clinical validation for its platform; the therapeutic value and
development potential of CRISPR/Cas9 gene editing technologies and
therapies; its ability to combine its CRISPR genome editing
platform with Kyverna’s CD19 CAR T-cell therapy expertise to create
successful therapeutic products; and the expected strategic
benefits of any current or future collaborations.
Any forward-looking statements in this press release are based
on management's current expectations and beliefs of future events,
and are subject to a number of risks, uncertainties and important
factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without
limitation, risks related to Intellia’s ability to protect and
maintain its intellectual property portfolio; risks related to
Intellia’s relationship with third parties, including its licensors
and licensees; risks related to the ability of Intellia’s licensors
to protect and maintain their intellectual property position;
uncertainties related to the authorization, initiation and conduct
of studies and other development requirements for the new company’s
product candidates; the risk that any one or more of the
collaboration product candidates (including KYV-201) will not be
successfully developed and commercialized; the risk that the
results of preclinical studies or clinical studies will not be
predictive of future results in connection with future studies; and
the risk that Intellia’s collaboration with Kyverna or its other
collaborations will not continue or will not be successful. These
and other risks and uncertainties are described in greater detail
in the section entitled “Risk Factors” in Intellia’s most recent
annual report on Form 10-K and quarterly report on Form 10-Q filed
with the SEC, as well as discussions of potential risks,
uncertainties, and other important factors in Intellia’s other
filings with the Securities and Exchange Commission. Any
forward-looking statements contained in this press release
represent Intellia’s views only as of the date hereof and should
not be relied upon as representing its views as of any subsequent
date. Intellia explicitly disclaims any obligation to update any
forward-looking statements, except as required by law.
Contacts:
For Intellia:
Investors:Ian KarpSenior Vice President, Investor Relations and
Corporate Communications+1-857-449-4175ian.karp@intelliatx.comLina
LiDirector, Investor
Relations+1-857-706-1612lina.li@intelliatx.com
Media:Matt Crenson Ten Bridge
Communications+1-917-640-7930media@intelliatx.com
mcrenson@tenbridgecommunications.com
For Kyverna:
Ryan Jonesmedia@kyvernatx.com
Kathy VincentGreig Communications,
Inc.kathy@greigcommunications.com
- Kansal R et al. Sustained B cell depletion by CD19-targeted CAR
T cells is a highly effective treatment for murine lupus. Sci.
Transl. Med. 2019; 11(482):eaav1648
- Brudno J et al. Safety and feasibility of anti-CD19 CAR T cells
with fully human binding domains in patients with B-cell lymphoma.
Nat. Medicine 2020;26:270-280.
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