WALTHAM, Mass. and WILMINGTON, Del., Sept.
27, 2021 /PRNewswire/ -- Syndax Pharmaceuticals, Inc.
(Nasdaq: SNDX) and Incyte (Nasdaq: INCY) announced today that they
have entered into an exclusive worldwide collaboration and license
agreement to develop and commercialize axatilimab, Syndax's
anti-CSF-1R monoclonal antibody.
"This partnership has the potential to significantly expand and
maximize the axatilimab program across multiple lines of treatment
in chronic graft-versus-host Disease (cGVHD), as well as additional
indications in which the monocyte-macrophage lineage plays a vital
role in the fibrotic disease process, such as idiopathic pulmonary
fibrosis (IPF)," said Briggs W.
Morrison, M.D., Chief Executive Officer of Syndax. "Incyte
is a proven leader in the development and commercialization of many
important innovative therapies, including a treatment for GVHD. We
are thrilled to be working alongside this talented and determined
team to combine our expertise as we strive to provide new treatment
options for patients in desperate need of effective
interventions."
"We are excited to partner with Syndax and for the opportunity
to bring another potential treatment to patients with
life-threatening conditions, like GVHD," said Hervé Hoppenot, Chief
Executive Officer of Incyte. "Collaborations between companies like
Incyte and Syndax, who are both dedicated to scientific
advancement, contribute to the development of new innovative
medicines that may benefit patient communities around the
world."
Syndax and Incyte are seeking to develop axatilimab as a
backbone therapy for patients with cGVHD as well as in additional
immune-mediated diseases where CSF-1R-dependent monocytes and
macrophages are believed to contribute to organ fibrosis. Syndax
recently completed a Phase 1/2 trial of axatilimab in patients with
cGVHD. Data from the Phase 1 portion of the
trial highlighting the tolerability and high response rate of
axatilimab in cGVHD patients refractory to multiple therapeutic
agents were reported during an oral presentation at the American
Society of Hematology Annual Meeting in December 2020. Updated results from the Phase 1
portion and preliminary results from the Phase 2 expansion portion
of the study, which evaluated 1 mg/kg of axatilimab every two
weeks, are expected to be presented at a medical meeting in the
fourth quarter of 2021.
Enrollment continues in the ongoing global pivotal Phase 2
AGAVE-201 trial of axatilimab monotherapy in patients with cGVHD,
with topline data expected in 2023. The companies also plan to
initiate additional trials of axatilimab in patients with cGVHD in
2022, including a Phase 2 trial in combination with a JAK inhibitor
in patients with steroid-refractory cGVHD. Beyond cGVHD, Syndax
plans to commence a Phase 2 proof of concept trial of axatilimab
early next year in patients with IPF, a serious, life-limiting
orphan disease for which axatilimab could represent a much-needed
treatment option with a novel mechanism of action.
Terms of the Collaboration
Under the terms of the agreement, Incyte will lead global
commercial activities for axatilimab across all indications. The
companies will participate in a 50:50 profit share in the U.S., and
Syndax will receive double-digit royalties on sales outside of the
U.S. Syndax will retain the option to co-promote axatilimab for any
approved indications in the U.S. In connection with the agreement,
Syndax will receive an upfront payment of $117 million plus a $35
million equity investment, which will be purchased at
$24.62 per share, a 30% premium to
the volume weighted average price over the 10 days prior to
September 24, 2021. Syndax will also
be eligible to receive up to an additional $450 million in potential regulatory, development
and commercial milestone payments.
The companies will share development costs associated with
global and U.S.-specific trials for all agreed upon trials at a
rate of 55% (Incyte) and 45% (Syndax), with Incyte responsible for
100% of future development costs for trials that are specific to
ex-U.S. countries. Syndax will fund the initial development of
axatilimab in IPF and Incyte will have the option to co-fund
late-stage development for this indication.
The agreement between Syndax and Incyte, including the upfront
payment and equity investment, is subject to clearance by the U.S.
antitrust authorities under the Hart-Scott-Rodino Act and will
become effective as soon as these conditions have been met.
Goldman Sachs & Co. LLC is acting as the exclusive financial
advisor to Syndax.
Syndax Conference Call and Webcast
In connection with this announcement, Syndax's management team
will host a conference call and live audio webcast at 8:00 a.m. ET today, September 27, 2021.
The live audio webcast may be accessed through the Events &
Presentations page in the Investors section of Syndax's website
at www.syndax.com. Alternatively, the conference call
may be accessed through the following:
Conference ID: 9875536
Domestic Dial-in Number: (855) 251-6663
International Dial-in Number: (281) 542-4259
Live webcast: https://edge.media-server.com/mmc/p/7qge5abd
For those unable to participate in the conference call or
webcast, a replay will be available for 30 days on the Investors
section of Syndax's website, www.syndax.com.
Incyte Conference Call and Webcast
Incyte will also host an analyst and investor conference call
and webcast at 10:00 a.m. ET to
discuss today's news and the Company's recent product approval in
chronic GVHD. The live and archived webcast will be available
via investor.incyte.com.
To access the conference call, please dial 877-407-3042 for
domestic callers or +1-201-389-0864 for international callers
(conference identification number 13723505).
If you are unable to participate, a replay will be available for
90 days. The replay dial-in number for the United States is 877-660-6853 and the
dial-in number for international callers is +1-201-612-7415
(conference identification number 13723505).
About Chronic Graft-Versus-Host Disease
Chronic graft-versus-host disease (cGVHD), an immune response of
the donor-derived hematopoietic cells against recipient tissues, is
a serious, potentially life-threatening complication of allogeneic
hematopoietic stem cell transplantation (HSCT) which can last for
years. Chronic GVHD is estimated to develop in approximately 40% of
transplant recipients, and affects approximately 14,000 patients in
the U.S.1,2 Chronic GVHD typically manifests
across multiple organ systems, with skin and mucosa being commonly
involved, and is characterized by the development of fibrotic
tissue.3
About Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF) is a serious, life-limiting
chronic lung disease characterized by fibrosis and scarring of lung
tissue with a median survival of 3-5 years after diagnosis.
Patients with IPF experience debilitating symptoms including
progressive shortness of breath, particularly with exertion,
chronic cough, fatigue, weakness, and chest discomfort. Currently
approved drugs slow but do not halt disease progression and the
only curative therapy is lung transplant, which is an option for
less than 5% of patients. Estimates indicate that IPF could affect
approximately 150,000 patients in the U.S. and
approximately 260,000 patients across the seven major
pharmaceutical markets
(U.S., Japan, UK, Spain, Germany, Italy,
and France).4
About Axatilimab
Axatilimab is an investigational monoclonal
antibody that targets colony stimulating factor-1 receptor, or
CSF-1R, a cell surface protein thought to control the survival and
function of monocytes and macrophages. In pre-clinical models,
inhibition of signaling through the CSF-1 receptor has been shown
to reduce the number of disease-mediating macrophages along with
their monocyte precursors, which has been shown to play a key role
in the fibrotic disease process underlying diseases, such as
chronic graft-versus-host disease (cGVHD) and idiopathic pulmonary
fibrosis (IPF). Axatilimab data has demonstrated deep, durable
responses and multiorgan clinical benefit in patients with cGVHD
refractory to multiple therapeutic agents, and is currently
being evaluated in the global pivotal Phase 2 AGAVE-201 trial in
patients with cGVHD. Axatilimab was granted Orphan Drug Designation
by the U.S. Food and Drug Administration for the
treatment of patients with cGVHD and IPF. Axatilimab is being
developed under an exclusive worldwide license from UCB entered
into between Syndax and UCB in 2016.
About Incyte
Incyte is a Wilmington,
Delaware-based, global biopharmaceutical company focused on
finding solutions for serious unmet medical needs through the
discovery, development, and commercialization of proprietary
therapeutics. For additional information on Incyte, please
visit Incyte.com and follow @Incyte.
About Syndax Pharmaceuticals, Inc.
Syndax Pharmaceuticals is a clinical stage biopharmaceutical
company developing an innovative pipeline of cancer therapies. The
Company's pipeline includes SNDX-5613, a highly selective inhibitor
of the Menin–MLL binding interaction, axatilimab, a monoclonal
antibody that blocks the colony stimulating factor 1 (CSF-1)
receptor, and entinostat, a class I HDAC inhibitor. For more
information, please visit www.syndax.com or follow the Company
on Twitter and LinkedIn.
Incyte Forward-Looking Statements
Except for the historical information set forth herein, the
matters set forth in this press release, including statements
regarding whether or when axatilimab might provide a successful
treatment option for patients with steroid-refractory cGVHD or
other diseases; Incyte's plans to develop and commercialize
axatilimab, either as a monotherapy or in combination with other
therapies; and Incyte's expectations for its collaboration with
Syndax, contain predictions, estimates, and other forward-looking
statements.
These forward-looking statements are based on Incyte's current
expectations and subject to risks and uncertainties that may cause
actual results to differ materially, including unanticipated
developments in and risks related to: unanticipated delays;
further research and development and the results of clinical trials
possibly being unsuccessful or insufficient to meet applicable
regulatory standards or warrant continued development; the ability
to enroll sufficient numbers of subjects in clinical trials and the
ability to enroll subjects in accordance with planned
schedules; the effects of the COVID-19 pandemic and measures
to address the pandemic on Incyte's clinical trials supply chain
and other third-party providers and development and discovery
operations; determinations made by the U.S. antitrust authorities,
the FDA or other regulatory authorities; Incyte's dependence
on its relationships with its collaboration partners; the efficacy
or safety of the Incyte's products and the products of
Incyte's collaboration partners; the acceptance of the Company's
products and the products of the Incyte's collaboration partners in
the marketplace; market competition; sales, marketing,
manufacturing and distribution requirements; and other risks
detailed from time to time in Incyte's reports filed with the
Securities and Exchange Commission, including its annual report and
its quarterly report on Form 10-Q for the quarter ended
June 30, 2021. Incyte disclaims any
intent or obligation to update these forward-looking
statements.
Syndax Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as "may," "will," "expect," "plan,"
"anticipate," "estimate," "intend," "believe" and similar
expressions (as well as other words or expressions referencing
future events, conditions or circumstances) are intended to
identify forward-looking statements. These forward-looking
statements are based on Syndax's expectations and assumptions as of
the date of this press release. Each of these forward-looking
statements involves risks and uncertainties. Actual results may
differ materially from these forward-looking statements.
Forward-looking statements contained in this press release include,
but are not limited to, statements regarding whether or when
axatilimab might provide a successful treatment option for patients
with steroid-refractory cGVHD or other diseases; Syndax's plans to
develop and commercialize axatilimab, either as a monotherapy or in
combination with other therapies; Syndax's expectations for its
collaboration with Incyte; the design, progress, timing, clinical
development and scope of clinical trials, plans for initiating
future clinical trials, reporting of clinical data for Syndax's
product candidates, the association of data with treatment
outcomes. Many factors may cause differences between current
expectations and actual results including unexpected safety or
efficacy data observed during preclinical or clinical trials,
clinical trial site activation or enrollment rates that are lower
than expected, changes in expected or existing competition, changes
in the regulatory environment, the COVID-19 pandemic may disrupt
our business and that of the third parties on which we depend,
including delaying or otherwise disrupting our clinical trials and
preclinical studies, manufacturing and supply chain, or impairing
employee productivity, failure of Syndax's collaborators to support
or advance collaborations or product candidates and unexpected
litigation or other disputes. Other factors that may cause Syndax's
actual results to differ from those expressed or implied in the
forward-looking statements in this press release are discussed in
Syndax's filings with the Securities and Exchange Commission,
including the "Risk Factors" sections contained in its annual
report of Form 10-K for the year ended December 31, 2020 and its quarterly report on
Form 10-Q for the quarter ended June 30,
2021. Except as required by law, Syndax assumes no
obligation to update any forward-looking statements contained
herein to reflect any change in expectations, even as new
information becomes available.
Syndax Contacts
Investor Contact
Melissa Forst
Argot Partners
melissa@argotpartners.com
Tel 212.600.1902
Media Contact
Ted Held
ted.held@gcihealth.com
Tel 212.798.9842
Incyte Contacts
Investor Contact
Christine Chiou
cchiou@incyte.com
Tel +1 302 498 5914
Media Contact
Catalina Loveman
cloveman@incyte.com
Tel +1 302 498 6171
References
- SmartAnalyst 2020 SmartImmunology Insights chronic GVHD
report.
- Bachier, CR. et al. ASH annual meeting 2019; abstract #2109
Epidemiology and Real-World Treatment of Chronic Graft-Versus-Host
Disease Post Allogeneic Hematopoietic Cell Transplantation:
A U.S. Claims Analysis.
- Kantar 2020 GVHD Expert Interviews N=32 interviews.
- SMARTImmunology Insights. "Idiopathic Pulmonary Fibrosis."
Presentation, March 2020.
SNDX-G INCY-G
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SOURCE Syndax Pharmaceuticals, Inc.; Incyte