TARRYTOWN, N.Y. and
SHANGHAI, April 8, 2020 /PRNewswire/ --
Zai Lab obtains rights to develop and exclusively
commercialize REGN1979 in oncology in mainland China, Hong
Kong, Taiwan and
Macau
Collaboration will also support enrollment of regional
patients into Regeneron's global trials evaluating REGN1979 in
B-cell non-Hodgkin lymphoma (B-NHL)
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and
Zai Lab Limited (NASDAQ: ZLAB) today announced a strategic
collaboration for the development and commercialization of REGN1979
(CD20xCD3 bispecific antibody) in mainland China, Hong
Kong, Taiwan and
Macau. The collaboration will
support global clinical development for REGN1979, starting with the
ongoing potentially registrational Phase 2 program in B-cell
non-Hodgkin lymphoma (B-NHL). Additionally, if REGN1979 is
approved, Zai Lab will leverage its capabilities to commercialize
REGN1979 in this region. REGN1979 is the most advanced
investigational bispecific monoclonal antibody from Regeneron's
bispecific platform and is designed to trigger tumor killing by
linking and activating a cytotoxic T-cell (binding to CD3) to a
lymphoma cell (binding to CD20).
Under the terms of the agreement, Regeneron will receive a
$30 million upfront payment and is
eligible to receive up to $160
million in additional regulatory and sales milestones. Zai
Lab will contribute to the global development costs for REGN1979
for certain trials and will receive the rights to develop and
exclusively commercialize REGN1979 in oncology in mainland
China, Hong Kong, Taiwan and Macau. Additionally, Zai Lab will make
payments to Regeneron based on net sales, such that Regeneron
shares in a significant portion of any potential profits. Regeneron
will be responsible for the manufacture and supply of REGN1979 for
development and commercialization in the region.
"Zai Lab is an ideal collaborator for us, with an established
and respected track record that aligns with our mission to use the
power of science to repeatedly bring new medicines to patients with
serious diseases," said Israel Lowy,
M.D., Ph.D., Senior Vice President and Head of Clinical and
Translational Sciences for Oncology at Regeneron. "Zai's support
will not only help bolster enrollment into global REGN1979 trials,
but will also enable this promising investigational medicine to
reach patients faster in this key region, if approved."
"Regeneron is a global leader in the research and development of
innovative medicines, and we are delighted to collaborate on the
investigational bispecific antibody REGN1979 as we expand our
oncology franchise into hematologic cancers," said Samantha Du, Ph.D., Founder, Chairperson and
Chief Executive Officer at Zai Lab. "Zai looks forward to
contributing significantly to the success of REGN1979 with our
regulatory and clinical expertise, and commercial footprint in
mainland China, Hong Kong, Taiwan and Macau. We are committed to collaborating with
Regeneron to expand its global effort and bring innovative
medicines to patients with unmet medical needs."
REGN1979 was granted orphan drug designation by the U.S. Food
and Drug Administration (FDA) for the treatment of follicular
lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL).
REGN1979 is currently being investigated as a treatment for late
stages of FL, DLBCL and other lymphomas in a Phase 1 trial as well
as a potentially registrational Phase 2 trial. Positive data for
REGN1979 from the Phase 1 trial were last shared at the 2019
American Society of Hematology (ASH) Annual Meeting.
About the Regeneron Bispecific Antibody Platform
All
of Regeneron's bispecifics are designed to closely resemble natural
human antibodies and bind to two different targets. They are
derived from a next-generation version of Regeneron's proprietary
VelocImmune® technology that utilizes a
proprietary genetically-engineered mouse platform endowed with a
genetically-humanized immune system to produce optimized
fully-human antibodies and further created using the company's
Veloci-Bi® platform. These allow for the
creation of bispecifics with no linkers or artificial sequences.
Additionally, Regeneron bispecifics are manufactured using similar
approaches used for human antibody medicines, with similar
pharmacokinetics.
VelocImmune has been used to create multiple antibodies
including Dupixent® (dupilumab), Praluent®
(alirocumab), Libtayo® (cemiplimab-rwlc) and
Kevzara® (sarilumab), which are approved in multiple
countries around the world. Regeneron previously used these
technologies to rapidly develop a treatment for Ebola virus
infection, which is currently under review by the FDA, and is now
being used in efforts to create prophylactic and treatment
medicines for COVID-19.
There are six Regeneron investigational bispecific antibodies
currently in ongoing clinical trials for multiple blood cancers and
solid tumors. These bispecifics fall into three categories:
- CD3 bispecifics are designed to bridge T-cells and
tumor cells. At the tumor site, they activate T-cells via their CD3
receptors and promote T-cell killing of the cancer cells.
Investigational candidates include:
- CD20xCD3 (REGN1979) for non-Hodgkin B-cell lymphomas;
- Two distinct BCMAxCD3s (REGN5458 and REGN5459) for multiple
myeloma;
- MUC16xCD3 (REGN4018) for ovarian cancer.
- CD28 costimulatory bispecifics are also designed to
bridge T-cells and tumor cells. At the tumor site, they costimulate
T-cells via their CD28 receptors and may synergize with PD-1
inhibitors and/or CD3 bispecifics. Investigational candidates
include:
- PSMAxCD28 (REGN5678) in combination with Libtayo for prostate
cancer.
- Tumor-targeted bispecifics are designed to target
proteins only on the cancer cell. In this way, they may affect
various signaling pathways to hamper the cancer cell's ability to
survive and proliferate. Investigational candidates include:
- METxMET (REGN5093) for non-small cell lung cancer that is
driven by MET mutations and/or amplifications. REGN5093 targets two
different parts of the MET receptor on cancer cells to degrade the
receptor and block its ability to trigger cell proliferation.
Regulatory Status of Regeneron Oncology Programs
The
bispecifics mentioned in this press release are currently under
clinical development, and their safety and efficacy have not been
fully evaluated by any regulatory authority.
Libtayo in combination with REGN5678 is currently under clinical
development for prostate cancer, and its safety and efficacy have
not been evaluated by any regulatory authority for this use.
Libtayo is currently approved in the U.S. for the treatment of
patients with metastatic cutaneous squamous cell carcinoma (CSCC)
or locally advanced CSCC who are not candidates for curative
surgery or curative radiation, and in other countries for similar
indications. In the U.S., the generic name for Libtayo is
cemiplimab-rwlc, with rwlc as the suffix designated in accordance
with Nonproprietary Naming of Biological Products Guidance for
Industry issued by the U.S. Food and Drug Administration.
As part of a global collaboration agreement, Regeneron and
Sanofi are jointly developing Libtayo, as well as Regeneron's
BCMAxCD3 and MUC16xCD3 bispecific programs.
About B-cell non-Hodgkin lymphoma (B-NHL) in China
Non-Hodgkin lymphomas (NHL)
represent a diverse group of cancers that originate from B-, T- or
natural killer-cells, with annual incidence and death rates in
China of more than 88,000 and
48,000, respectively, as of 2018. NHL originating in B-cells
(B-NHL) make up 85% of all NHL cases, with the two most common
subtypes being DLBCL and FL.
DLBCL is an aggressive form of B-NHL with up to 50% of patients
with advanced stage disease progressing after first-line treatment
(e.g., relapsing or becoming refractory to treatment). For patients
with R/R DLBCL, treatment options are limited and the prognosis is
poor.
FL is a slow-growing (indolent) form of B-NHL with most cases
diagnosed in advanced stages. Although median survival ranges from
8 to 15 years in advanced FL, current therapeutic options are not
curative, and most patients relapse within 5 years regardless of
the regimen. In some cases, FL can transform into DLBCL, at which
point it is often treated in the same way as DLBCL.
About Regeneron Pharmaceuticals
Regeneron (NASDAQ:
REGN) is a leading biotechnology company that invents
life-transforming medicines for people with serious diseases.
Founded and led for over 30 years by physician-scientists, our
unique ability to repeatedly and consistently translate science
into medicine has led to seven FDA-approved treatments and numerous
product candidates in development, all of which were homegrown in
our laboratories. Our medicines and pipeline are designed to help
patients with eye diseases, allergic and inflammatory diseases,
cancer, cardiovascular and metabolic diseases, pain, infectious
diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our
proprietary VelociSuite® technologies,
such as VelocImmune which uses unique
genetically-humanized mice to produce optimized fully-human
antibodies and bispecific antibodies, and through ambitious
research initiatives such as the Regeneron Genetics Center, which
is conducting one of the largest genetics sequencing efforts in the
world.
For additional information about the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
About Zai Lab
Zai Lab (NASDAQ:ZLAB) is a China and U.S.-based innovative commercial
stage biopharmaceutical company focused on bringing transformative
medicines for cancer, infectious and autoimmune diseases to
patients in China and around the
world. To quickly target the large, fast-growing segments of
China's pharmaceutical market and
address unmet medical needs, Zai Lab's experienced team has secured
partnerships with leading global biopharma companies, generating a
broad pipeline of innovative drug candidates. Zai Lab has also
built an in-house team with strong drug discovery and translational
research capabilities, aiming to establish a global pipeline of
proprietary drug candidates against targets in our focus areas. Zai
Lab's vision is to become a fully integrated biopharmaceutical
company, discovering, developing, manufacturing and commercializing
its portfolio in order to impact human health worldwide.
For additional information about the company, please visit
www.zailaboratory.com.
Regeneron Forward-Looking Statements
This press
release includes forward-looking statements that involve risks and
uncertainties relating to future events and the future performance
of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"),
and actual events or results may differ materially from these
forward-looking statements. Words such as "anticipate," "expect,"
"intend," "plan," "believe," "seek," "estimate," variations of such
words, and similar expressions are intended to identify such
forward-looking statements, although not all forward-looking
statements contain these identifying words. These statements
concern, and these risks and uncertainties include, among others,
the impact of SARS-CoV-2 (the virus that has caused the COVID-19
pandemic) on Regeneron's business and its employees, collaborators,
suppliers, and other third parties on which Regeneron relies,
Regeneron's and its collaborators' ability to continue to conduct
research and clinical programs, Regeneron's ability to manage its
supply chain, net product sales of products marketed by Regeneron
and/or its collaborators (collectively, "Regeneron's Products"),
and the global economy; the nature, timing, and possible success
and therapeutic applications of Regeneron's Products and
Regeneron's product candidates and research and clinical programs
now underway or planned, such as the programs discussed in this
press release evaluating REGN1979 in collaboration with Zai Lab
Limited (including the program evaluating REGN1979 for the
treatment of B-cell non-Hodgkin lymphoma) and Regeneron's other
investigational bispecific antibodies; the extent to which the
results from the research and development programs conducted by
Regeneron and/or its collaborators (including based on the
collaboration discussed in this press release) may be replicated in
other studies and lead to therapeutic applications; the potential
for any license or collaboration agreement, including Regeneron's
agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries
Ltd. (or their respective affiliated companies, as applicable), as
well as Regeneron's collaboration with Zai Lab Limited discussed in
this press release, to be cancelled or terminated without any
further product success; the likelihood, timing, and scope of
possible regulatory approval and commercial launch of Regeneron's
product candidates and new indications for Regeneron's Products,
such as REGN1979 for the treatment of follicular lymphoma, diffuse
large B-cell lymphoma, and other lymphomas; unforeseen safety
issues resulting from the administration of Regeneron's Products
and product candidates (such as REGN1979) in patients, including
serious complications or side effects in connection with the use of
Regeneron's Products and product candidates in clinical trials;
determinations by regulatory and administrative governmental
authorities which may delay or restrict Regeneron's ability to
continue to develop or commercialize Regeneron's Products and
product candidates, including without limitation REGN1979; ongoing
regulatory obligations and oversight impacting Regeneron's
Products, research and clinical programs, and business, including
those relating to patient privacy; uncertainty of market acceptance
and commercial success of Regeneron's Products and product
candidates and the impact of studies (whether conducted by
Regeneron or others and whether mandated or voluntary) on the
commercial success of Regeneron's Products and product candidates;
the availability and extent of reimbursement of Regeneron's
Products from third-party payers, including private payer
healthcare and insurance programs, health maintenance
organizations, pharmacy benefit management companies, and
government programs such as Medicare and Medicaid; coverage and
reimbursement determinations by such payers and new policies and
procedures adopted by such payers; competing drugs and product
candidates that may be superior to Regeneron's Products and product
candidates; the ability of Regeneron to manufacture and manage
supply chains for multiple products and product candidates; the
ability of Regeneron's collaborators, suppliers, or other third
parties (as applicable) to perform manufacturing, filling,
finishing, packaging, labeling, distribution, and other steps
related to Regeneron's Products and product candidates;
unanticipated expenses; the costs of developing, producing, and
selling products; the ability of Regeneron to meet any of its
financial projections or guidance and changes to the assumptions
underlying those projections or guidance; and risks associated with
intellectual property of other parties and pending or future
litigation relating thereto (including without limitation the
patent litigation and other related proceedings relating to
Dupixent® (dupilumab) and Praluent®
(alirocumab)), other litigation and other proceedings and
government investigations relating to the Company and/or its
operations, the ultimate outcome of any such proceedings and
investigations, and the impact any of the foregoing may have on
Regeneron's business, prospects, operating results, and financial
condition. A more complete description of these and other material
risks can be found in Regeneron's filings with the U.S. Securities
and Exchange Commission, including its Form 10-K for the year ended
December 31, 2019. Any
forward-looking statements are made based on management's current
beliefs and judgment, and the reader is cautioned not to rely on
any forward-looking statements made by Regeneron. Regeneron does
not undertake any obligation to update publicly any forward-looking
statement, including without limitation any financial projection or
guidance, whether as a result of new information, future events, or
otherwise.
Regeneron uses its media and investor relations website and
social media outlets to publish important information about the
Company, including information that may be deemed material to
investors. Financial and other information about Regeneron is
routinely posted and is accessible on Regeneron's media and
investor relations website (http://newsroom.regeneron.com) and its
Twitter feed (http://twitter.com/regeneron).
Zai Lab Forward-Looking Statements
This press
release contains statements about future expectations, plans and
prospects for Zai Lab, including, without limitation, statements
regarding business strategy, plans and objectives for future
operations of REGN1979 within mainland China, Hong
Kong, Taiwan and
Macau. Such statements constitute
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements are not statements of historical fact nor are they
guarantees or assurances of future performance. Forward-looking
statements are based on Zai Lab's expectations and assumptions as
of the date of this press release and are subject to inherent
uncertainties, risks and changes in circumstances that may differ
materially from those contemplated by the forward-looking
statements. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including but not limited to (1) Zai Lab's
ability to obtain additional future funding, (2) Zai Lab's results
of clinical and pre-clinical development of its drug candidates,
(3) the content and timing of decisions made by the relevant
regulatory authorities regarding regulatory approvals of Zai Lab's
drug candidates, (4) Zai Lab's ability to generate revenue from its
drug candidates, and (5) other factors discussed in Zai Lab's
Annual Report on Form 20-F for the fiscal year ended December 31, 2018 and its other filings with the
Securities and Exchange Commission. Zai Lab anticipates that
subsequent events and developments will cause Zai Lab's
expectations and assumptions to change and undertakes no obligation
to publicly update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise,
except as may be required by law. These forward-looking statements
should not be relied upon as representing Zai Lab's views as of any
date subsequent to the date of this press release.
Contacts:
Regeneron Contacts:
Media Relations
Daren Kwok
Tel: +1 (914) 847-1328
Daren.Kwok@regeneron.com
Investor Relations
Justin Holko
Tel: +1 (914) 847-7786
Justin.Holko@regeneron.com
Zai Lab Contacts:
Billy Cho, CFO
+86 137 6151 2501
billy.cho@zailaboratory.com
Media: Ryo Imai / Robert Flamm
Burns McClellan, on behalf of Zai Lab
212-213-0006, ext. 315 / 364
rimai@burnsmc.com / rflamm@burnsmc.com
Investors: Peter Rahmer /
Mike Zanoni
Endurance Advisors, on behalf of Zai Lab
415-515-9763 / 610-442-8570
prahmer@enduranceadvisors.com / mzanoni@enduranceadvisors.com
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SOURCE Regeneron Pharmaceuticals, Inc.