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.
Conference Call and Webcast
Information
Zai Lab will host a live conference call and
webcast today, April 8, 2020 at 8:00 a.m. EST to discuss the
strategic collaboration. Listeners may access the live webcast by
visiting the Company’s website at http://ir.zailaboratory.com.
Participants must register in advance of the conference call.
Details are as follows:
Registration Link:
http://apac.directeventreg.com/registration/event/4299594
Conference ID:
4299594
All participants must use the link provided above
to complete the online registration process in advance of the
conference call. Upon registering, each participant will receive a
dial-in number, Direct Event passcode, and a unique access PIN,
which can be used to join the conference call.
A replay will be available shortly after the call
and can be accessed by visiting the Company’s website at
http://ir.zailaboratory.com.
About the Regeneron Bispecific Antibody
PlatformAll 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
ProgramsThe 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 ChinaNon-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
PharmaceuticalsRegeneron (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 LabZai 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
StatementsThis 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
StatementsThis 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 KwokTel: +1 (914) 847-1328 Daren.Kwok@regeneron.com
Investor Relations Justin HolkoTel: +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 FlammBurns McClellan, on
behalf of Zai Lab212-213-0006, ext. 315 / 364rimai@burnsmc.com /
rflamm@burnsmc.com
Investors: Peter Rahmer / Mike ZanoniEndurance
Advisors, on behalf of Zai Lab415-515-9763 /
610-442-8570prahmer@enduranceadvisors.com /
mzanoni@enduranceadvisors.com
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