- Partnership with Everest Medicines will address a critical
unmet medical need for patients with active lupus nephritis in
Asia
- Kezar is eligible to receive up to $132.5 million in total
payments, as well as tiered royalties
Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage
biotechnology company discovering and developing breakthrough
treatments for immune mediated and oncologic disorders, today
announced that it entered into a collaboration and license
agreement with Everest Medicines, a biopharmaceutical company
focused on development, manufacturing and commercialization of
innovative medicines and vaccines, to develop and commercialize
zetomipzomib, Kezar’s novel, first-in-class selective
immunoproteasome inhibitor, in Greater China, South Korea and
Southeast Asia.
Under the terms of the agreement, Kezar will receive an initial
upfront payment, as well as future payments upon achievement of
development, regulatory and commercialization milestones, for a
potential total of up to $132.5 million. Everest Medicines will
also pay tiered royalties on net sales. Everest Medicines will have
exclusive rights to develop and commercialize zetomipzomib in
Greater China, South Korea, Singapore, Malaysia, Thailand,
Indonesia, Vietnam and the Philippines.
Everest Medicines will join Kezar on PALIZADE, a global,
placebo-controlled Phase 2b clinical trial evaluating zetomipzomib
in patients with active lupus nephritis (LN), in Greater China,
South Korea and Southeast Asia. Everest Medicines has a successful
track record of conducting clinical trials in renal disease, which
provides the potential to accelerate enrollment in these
geographies. For the PALIZADE trial, Everest Medicines will
contribute their local regulatory and clinical trial expertise and
will be responsible for study costs in the licensed territories. In
addition to LN, Kezar and Everest Medicines have the opportunity to
collaborate on future clinical trials and indications for the
continued development of zetomipzomib.
“This partnership with Everest Medicines is an important
milestone in the development of zetomipzomib,” said John Fowler,
co-founder and CEO of Kezar. “Everest stood out as an ideal
regional partner due to its strong nephrology focus and outstanding
team with deep global pharma experience. It is clear that they
understand zetomipzomib’s broad potential and that their team will
integrate seamlessly with ours to help drive enrollment in
PALIZADE, our global lupus nephritis trial. It’s well-known that
prevalence rates for many autoimmune diseases, including LN and
SLE, are higher in Asia, and we are happy that even more patients
in need will potentially get access to zetomipzomib as a result of
this partnership.”
It is estimated that there are 1 million patients in China with
systemic lupus erythematosus (SLE), and 40-60% of SLE patients have
renal disease. Infection is the leading cause of mortality in SLE
patients in China, accounting for up to 65% of deaths.
“We are glad to form a partnership with Kezar through our
cooperation on zetomipzomib,” said Rogers Yongqing Luo, Chief
Executive Officer of Everest Medicines. “Renal and autoimmune
diseases are key therapeutic areas for Everest. We look forward to
working closely with our partner on the clinical trials, utilizing
Everest’s strong expertise in clinical development and regulatory
filings, to bring this innovative therapy to the region as quickly
as possible.”
Stifel acted as exclusive financial advisor to Kezar Life
Sciences on the transaction.
About Zetomipzomib
Zetomipzomib (KZR-616) is a novel, first-in-class, selective
immunoproteasome inhibitor with broad therapeutic potential across
multiple autoimmune diseases. Preclinical research demonstrates
that selective immunoproteasome inhibition results in a broad
anti-inflammatory response in animal models of several autoimmune
diseases, while avoiding immunosuppression. Data generated from
Phase 1 and Phase 2 clinical trials provide evidence that
zetomipzomib exhibits a favorable safety and tolerability profile
for development in severe, chronic autoimmune diseases.
About PALIZADE
PALIZADE is a global, placebo-controlled, randomized,
double-blind Phase 2b clinical trial evaluating the efficacy and
safety of two dose-levels of zetomipzomib in patients with active
LN. Target enrollment will be 279 patients, randomly assigned
(1:1:1) to receive 30 mg of zetomipzomib, 60 mg of zetomipzomib or
placebo subcutaneously once weekly for 52 weeks, in addition to
standard background therapy. Background therapy can, but will not
be mandated to, include standard induction therapy. Over the
initial 16 weeks, there will be a mandatory corticosteroid taper to
5 mg per day or less. End-of-treatment assessments will occur at
Week 53. The primary efficacy endpoint is the proportion of
patients who achieve a complete renal response (CRR) at Week 37,
including a urine protein-to-creatine ratio (UPCR) of 0.5 or less
without receiving rescue or prohibited medications.
About Kezar Life Sciences
Kezar Life Sciences is a clinical-stage biopharmaceutical
company discovering and developing novel treatments for
immune-mediated and oncologic disorders. The company is pioneering
first-in-class, small-molecule therapies that harness master
regulators of cellular function to inhibit multiple drivers of
disease via single, powerful targets. Zetomipzomib, its lead
development asset, is a selective immunoproteasome inhibitor that
has completed a Phase 2 clinical trial in lupus nephritis. This
product candidate also has the potential to address multiple
chronic immune-mediated diseases. KZR-261 is the first anti-cancer
clinical candidate from the company’s platform targeting the Sec61
translocon and the protein secretion pathway. An open-label,
dose-escalation Phase 1 clinical trial of KZR-261 to assess safety,
tolerability and preliminary tumor activity in solid tumors is
underway. For more information, visit www.kezarlifesciences.com,
and follow us on LinkedIn, Facebook, Twitter and Instagram.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on
developing, manufacturing and commercializing transformative
pharmaceutical products and vaccines that address critical unmet
medical needs for patients in Asian markets. The management team of
Everest Medicines has deep expertise and an extensive track record
from both leading global pharmaceutical companies and local Chinese
pharmaceutical companies in high-quality discovery, clinical
development, regulatory affairs, CMC, business development and
operations. Everest Medicines has built a portfolio of potentially
global first-in-class or best-in-class molecules, many of which are
in late-stage clinical development. The Company’s therapeutic areas
of interest include renal diseases, infectious diseases, mRNA
platform and autoimmune disorders. For more information, please
visit its website at www.everestmedicines.com.
Cautionary Note on 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,” “can,” “should,” “expect,”
“believe”, “potential” 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 Kezar’s expectations
and assumptions as of the date of this press release. Each of these
forward-looking statements involves risks and uncertainties that
could cause Kezar’s clinical development programs, future results
or performance to differ materially from those expressed or implied
by the forward-looking statements. Forward-looking statements
contained in this press release include, but are not limited to,
statements about the potential payment and receipt of milestone
payments and royalties, collaboration on clinical trials and
development of zetomipzomib in additional indications, the
potential acceleration of enrollment of clinical trials, the
design, initiation, timing, scope and results of clinical trials,
the anticipated therapeutic benefit and ability of Kezar’s product
candidates to address unmet medical need, the regulatory
development and potential commercialization of Kezar’s product
candidates and the likelihood of obtaining regulatory approval of
Kezar’s product candidates. Many factors may cause differences
between current expectations and actual results, including
unexpected safety or efficacy data observed during clinical
studies, difficulties enrolling and conducting our clinical trials,
disputes or failure to perform under the collaboration and license
agreement, changes in expected or existing competition, changes in
the regulatory environment, the uncertainties and timing of the
regulatory approval process, and unexpected litigation or other
disputes. Other factors that may cause actual results to differ
from those expressed or implied in the forward-looking statements
in this press release are discussed in Kezar’s filings with the
U.S. Securities and Exchange Commission, including the “Risk
Factors” contained therein. Except as required by law, Kezar
assumes no obligation to update any forward-looking statements
contained herein to reflect any change in expectations, even as new
information becomes available.
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version on businesswire.com: https://www.businesswire.com/news/home/20230920488775/en/
Investor Contact: Gitanjali Jain Vice President, Investor
Relations and External Affairs gjain@kezarbio.com
Media Contact: Will Zasadny Evoke Canale
will.zasadny@evokegroup.com
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