– Phase 1b/2 clinical trial expected to
begin enrolling patients before year-end 2023 –
Exelixis, Inc. (Nasdaq:EXEL) and Arcus Biosciences (NYSE:RCUS)
today announced that the companies have entered into a clinical
trial collaboration for STELLAR-009, a phase 1b/2 trial evaluating
zanzalintinib, Exelixis’ next-generation tyrosine kinase inhibitor
(TKI), in combination with AB521, an inhibitor of the transcription
factor HIF-2⍺, in patients with advanced solid tumors, including
clear cell renal cell carcinoma (ccRCC). Exelixis is sponsoring
STELLAR-009, and Arcus is co-funding the study and providing AB521
for use in the trial. Patient enrollment for STELLAR-009 is
expected to begin before the end of 2023.
“We are excited to learn more about the potential effects of
zanzalintinib plus Arcus’ HIF-2⍺ inhibitor, as these two molecules
approach the inhibition of cancer cell proliferation and tumor
angiogenesis from differing angles, and combination therapy may
provide better outcomes than either therapy alone,” said Amy
Peterson, M.D., Executive Vice President, Product Development &
Medical Affairs, and Chief Medical Officer, Exelixis. “We have a
long-established commitment to advancing treatment options in
kidney cancer, and we are eager to maximize the potential of
zanzalintinib through this collaboration with Arcus and look
forward to advancing the combination in the clinic.”
“We are excited to partner with Exelixis on the STELLAR-009
study to determine the best-in-class potential of AB521 in
combination with zanzalintinib and look forward to generating a
robust set of data to move this combination into full development,”
said Dimitry S.A. Nuyten, M.D., Ph.D., Chief Medical Officer of
Arcus Biosciences. “The STELLAR-009 study is an important step in
the development of AB521 and enables a cost-effective path to
evaluating our HIF-2⍺ inhibitor with a next-generation TKI.”
The dose-finding stage of this open-label study will determine a
recommended dose for zanzalintinib in combination with AB521 in
patients with advanced solid tumors and in patients with advanced
ccRCC. Expansion cohorts will further evaluate the tolerability and
activity of this combination in ccRCC as well as investigate the
contribution of components, supported by activity data generated
from monotherapy studies in ccRCC patients, to support full
development.
More information about this trial will be available soon on
ClinicalTrials.gov.
About Zanzalintinib
Zanzalintinib is a next-generation oral TKI that inhibits the
activity of receptor tyrosine kinases implicated in cancer growth
and spread, including VEGF receptors, MET, AXL and MER. These
receptor tyrosine kinases are involved in both normal cellular
function and in pathologic processes such as oncogenesis,
metastasis, tumor angiogenesis and resistance to multiple
therapies, including immune checkpoint inhibitors (ICIs). With
zanzalintinib, Exelixis sought to build upon its extensive
experience with the target profile of cabozantinib, the company’s
flagship medicine, while improving key characteristics, including
pharmacokinetic half-life. Zanzalintinib is currently being
developed for the treatment of advanced solid tumors, including
genitourinary, colorectal and head and neck cancers.
About AB521
AB521 is a small molecule inhibitor of HIF-2⍺, a transcription
factor involved in oxygen sensing in multiple organs as well as in
tumors. Clear cell RCC is almost universally associated with HIF-2⍺
dysregulation as a result of genetic abnormalities in the VHL
pathway. This creates a situation of pseudohypoxia and the abnormal
increase in HIF-2⍺-mediated expression of a wide array of proteins
involved in cancer cell proliferation and survival, treatment
resistance and angiogenesis. Arcus is currently evaluating AB521 in
ARC-20, a phase 1/1b study in cancer patients. Enrollment for the
dose-expansion stage in ccRCC patients is complete for the target
dose of 100 mg, and efficacy data from this stage are expected in
2024. In the dose-escalation stage up to 100 mg, as of December 1,
2023, pharmacokinetic and pharmacodynamic data were consistent with
the data generated in healthy volunteers, and no dose-limiting
toxicities were observed. AB521 has the potential to achieve
substantially greater HIF-2⍺ inhibition than the approved dose of
the marketed competitor.
About RCC
Kidney cancer is among the top ten most commonly diagnosed forms
of cancer among both men and women in the U.S.1 An estimated 81,800
Americans will be diagnosed with kidney cancer in 2023.1 Clear cell
RCC is the most common type of kidney cancer in adults.2 If
detected in its early stages, the five-year survival rate for RCC
is high; for patients with advanced or late-stage metastatic RCC,
however, the five-year survival rate is only 15%.3 In 2022,
approximately 32,200 patients with advanced kidney cancer required
systemic therapy in the U.S., with over 20,000 patients receiving
first-line treatment.4
About Exelixis
Exelixis is a globally ambitious oncology company innovating
next-generation medicines and regimens at the forefront of cancer
care. Powered by bi-coastal centers of discovery and development
excellence, we are rapidly evolving our product portfolio to target
an expanding range of tumor types and indications with our
clinically differentiated pipeline of small molecules,
antibody-drug conjugates and other biotherapeutics. This
comprehensive approach harnesses decades of robust investment in
our science and partnerships to advance our investigational
programs and extend the impact of our flagship commercial product,
CABOMETYX® (cabozantinib). Exelixis is driven by a bold scientific
pursuit to create transformational treatments that give more
patients hope for the future. For information about the company and
its mission to help cancer patients recover stronger and live
longer, visit www.exelixis.com, follow @ExelixisInc on X (Twitter),
like Exelixis, Inc. on Facebook and follow Exelixis on
LinkedIn.
About Arcus Biosciences
Arcus Biosciences is a clinical-stage, global biopharmaceutical
company developing differentiated molecules and combination
medicines for people with cancer. In partnership with industry
partners, patients and physicians around the world, Arcus is
expediting the development of first- or best-in-class medicines
against well-characterized biological targets and pathways and
studying novel, biology-driven combinations that have the potential
to help people with cancer live longer. Founded in 2015, the
company has expedited the development of multiple investigational
medicines into clinical studies, including new combination
approaches that target TIGIT, PD-1, the adenosine axis (CD73 and
dual A2a/A2b receptor), HIF-2a, CD39 and AXL. For more information
about Arcus Biosciences’ clinical and preclinical programs, please
visit www.arcusbio.com or follow us on X.
Exelixis Forward-Looking Statements
This press release contains forward-looking statements,
including, without limitation, statements related to: the
therapeutic potential of zanzalintinib in combination with AB521 to
improve outcomes for patients with advanced solid tumors, including
ccRCC, and for the combination to provide better outcomes than
either therapy alone; Exelixis’ expectation that patient enrollment
for STELLAR-009 will begin before the end of 2023; Exelixis’ plans
to continue studying the therapeutic potential of zanzalintinib in
kidney cancer, as well as in other advanced solid tumors; and
Exelixis’ scientific pursuit to create transformational treatments
that give more patients hope for the future. Any statements that
refer to expectations, projections or other characterizations of
future events or circumstances are forward-looking statements and
are based upon Exelixis’ current plans, assumptions, beliefs,
expectations, estimates and projections. Forward-looking statements
involve risks and uncertainties. Actual results and the timing of
events could differ materially from those anticipated in the
forward-looking statements as a result of these risks and
uncertainties, which include, without limitation: complexities and
the unpredictability of the regulatory review and approval
processes in the U.S. and elsewhere; Exelixis’ and Arcus
Biosciences’ continuing compliance with applicable legal and
regulatory requirements; the potential failure of zanzalintinib in
combination with AB521 to demonstrate safety and/or efficacy in
STELLAR-009 and in future clinical testing; uncertainties inherent
in the product development process, including evolving regulatory
requirements, slower than anticipated patient enrollment or
inability to identify a sufficient number of clinical trial sites;
the costs of conducting clinical trials, including the ability or
willingness of Exelixis’ clinical collaboration partners to invest
in the resources necessary to complete the trials; Exelixis’
dependence on third-party vendors for the development, manufacture
and supply of zanzalintinib; Exelixis’ ability to protect its
intellectual property rights; market competition; changes in
economic and business conditions; and other factors affecting
Exelixis and its development programs detailed from time to time
under the caption “Risk Factors” in Exelixis’ most recent Annual
Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q,
and in Exelixis’ future filings with the Securities and Exchange
Commission. All forward-looking statements in this press release
are based on information available to Exelixis as of the date of
this press release, and Exelixis undertakes no obligation to update
or revise any forward-looking statements contained herein, except
as required by law.
Arcus Forward-Looking Statements
This press release contains forward-looking statements. All
statements regarding events or results to occur in the future
contained herein are forward-looking statements reflecting the
current beliefs and expectations of management made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995, including, but not limited to, the timing for
enrollment of the study, the potential of AB521 plus zanzalintinib
and the enablement of future development plans for AB521. All
forward-looking statements involve known and unknown risks and
uncertainties and other important factors that may cause Arcus’s
actual results, performance or achievements to differ significantly
from those expressed or implied by the forward-looking statements.
Factors that could cause or contribute to such differences include,
but are not limited to: difficulties or delays in initiating or
conducting clinical trials due to difficulties or delays in the
regulatory process, enrolling subjects or manufacturing or
supplying product for such clinical trials; the emergence of
adverse events or other undesirable side effects; the applicability
of data resulting from the study described herein to later trials;
difficulties associated with the management of the collaboration
activities or expanded clinical programs; changes in the
competitive landscape for Arcus’s programs; and the inherent
uncertainty associated with pharmaceutical product development and
clinical trials. Risks and uncertainties facing Arcus are described
more fully in the “Risk Factors” section of Arcus’s most recent
Quarterly Report on Form 10Q filed with the U.S. Securities and
Exchange Commission. You are cautioned not to place undue reliance
on the forward-looking statements, which speak only as of the date
of this press release. Arcus disclaims any obligation or
undertaking to update, supplement or revise any forward-looking
statements contained in this press release except to the extent
required by law.
Exelixis, the Exelixis logo and CABOMETYX are
registered U.S. trademarks of Exelixis.
____________________
1 Key Statistics About Kidney Cancer. American Cancer Society
website. Available at:
https://www.cancer.org/cancer/kidney-cancer/about/key-statistics.html.
Accessed December 2023. 2 What Is Kidney Cancer? American Cancer
Society website. Available at
https://www.cancer.org/cancer/kidney-cancer/about/what-is-kidney-cancer.html.
Accessed December 2023. 3 Survival Rates for Kidney Cancer.
American Cancer Society website. Available at
https://www.cancer.org/cancer/kidney-cancer/detection-diagnosis-staging/survival-rates.html.
Accessed December 2023. 4 Citeline’s Datamonitor Healthcare: Renal
Cell Carcinoma. September 2023 (internal data on file).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231204708620/en/
Investors Contact: Susan Hubbard EVP, Public Affairs and
Investor Relations Exelixis, Inc. (650) 837-8194
shubbard@exelixis.com
Investors Contact: Pia Eaves (Banerjee) Head of Investor
Relations & Strategy (617) 459-2006 peaves@arcusbio.com
Media Contact: Stekki Millman Senior Director, Public
Affairs Exelixis, Inc. (650) 837-7187 smillman@exelixis.com
Media Contact: Holli Kolkey VP of Corporate
Communications (650) 922-1269 hkolkey@arcusbio.com
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