- Dr. Markus will oversee Arcus’s clinical development
organization and portfolio that includes seven clinical-stage
programs with multiple ongoing Phase 3 studies
Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global
biopharmaceutical company focused on developing differentiated
molecules and combination therapies for people with cancer, today
announced that Richard Markus, M.D., Ph.D., has been appointed
chief medical officer (CMO) effective January 31, 2025. Dr. Markus
replaces Dimitry Nuyten, M.D., Ph.D., who will be leaving the
company at the end of January to pursue other opportunities. Dr.
Markus’s responsibilities will include oversight of Arcus’s
clinical development organization and its late-stage portfolio,
currently including four ongoing registrational Phase 3 studies,
the first of which, STAR-221, is expected to read out next year.
Arcus plans to initiate a fifth registrational Phase 3 study,
PEAK-1, in the first half of 2025, to evaluate its HIF-2a inhibitor
casdatifan plus cabozantinib in people with clear-cell renal cell
carcinoma (ccRCC) who have progressed on immunotherapy. Dr.
Markus’s extensive late-stage development experience will be
essential as he leads Arcus’s strategy and efforts to fully
leverage the opportunities in Arcus’s portfolio.
“Dr. Markus is a biotechnology industry veteran who will advance
our late-stage programs into commercialization. His decades and
breadth of clinical development success will solidify Arcus’s
emerging position as a leader in creating and developing a next
generation of therapies in oncology,” said Terry Rosen, Ph.D.,
chief executive officer of Arcus. “Our development organization has
seamlessly advanced our broad portfolio of investigational
molecules to address multiple cancers with high unmet need, and we
are thrilled that Dr. Markus will be leading our organization and
creating the infrastructure and culture to reproducibly deliver
innovative therapies. I would also like to acknowledge and thank
Dr. Nuyten for building a world-class development organization and
leading Arcus through a period of incredibly rapid growth with
parallel creation of a late-stage portfolio.”
“Arcus stands out as a mid-sized biotech company with its
breadth and depth of oncology assets and entry into inflammation
and immunology; it’s an exciting time to be joining the company,”
said Richard Markus, M.D., Ph.D., incoming chief medical officer at
Arcus Biosciences. “The company’s portfolio of molecules, most of
which are being developed on top of the current standards of care,
has the potential to change clinical practice with meaningful
advancements for patients. I’m looking forward to working with the
oncology community and our clinical and business partners to make
this a reality.”
Dr. Markus established a unique track record of late-stage
development experience during a 13-year tenure at Amgen in
increasing roles of responsibility, including as vice president of
global development. Dr. Markus oversaw the development and approval
of multiple products and was also the first R&D head for the
biosimilars division, leading the development of a 10-product
pipeline across multiple therapeutic areas, including oncology and
rheumatology. Most recently, Dr. Markus founded Dantari, a
clinical-stage oncology-focused antibody-drug conjugate company,
where he served as president, CEO and member of the Board. Dr.
Markus earned his medical degree and a Ph.D. in epidemiology from
the University of Southern California, and then his surgery
internship and residency in urology.
Arcus’s Ongoing and Announced Clinical Studies
Trial Name
Arms
Setting
Status
NCT No.
Upper Gastrointestinal Cancers
STAR-221
dom + zim + chemo vs. nivo + chemo
1L Gastric, GEJ and EAC
Ongoing Registrational Phase 3
NCT05568095
EDGE-Gastric (ARC-21)
dom +/- zim +/- quemli +/- chemo
1L/2L Upper GI Malignancies
Ongoing
Randomized Phase 2
NCT05329766
Lung Cancer
STAR-121
dom + zim + chemo vs. pembro + chemo
1L NSCLC (PD-L1 all-comers)
Ongoing Registrational Phase 3
NCT05502237
PACIFIC-8
dom + durva vs. durva
Unresectable Stage 3 NSCLC
Ongoing Registrational Phase 3
NCT05211895
ARC-7
zim vs. dom + zim vs. etruma + dom +
zim
1L NSCLC (PD-L1 ≥ 50%)
Ongoing Randomized Phase 2
NCT04262856
ARC-10
dom + zim vs. zim or chemo
1L NSCLC (PD-L1 ≥ 50%)
Ongoing Randomized Phase 2
NCT04736173
EDGE-Lung
dom +/- zim +/- quemli +/- chemo
1L/2L NSCLC (lung cancer platform
study)
Ongoing Randomized Phase 2
NCT05676931
VELOCITY-Lung
dom +/- zim +/- etruma +/- sacituzumab
govitecan-hziy or other combos
1L/2L NSCLC (lung cancer platform
study)
Ongoing Randomized Phase 2
NCT05633667
Pancreatic Cancer
PRISM-1
quemli + gem/nab-pac vs. gem/nab-pac
1L PDAC
Ongoing Randomized Phase 3
NCT06608927
ARC-8
quemli + zim + gem/nab-pac vs. quemli +
gem/nab-pac
1L/2L PDAC
Ongoing Randomized Phase 1/1b
NCT04104672
Kidney Cancer
PEAK-1
cas + cabo vs. cabo
Post-IO ccRCC
Planned Phase 3
TBD
ARC-20
cas, cas + cabo
Cancer Patients/ccRCC
Ongoing Phase 1/1b
NCT05536141
Colorectal Cancer
ARC-9
etruma + zim + mFOLFOX vs. SOC
2L/3L/3L+ CRC
Ongoing
Randomized Phase 2
NCT04660812
Head and Neck
VELOCITY-HNSCC
dom + zim + chemo vs zim + chemo
1L
Ongoing Phase 2
NCT06727565
Other
ARC-25
AB598
Advanced Malignancies
Ongoing
NCT05891171
ARC-27
AB801
Advanced Malignancies
Ongoing
NCT06120075
cabo: cabozantinib; cas: casdatifan;
ccRCC: clear cell renal cell carcinoma; CRC: colorectal cancer;
dom: domvanalimab; durva: durvalumab; EAC: esophageal
adenocarcinoma; etruma: etrumadenant; GEJ: gastroesophageal
junction; gem/nab-pac: gemcitabine/nab-paclitaxel; GI:
gastrointestinal; HNSCC: head and neck squamous cell carcinoma;
nivo: nivolumab; NSCLC: non-small cell lung cancer; PDAC:
pancreatic ductal adenocarcinoma; pembro: pembrolizumab; quemli:
quemliclustat; SOC: standard of care; zim: zimberelimab
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
collaborators, 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, HIF-2a, CD73, A2a/A2b
receptors, CD39 and AXL. For more information about Arcus
Biosciences’s clinical and preclinical programs, please visit
www.arcusbio.com.
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 statements in Dr.
Rosen’s quote and statements regarding: expected timing for data
readouts, including timing for a readout from STAR-221; the
potency, efficacy or safety of Arcus’s investigational products,
including their potential to impact clinical practices or result in
meaningful advancements for patients; and the initiation, design of
and associated timing for future studies, including statements
about PEAK-1. 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: risks
associated with preliminary and interim data not being guarantees
that future data will be similar; the unexpected emergence of
adverse events or other undesirable side effects in Arcus’s
investigational products; 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; unfavorable global
economic, political and trade conditions; Arcus’s dependence on the
collaboration with third parties such as Gilead and Taiho for the
successful development and commercialization of its optioned
molecules; 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
periodic report 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.
The Arcus name and logo are trademarks of Arcus Biosciences,
Inc. All other trademarks belong to their respective owners.
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version on businesswire.com: https://www.businesswire.com/news/home/20250121029782/en/
Investor Inquiries: Pia Eaves VP of Investor Relations
& Strategy (617) 459-2006 peaves@arcusbio.com
Media Inquiries: Holli Kolkey VP of Corporate Affairs
(650) 922-1269 hkolkey@arcusbio.com
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