Arcus Biosciences Appoints Richard Markus, M.D., Ph.D. as Chief Medical Officer

Rhea-AI Summary

Arcus Biosciences (NYSE:RCUS) has appointed Richard Markus, M.D., Ph.D. as Chief Medical Officer, effective January 31, 2025, replacing Dimitry Nuyten, M.D., Ph.D. Dr. Markus will oversee the company's clinical development organization and portfolio, which includes seven clinical-stage programs with multiple Phase 3 studies.

The company plans to initiate PEAK-1, its fifth registrational Phase 3 study, in the first half of 2025, evaluating casdatifan plus cabozantinib in clear-cell renal cell carcinoma patients. Dr. Markus brings extensive experience from his 13-year tenure at Amgen, where he served as vice president of global development and oversaw multiple product approvals. Most recently, he founded Dantari, a clinical-stage oncology-focused antibody-drug conjugate company.

Positive

• Appointment of experienced CMO with proven track record in late-stage development and product approvals
• Extensive clinical pipeline with seven clinical-stage programs and four ongoing Phase 3 trials
• Planned expansion with fifth Phase 3 study (PEAK-1) in first half 2025

Negative

• Departure of current CMO could potentially impact ongoing clinical programs continuity

• Dr. Markus will oversee Arcus’s clinical development organization and portfolio that includes seven clinical-stage programs with multiple ongoing Phase 3 studies

 

HAYWARD, Calif.--(BUSINESS WIRE)-- 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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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

Source: Arcus Biosciences

FAQ

When will Richard Markus start as CMO at Arcus Biosciences (RCUS)?

Richard Markus, M.D., Ph.D. will start as Chief Medical Officer at Arcus Biosciences on January 31, 2025.

How many Phase 3 clinical trials does Arcus Biosciences (RCUS) currently have ongoing?

Arcus Biosciences currently has four ongoing registrational Phase 3 studies, with plans to initiate a fifth study (PEAK-1) in the first half of 2025.

What is the PEAK-1 trial that Arcus Biosciences (RCUS) is planning?

PEAK-1 is a planned Phase 3 study evaluating casdatifan plus cabozantinib in clear-cell renal cell carcinoma (ccRCC) patients who have progressed on immunotherapy.

What is Dr. Markus's previous experience before joining Arcus Biosciences (RCUS)?

Dr. Markus had a 13-year tenure at Amgen as vice president of global development, overseeing multiple product approvals, and most recently founded and served as CEO of Dantari, a clinical-stage oncology-focused company.