Arcus Biosciences Appoints Dimitry Nuyten, M.D., Ph.D. as Chief Medical Officer

HAYWARD, Calif.–()–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 Dimitry S.A. Nuyten, M.D., Ph.D has been appointed chief medical officer (CMO) effective August 1, 2022. In his role as CMO, Dr. Nuyten will oversee Arcus’s clinical development organization that includes nearly 200 employees and six clinical-stage programs targeting TIGIT, the adenosine axis (CD73 and dual A2a/A2b), HIF-2a and PD-1. Dr. Nuyten will oversee the advancement of four registrational Phase 3 trials that are ongoing or expected to start by year end for the anti-TIGIT antibody domvanalimab in novel combinations across multiple cancers.

“Dr. Nuyten’s attributes and experiences are well matched to Arcus’s rapid evolution as we enter 2023 with four ongoing registrational trials for domvanalimab-based combinations and a portfolio of Phase 2 and early signal-seeking trials investigating combinations of our six clinical molecules,” said Terry Rosen, Ph.D., chief executive officer of Arcus. “His proven abilities to grow and lead large cross-functional teams, interface with commercial and regulatory organizations and navigate complex portfolio management will complement our exceptional development organization and facilitate the continued growth of Arcus. In Dr. Nuyten’s new role, he will also be working closely with our global partners, including Gilead Sciences, to optimize and implement our clinical development strategy.”

As part of his role as CMO, Dr. Nuyten will serve as a member of Arcus’s executive committee and co-chair of Arcus’s and Gilead’s Joint Steering Committee. He will be responsible for our clinical organization, including clinical development and operations, clinical pharmacology and biometrics. Prior to joining Arcus, Dr. Nuyten served as senior vice president and CMO of Nektar Therapeutics where he led a 200-person development organization which included clinical development, safety, clinical operations, medical affairs, clinical and non-clinical pharmacology, biostats, data management and programming. Prior to Nektar, he served as CMO of Aduro Biotech and served as the immuno-oncology development leader and vice president of global product development for oncology at Pfizer, where he led the late-stage development of Bavencio® and early-stage clinical programs for oncology and immune-oncology. Prior to Pfizer, Dr. Nuyten was group medical director at BristolMyers Squibb. He holds a Ph.D. in cancer biology from the University of Amsterdam Medical School in The Netherlands, is Board Certified in radiation oncology and certified as a physician in The Netherlands by the University of Groningen Medical School. Over the course of his career, Dr. Nuyten has authored numerous peer-reviewed papers, is co-inventor on multiple patents and has been recognized with prestigious awards, including as a two-time recipient of the American Society of Clinical Oncology Merit Award.

“My career has been dedicated to understanding and exploiting the biologic drivers of cancer to develop new treatments that have the potential to improve outcomes or even cure cancer,” said Dimitry Nuyten, M.D., Ph.D, incoming chief medical officer at Arcus Biosciences. “I was attracted to Arcus by the breadth and diversity of its portfolio of molecules and clinical programs and the corresponding opportunity to substantially impact the way that many important cancers are treated. I am thrilled to join the company and excited to work with the talented and patient-centric Arcus team to translate an innovative pipeline into clinically meaningful therapies for a broad array of cancers with high unmet medical need.”

Arcus Ongoing and Announced Clinical Studies

Trial Name

Arms

Setting

Status

NCT No.

Lung Cancer

ARC-7

zim vs. dom + zim vs. etruma + dom + zim

1L NSCLC (PD-L1 ≥ 50%)

Ongoing Randomized Phase 2

NCT04262856

PACIFIC-8

(AZ)

dom + durva vs. durva

Curative-Intent Stage 3 NSCLC

Ongoing Registrational Phase 3

NCT05211895

ARC-10

dom + zim vs. zim vs. chemo

1L NSCLC (PD-L1 ≥ 50%)

Ongoing Registrational Phase 3

NCT04736173

STAR-121

(GILD)

dom + zim + chemo vs pembro + chemo

1L NSCLC (PD-L1 all-comers)

Planned Registrational Phase 3

TBD

EDGE-Lung

dom + zim +/- quemli

1L/2L NSCLC (lung cancer platform study)

In Planning Phase 2

TBD

Lung Platform (GILD)

dom + zim +/- etruma or sacituzumab govitecan (Trodelvy) or other combos

1L/2L NSCLC (lung cancer platform study)

In Planning Phase 2

TBD

Gastrointestinal Cancers

ARC-9

etruma + zim + mFOLFOX vs. SOC

2L/3L/3L+ CRC

Ongoing

Randomized Phase 2

NCT04660812

ARC-21

dom + zim ± chemo

1L/2L Upper GI Malignancies

Ongoing

Phase 2

NCT05329766

STAR-221

dom + zim + chemo vs. nivo + chemo

GI Malignancies

Planned Registrational Phase 3

TBD

Pancreatic Cancer

ARC-8

quemli + zim + gem/nab-pac vs. quemli + gem/nab-pac

1L, 2L PDAC

Ongoing Randomized Phase 1/1b

NCT04104672

Prostate Cancer

ARC-6

etruma + zim + SOC vs. SOC (Adding sacituzumab govitecan (Trodelvy) combination cohorts)

2L/3L CRPC

Ongoing Randomized Phase 2

NCT04381832

Various

ARC-12

AB308 + zim

Advanced Malignancies

Ongoing

Phase 1/1b

NCT04772989

ARC-14

AB521

Healthy Volunteers

Ongoing

NCT05117554

ARC-20

AB521

Cancer Patients / ccRCC

Planned Phase 1/1b

TBD

dom: domvanalimab; durva: durvalumab; etruma: etrumadenant; gem/nab-pac: gemcitabine/nab-paclitaxel; nivo: nivolumab; pembro: pembrolizumab; quemli: quemliclustat; SOC: standard of care; zim: zimberelimab; ccRCC: clear-cell renal cell carcinoma

About the Gilead Collaboration

In May 2020, Gilead and Arcus entered into a 10-year collaboration that provided Gilead immediate rights to zimberelimab and the right to opt into all other Arcus programs arising during the collaboration term. In November 2021, Gilead and Arcus amended the collaboration in connection with Gilead’s option exercise for three of Arcus’s then-clinical stage programs. For all other programs that are in clinical development or new programs that enter clinical development thereafter, the opt-in payments are $150 million per program. Gilead’s option, on a program-by-program basis, expires after a specified period of time following the achievement of a development milestone for such program and Arcus’s delivery to Gilead of the requisite qualifying data package. Concurrent with the May 2020 collaboration agreement, Gilead and Arcus entered into a stock purchase agreement under which Gilead made a $200 million equity investment in Arcus. That stock purchase agreement was amended and restated in February 2021 in connection with Gilead’s increased equity stake in Arcus from 13% to 19.5%, with an additional $220 million investment.

Gilead and Arcus are co-developing and equally share global development costs for five clinical candidates, including domvanalimab, an Fc-silent anti-TIGIT antibody, etrumadenant, a dual adenosine A2a/A2b receptor antagonist, quemliclustat, a small molecule inhibitor of CD73, and zimberelimab, an anti-PD1 antibody.

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 six investigational medicines into clinical studies, including new combination approaches that target TIGIT, PD-1, the adenosine axis (CD73 and dual A2a/A2b receptor) and most recently, HIF-2a. For more information about Arcus Biosciences’ clinical and pre-clinical programs, please visit www.arcusbio.com or follow us on Twitter.

Forward-Looking Statements

This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein, including, but not limited to, statements regarding upcoming trials and initiation timelines and continued growth of Arcus 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. 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, all of which may be exacerbated by the COVID-19 pandemic; changes in the competitive landscape for Arcus’s programs; the unexpected emergence of adverse events or other undesirable side effects; and the inherent uncertainty associated with pharmaceutical product development and clinical trials. Risks and uncertainties facing Arcus are described more fully in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, filed on August 3, 2022 with the SEC. 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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