Arcus Biosciences (RCUS) Appoints Dimitry Nuyten as Chief Medical Officer

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Arcus Biosciences, Inc. (NYSE: RCUS), a global clinical-stage biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, today announced that Dimitry SA Nuyten, MD, Ph. D has been appointed Chief Medical Officer (CMO) effective August 1, 2022. In his role as CMO, Dr. Nuyten will oversee Arcus’ clinical development organization which includes nearly 200 employees and six clinical-stage programs targeting TIGIT, the adenosine axis (CD73 and double A2a/A2b), HIF-2a and PD-1. Dr. Nuyten will oversee the progress of four Phase 3 registrational trials that are underway or expected to begin by the end of the year for the anti-TIGIT antibody domvanalimab in novel combinations for multiple cancers.

“Dr. Nuyten’s attributes and experiences align well with Arcus’ rapid evolution as we enter 2023 with four ongoing registration trials for domvanalimab-based combinations and a portfolio of phase 2 trials and finding early signals involving combinations of our six clinical molecules,” said Terry Rosen, Ph.D., Chief Executive Officer of Arcus. “His proven abilities to develop and lead large cross-functional teams, interact with commercial and regulatory organizations and navigate complex portfolio management will complement our outstanding development organization and facilitate Arcus’ continued growth. In Dr. Nuyten’s new role, he will also work closely with our global partners, including Gilead Sciences, to optimize and execute our clinical development strategy.

As part of his role as chief marketing officer, Dr. Nuyten will serve as a member of the Arcus executive committee and co-chair of the joint Arcus and Gilead 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 that included clinical development, safety, clinical operations, medical affairs, clinical pharmacology and non-clinical, biostats, data management and programming. Prior to Nektar, he served as CMO of Aduro Biotech and served as Development Leader in Immuno-Oncology and Vice President of Global Oncology Product Development at Pfizer, where he led development Bavencio® late-stage and early-stage clinical programs for oncology and immuno-oncology. Prior to Pfizer, Dr. Nuyten was Group Medical Director at BristolMyers Squibb. He holds a doctorate. in Cancer Biology from the Faculty of Medicine of the University of Amsterdam in the Netherlands, is certified in radiation oncology and certified as a doctor in the Netherlands by the Faculty of Medicine of the University of Groningen. During his career, Dr. Nuyten has authored numerous peer-reviewed papers, co-invented several patents, and has been honored with prestigious awards, including being a two-time recipient of the Merit Award of the American Society of Clinical Oncology.

“My career has been dedicated to understanding and harnessing the biological drivers of cancer to develop new treatments that may improve outcomes or even cure cancer,” said Dimitry Nuyten, MD, Ph.D, new medical director 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 have a substantial impact on the way many important cancers are treated. I am thrilled to join the company and excited to work with the talented, patient-centric team at Arcus to translate an innovative pipeline into clinically meaningful therapies for a wide range of cancers with unmet medical needs.

Arcus Ongoing and Announced Clinical Studies

Trial name

Arms

Setting

Status

CTN No.

Lung cancer

ARC-7

zim against dom + zim against etruma + dom + zim

NSCLC 1L (PD-L1 ≥ 50%)

Randomized phase 2 in progress

NCT04262856

PACIFIC-8

(AZ)

dom + durva vs. durva

Stage 3 NSCLC with curative intent

Current recording phase 3

NCT05211895

ARC-10

dom+zim vs zim vs chemo

NSCLC 1L (PD-L1 ≥ 50%)

Current recording phase 3

NCT04736173

STAR-121

(BROWN)

dom+zim+chemo vs pembro+chemo

NSCLC 1L (all comers PD-L1)

Planned registration phase 3

To be determined

EDGE-Lung

dom + zim +/- quemli

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

In planning phase 2

To be determined

Lung Platform (GILD)

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

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

In planning phase 2

To be determined

Gastrointestinal cancers

ARC-9

etruma + zim + mFOLFOX vs SOC

2L/3L/3L+CRC

In progress

Randomized Phase 2

NCT04660812

ARC-21

dom + zim ± chemo

1L/2L Upper gastrointestinal tumors

In progress

Phase 2

NCT05329766

STAR-221

dom+zim+chemo vs nivo+chemo

Gastrointestinal malignancies

Planned registration phase 3

To be determined

Pancreatic cancer

ARC-8

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

PDAC 1L, 2L

Randomized phase 1/1b in progress

NCT04104672

Prostate cancer

ARC-6

etruma + zim + SOC vs SOC (Addition of sacituzumab govitecan (Trodelvy) combination cohorts)

CRPC 2L/3L

Randomized phase 2 in progress

NCT04381832

Various

ARC-12

AB308 +zim

Advanced malignancies

In progress

Phase 1/1b

NCT04772989

ARC-14

AB521

Healthy volunteers

In progress

NCT05117554

ARC-20

AB521

Cancer patients / ccRCC

Phase 1/1b planned

To be determined

dom: domvanalimab; durva: durvalumab; etruma: stupendous; 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 which provided Gilead with immediate rights to zimberelimab and the right to opt-in to all other Arcus programs arising during the term of the collaboration. In November 2021, Gilead and Arcus amended the collaboration as part of Gilead’s option exercise for three of Arcus’ then-clinical-stage programs. For all other programs that are in clinical development or new programs that subsequently enter clinical development, 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 completion of a development milestone for that program and Arcus’ delivery to Gilead of the required qualifying data package. Along with the May 2020 collaboration agreement, Gilead and Arcus entered into a stock purchase agreement under which Gilead invested $200 million in Arcus. This share purchase agreement was amended and restated in February 2021 as part of Gilead’s increased stake in Arcus from 13% to 19.5%, with an additional investment of $220 million.

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

About Arcus Biosciences

Arcus Biosciences is a global clinical-stage biopharmaceutical company developing differentiated molecules and combination drugs for people with cancer. In partnership with industry partners, patients and physicians around the world, Arcus is accelerating the development of first-in-class or best-in-class drugs against well-characterized targets and biological pathways and investigating novel biology-based combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has accelerated the development of six investigational drugs into clinical studies, including novel combination approaches targeting TIGIT, PD-1, the adenosine axis (CD73 and dual A2a/A2b receptor) and, more recently, HIF-2a. For more information on Arcus Biosciences’ clinical and preclinical programs, please visit www.arcusbio.com or follow us on Twitter.

Forward-looking statements

This press release contains forward-looking statements. All statements regarding future events or results contained herein, including, but not limited to, statements regarding upcoming trials and initiation timelines and the continued growth of Arcus are statements. 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 the actual results, performance or achievements of Arcus to differ materially from those expressed or implied by the forward-looking statements. – look at the 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, recruitment of subjects or the manufacture or supply of products for such clinical trials, all of which may be exacerbated by the COVID-19 pandemic; changes in the competitive landscape for Arcus’ programs; unexpected occurrence of adverse events or other adverse side effects; and the inherent uncertainty associated with pharmaceutical product development and clinical trials. The risks and uncertainties facing Arcus are further described in its Quarterly Report on Form 10-Q for the three months ended June 30, 2022, filed on August 3, 2022 with the SEC. You are cautioned not to place undue reliance on 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 as required by law.

The Arcus name and logo are trademarks of Arcus Biosciences, Inc. All other trademarks are the property of their respective owners.

Investor requests:

Pia Banerjee

Head of Investor Relations & Strategy

(617) 459-2006

[email protected]

Media inquiries:

Holly Kolkey

VP of Corporate Communications

(650) 922-1269

[email protected]

Source: Arcus Biosciences, Inc.

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