On August Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, reported that Dimitry S.A. Nuyten, M.D., Ph.D has been appointed chief medical officer (CMO) effective August 1, 2022 (Press release, Arcus Biosciences, AUG 8, 2022, View Source [SID1234617818]). 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.
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"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 (ASCO) (Free ASCO Whitepaper) 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.