Arcus Biosciences Presents Data from its Pipeline at Multiple Scientific Conferences

Rhea-AI Summary

Arcus Biosciences (NYSE:RCUS) announced promising initial data for AB521, a HIF-2a inhibitor, suggesting it may outperform the only approved HIF-2a inhibitor. The findings were detailed at the ESMO Targeted Anticancer Therapies Congress on March 7-8, 2022. Future presentations will include PK/PD modeling for etrumadenant, quemliclustat, and zimberelimab at the ASCPT conference on March 16-18, 2022, and insights into enhancing anti-tumor immunity at AACR on April 8-13, 2022. The company is progressing with its clinical trials, particularly a Phase 1/1b study for AB521 in renal cancer.

Positive

• Initial data for AB521 indicates potential superior clinical profile over existing HIF-2a inhibitors.
• Plans to advance AB521 into a Phase 1/1b study for clear-cell renal cell carcinoma in mid-2022.
• Ongoing investigations of etrumadenant, quemliclustat, and zimberelimab in late-stage trials across multiple cancers.

Negative

• None.

• Initial pharmacokinetic (PK)/pharmacodynamic (PD) data for AB521, Arcus’s HIF-2a inhibitor, in healthy volunteers confirm its potential to have an improved clinical profile compared to that of the only approved HIF-2a inhibitor; data were presented at ESMO Targeted Anticancer Therapies Congress, March 7-8, 2022.

• PK/PD modeling for etrumadenant, quemliclustat and zimberelimab will be presented at the American Society for Clinical Pharmacology & Therapeutics (ASCPT), March 16-18, 2022.

• Preclinical research related to therapeutic opportunities to enhance anti-tumor immunity and new insights into the benefit of dual A2a/A2b adenosine receptor antagonism, CD39 inhibition and HPK1 inhibition will be presented at the American Association for Cancer Research, April 8-13, 2022.

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 several poster presentations at upcoming scientific conferences that support the ongoing investigation of its clinical and preclinical pipeline.

“Scientific exchange fosters progress in research, and we value the opportunity to contribute to the advancement of cancer research by presenting early data that support the clinical approach to investigating our molecules,” said Terry Rosen, Ph.D., Chief Executive Officer of Arcus. “The AB521 data presented at the ESMO TAT Congress confirm its potential to have an improved clinical profile compared to that of the approved HIF-2a inhibitor; we plan to advance this molecule into a Phase 1/1b study in patients with clear-cell renal cell carcinoma in mid-2022. Etrumadenant, quemliclustat and zimberelimab are already being investigated in randomized and late-stage studies across common cancers like colon, lung, pancreas and prostate.”

ESMO Targeted Anticancer Therapies Congress, March 7-8, 2022

Title: AB521, a Clinical-Stage, Potent, and Selective Hypoxia-Inducible Factor (HIF)-2α Inhibitor, for the Treatment of Renal Cell Carcinoma
Abstract number: 252

American Society for Clinical Pharmacology & Therapeutics (ASCPT), March 16-18, 2022

Title: A Mechanistic Pharmacokinetic-Pharmacodynamic (PK-PD) Model of Quemliclustat (AB680), a Small-Molecule Inhibitor of CD73, in Healthy Volunteers and Patients with Gastrointestinal Malignancies
Abstract number: P-102

Title: Population Pharmacokinetics and Pharmacodynamics of Etrumadenant (AB928) in Healthy Volunteers and Cancer Patients
Abstract number: P-196

Title: Population Pharmacokinetics of Zimberelimab (AB122) and Dose Justification by Model Informed Drug Development (MIDD) Approach
Abstract number: P-032

American Association for Cancer Research, April 8-13, 2022

Title: Inhibition of CD39 Results in Elevated ATP and Activation of Myeloid Cells to Promote Anti-Tumor Immunity
Abstract number: 4151

Title: Dual A2aR/A2bR Antagonism with Etrumadenant (AB928) Eliminates the Suppressive Effects of Adenosine on Immune and Cancer Cells in the Tumor Microenvironment
Abstract number: 2728

Title: HPK1 Inhibition Enhances T Cell Activation and Relieves the Immunosuppressive Phenotype of Inhibitory Signals Found in the Tumor Microenvironment
Abstract number: 5762

Arcus Clinical Study Overview

Trial Name	Arms	Setting	Status	NCT No.
Lung Cancer
ARC-7	zim vs. zim + dom vs. zim + dom + etruma	1L NSCLC (PD-L1 ≥ 50%)	Ongoing Randomized Phase 2	NCT04262856
PACIFIC-8	durva ± dom	Curative-Intent Stage 3 NSCLC	Ongoing Registrational Phase 3	NCT05211895
ARC-10	chemo vs. zim vs. zim + dom	1L NSCLC (PD-L1 ≥ 50%)	Ongoing Registrational Phase 3	NCT04736173
Colon Cancer
ARC-9	etruma + zim + mFOLFOX vs. SOC	2L/3L/3L+ CRC	Ongoing Randomized Phase 2	NCT04660812
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	2L/3L CRPC	Ongoing Randomized Phase 2	NCT04381832
Various
ARC-12	AB308 + zim	Advanced Malignancies	Ongoing Phase 1/1b	NCT04772989
ARC-14	AB521	Healthy Volunteer	Ongoing Phase 1	NCT05117554

Carbo/pem: carboplatin/pemetrexed; dom: domvanalimab; durva: durvalumab; etruma: etrumadenant; gem/nab-pac: gemcitabine/nab-paclitaxel; quemli: quemliclustat; R/R: relapsed/refractory; SOC: standard of care; zim: zimberelimab CRC: colorectal cancer; CRPC: castrate-resistant prostate cancer; NSCLC: non-small cell lung cancer; PDAC: pancreatic ductal adenocarcinoma

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 biology 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, the potential for AB521 to have an improved clinical profile, and the advancement and associated timing of the Phase 1/1b study in patients, 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: risks associated with preliminary and interim data; the unexpected emergence of adverse events or other undesirable side effects; the inherent uncertainty associated with pharmaceutical product development and clinical trials; 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; and changes in the competitive landscape for Arcus’s programs. Risks and uncertainties facing Arcus are described more fully in its Annual Report on Form 10-K for the year ended December 31, 2021, filed on February 23, 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.

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

Source: Arcus Biosciences

View source version on businesswire.com: https://www.businesswire.com/news/home/20220308005377/en/

Investor and Media Inquiries:

Holli Kolkey

VP of Corporate Communications

(650) 922-1269

hkolkey@arcusbio.com

Source: Arcus Biosciences

FAQ

What were the key findings presented by Arcus Biosciences at the ESMO Congress regarding AB521?

Initial pharmacokinetic and pharmacodynamic data for AB521 suggest it may have a superior clinical profile compared to the only approved HIF-2a inhibitor.

When is the Phase 1/1b study for AB521 scheduled to begin?

The Phase 1/1b study for AB521 in patients with clear-cell renal cell carcinoma is planned to start in mid-2022.

What other drugs are being presented by Arcus Biosciences at upcoming conferences?

PK/PD modeling for etrumadenant, quemliclustat, and zimberelimab will be presented at the ASCPT conference from March 16-18, 2022.

What is the focus of Arcus Biosciences in its clinical trials?

Arcus Biosciences focuses on developing differentiated molecules and combination therapies for various cancers.

What future insights will be shared at the AACR conference?

Preclinical research on enhancing anti-tumor immunity and benefits of dual A2a/A2b receptor antagonism will be presented at the AACR conference from April 8-13, 2022.