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The Role, Pathoimmunobiology, and Translational Implications of a

Novel, Engineered Cytokine Fusion Protein Targeting the Interleukin-2 (IL-2) Pathway

Focusing on Nemvaleukin in Mucosal Melanoma and Ovarian Cancer

FEATURED AUTHORITIES ON IMMUNO-ONCOLOGY
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Michael Lotze, MD

Michael Lotze, MD

Professor of Surgery, Immunology, and Bioengineering

University of Pittsburgh Cancer Institute

University of Pittsburgh School of Medicine

University of Pittsburgh Schools of the Health Sciences

Pittsburgh, PA

John L. Hays, MD

John L. Hays, MD

Associate Professor, Department of Internal Medicine

Medical Director of the Clinical Trials Office

The Ohio State University College of Medicine

Wexner Medical Center & James Cancer Hospital

Columbus, OH

Ulka Vaishampayan, MBBS

Ulka Vaishampayan, MBBS

Professor of Internal Medicine

Director, Phase I Program

Rogel Cancer Center

University of Michigan

Ann Arbor, MI

Richard Carvajal, MD

Richard Carvajal, MD

Deputy Physician-in-Chief and Director of Medical Oncology

Roy J. and Tara Zuckerberg Professor in Medical Oncology

Northwell Health Cancer Institute

Lake Success, NY

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What was it about cytokine-based treatments targeting the IL-2 pathway that suggested they had potential to provide immune system-directed treatment where other therapies had failed? And how did the results from ARTISTRY-1 inform your analysis?

What was it about cytokine-based treatments targeting the IL-2 pathway that suggested they had potential to provide immune system-directed treatment where other therapies had failed? And how did the results from ARTISTRY-1 inform your analysis?

What kinds of reporters were use to confirm and observe the differentiated biological and side effect profiles associated with the current dosing strategies for nemvaleukin?

What kinds of reporters were use to confirm and observe the differentiated biological and side effect profiles associated with the current dosing strategies for nemvaleukin?

What were the specific endpoints for ARTISTRY-7 and how will the trial results translate into possible approvals for nemvaleukin and/or ICIs for platinum-resistant ovarian cancer (PROC)?

What were the specific endpoints for ARTISTRY-7 and how will the trial results translate into possible approvals for nemvaleukin and/or ICIs for platinum-resistant ovarian cancer (PROC)?

Can you comment on the enduring responses (long term remissions) observed with nemvaleukin in ARTISTRY-1 and its manageable safety profile, and how it is unique among novel, engineered cytokine fusion proteins developed in the immunotherapy space?

Can you summarize the key findings from the ARTISTRY-1 trial, with a special emphasis on signals that Part A of the trial provided regarding the potential efficacy and safety of nemvaleukin within the context of a small dose escalation study?

Can you summarize the key findings from the ARTISTRY-1 trial, with a special emphasis on signals that Part A of the trial provided regarding the potential efficacy and safety of nemvaleukin within the context of a small dose escalation study?

Against this backdrop of positive signals for mucosal melanoma observed in ARTISTRY-1, and confirmation that nemvaleukin could be managed effectively and safely in the outpatient environment, how did you approach the design of ARTISTRY-6?

Against this backdrop of positive signals for mucosal melanoma observed in ARTISTRY-1, and confirmation that nemvaleukin could be managed effectively and safely in the outpatient environment, how did you approach the design of ARTISTRY-6?

While the formidable challenges of treating platinum-resistant ovarian cancer are well known, can you summarize the current, approaches for treating these patient cohorts, and specifically, the trigger points and reported outcomes for immunotherapy?

While the formidable challenges of treating platinum-resistant ovarian cancer are well known, can you summarize the current, approaches for treating these patient cohorts, and specifically, the trigger points and reported outcomes for immunotherapy?

Can you clarify: (a) what the novel, engineered cytokine fusion protein nemvaleukin is; (b) its differentiating biological properties; (c) MOA; and (d) its effects on immune-centric cell subpopulations such as Tregs, CD8+ and natural killer cells?

Can you clarify: (a) what the novel, engineered cytokine fusion protein nemvaleukin is; (b) its differentiating biological properties; (c) MOA; and (d) its effects on immune-centric cell subpopulations such as Tregs, CD8+ and natural killer cells?

Based on the accumulated data thus far from ARTISTRY-1 and interim monitoring, can you characterize the side effect profile and regimen discontinuation rates observed thus far for nemvaleukin, and its manageability in the outpatient setting?