Patient at HonorHealth Research Institute is first in the world to receive new immunotherapy against solid tumors
Anti-cancer drug developed by Trutino Biosciences uses the body’s own immune system to fight cancer; engineered to have minimum side effects
SCOTTSDALE, Ariz., and SAN DIEGO, Calif. — Jan. 9, 2025 — For the first time, a patient has received a new type of drug, ODC-IL2, designed to enhance the immune system’s ability to target and destroy solid tumors in adults while minimizing toxicity throughout the body, according to HonorHealth Research Institute and Trutino Biosciences.
This first-in-human clinical trial marks a pivotal milestone in the clinical development of Trutino’s proprietary On-Demand Cytokine (ODC) platform, in which Interleukin 2 (IL-2) activates a patient’s own tumor-killing T cells locally, while striving to minimize systemic off-target cytokine toxicity.
This Phase 1/1b clinical trial at HonorHealth Research Institute is based on preclinical studies that demonstrated robust antitumor activity in murine syngeneic tumor models with improved safety, compared to traditional IL-2 therapies.
Justin Moser, M.D., an associate clinical investigator in the Oncology Research Division of HonorHealth Research Institute, said his team plans to treat at least 20 patients with ODC-IL2, while up to 50 patients will be treated internationally.
“We are, without question, privileged to be the first in the world to offer this potentially revolutionary new drug to our patients. Historically, IL-2 could provide long term benefit to some patients with cancer but was extremely toxic. The ability to offer our patients the potential benefits of IL-2 without the side effects is very exciting,” said Dr. Moser, who also is a board member of the Arizona Skin Cancer Foundation.
If successful in demonstrating the safety and effectiveness of this drug at various doses, a larger Phase II clinical trial will further evaluate its potential.
“The dosing of our first patient is a critical milestone in the advancement of ODC-IL2,” said Dr. Phillip Kim, Ph.D., MBA, the CEO and President of Trutino Biosciences. “Our On-Demand Cytokine platform represents a new paradigm in cytokine therapies, and we are optimistic about its potential to address significant unmet needs in oncology. We are grateful to the patients, clinical teams, and collaborators who make this progress possible.”
Eligible patients are being enrolled internationally, and the first patient was successfully dosed on Jan. 6, 2025. Preliminary reports indicate no significant drug-related adverse events.
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About the HonorHealth Research Institute
HonorHealth Research Institute is an international destination that is at the forefront of providing patients with a better quality of life through its clinical trials and innovative treatment options. Headquartered in Scottsdale, Arizona, the institute’s team of physicians and researchers collaborate with experts from across the nation to offer life-changing therapies, drugs and devices. At HonorHealth Research Institute, patients have access to tomorrow’s health innovations, today. Learn more at: HonorHealth.com/research.
About the TRT-ODC-IL2-001 Study
The TRT-ODC-IL2-001 study is a Phase 1/1b, multicenter, open-label trial evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of ODC-IL2 in patients with advanced or metastatic solid tumors. The trial consists of two stages: an open-label, dose-escalation phase to determine the maximum tolerated dose (MTD) or recommended dose range (RDR), followed by an expansion phase at a single dose level to further assess safety and preliminary efficacy in select tumor types.
About Trutino Biosciences
Based in San Diego, Trutino is pioneering cytokine therapies with its On-Demand Cytokine (ODC) platform. Trutino’s ODC therapeutics are designed to activate the immune system only within the tumor microenvironment, significantly improving efficacy while reducing systemic side effects. With a growing pipeline of therapeutic candidates targeting cancer and autoimmune diseases, Trutino Biosciences is committed to transforming patient care through innovative cytokine engineering. For more information, visit www.trutinobio.com.
