The first patient in the world to be enrolled on a clinical trial of a new investigational drug, AN0025, was treated at Huntsman Cancer Institute (HCI) at the University of Utah (U of U) earlier this year. The drug, developed by Adlai Nortye USA, is being studied for use in patients with non-small cell lung cancer and other solid tumors who have previously been treated with immunotherapy and whose cancers later developed ways to resist immunotherapy.
The Phase Ib study is an early phase trial that examines AN0025, a drug shown in previous clinical trials to be potentially safe and effective, in combination with the immunotherapy drug pembrolizumab for the first time. Immunotherapy is a type of treatment that engages a patient’s own immune system to fight the tumor. While immunotherapy has shown promise, many patients’ cancers ultimately find ways to resist immunotherapy drugs.
"Certain cancers, such as non-small cell lung cancer, have failed a prior attempt of treatment with immunotherapy," says Sonam Puri, MD, a physician-scientist at HCI and assistant professor of medicine at the U of U. "This trial combines immunotherapy with another agent, AN0025, which has the potential to improve response to immunotherapy."
Clinical trials help find better ways to prevent, diagnose, or treat cancer by testing the safety and effectiveness of new cancer drugs. This study is one of more than 150 open at any given time at HCI.
"All clinical trials equal hope," says Wallace Akerley, MD, lead HCI investigator of the AN0025 clinical trial. Akerley is a physician-scientist at HCI and professor of internal medicine at the U of U. "Contemporary clinical trials have such a high likelihood of being biologically active that we are able to integrate clinical research into standard-of-care treatment to give patients more options. And sometimes patients live for several years after they have exhausted all other available treatment options."
The ability to conduct clinical research, particularly early phase trials, requires substantial expertise, infrastructure, and monitoring to ensure patient safety and to gather data to determine whether a new drug is effective. HCI’s clinical research efforts are facilitated by its Clinical Trials Office, which has a special unit focused on Phase I studies. The teams bring together a variety of experts, from clinical professionals to administrative staff to scientists, who all take part in the process of identifying new, more effective ways to treat cancer.
Ignacio Garrido-Laguna, MD, PhD, Phase I director, says, "Early phase trials are not just testing for safety but have a true therapeutic intent and can provide important clues to identify subsets of patients more likely to benefit from an investigational drug. A number of drugs have now been approved by the FDA based on emerging data from early phase trials."
Find more information about clinical trials for cancer patients at HCI.
About AN0025S0103
AN0025S0103 is an open-label, multicenter, Phase Ib study to evaluate the safety and preliminary efficacy of AN0025 in combination with pembrolizumab in patients with locally advanced/static tumors. It will include a dose-limiting toxicity observation phase followed by an expansion phase. All enrolled patients will be treated with AN0025 and pembrolizumab until the patient experiences disease progression, unacceptable toxicity or withdraws consent, or for a maximum of 35 cycles (approximately 2 years). The dose of pembrolizumab will remain constant at 200 mg every 3 weeks (Q3W) for each dose level of AN0025 and in each cohort.
About AN0025 (EP4 Antagonist)
AN0025 (previously E7046) is an investigational, potentially first in class oral EP4 antagonist that blocks prostaglandin E2 from binding to its subtype 4 receptor (EP4), changing the immunosuppressive character of the tumor microenvironment. Based on preliminary results, it is well tolerated in patients with solid tumors. A Phase Ib study of AN0025 in combination with the standard of care in a neoadjuvant setting for locally advanced rectal cancer showed excellent results, with nearly 40% of patients not requiring surgery or achieving a complete pathological response in the post-surgical specimen in this study.
About Adlai Nortye
Adlai Nortye is a global clinical-stage biopharmaceutical company that is developing differentiated, innovative immuno-oncology medicines. Adlai Nortye focuses on discovering and developing important new treatments for cancer with a mission to improve patient lives by identifying and developing differentiated innovative medicines that help people live better, live longer. Through close collaborations with global partners, Adlai Nortye has successfully positioned itself in the field of immuno-oncology and has several programs ongoing from early pre-clinical to phase III ready. AN0025 was licensed from Eisai.