The first patient has been dosed in Immune-Onc Therapeutic’s Phase 1 clinical trial of IO-202, its lead antibody treatment candidate for advanced acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML).
The trial (NCT04372433), underway at City of Hope, in California, and at the MD Anderson Cancer Center, in Texas, is currently recruiting participants with relapsed or refractory (resistant) AML and CMML. More information on enrollment can be found here.
IO-202 was designed to specifically recognize and block the activity of LILRB4, a protein receptor found at the surface of immune T-cells that normally inhibits their activity. By blocking LILRB4, IO-202 is expected to boost the T-cells’ activation, increasing their capacity to target and destroy malignant cells.
In preclinical studies, IO-202 was able to activate and instruct T-cells to eliminate leukemia cancer cells, effectively preventing tumor infiltration.
“I am thrilled that we’ve met this important goal and with the support of our investigators are one step closer to bringing a new approach to the treatment of blood cancers, AML and CMML,” Charlene Liao, PhD, CEO of Immune-Onc, said in a press release.
The trial will assess the safety, tolerability, clinical activity, and pharmacological properties of IO-202. The study is divided into two phases. The first is a dose-escalation phase in which participants receive increasing doses of the medication to determine the optimal dose.
The second part is an expansion phase, in which patients will be treated with the determined optimal dose of IO-202 for approximately one year.
While IO-202 was originally designed to be given alone as a monotherapy, the study’s protocol may be amended to allow it to be given alongside other medications, such as Vidaza (azacitidine).
Several biomarkers also will be evaluated in the trial, as a way to further understand the mechanism of action of IO-202. The resulting data will be used to inform future trials.
“As we learn more about myeloid cell biology and its role in cancer, we see opportunities to explore the potential of IO-202 and other novel antibodies in other types of cancer, including solid tumors, in the near future,” Liao said.
The clinical development of IO-202 is being supported by a recent $2.14 million Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH).