US-based clinical-stage biotechnology company ARMO has reported positive Phase I study data of its AM0010 (PEGylated Interleukin-10) to treat advanced solid tumours.
Developed as an immuno-oncology drug, AM0010 is a PEGylated form of recombinant human IL-10 resulting in strong immune-stimulating effects that trigger the activation, proliferation, and survival of intratumoral, tumour-reactive, cytotoxic CD8+ T cells in patients.
The CD8+ T cells are responsible for the anti-tumour activity of AM0010.
The Phase I study involved 51 patients with advanced solid tumours and was divided into two cohorts.
The first was the dose escalation cohort, which administered 33 patients with AM0010 monotherapy, while the dose expansion cohort treated 18 patients with renal cell cancer (RCC) and AM0010 being administered on a daily basis.
The study was primarily focused on determining the safety within AM0010 administration, while the secondary objective was to examine the objective tumour responses (ORR), progression free survival (PFS) and immune activation of the immuno-oncology drug.
Results of the study suggested that the AM0010 resulted in systemic immune activation with elevated immune stimulatory cytokines, as well as a decrease in immune suppressive cytokine TGF-β within the serum.
AM0010 was well tolerated during the study.
University of Texas MD Anderson Cancer Center cancer medicine division investigational cancer therapeutics department associate professor Aung Naing said: "The results of this study show exciting early signs of efficacy, with objective and durable responses achieved in advanced cancer patients who were treated with this single agent.
"Importantly, this appears to be a well-tolerated immunotherapy, which opens the door to combinations with additional immuno-oncology drugs, as well as with other cancer chemotherapies, since advanced cancer patients urgently need new treatment options."
According to ARMO BioSciences president and CEO Peter Van Vlasselaer, the company is planning to conduct a Phase III trial to seek approval from the US Food and Drug Administration for AM0010.