11 September 2017 - - Redwood City, California-based immuno-oncology company Armo BioSciences, Inc. is reporting clinical trial results on its lead investigational immuno-oncology drug AM0010 (pegilodecakin, PEGylated Interleukin-10) at the European Society of Medical Oncology 2017 Congress being held in Madrid, Spain, the company said.
These presentations include additional clinical trial results from the ongoing Phase 1b studies of AM0010 in pancreatic cancer, non-small cell lung cancer (NSCLC), and renal cell carcinoma.
AM0010 (pegilodecakin) is a long-acting pegylated form of recombinant human Interleukin-10 (IL-10) that stimulates the survival, expansion and cytotoxic potential of a particular type of white blood cell in the immune system called CD8+ T cells.
CD8+ T cells recognize and kill cancer cells and an increased presence of intra-tumoral CD8+ T cells may result in improved prognosis and survival in patients.
In a large Phase 1/1b clinical trial, AM0010 was dosed in more than 350 advanced cancer patients and showed a good safety/tolerability profile and sustained anti-tumor effects in patients across different cancer types.
Due to its enhanced half-life, AM0010 has strong immune-stimulating effects that induce the activation, proliferation, and survival of intra-tumoral, tumor-reactive, cytotoxic CD8+ T cells in patients. CD8+ T cells mediate the cancer cytotoxic effect of this immuno-oncology agent.
The US Food and Drug Administration and the European Commission have granted AM0010 Orphan Drug designation for the treatment of pancreatic cancer. The FDA also granted Fast Track designation for AM0010 in combination with Folfox as second-line therapy in patients with pancreatic cancer.
ARMO is conducting an international Phase 3 randomized clinical trial evaluating AM0010 in combination with Folfox (folinic acid, 5-fluorouracil and oxaliplatin) versus Folfox alone, as second-line therapy in patients with pancreatic ductal adenocarcinoma that has progressed during or following a first-line gemcitabine-containing regimen.
The study expects to enroll approximately 566 patients and will evaluate overall survival as the primary endpoint.
Progression-free survival, overall response rate and safety are the secondary endpoints. Exploratory endpoints will evaluate biomarkers that may correlate with tumor response, immune activation and relationships to clinical efficacy outcomes.
Armo BioSciences is developing a pipeline of novel, proprietary products that activate the immune system of cancer patients to recognize and eradicate tumors.
In addition, the company is developing an immuno-oncology pipeline that includes validated product candidates such as an anti-PD-1 monoclonal antibody, aimed at treating a variety of cancers in combination with standard of care treatments and emerging immunotherapies.