REDWOOD CITY, CA – November 25, 2013 – ARMO BioSciences, Inc., a clinical-stage biotechnology company, today announced that it initiated the first cohort of patients with advanced solid tumors in a Phase 1 clinical trial of AM0010, a PEGylated form of recombinant human interleukin-10 (IL-10). Based on extensive clinical and preclinical data, ARMO plans to develop this unique molecule for known indications and innovative applications including cancer, fibrosis, hypercholesterolemia/atherosclerosis and inflammatory diseases.
“Since its founding in December 2012, ARMO raised $20 million in a Series A round, licensed the PEGylated human IL-10 polypeptide from Merck, purchased the Prevascar (rHuIL-10) assets from Renovo Ltd. and assembled an outstanding scientific team with remarkable depth and knowledge of IL-10 to bring AM0010 into the clinic in record time,” said Beth Seidenberg, M.D., partner at Kleiner Perkins Caufield & Byers and a member of the ARMO board of directors. “We see enormous potential in the development of this promising molecule.”
“Multiple studies have shown that AM0010 directly activates tumor specific CD8+ killer T lymphocytes, which completely eradicate large tumor masses while establishing a lasting anti-tumor immune surveillance and significantly reduce metastatic disease in preclinical models,” said Peter Van Vlasselaer, Ph.D., president and chief executive officer of ARMO. “We expect our exceptional momentum in advancing AM0010 into development to continue, with initiation of additional clinical studies potentially in fibrosis, homozygous familial hypercholesterolemia and other indications in 2014, and anticipate results from our first study as soon as mid-2014.”
The Phase 1 clinical trial is designed to establish the safety and tolerability of AM0010 in patients with advanced solid tumors. Additional objectives include the exploration of anti-tumor and biomarker responses to allow dose determination and potential patient stratification in subsequent studies. The trial will enroll patients at four locations in the United States.
“In addition to its potential in cancer, recombinant IL-10 has demonstrated anti-inflammatory and anti-fibrotic activities as well as cholesterol lowering abilities in preclinical disease models and in human subjects,” commented Carl L. Gordon, Ph.D., C.F.A., partner and co-head of global private equity at OrbiMed, and a member of the ARMO board of directors. “We believe that ARMO is ideally positioned to explore the unique mechanisms of action for this important immunotherapy compound, with possible breakthrough potential in several indications.”
ARMO has over 45 issued and pending US and foreign patents and applications covering compositions of matter, methods of use, and methods of manufacturing of AM0010.