ARMO BioSciences Announces Publication of AM0010 Clinical Data in Advanced Solid Tumor Patients in Journal of Clinical Oncology (JCO)

First Peer-Reviewed Publication of Clinical Data for Investigational Immuno-oncology Therapy AM0010

Redwood City, CA, August 15, 2016 —ARMO BioSciences, Inc., a clinical-stage biotechnology company, announced that the Journal of Clinical Oncology (JCO) has published clinical safety and efficacy data on the Company’s lead investigational immuno-oncology drug AM0010 (PEGylated Interleukin-10) in patients with advanced solid tumors. The peer-review article titled “Safety, Antitumor Activity, and Immune Activation of Pegylated Recombinant Human Interleukin-10 (AM0010) in Patients with Advanced Solid Tumors” was first published today in the online version of the JCO (

“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,” said Aung Naing, M.D., Associate Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center and lead author of the JCO publication. “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 as advanced cancer patients urgently need new treatment options.”

“This first peer-reviewed publication of clinical data for AM0010 further validates our understanding of the biological activity of AM0010, which specifically engages the immune system to induce comprehensive T-cell activation and objective tumor responses in cancer patients with advanced malignancies," said Peter Van Vlasselaer, Ph.D., President and Chief Executive Officer of ARMO BioSciences. “As our Phase 1 trial continues to progress, we look forward to sharing additional data at upcoming scientific and medical meetings for AM0010 when used in combination with other immuno-oncology and cancer chemotherapies. To further the development of AM0010 for patients with advanced solid malignancies, we are moving forward with our plans to discuss the first registration-enabling Phase 3 trial with the FDA for this novel immunotherapy.”

About the Study Published in JCO

In the JCO publication of this Phase 1 study, 51 patients with advanced solid tumors were treated with AM0010 monotherapy, first in a dose escalation study and subsequently in a dose expansion cohort in patients with renal cell cancer (RCC). AM0010 was administrated daily at doses of 1-40µg/kg. The primary endpoint was safety and secondary endpoints included objective tumor responses (ORR), progression free survival (PFS) and immune activation.

33 patients were treated in the dose escalation cohort and 18 were treated in the expansion cohort. ¬†AM0010 led to systemic immune activation with elevated immune stimulatory cytokines and a reduction in the immune suppressive cytokine TGF-β in the serum. AM0010 was well tolerated in this heavily pretreated patient population who had failed a median of four prior therapies for metastatic resistant or refractory disease. The most common treatment-related adverse events were anemia and thrombocytopenia. Partial responses were observed in one patient with uveal melanoma and in four of 15 (27% objective response rate) evaluable RCC patients treated at 20µg/kg.

About AM0010

AM0010 is a PEGylated form of recombinant human IL-10, which has shown sustained anti-tumor effects and a good safety/tolerability profile in patients from multiple oncology indications. Due to its enhanced half-life, AM0010 has strong immune-stimulating effects that induce the activation, proliferation, and survival of intratumoral, tumor-reactive, cytotoxic CD8+ T cells in patients. CD8+ T cells mediate the tumor clearing effect of this immuno-oncology agent.

About ARMO BioSciences

Founded in 2012, ARMO BioSciences is a clinical-stage company developing immunotherapies focused on multiple difficult-to-treat oncology indications. The company’s lead immunotherapy AM0010, a PEGylated form of recombinant human IL-10, primes the tumor micro-environment for immune-mediated therapies and has demonstrated durable clinical responses in several types of cancer, as both a single agent and in combination with standard-of-care chemotherapy or anti-Programmed Cell Death Protein (anti-PD-1) monoclonal antibodies. ARMO plans to initiate the first of several registration-enabling studies for AM0010 in solid tumors. The company also has a robust pipeline of therapeutic cytokines and an anti-PD-1 checkpoint inhibitor.

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ARMO BioSciences
Scott Ogg, PhD
Vice President Corporate Development and Operations