ARMO BioSciences' AM0010 Demonstrates Promising Clinical Data as an Immuno-oncology Monotherapy and in Combination with an Anti-PD-1 Checkpoint Inhibitor in Advanced Solid Tumors, Including Immune-Resistant Cancers

REDWOOD CITY, Calif., June 6, 2016 /PRNewswire/ -- ARMO BioSciences, Inc., a clinical-stage biotechnology company, announced new clinical data on the Company's lead investigational immuno-oncology drug AM0010 (PEGylated Interleukin-10) as a monotherapy and in combination with an anti-PD-1 monoclonal antibody for the treatment of advanced cancers.  These data were presented yesterday at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

"These positive results from our ongoing Phase 1 study further demonstrate the promise of AM0010 to engage the immune system to fight cancer cells, even in the most difficult-to-treat immune-resistant cancers," said Peter Van Vlasselaer, Ph.D., President and Chief Executive Officer of ARMO BioSciences. "Previously, AM0010 was shown to induce comprehensive T-cell activation and demonstrated encouraging therapeutic efficacy as a monotherapy, and these new clinical data show AM0010's ability to induce objective tumor responses when used in combination with anti-PD-1 checkpoint inhibitors.  In addition, AM0010 showed both mechanistic and clinical efficacy in patients with cancers that do not respond to checkpoint inhibitors.  As this Phase 1 trial continues to progress, we look forward to initiating the first registration-enabling trial of AM0010 in patients with advanced solid tumors, potentially as early as the end of this year."

ARMO's Phase 1b basket trial is a multi-cohort, non-randomized study evaluating the safety, tolerability and efficacy of AM0010 as a monotherapy and in combination with immunotherapy, targeted therapy, or chemotherapy.  The trial has enrolled over 300 patients across the dose escalation and expansion parts of this study and has included 12 different types of cancer.

AM0010 in Combination with Anti-PD-1 (Abstract #3018)

In the Phase 1 trial, 19 patients with advanced melanoma, renal cell carcinoma (RCC), or non-small cell lung cancer (NSCLC) were treated with daily AM0010 in combination with an anti-PD-1 checkpoint inhibitor.  The overall response rate (ORR) was 42% (n=8/19) (per irRC) and two additional melanoma patients had initial increases in tumor size followed by decreases (pseudoprogression).  Durable responses were observed in 4 of 8 RCC patients (2 complete responses and 2 partial responses) and 2 of 5 NSCLC patients. Two NSCLC patients with PD-L1 negative tumors are on treatment for more than 40 and 52 weeks with continuing partial responses.  These clinical data were presented on Sunday, June 5, 2016 in a poster discussion session by Aung Naing, M.D. of The University of Texas MD Anderson Cancer Center.

Consistent with the AM0010 monotherapy cohorts, patients treated with AM0010 in combination with anti-PD-1 had increased Th1 cytokines (IL-18, IFNg, IL-7) as well as an increase in the number and proliferation of PD-1⁺ activated CD8 T cells, while decreasing the proliferation of FoxP3⁺ Tregs and TGF-b in the blood. Patients also had de-novo oligoclonal expansion of T cell clones in the blood without affecting total lymphocyte counts and an increase in the number of tumor infiltrating Granzyme⁺ PD-1⁺ CD8⁺ T cells in tumor biopsies.

AM0010 in combination with anti-PD-1 was well-tolerated and all treatment-related adverse events were transient and did not lead to study discontinuation. Grade 3-4 treatment-related adverse events were observed in 7 of 19 patients and included anemia (n=3), thrombocytopenia (n=3), ALT/AST increase (n=2), hypertriglyceridemia (n=2) and rash (n=2).

AM0010 in Patients with Advanced Pancreatic or Colorectal Cancer (Abstract #3082)

In the Phase 1 trial, 38 patients with advanced pancreatic ductal adenocarcinoma and 27 patients with colorectal cancer were treated with daily AM0010. AM0010 demonstrated both clinical and mechanistic activity with enhanced immune stimulation in these difficult-to-treat "immune-resistant" cancers. These clinical data were presented in a poster session on Sunday, June 5, 2016 by Kyriakos Papadopoulos, M.D. of START Center for Cancer Care.

Patients with advanced pancreatic cancer were treated daily with either AM0010 alone (n=22) or in combination with FOLFOX (n=5), capecitabine (n=5), or gemcitabine/nab-paclitaxel (n=6).  The median overall survival of advanced pancreatic and colorectal cancer patients treated with AM0010 monotherapy in third to fifth-line therapy was 3.8 months (n=22) and 11.4 months (n=27; observation >11 months), respectively.  67% (10/15) of advanced pancreatic cancer patients with elevated CA 19-9 had a reduction upon treatment with AM0010 monotherapy and 47% of patients had a reduction in CA 19-9 of more than 20%.  87% (13/15) of advanced pancreatic cancer patients treated with AM0010 plus chemotherapy had stable disease and two patients (13%) had a partial response.  AM0010 increased Th1 cytokines in the blood, novel oligoclonal T cells in the blood, and PD-1⁺ activated CD8 T cells in the blood and in tumor biopsies.

AM0010 was generally well-tolerated in advanced pancreatic cancer patients.  In pancreatic patients treated with AM0010 monotherapy, grade 3-4 treatment-related adverse events were observed in 9 of 22 patients and included rash (n=3), anemia (n=2), fatigue (n=2), thrombocytopenia (n=1) and transaminitis (n=1). Most of these events were transient, resolved without sequelae, and only one patient discontinued treatment due to anemia. Colitis, pneumonitis, or endocrine abnormalities were not observed. In patients with advanced pancreatic cancer treated with AM0010 in combination with chemotherapy, treatment-related adverse events were observed in 11 of 16 patients and included thrombocytopenia (n=10).

About AM0010

AM0010 is a PEGylated form of recombinant human IL-10, which has shown sustained antitumor 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.

For more information, please visit www.armobio.com.

SOURCE ARMO BioSciences, Inc.

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