ARMO BioSciences Announces Data Presentations at the CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference

REDWOOD CITY, Calif., Sept. 26, 2016 /PRNewswire/ -- ARMO BioSciences, Inc., a clinical-stage biotechnology company, today announced the presentation of new Phase 1b clinical data on the Company's lead investigational immuno-oncology drug AM0010 (a PEGylated form of recombinant human cytokine Interleukin-10) in combination with an anti-PD-1 checkpoint inhibitor in patients with renal cell carcinoma (RCC) or non-small cell lung cancer (NSCLC).  These data are being presented at the Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference: Translating Science into Survival, being held September 25-28, 2016.

"There is a growing body of clinical data highlighting AM0010's ability to induce durable responses as monotherapy and when used in combination with other immunotherapies for cancer," said Peter Van Vlasselaer, Ph.D., President and Chief Executive Officer of ARMO BioSciences. "The data presented at the conference have shown that the combination of AM0010 and an anti-PD-1 checkpoint inhibitor is well tolerated and induces strong objective tumor responses.  In patients who responded to treatment, investigators found new T-cell clones in the blood, suggesting tumor-specific vaccination. We are eager to move AM0010 into the first Phase 3 randomized trial and we are making progress to initiate the Phase 3 study with this novel immunotherapy by the end of this year."

Two presentations titled "Antitumor activity and immune correlates of PEGylated human IL-10 (AM0010) alone or in combination with anti-PD-1," report results from an ongoing Phase 1b clinical trial and include new clinical data on AM0010 in combination therapy with an anti-PD-1 checkpoint inhibitor (pembrolizumab). 

Presenter: Aung Naing, M.D., Associate Professor, Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, Houston, Texas
Poster Session B: Clinical Trials of Cancer Immunotherapies
Time: 5:15 PM – 7:45 PM Eastern Time on Monday, September 26, 2016
Abstract number: B010

Presenter: Martin Oft, M.D., Vice President of Pre-Clinical and Clinical Development, ARMO BioSciences, Inc.
Session 5:  Mechanistic Merging of Treatment Modalities
Time: 11:25 AM – 11:40 AM Eastern Time on Tuesday, September 27, 2016

New data are being presented for 19 patients with advanced melanoma, RCC, or NSCLC.  The patients received one of the two doses (dose-ranging) of AM0010 subcutaneously daily at 10 or 20 µg/kg and pembrolizumab at 2 mg/kg intravenously every three weeks. Patients were assessed every 8 weeks for objective tumor response and key data included:

• Four of the eight patients with RCC who had received a median of 2.5 prior lines of therapy (range 0-5) had objective responses (ORR=50%), including two who had complete responses (CRs) and two who had partial response (PRs) measured by a 92% and 77% tumor reduction. The median progression-free survival (PFS) was 9.95 months with a median follow-up period of 14 months (range 6.9-16.6 months).
• Two of the five patients with NSCLC who had received a median of 2 prior lines of therapy (range 0-5) had durable PRs (ORR=40%) after one year of follow up. Importantly, both of these patients had PD-L1 negative expression cancers (<1%) and NSCLC patients with cancers that are PD-L1 negative typically show a low response rate to pembrolizumab alone. The median PFS was 9.3 months. All five patients are currently alive with a median follow up period of 14.4 months (range 12.4-17.3 months).

AM0010 in combination with anti-PD-1 was well-tolerated and all treatment-related adverse events were transient and did not lead to study treatment discontinuation. The most common AM0010 adverse events included: Grades 1-2 anemia, thrombocytopenia, and fatigue, notably with no autoimmune adverse events. The pembrolizumab-related adverse events were consistent with the safety profile observed in other studies.

AM0010 leads to a de-novo expansion of previously not detected T cell clones in the blood of patients who received AM0010 – either in monotherapy or in combination with pembrolizumab. The expanded T cell clones represented 1-20% of the total T cell repertoire of the patient and patients with an objective response typically had 600-800 clones expanding more than 10 fold. This was accompanied by an increase of immune stimulatory cytokines such as IFNg, IL-4 and IL-18 and an increase in CD8 T cell effector molecules, including FasL and lymphotoxin beta. AM0010 induces phosphorylation of the anti-apoptotic transcription factor STAT3, specifically in CD8+ T cells.

Copies of the presentations can be found at http://www.armobio.com/news-presentations.php.

About AM0010
AM0010 is a PEGylated form of the recombinant human cytokine Interleukin-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 the recombinant human cytokine Interleukin-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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