ARMO BioSciences Presents New Phase 1b Clinical Data for AM0010 in Advanced Pancreatic Cancer Patients at 2017 Gastrointestinal Cancers Symposium

REDWOOD CITY, Calif., Jan. 20, 2017 /PRNewswire/ -- ARMO BioSciences, Inc., a late-stage immuno-oncology company, presented new Phase 1b clinical data on the Company's lead investigational immuno-oncology drug AM0010 (PEGylated Interleukin-10) at the 2017 Gastrointestinal Cancers Symposium, co-sponsored by the American Society of Clinical Oncology (ASCO), taking place January 19-21, 2017 in San Francisco, CA.

"AM0010 induces the expansion of novel T cell clones and activated CD8⁺ T cells in the blood and tumors of our patients," said Peter Van Vlasselaer, Ph.D., President and Chief Executive Officer of ARMO BioSciences.  "Our Phase 1b study in advanced pancreatic cancer patients evaluates the additive or synergistic anti-tumor function of AM0010 in combination with the FOLFOX chemotherapy regimen. We are excited to present for the first time the data from this study in which we achieved a 16% objective response rate, including 2 complete responses.  To advance our AM0010 program, we began enrolling patients in an international Phase 3 randomized pivotal clinical trial of AM0010 in combination with FOLFOX as second-line therapy for advanced metastatic pancreatic cancer."

In the Phase 1b clinical trial, 21 patients with advanced pancreatic cancer were treated with AM0010 in combination with FOLFOX.  The patients had previously progressed on a prior gemcitabine containing regimen and had a median number of two prior therapies (ranging from 1 to 5).  Fifteen of 19 (79%) patients who were evaluable for tumor responses had disease control according to the immune-related Response Criteria (irRC).  Three (16%) had objective responses, including 2 that achieved a complete response and 1 partial response.  The median progression free survival of all 21 treated patients was 3.5 months and the median overall survival has not been reached after a median follow-up of 10.5 months (3.8-15.6⁺ months). AM0010 in combination with FOLFOX has been well tolerated.

About AM0010 Poster Presentation at ASCO Gastrointestinal Cancers Symposium
Abstract Title: Phase 1b study with PEGylated human IL-10 (AM0010) with 5-FU and oxaliplatin (FOLFOX) in metastatic pancreatic adenocarcinoma (PDAC). (Abstract #399)
Lead Author: J. Randolph Hecht, M.D., Professor of Clinical Medicine and Director of the Gastrointestinal Oncology Program, David Geffen School of Medicine, UCLA
Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Date: Friday, January 20, 2017, 12:30-2:00 PM and 5:30-6:30 PM (Pacific Time)
Location: Level 1, West Hall (Board #J5)

About AM0010
AM0010 is a long-acting 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.

The U.S. Food and Drug Administration (FDA) and the European Commission (EC) 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 a second-line therapy in patients with pancreatic cancer.

ARMO is conducting an international Phase 3 randomized pivotal clinical trial with AM0010 for the treatment of pancreatic ductal adenocarcinoma (PDAC). In a Phase 1/1b clinical trial in 350 cancer patients across more than 14 different types of cancer, AM0010 demonstrated the ability to increase the number of activated CD8⁺ T cells in the blood and tumors of patients and achieve objective tumor responses, including partial and complete responses, in patients treated with AM0010 as a single agent or in combination with chemotherapeutic drugs or anti-PD-1 checkpoint inhibitors.

About ARMO BioSciences
ARMO BioSciences is a late-stage immuno-oncology company that is developing a pipeline of novel, proprietary products that activate the immune system of cancer patients to recognize and eradicate tumors. The Company's lead product candidate, AM0010, stimulates the survival, expansion and killing (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 addition, ARMO is developing a robust immuno-oncology pipeline that includes validated product candidates aimed at treating a variety of cancers in combination with standard of care treatments and emerging immunotherapies. For more information, please visit www.armobio.com.

SOURCE ARMO BioSciences, Inc.

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