ARMO BioSciences Presents Positive Phase 1 Trial Results of AM0010 at Upcoming Medical Conferences
Redwood City, CA, October 30, 2015 — ARMO BioSciences, Inc., a leading developer of immuno-oncology therapeutics, today announced that positive results from an ongoing Phase 1 clinical trial of ARMO’s investigational drug AM0010 (PEGylated Interleukin-10) for the treatment of advanced solid tumors, will be presented at three upcoming oncology conferences. The conferences are:
- Society for Immunotherapy of Cancer (SITC) 30th Anniversary Annual Meeting & Associated Programs in National Harbor, Maryland on November 4 - 8, 2015. Aung Naing, MD FACP, Associate Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX will present in the Cutting-Edge Clinical Trials Track on Saturday, November 7 at 12:45-2:00 PM ET.
- AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, MA on November 5 - 9, 2015. Jeffrey Infante, M.D., Director, Drug Development Program and Principal Investigator, Sarah Cannon Research Institute will present Abstract A194 in the Tumor Immunology Targets session on Friday, November 6 at 12:15-3:15 PM ET.
- ESMO Symposium on Immuno-Oncology in Lausanne, Switzerland on November 20 - 21, 2015. Aung Naing, MD FACP, Associate Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX will present abstract 3PD in a poster discussion session on Friday, November 20 at 5:00-6:00 PM CET.
Poster presentations at the conferences will be available by visiting the publications section of the ARMO website at www.armobio.com.
“It’s a pleasure to share results from the ongoing Phase 1b study of our immuno-oncology program AM0010 at these important medical forums. In addition to having a well-tolerated safety profile, AM0010 has demonstrated impressive single agent activity and increased intratumoral activated cytotoxic CD8+ T cells in immune-sensitive tumors inclusive of melanoma and renal cell carcinoma along with other tumors not previously thought to be sensitive to immunotherapy, such as colorectal cancer,” commented Peter Van Vlasselaer, PhD, President and Chief Executive Officer of ARMO BioSciences. “These data may support the initiation of Phase 2/3 studies of AM0010 in combination with standards of care therapies or immunotherapies that work through complementary but distinct mechanisms on CD8+ T cells such as anti-PD-1 agents.”
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 agent.
In a phase 1 study, AM0010 has been dosed in over 250 advanced cancer patients across several indications. Thirty-three patients were treated in the monotherapy dose-escalation segment of the trial and the remainder were enrolled in expansion cohorts for treatment with either monotherapy, or in combination with anti-PD-1 agents or standards of care. AM0010 has shown clinical activity in melanoma (with and without liver metastases), renal, pancreatic, non-small cell lung, breast and colorectal cancers, either as single agent or in combination therapies. All patients treated with AM0010 demonstrated signature elevations of target cytokines such as IFNγ, IL-18, IL-7, IL-4 and GM-CSF. These effects were more pronounced in responding patients. Early results from these trials are suggestive of AM0010’s role in increasing tumor infiltrating T cells and PD-1 expression, thereby bestowing anti-PD-1 sensitivity on tumors, including those that had been refractory to anti- PD-1 treatment. Accordingly, combination of AM0010 with an anti-PD-1 agent appears to have synergistic clinical activity in immune-sensitive tumors such as melanoma, RCC and NSCLC.
Final results from this trial across all indications are awaited and may offer standard-of-care changing front-line options for these tumors. Registration enabling phase 2/3 studies for AM0010 are planned to begin in 2016.
About ARMO BioSciences
Founded in 2012, ARMO BioSciences is a clinical stage developer of immuno-therapeutics focused on the oncology space and is anchored by its platform molecule AM0010, a PEGylated form of recombinant human IL-10. The company has a unique approach to developing therapeutic cytokines that are complimentary to other immune-oncology therapeutics and standard of care drugs. ARMO plans to initiate registration enabling phase 2/3 studies for AM0010 in multiple solid tumors. In addition to the lead programs addressing cancer, the company has a robust R&D platform with preclinical and clinical molecules for the treatment of fibrosis, hypercholesterolemia/ atherosclerosis and inflammatory diseases. ARMO is backed by investors Kleiner Perkins Caufield & Byers, OrbiMed, DAG Ventures, and NanoDimension.
For more information, please visit www.armobio.com
Scott Ogg, PhD
Vice President Corporate Development and Operations