REDWOOD CITY, Calif., March 16, 2016 /PRNewswire/ -- ARMO BioSciences, Inc., a clinical-stage biotechnology company, 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 as oral presentations at two upcoming oncology medical meetings:
3rd Immunotherapy of Cancer Conference (ITOC3) in Munich, Germany, March 21-23, 2016
Presentation Title: Safety, immune activation and antitumor efficacy of PEGylated recombinant human IL-10 (AM0010) in patients with advanced solid tumors – a phase 1 study
Presenter: Martin Oft, M.D., Vice President Pre-Clinical and Clinical Research and Development, ARMO BioSciences
Plenary Symposium: Combination Therapy
Presentation Time: Tuesday, March 22, 2016, 12:20 - 12:35 pm Central European Time
AACR Annual Meeting 2016 in New Orleans, LA, April 16-20, 2016
Presentation Title: Anti-tumor activity of PEGylated human IL-10 (AM0010) in patients with advanced solid tumors
Presenter: Jeffrey Infante, M.D., Director, Drug Development Program and Principal Investigator, Sarah Cannon Research Institute
Plenary Session: Immuno-oncology Clinical Trials II
Presentation Time: Tuesday, April 19, 2016, 10:30 am – 12:15 pm Eastern Time
Location: Room 391, Morial Convention Center
"As we advance our phase 1 study of AM0010, we look forward to sharing new clinical data on this experimental immuno-oncology therapeutic at important medical meetings such as ITOC and AACR. To date, AM0010 has demonstrated a well-tolerated safety profile, impressive single-agent activity and an increase in intratumoral-activated cytotoxic CD8+ T cells, both in immune-sensitive tumors, such as melanoma and renal cell carcinoma, and in tumors previously not considered to be sensitive to immunotherapy, such as colorectal cancer," commented Peter Van Vlasselaer, Ph.D., President and Chief Executive Officer of ARMO BioSciences. "We are encouraged by these data that support advancing the ongoing phase 1b studies of AM0010 in combination with standard-of-care therapies and anti-PD-1 agents that work through complementary yet distinct mechanisms on CD8+ T cells. In addition, we are working to initiate the first registration-enabling phase 2/3 study of AM0010 in solid tumors."
ARMO's lead immunotherapy product candidate 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. Over 280 advanced cancer patients have been dosed with AM0010 in a large phase 1 study in several difficult-to-treat solid tumor indications. Thirty-three patients were treated in the monotherapy dose-escalation segment of the trial and the remainder were treated in expansion cohorts with either monotherapy or in combination with anti-PD-1 agents or standards of care. Final results from this trial across all indications are awaited and may offer standard-of-care changing front-line options for these cancers.
AM0010 has shown activity as a monotherapy and in combination with anti-PD-1 agents in immune-sensitive tumors, such as melanoma, renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC), as well as in tumors previously not thought to be sensitive to immunotherapy, such as colorectal (CRC) and pancreatic (PDAC) cancers. Early clinical results indicate that AM0010 primes the tumor micro-environment to become more susceptible to immune-mediated events such as increases in tumor infiltrating PD-1 positive T cells, thereby bestowing anti-PD-1 sensitivity on tumors, including those previously refractory to anti-PD-1 treatment. Since combining AM0010 with an anti-PD-1 agent appears to have synergistic clinical activity in immune-sensitive tumors such as melanoma, RCC and NSCLC, this mechanism may add an immune-mediated benefit in immune-insensitive cancers such as pancreatic, colorectal and breast cancer.
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 phase 2/3 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
Scott Ogg, Ph.D.
Vice President Corporate Development and Operations
SOURCE ARMO BioSciences, Inc.