Clinical Development

Overview

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. Our robust pipeline includes validated product candidates aimed at treating a variety of cancers in combination with standard of care and emerging immunotherapies.

Preclinical Pre-IND IND Phase 1 Phase 1b Phase 2 Phase 3
AM0010 (PEG-IL-10)
PDAC/FOLFOX
PDAC/FOLFOX
Non-Small Cell Lung Cancer / Anti-PD-1
Non-Small Cell Lung Cancer / Anti-PD-1
Renal Cell Cancer / Anti-PD-1
Renal Cell Cancer / Anti-PD-1
Other Solid Tumor Indications
Other Solid Tumor Indications
AM0001 (Anti-PD-1 mAb)
 
 
AM0015 (IL-15)
 
 
AM0012 (IL-12)
 
 

CLINICAL STAGE

AM0010

Our lead product candidate is AM0010, a long-acting form of recombinant human Interleukin 10 (IL-10). IL-10 is a naturally occurring immune growth factor in humans that 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. Linking IL-10 to polyethylene glycol (PEG), ARMO increased IL-10’s size to prolong its circulation time in the body of patients, maximizing its capability to activate anti-tumor CD8+ T cells.

ARMO has initiated an international randomized Phase 3 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. Results have been presented and published in a number of peer-reviewed settings.

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.

Additional details are available here (www.clinicaltrials.gov).

PRE-IND PRODUCT CANDIDATES

AM0001

AM0001 is a monoclonal antibody (mAb) that activates CD8+ T cells by blocking the interaction between the checkpoint inhibitors Programmed Cell Death Protein-1 (PD-1) and Programmed Cell Death Ligand-1 (PD-L1). AM0001 has similar characteristics to the marketed anti-PD-1 checkpoint inhibitors, nivolumab and pembrolizumab. ARMO is currently performing IND-enabling studies with AM0001.

AM0015

AM0015 is a recombinant human Interleukin-15. IL-15 is an activator of the immune system that induces proliferation of CD8+ T cells in the blood of cancer patients. In preclinical animal models, AM0015 induced anti-tumor responses that are additive or synergistic with the anti-tumor effects of AM0010. The mechanism of action by which AM0015 affects CD8+ T cells and induces anti-tumor responses is different than that of AM0010. ARMO is currently planning for the future development of AM0015 in combination with AM0010.

PRE-CLINICAL PRODUCT CANDIDATE

AM0012

AM0012 is a recombinant human Interleukin-12. IL-12 is an activator of the immune system and induces activation and proliferation of CD8+ T cells. In preclinical animal models, AM0012 induced anti-tumor responses through a mechanism of action that could be additive or synergistic with the anti-tumor effects of AM0010.