Immunomodulation is developing IMM-010 which is a highly conserved naturally occurring protein. Initial indications targeted are multiple high value oncology and serious infectious diseases. The Company is working in collaboration with a network of leading institutions, including Stanford University School of Medicine and the University of South Alabama to extend our understanding of the mode of action of annexin V and to execute a preclinical development plan. Previous experience of the founding team with the clinical development of an annexin V based product gives us confidence that an aggressive timeline is realistic, and we expect to file an IND for IMM-010 in less than 18 months from full funding.
We know how to manufacture the compound, shown it to be safe in humans, and have a foundation of preclinical data supporting our approach.
Cancerous cells express low levels of PS on external cell surface to induce active immunosuppression via interactions with macrophages and other immune cells. In preclinical mouse models with the 4T1 metastatic breast cancer cell line, IMM-010 has shown high levels of binding to PS in vivo, has demonstrated slowing of tumor development compared to PD-1 or CTLA-4 antibodies and significantly increased survival. Immunomodulation is targeting solid tumors such as breast cancer as its initial oncology indication and expects to commence its oncology IND-enabling studies in the second half of 2018.
IMM-010 Binds to PS on Tumor Cells Eliciting Direct Immune Response
PS is expressed on the cellular surfaces of viruses, fungi and select bacteria. In a mouse model of Listeria monocytogenes, an obligate intracellular bacterial pathogen, exogenous IMM-010 demonstrated an improved survival rate of 90% at 6 days after infection compared with 50% in untreated mice. Infectious disease represents an area of acute need with potential for multiple non-dilutive funding opportunities and multiple government development incentive programs such as Orphan Drug and QIDP designations and priority review vouchers under the Infectious Disease category. Immunomodulation is initially targeting IMM-010 development for treating severe and often fatal infections such as Ebola, Chikungunya, Dengue and Marburg and widespread concerns like Zika, with expectations to initiate its infectious disease Investigational New Drug (IND) enabling studies in the second half of 2018.