Immunomodulation Inc. recently outlined its upcoming plans to advance its investigational product candidate, IMM-010, following consistent positive data from preclinical studies.
Immunomodulation, an immuno-therapy company, develops adjunctive therapeutic agents to support immune system activation to suppress tumors and fight infection. The company’s lead program, IMM-010 (annexin V), a naturally occurring protein that binds to phosphatidylserine (PS), is currently in preclinical development for the treatment of multiple, high-value oncology and serious infectious disease indications. The company has an exclusive license to IMM-010 from Stanford University, which has a robust intellectual property (IP) portfolio that covers its therapeutic use in oncology and infectious diseases.
“Many viruses, parasites, bacteria and tumor cells utilize externalized PS to evade recognition and attack by the innate and adaptive immune systems in a process known as apoptotic mimicry. We believe IMM-010, a naturally occurring protein that binds to PS, will efficiently block the immunosuppressive actions of PS in both apoptosis and tumor cell or pathogen evasion of the immune system,” Dr. Michael Beaubaire, Chief Executive Officer of Immunomodulation, explained.
IMM-010 has been effective in generating immune responses resulting in slowing tumor size (comparable to approved checkpoint antibodies) and increased survival as well as anti-intracellular pathogen effects in animal models of disease.
Additionally, Francis Blankenberg, MD, at the Stanford University School of Medicine, and Jonathan Rayner, PhD, at University of South Alabama are conducting studies on the efficacy of IMM-010. Based on these studies, Immunomodulation is working to drive the execution of its development plan.
Annexin V has been studied extensively as an imaging agent in multiple Phase 2 and Phase 3 clinical trials in the US and Europe. Collaboratively, it has been demonstrated that IMM-010 is effective in generating an immune response which dramatically slowed tumor growth, significantly increased survival and was more effective than either anti-PD-1 or anti-CTLA-4 antibody immune checkpoint therapy. Additional studies have shown the combination of PD-1, CTLA-4, and IMM-010 significantly improves survival compared to antibody or IMM-010 intervention alone.
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.
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.
“We have developed a strategic, stepwise development plan in collaboration with industry leading experts, and over the next year, we intend to work collaboratively with researchers and their institutions to aggressively advance our IMM-010 program through confirmatory preclinical mechanism-of-action and proof-of-concept studies,” said Dr. Beaubaire. “We intend to file our IND application in the summer of 2019. In parallel we will advance our funding strategy to close our Series A round as quickly as possible. We look forward to providing frequent updates on our progress.”
Immunomodulation is a privately held biopharmaceutical company focused on developing breakthrough therapies to modulate immune responses in multiple high value oncology and serious infectious disease indications. The company’s lead program, IMM-010 (annexin V) is in preclinical development for the treatment of solid tumors and certain viruses and has the potential for additional pipeline expansion opportunities. IMM-010 binds to phosphatidylserine (PS) on tumor cells and infective organisms. IMM-010 has been demonstrated to be effective in generating immune responses and has shown both tumor size reduction and anti-infective effects in animal models of diseases.
Immunomodulation, working in collaboration with a network of leading institutions, is sponsoring research and manufacturing to drive the execution of its development plan. Based on previous clinical experience of the Company’s founders with annexin-V as an imaging agent, Immunomodulation expects to file an IND for IMM-010 in less than 18 months. For more information, visit www.immunomodulation.com.