Innovation & Business Idea
SLE treatments that are safe and effective are needed. Overactivity of STING has been implicated in the pathogenesis of severe SLE and offers a possibility for a targeted treatment for these patients. ISD has developed a small peptide which targets the STING pathway early in the biology to dampen IFN-1 signature as well as other events involved in SLE. Furthermore, by testing blood samples of patients in an ex-vivo assay ISD can predict which patients will respond to the peptide drug. We intend to preselect patients based on this ex-vivo assay to remove the complexity and challenge from SLE clinical trials.
Customers / Target Market
ISD is targeting the severe SLE market in North America and Europe comprising a total of about 50,000 SLE patients.
Targeting STING rather than IFN-1 in general is expected to result in better efficacy and less severe side effects. By inhibiting STING early in the pathway, ISD is able to dampen the EXCESS IFN-1 which is responsible for the disease while leaving basal IFN-1 intact for a healthy immune system. Using anti-IFN antibodies may result in a heightened risk of cancer and infection with long term use. Furthermore SLE is emerging as not just an IFN-1 disease. Other events such as apoptosis, autophagy and other cytokines result in SLE and cannot be addressed with a IFN-1 targeted approach. We have preliminary data supporting that STING antagonism early in the pathway can affect downstream effects more broadly than just modulating IFN-1.
Intellectual Property Status
ISD-Immunotech holds a patent on the discovery and generation of the immunosuppressive domains (WO2013/050048 A2) which is 100% owned by ISD and ISD owns 50% of a medical use patent for the use of our research lead compound ISD017 for the therapeutic treatment of SLE and autoimmune diseases (W0214/166502 A2). Our strategy is to further expand our IP position by performing peptide optimization and creating new composition of matter IP vi research a optimization of our lead ISD017.
Development Status & Future Steps
ISD is at the cusp of peptide optimization. We have identified a world class CRO to perform the optimization (IRBM). A plan and proposal is in place.
We are also ready to perform in vivo dose escalation studies in an SLE mouse model to confirm an earlier pilot study and to expand our understanding of the MOA by running a prevention and treatment arm using the peptide as a monomer and a dimer.
ISD plans to apply for orphan drug designation and preselect a subset of severe SLE patients we can predict will respond to the therapy in an in vivo assay.
ISD-Immunotech intends to run the program to FIM to a Phase Ib/IIa study and outlicense the program to an external large pharm partner.
Tara Heitner, PhD, MBA is a serial entrepreneur and former scientist with expertise in fundraising, partnering, licensing, patenting, development & commercialization of early stage technologies and therapies.
Kristian Hansen, PhD, spent over 30 years in various leadership R&D roles in Novo Nordisk in the development of peptide, mAb and small molecule drugs from target identification to early clinical development.
Ingelise Saunders is Chairman of the Board. Ingelise is a serial entrepreneur and industry veteran. She has held executive positions at Novo Nordisk before taking on several CEO roles in biotech. She holds board positions today in several biotech companies and is board member of the Lundbeck Foundation.
ISD-Immunotech has identified a lead investor (Novo Seeds) and seeks a second co-investor or co-lead for a seed round