si-544, a Kv1.3 blocker with class leading selectivity and excellent preclinical safety profile, scheduled to advance towards clinical development in early 2021
SAN DIEGO, September 16, 2020 – selectION, Inc. a biotechnology company developing novel peptide therapies for autoimmune diseases by targeting autoreactive, chronically activated T cells, today announced a $5 million convertible promissory note financing. The financing follows the successful completion of preclinical safety and toxicology studies in rats and non-human primates.
The funds will be used to advance si-544 into clinical development in early 2021.
Antonius Schuh, PhD, Chief Executive Officer of selectION, commented: “We can now confirm that the class-leading selectivity of si-544 translates into a most favorable safety profile, and as a result, we will be able to dose si-544 at levels achieving meaningful Kv1.3 target engagement in patients. This has not been possible to date in a clinical setting.”
Andreas Klostermann, PhD, Founder & CSO of selectION commented: “The Company has made excellent progress in its pre-clinical, CMC and regulatory scientific advice communications over the past eighteen months. We finished repeated dose toxicity and safety studies both in rats and monkeys. All studies were completed with excellent results. High tolerability to si-544 was observed with no signs of interference with the respiratory and cardiovascular systems of the animals at the highest dose level. A recently held scientific advice meeting with the German regulatory authorities, Bundesamt für Arzneimittel und Medizinprodukte (BfArM), was a clear success. The Company will enter into detailed discussions with the BfArM to determine the optimal structure of our clinical program.”
selectION, Inc., San Diego, is developing a novel peptide therapy based on its lead candidate si-544 to treat severe effector memory T cell (TEM) driven diseases like autoimmune indications such as Vasculitis, Rheumatoid Arthritis or Multiple Sclerosis or certain rare cancers like cutaneous T cell lymphoma (CTCL). The immuno-selective agent si-544 addresses an unmet medical need by functionally inhibiting/eliminating disease-specific chronically activated TEM cells without compromising the protective immune response.
si-544 – A Selective Antagonist of Kv1.3
selectION´s lead candidate si-544 selectively binds to Kv1.3 with a picomolar IC50 and does not bind to other key functional ion channels, such as hERG or Kv1.5, avoiding off-target effects. Preclinical data in the antigen-induced arthritis rat model, in the rat influenza model and ex vivo proliferation experiments with human TEM cells, indicate proof of concept. These data also indicate that the general immune response in the rat is not impaired under si-544 therapy. The BfArM already recognized the preclinical data package.
Immuno-Selective Therapy – Background and Scientific Rationale
TEM cells play a cardinal role in the human immune response system reacting to pathogen-derived antigenic stimuli. The voltage gated potassium channels Kv1.3 and KCa3.1 are compensatory and cooperatively maintaining ion homeostasis in TEM cells upon antigen stimulation. Interestingly, disease associated chronically activated TEM cells become exclusively dependent on Kv1.3 due to loss of KCa3.1 compensatory expression. Blockade of Kv1.3 by selective antagonists disrupts the signaling pathway of chronically activated TEM cells, terminates the activation and inhibits the pathogenic proliferation cascade, and leaves the overall immune response untouched. Therefore, Kv1.3 can be regarded as a target of choice for immuno-selective therapies.
Investor & Media Contacts:
Dr. Andreas Klostermann
Founder & CSO