Innovation & Business Idea
SLE is a chronic inflammatory disease that can affect virtually any organ and imposes a threefold increased risk of death due to SLE maifestations and infections. Current therapy consists of long term treatment with glucocorticoids, anti-malarials and immunosuppressive drugs. The only biologic (Belimumab) has low activity against SLE. All of these drugs, especially glucocorticoids have considerable side effects. There is clearly a high need for more specific, more effective, and less toxic therapies of SLE. In recent years IL-3 was identified as an important regulator and inducer of autoimmunity and inflammation. IL-3 strongly acts on plasmacytoid dendritic cells, basophils, B cells, monocytes and endothelial cells, all of which contribute to autoimmunity by production of interferon, activation of B cells, production of autoantibodies, release of proinflammatory cytokines, and recruitment of leukocytes. Thus IL-3 is stronlgy involved in all relevant pathways of SLE. In addition, we have demonstrated that IL-3 is markedly over-expressed in patients with active SLE, rheumatoid arthritis and psoriatic arthritis. Moreover, IL-3 expression correlates with disease activity and was not reduced by currently available drugs. Blockade or knock-out of IL-3 markedly improved disease activity in animal models of lupus nephritis, arthritis, encephalitis and myocarditis. In a sepsis model, IL-3-deficient mice did not develop the typical cytokine storm and were protected from death. In contrast, overexpression or injection of IL-3 aggravated disease activity in mice and induced a pronounced inflammation with polyarthritis in rhesus monkeys. Under basal conditions, IL-3 KO-mice have no overt phenotype and no hematopoietic abnormalities.
Customers / Target Market
The prevalence of SLE is 0.122%. About 30% of SLE patients are not well controlled with currently available drugs. Assuming a 25% market penetration and costs of €40.000 / patient / year a market potential of up to €4 B could be reached. Additional indications include rheumatoid arthritis and psoriatic arthritis.
There are no competitors that develop antibodies against IL-3.
Intellectual Property Status
ImmuCon will be able to obtain a strong patent portfolio of 5 patents from the Univeristy of Regensburg covering IL-3 antibodies and inhibition of IL-3 for treatment of SLE and RA.
Development Status & Future Steps
We have developed a fully humanized antibody against IL-3 that blocks human IL-3 with high potency. In contrast to commercially available antibodies, our antibody is able to block the heavily glycosylated primary human IL-3 obtained from patients. The antibody has been extensively characterized and is suitable for GMP-production and clinical testing.
ImmuCon will perform the preclinical and clinical development until prove of concept in a phase II clinical trial in patients with SLE and subsequently licence or sell the products to a pharmaceutical company for further development.
ImmuCon will have a core management team (CEO, CSO, CMO) as well as experienced scientists and study nurses that will coordinate all work packages (Company Team). This team will be supported by a University Team providing scientific and medical know-how and performing lab work. Thus, ImmuCon has access to a fully equipped and well established lab infrastructure with experienced personnel.
The preclinical and clinical development including proof of concept in a clinical phase IIa study is estimated to cost about €22 M and to take about 5 years.
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