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Selecta Biosciences And IGAN Biosciences Enter Into Research License And Option Agreement To Study Selecta's ImmTOR Immune Tolerance Platform In Combination With IGAN's IgA Protease For Treatment Of IgA Nephropathy

Application of ImmTOR™ plus IGAN's IgA protease to target immunoglobulin A (IgA) deposition, the critical event leading to IgA Nephropathy

· 10/08/2020 16:10

Application of ImmTOR™ plus IGAN's IgA protease to target immunoglobulin A (IgA) deposition, the critical event leading to IgA Nephropathy (IgAN)
 

Selecta's IgA nephropathy program builds upon SEL-212, which has demonstrated ImmTOR™ effective at tolerizing a highly immunogenic therapeutic enzyme

Investigational New Drug (IND) application expected in Q4 2021

WATERTOWN, Mass., and BOSTON, Oct. 08, 2020 (GLOBE NEWSWIRE) -- Selecta Biosciences, Inc. (NASDAQ:SELB) and IGAN Biosciences, Inc. today announced that they have entered into a Research License and Option agreement to study Selecta's ImmTOR™ immune tolerance platform in combination with IGAN's immunoglobulin A (IgA) protease for the treatment of IgA Nephropathy (IgAN). In advance of exercising its option to enter into an exclusive license agreement, Selecta will conduct preclinical research to evaluate the utility of the combination of ImmTOR and IGAN's IgA protease.

Previous studies in animal models conducted at independent laboratories established the ability of IGAN's IgA protease to remove injurious IgA from kidneys and improve markers of renal dysfunction. These results suggest that it is an excellent candidate to decrease the rate of disease progression and possibly even reverse the disease. The barrier to IgA protease commercialization is the bacterial origin of the protease, which makes it immunogenic. Selecta's proprietary immune tolerance platform, ImmTOR, has shown in clinical studies the ability to mitigate the formation of anti-drug antibodies (ADAs) to immunogenic enzymes. This has been demonstrated with its phase 3 lead product candidate, SEL-212, which is a combination of ImmTOR and pegadricase, an immunogenic proprietary pegylated uricase for the treatment of chronic refractory gout. Selecta and IGAN intend to combine IGAN's IgA protease with Selecta's ImmTOR platform to develop a novel combination product to treat IgA nephropathy, a disease with significant unmet medical need.

"We are excited to build on our learnings from SEL-212 in combining an immunogenic enzyme with our ImmTOR platform to develop a product candidate for IgA nephropathy," said Carsten Brunn, Ph.D., President and Chief Executive Officer of Selecta Biosciences. "IGAN's IgA protease has shown tremendous promise in preclinical studies and combining it with ImmTOR to prevent ADAs could lead to a transformational product for patients with this debilitating disease."

"IGAN is pleased to enter into this agreement with Selecta Biosciences to use their ImmTOR technology with IgA proteases as biological therapy for IgA nephropathy," said Andrew G. Plaut, M.D., Co-Founder and Chief Medical Officer of IGAN Biosciences Inc. "In combination, these products offer the prospect of realizing the potential value of IgA proteases to remove kidney IgA deposits, thus reducing progression of renal injury to renal failure."

IgA Nephropathy is characterized by deposition of galactose-deficient IgA1 immunoglobulin in the glomerular mesangium and is a leading contributor to development of chronic kidney disease and renal failure. Genetic or environmental causes that form this abnormal IgA1 and its accumulation in the kidney can result in the development of IgAN. Hypertension, proteinuria and decreased eGFR at the time of diagnosis are associated with poor prognosis. It can result in incremental loss of renal function and results in end stage renal disease (ESRD) in approximately 30 - 40% of patients. There are no approved therapies for the treatment of IgAN.

Under the terms of the research license and option agreement, Selecta will make an initial payment to IGAN. If Selecta exercises its option to enter into an exclusive license agreement, IGAN will receive an additional payment and will be eligible for additional development, regulatory, and commercial milestone payments, as well as tiered royalties on net product sales.