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Unlocking the full potential of enzymatic therapies by ameliorating unwanted immune responses
SEL-212 shows success of ImmTORTM for tolerogenic therapies
Building upon the proven success of SEL-212, ImmTOR has exciting potential to give rise to antigen-specific immunity across a range of immunogenic compounds when co-administered with biologic therapies like enzymes.
Chronic refractory gout is a severe form of inflammatory arthritis characterized by intense inflammation, debilitating pain, and the formation of tophi (painful deposits of urate crystals in joints and soft tissues). The vast majority of patients develop an immune response to the current standard of care and are often forced to discontinue treatment.
These patients are in desperate need of a new, more sustainable treatment option.
SEL-212 is Selecta’s Phase 3 clinical product candidate in chronic refractory gout, licensed to Sobi in mid 2020. Under the terms of the licensing agreement, Sobi takes on SEL-212 development, regulatory and commercial activities in all markets outside of China.
SEL-212 lays the foundation for Selecta’s pipeline of tolerogenic therapies driven by ImmTOR™
How SEL-212 Works
SEL-212 is comprised of ImmTOR co-administered with pegadricase, a highly immunogenic enzyme that, when given alone, decreases serum uric acid levels in patients with chronic refractory gout but triggers an immune response to the treatment, as measured by the production of anti-drug antibodies (ADAs).
When ImmTOR™ is co-administered with pegadricase, it has the potential to ameliorate this immune response.
Stage of Development
Amplifying the Efficacy of Biologic Therapies
Chronic Refractory Gout
Phase 3 data H2 2022
IgA nephropathy (IgAN)
IND filing H2 2021
SEL-212 Phase 3 trial
SEL-212 is currently being evaluated in a Phase 3 clinical trial being run by Selecta on behalf of Sobi.
The trial consists of two double-blinded, placebo-controlled studies, DISSOLVE I and DISSOLVE II. DISSOLVE I will access efficacy, as measured by serum uric acid levels at 6 months, with a 6 month extension to evaluate safety. DISSOLVE II will access efficacy as measured by serum uric acid levels at 6 months.
The trial is currently enrolling. For more information, please visit clinicaltrials.gov.
Selecta and IGAN Biosciences are developing a candidate for the treatment of IgAM combining ImmTOR with IGAN’s IgA protease to remove deposits of IgA from kidneys and improve markers of renal dysfunction.
Iga nephropathy is a leading cause of chronic kidney disease (CKD) and renal failure with 30-40% of patients reaching end-stage renal disease 20-30 years after the first clinical presentation. Caused by deposits of the protein immunoglobulin A (IgA) inside the filters (glomeruli) in the kidney which may lead to blood (hemauria) and protein (proteinuria) being present in urine. Preclinical studies have shown treatment with IgA protease clears glomerular IgA1 deposits and associated inflammation and hematuria.
An IND for IgAN is expected to be filed in the second half of 2021.
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Selecta licensed its Phase 3 clinical product candidate, SEL-212 , in chronic refractory gout, to Sobi in mid 2020. Selecta has also partnered with leading gene therapy companies, including AskBio and Sarepta Therapeutics to evaluate the potential of ImmTOR in combination with AAV gene therapies.
Validated and peer-reviewed research
Our research is validated by a long track record of peer-reviewed publications in high-impact journals in collaboration with our industry and scientific partners.
Development of ImmTOR Tolerogenic Nanoparticles for the Mitigation of Anti-drug Antibodies
Frontiers in Immunology
Improving the efficacy and safety of biologic drugs with tolerogenic nanoparticles
Antigen-selective modulation of AAV immunogenicity with tolerogenic rapamycin nanoparticles enables successful vector readministration
Enhancement of liver-directed transgene expression at initial and repeat doses of AAV vectors admixed with ImmTOR nanoparticles
Polymeric synthetic nanoparticles for the induction of antigen-specific immunological tolerance