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Amplifying the efficacy of biologic therapies by ameliorating unwanted immune responses
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Biologic Therapy

SEL-212 shows the potential of ImmTOR® for tolerogenic therapies

Building upon the proven success of SEL-212, ImmTOR® has exciting potential to provide antigen-specific immunity across a range of immunogenic compounds when co-administered with biologic therapies such as enzymes.


Amplifying the Efficacy of Biologic Therapy

  • The Challenge

    Many biologics can be highly immunogenic resulting in suboptimal responses to the standard of care due to the development of anti-drug antibodies (ADAs) after multiple treatments.

    ADAs are antibodies that bind to a biologic therapy, rendering them ineffective.

    Patients that develop an immune response to the current standard of care may be forced to discontinue treatment or experience adverse reactions.

    These patients are in desperate need of a new, more sustainable treatment option.

  • The Solution

    ImmTOR®, co-administered with immunogenic therapeutic biologics, has the potential to ameliorate an immune response to the biologic treatment allowing patients to stay on therapy longer.

    Human data in both immunogenic biologics and gene therapy AAV empty capsids shows the promise of ImmTOR® in enhancing biologics.

  • The Opportunity

    The use of ImmTOR® as an adjunct to biologic therapies offers a promising approach to minimize the healthcare and economic burden of ADAs.

    Extensive human data and significant safety data across multiple biologics demonstrates the broad potential applicability of the technology in immunogenic biologics.

Clinical Validation

SEL-212 has been observed to be well-tolerated and effective

We have observed indications of clinical activity and tolerability from SEL-212 in chronic refractory gout. Results from a Phase 2 trial showed that ImmTOR® mitigated the immune response against pegadricase, enabling monthly dosing and sustained reduction of serum uric acid (SUA) levels, with 66% of evaluable patients completing the 20-week trial period with an SUA level below 6mg/dL. In addition, dual energy computed tomography (DECT) scan images demonstrated the ability of SEL-212 to reduce tissue urate burden. Patients treated with SEL-212 experienced fewer and less severe flares compared to patients treated with enzyme alone.

Most importantly, ImmTOR® significantly reduced the production of ADA’s to pegadricase, demonstrating the potential to tolerize against highly immunogenic therapeutic enzymes.

Wholly-Owned Pipeline

Indication

Antigen

Stage of Development

Preclinical
Phase 1
Phase 2
Phase 3

          

Commercial Rights

Amplifying the efficacy of biologic therapies

Biologic Therapies

IgA nephropathy (IgAN)

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IgA protease

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25

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Partnered

Indication

Antigen

Stage of Development

Preclinical
Phase 1
Phase 2
Phase 3

Upcoming Milestone

Commercial Rights

Amplifying the efficacy of biologic therapies

Biologic Therapies

Chronic Refractory Gout

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Pegadricase

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90

SEL-212

BLA filing expected 1H 2024

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SEL-212 in Chronic Refractory Gout — Phase 3 Trial

SEL-212 lays the foundations for Selecta’s pipeline of tolerogenic therapies driven by ImmTOR®.

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). SEL-212 is being developed and commercialized through an out-licensing partnership with Swedish Orphan Biovitrum AB (Sobi).

In March 2023, Selecta and Sobi announced that the two double-blinded, placebo-controlled studies evaluating SEL-212 in adult patients with chronic refractory gout, DISSOLVE I (clinicaltrials.gov NCT04513366) and DISSOLVE II (clinicaltrials.gov NCT04596540), each met its primary endpoint. 

IgA Nephropathy (IgAN)

Selecta has partnered with IGAN Biosciences and Ginkgo Bioworks to develop a clinical candidate for the treatment of IgAN. ImmTOR® in combination with an IgA protease has the potential to selectively 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. It is caused by deposits of the protein immunoglobulin A (IgA) inside the filters (glomeruli) in the kidney which may lead to blood (hematuria) and protein (proteinuria) being present in urine. Preclinical studies have shown the potential for treatment with IgA protease to clear glomerular IgA1 deposits and associated inflammation and hematuria.

Partner with Us

Learn more about partnership opportunities

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 Takeda, AskBio and Sarepta Therapeutics to evaluate the potential of ImmTOR in combination with AAV gene therapy. Selecta is also looking for partnerships to unlock the potential of its proprietary IgG protease, Xork, for the mitigation of pre-existing anti-AAV antibodies.

Partnerships

Publications

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.