On January 9 2023 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies for autoimmune diseases and gene therapies, reported a corporate update, including its roadmap for 2023 (Press release, Selecta Biosciences, JAN 9, 2023, View Source [SID1234626107]).
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Key 2023 Anticipated Milestones
Report top-line data from Phase 3 DISSOLVE I & II programs of SEL-212 in chronic refractory gout in Q1 2023
Preliminary Phase 1 SEL-302 data in gene therapy for MMA
Initiate IND enabling studies with the selected IL-2 candidate to further advance and expand the immune tolerance platform in autoimmune disease
Begin IND enabling studies with the selected IgA protease candidate from IGAN Biosciences
"In 2022, we delivered on key milestones that further validated the value and breadth of our innovative ImmTOR and ImmTOR-IL immune tolerance platforms, continued to advance our diversified clinical pipeline and established strategic collaborations that will propel our next-generation programs toward multiple IND filings," said Carsten Brunn, Ph.D., President and Chief Executive Officer of Selecta. "Building on the momentum of our recently announced deal with Astellas Gene Therapies’ for Xork in Pompe disease, the initiation of the Phase 1/2 trial in methylmalonic acidemia, the identification of an IL-2 candidate and selection of an IgA protease candidate, we also expect joint topline data from the Phase 3 DISSOLVE clinical program investigating SEL-212 in chronic refractory gout in Q1 2023. We are at a pivotal moment in the Company’s growth trajectory and as we look ahead, we believe we are well positioned to take a potentially generational leap forward for our precision immune tolerance platform, advance our pipeline in autoimmune disease and continue to explore additional collaborations to maximize the value of our ImmTOR platform and pipeline."
Clinical Development Overview
Tolerogenic Therapies for Autoimmune Disease:
ImmTOR-IL: In December 2022, the Company opted into an agreement for an identified IL-2 candidate and is currently negotiating the terms of the license. The IL-2 candidate will be studied in combination with ImmTOR to further advance and expand the pipeline in autoimmune disease. The combination of ImmTOR and IL-2 (ImmTOR-IL) represents an evolution of the precision immune tolerance platform to further enhance the magnitude and duration of antigen-specific immune tolerance for the treatment of patients with autoimmune diseases.
The Company plans to initiate IND enabling studies in 2023 while also exploring multiple autoimmune indications that would be suitable for study with ImmTOR-IL.
Gene Therapies:
SEL-302 for Methylmalonic Acidemia (MMA): In December 2022, Selecta initiated ReiMMAgine, the Phase 1/2 clinical trial of SEL-302, an adeno-associated virus (AAV) gene therapy combined with ImmTOR for the treatment of MMA.
The ReiMMAgine trial is now enrolling patients and aims to evaluate the safety, tolerability and efficacy of SEL-302, a combination of ImmTOR and AAV gene therapy.
SEL-018 IgG Protease (Xork) for Pompe Disease: In January 2023, the Company announced an exclusive licensing and development agreement for IdeXork (Xork), a next-generation immunoglobulin G (IgG) protease, to be developed for use with AT845, Astellas Gene Therapies’ investigational AAV-based treatment for Late-Onset Pompe disease (LOPD) in adults.
Xork has the potential to expand access of life-changing gene therapies to more patients by addressing pre-existing immunity to AAV. Xork is differentiated by its low cross reactivity to pre-existing antibodies in human serum.
Under the terms of the agreement, Selecta will receive a $10M upfront payment and is eligible to receive up to $340M for certain additional development and commercial milestones plus royalties on commercial sales. Selecta is responsible for the early development activities and manufacturing of Xork and will maintain the rights for the development of additional indications beyond Pompe disease.
Biologic Therapies:
SEL-212 for chronic refractory gout: DISSOLVE, the Phase 3 development program of SEL-212, which has been licensed to Sobi continues to advance. DISSOLVE I & II trials are on track for joint topline data expected in Q1 2023.
ImmTOR with IgA Protease for IgA Nephropathy: In December 2022, the Company selected the next generation Immunoglobulin A (IgA) protease from IGAN Biosciences for the treatment of IgAN.
Identified a new class of IgA protease from commensal bacteria with a lower level of baseline anti-drug antibodies (ADAs). Combining ImmTOR with this next generation IgA protease candidate has the potential to mitigate the formation of new ADAs and address the underlying pathophysiology of IgAN.
Further Corporate Updates:
In November 2022, Blaine Davis was appointed as Chief Financial Officer. Mr. Davis brings more than 25 years of experience in investor relations, business development, corporate affairs and sales and marketing at life sciences companies, with a particular focus on rare diseases.