pegsiticase (SEL-037) / Cartesian Therapeutics - LARVOL DELTA

Safety, Tolerability, and Pharmacokinetic Characteristics of SSS11 in Patients With Gout and Hyperuricemia (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD. | Trial completion date: Aug 2025 ➔ Aug 2027 | Trial primary completion date: Apr 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Gout • Inflammatory Arthritis • Rheumatology

Safety, Tolerability, and Pharmacokinetic Characteristics of SSS11 in Patients With Gout and Hyperuricemia (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.

New P1 trial • Gout • Inflammatory Arthritis • Rheumatology

A Study to Determine the Safety, Tolerability, PK and Preliminary PD of SSS11 in Chinese Healthy Adult Volunteers (clinicaltrials.gov) - P1; N=33; Recruiting; Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.; Not yet recruiting ➔ Recruiting; Trial completion date: Sep 2020 ➔ Dec 2022; Trial primary completion date: Jun 2020 ➔ Oct 2022

Clinical • Enrollment open • Trial completion date • Trial primary completion date • Gout • Inflammatory Arthritis • Rheumatology

[VIRTUAL] IMMTOR NANOPARTICLES ENHANCE THE TOLEROGENIC ENVIRONMENT OF THE LIVER IN MICE (EULAR 2021) - "Background: Tolerogenic ImmTOR biodegradable nanoparticles encapsulating rapamycin have been shown to mitigate the formation of anti-drug antibodies against pegadricase, a pegylated uricase enzyme, which enabled monthly dosing and sustained reduction of serum uric acid levels in a Phase 2 clinical trial of SEL-212, a combination of pegadricase + ImmTOR, in patients with symptomatic gout with hyperuricemia. These results suggest that the liver may contribute to the tolerogenic properties of ImmTOR in mitigating anti-drug antibody responses to biologic therapies, such as pegadricase."

Preclinical • Gout • Immune Modulation • Inflammation • Inflammatory Arthritis • Rheumatology • CD4 • CD8 • CTLA4 • PD-1

A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Patients Refractory to Conventional Therapy (clinicaltrials.gov) - P2; N=170; Completed; Sponsor: Selecta Biosciences, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Gout • Inflammatory Arthritis • Rheumatology

Development of ImmTOR Tolerogenic Nanoparticles for the Mitigation of Anti-drug Antibodies. (PubMed, Front Immunol) - "The focus of this review is the development of ImmTOR, a platform technology designed to prevent the formation of ADAs that can be applied broadly across a wide variety of biologics by inducing immunological tolerance with ImmTOR nanoparticles encapsulating rapamycin...The ability of ImmTOR to mitigate the formation of ADAs has been demonstrated for coagulation factor VIII in a mouse model of hemophilia A, an anti-TNFα monoclonal antibody in a mouse model of inflammatory arthritis, pegylated uricase in hyperuricemic mice and in non-human primates, acid alpha-glucosidase in a mouse model of Pompe disease, recombinant immunotoxin in a mouse model of mesothelioma, and adeno-associated vectors in a model of repeat dosing of gene therapy vectors in mice and in non-human primates. Human proof-of concept for the mitigation of ADAs has been demonstrated with SEL-212, a combination product consisting of ImmTOR + pegadricase, a highly immunogenic enzyme therapy for the treatment..."

Journal • Review • Gene Therapies • Gout • Hematological Disorders • Hemophilia • Immunology • Inflammatory Arthritis • Lung Cancer • Mesothelioma • Oncology • Rare Diseases • Rheumatology • Thoracic Cancer

A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Patients Refractory to Conventional Therapy (clinicaltrials.gov) - P2; N=150; Active, not recruiting; Sponsor: Selecta Biosciences, Inc.; Recruiting ➔ Active, not recruiting; Trial completion date: Feb 2020 ➔ Aug 2020; Trial primary completion date: Jan 2020 ➔ Jul 2020

Clinical • Enrollment closed • Trial completion date • Trial primary completion date

Monthly Dosing of ImmTOR Tolerogenic Nanoparticles Combined with Pegylated Uricase (Pegadricase) Mitigates Formation of Anti-Drug Antibodies Resulting in Sustained Uricase Activity in Symptomatic Gout Patients (ACR-ARHP 2019) - "SEL-212 is a novel combination product consisting of pegadricase co-administered with proprietary ImmTOR tolerogenic nanoparticles. By mitigating the formation of ADAs, monthly dosing of ImmTOR combined with pegadricase increases uricase activity in symptomatic gout patients relative to pegadricase alone. When anti-uricase titers are < 1080, patients show sustained uricase activity, enabling 28 day treatment intervals. Effect of Treatment and Antibody Titer on Uricase Activity"

Clinical

Monthly Dosing of ImmTOR Tolerogenic Nanoparticles Combined with Pegylated Uricase (Pegadricase) Enables Sustained Reduction of Acute Gout Flares in Symptomatic Gout Patients (ACR-ARHP 2019) - "SEL-212 is a novel combination product consisting of pegadricase co-administered with proprietary ImmTOR tolerogenic nanoparticles...94% (49/52) of all randomized patients received premedication for gout flare prevention as per standard of care in the form of colchicine (1.2 mg as loading dose, 0.6 mg QD for the remainder of their participation), ibuprofen, or equivalent dose of NSAID... Monthly dosing of ImmTOR combined with pegadricase has been well-tolerated and has a lower incidence of flares at the initiation of therapy relative to pegylated uricases alone and the reported ULT flare incidence, and the effect persists over the duration of therapy. *JAMA. 2011;306(7):711-720 % of Patients with Flare by Treatment Month"

Clinical

Phase 2 Dose-ranging Study of SEL-212 in Symptomatic Gout Patients: Selection of Doses for Further Clinical Development (ACR-ARHP 2019) - P2; "Based on these results, the combination of pegadricase (0.2 mg/kg) and ImmTOR (0.15 mg/kg) were selected for use in a head-to-head comparison study of SEL-212 to pegloticase, a pegylated uricase currently FDA approved for use in patients with treatment-refractory gout (NCT03905512). Cohort layout for ImmTOR dose of 0.08 mg/kg and above"

Clinical • P2 data

A Phase Ⅰ Study of SSS11 in Chinese Healthy Adult Volunteers (clinicaltrials.gov) - P1; N=36; Not yet recruiting; Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.

Clinical • New P1 trial

A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Patients Refractory to Conventional Therapy (clinicaltrials.gov) - P2; N=150; Recruiting; Sponsor: Selecta Biosciences, Inc.

Clinical • New P2 trial

Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid (clinicaltrials.gov) - P2; N=152; Completed; Sponsor: Selecta Biosciences, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion