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- abiprubart (KPL-404) / Kiniksa
EFFICACY, SAFETY, AND PHARMACOKINETICS OF ANTI-CD40 ANTIBODY ABIPRUBART (KPL-404) IN PATIENTS WITH RHEUMATOID ARTHRITIS: A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED 12-WEEK-TREATMENT PROOF-OF-CONCEPT STUDY (C9) - Mar 29, 2024 - Abstract #EULAR2024EULAR_903;
Sustained treatment with abiprubart was well tolerated, with a PK profile that supports practical chronic SC dosing. A fourth cohort, administering a 600mg loading dose followed by fixed doses of 400 mg SC q4wk or placebo for 12 weeks is ongoing.
- || abiprubart (KPL-404) / Kiniksa
Trial completion date, Trial primary completion date: Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Participants With Rheumatoid Arthritis With Inadequate Response or Intolerance to at Least One Biologic Disease-modifying Anti-rheumatic Drug or a Janus Kinase Inhibitor (clinicaltrials.gov) - Jan 1, 2024
P2, N=131, Active, not recruiting, Sponsor: Kiniksa Pharmaceuticals, Ltd.
- || abiprubart (KPL-404) / Kiniksa
Enrollment closed: Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Participants With Rheumatoid Arthritis With Inadequate Response or Intolerance to at Least One Biologic Disease-modifying Anti-rheumatic Drug or a Janus Kinase Inhibitor (clinicaltrials.gov) - Nov 27, 2023
P2, N=131, Active, not recruiting, Sponsor: Kiniksa Pharmaceuticals, Ltd.
A fourth cohort, administering a 600mg loading dose followed by fixed doses of 400 mg SC q4wk or placebo for 12 weeks is ongoing. Recruiting --> Active, not recruiting
- || KPL-404 / Kiniksa
Clinical, P1 data, Journal: First-in-Human Phase 1 Randomized Trial with the Anti-CD40 Monoclonal Antibody KPL-404: Safety, Tolerability, Receptor Occupancy, and Suppression of T-Cell-Dependent Antibody Response. (Pubmed Central) - Nov 17, 2023
P1
The pharmacokinetic profile, duration of full CD40 receptor occupancy, and magnitude and duration of memory immune response suppression observed confirms pharmacodynamic activity regardless of administration route. These data provide evidence that chronic KPL- dosing regimens (intravenous or subcutaneous) could be practical.
- ||| abiprubart (KPL-404) / Kiniksa
Enrollment change, Trial completion date, Trial primary completion date: Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Participants With Rheumatoid Arthritis With Inadequate Response or Intolerance to at Least One Biologic Disease-modifying Anti-rheumatic Drug or a Janus Kinase Inhibitor (clinicaltrials.gov) - Sep 22, 2023
P2, N=131, Recruiting, Sponsor: Kiniksa Pharmaceuticals, Ltd.
These data provide evidence that chronic KPL- dosing regimens (intravenous or subcutaneous) could be practical. N=91 --> 131 | Trial completion date: Mar 2024 --> Jun 2024 | Trial primary completion date: Dec 2023 --> Mar 2024
- KPL-404 / Kiniksa, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Immune Monitoring of The First Cardiac Xenotransplant From Genetically engineered pig to a Human (Indigo H) - Aug 9, 2023 - Abstract #IPITAIXACTRMS2023IPITA_IXA_CTRMS_521;
Induction included ATG (after xTX), Rituxan (one dose only), C1 esterase, and costimulation blockade with humanized anti-CD40 (KPL404) antibody. Our study demonstrates that immune monitoring accurately reflects the immune response status of the recipient after cardiac xTX and continuous monitoring will aid in the early detection of rejection even and allow effective intervention.
- KPL-404 / Kiniksa
Dose-dependent Suppression of T Cell-Dependent Antibody Response in Healthy Volunteers by KPL-404, an Anti-CD40 Monoclonal Antibody, Supports Phase 2 Study in Patients with Rheumatoid Arthritis (Virtual Poster Hall) - Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_1585;
KPL-404 demonstrated prolonged absorption/excretion capable of suppressing TDAR for extended periods allowing for use of extended dosing intervals irrespective of IV or SC dosing. These analyses supported the design of the ongoing Phase 2 study assessing the efficacy and safety KPL-404 in RA.Figure 1.
- KPL-404 / Kiniksa
DOSE-DEPENDENT SUPPRESSION OF T CELL-DEPENDENT ANTIBODY RESPONSE IN HEALTHY VOLUNTEERS BY KPL-404, AN ANTI-CD40 MONOCLONAL ANTIBODY, SUPPORTS CHRONIC DOSING STUDY IN PATIENTS WITH RHEUMATOID ARTHRITIS () - May 24, 2022 - Abstract #EULAR2022EULAR_3343;
KPL-404 demonstrated prolonged absorption/excretion capable of suppressing TDAR for extended periods allowing for use of extended dosing intervals irrespective of IV or SC dosing. These analyses supported the design of the ongoing Phase 2 study assessing the efficacy and safety KPL-404 in RA.
- KPL-404 / Kiniksa
SAFETY, TOLERABILITY, PHARMACOKINETICS, RECEPTOR OCCUPANCY, AND SUPPRESSION OF T-CELL-DEPENDENT ANTIBODY RESPONSE IN A PHASE 1 STUDY WITH KPL-404, AN ANTI-CD40 MONOCLONAL ANTIBODY () - May 24, 2022 - Abstract #EULAR2022EULAR_3322;
The safety and tolerability data and the PK/PD profile of KPL-404 support further investigation of KPL-404 in a broad range of autoimmune diseases, including rheumatoid arthritis. These data support the optionality for studying chronic KPL-404 dosing in patients with subcutaneous and/or intravenous administration.
- | KPL-404 / Kiniksa
Preclinical, Journal: Preclinical immunopharmacologic assessment of KPL-404, a novel, humanized, non-depleting antagonistic anti-CD40 monoclonal antibody. (Pubmed Central) - Apr 28, 2022
In vitro and in vivo findings characterize KPL-404 as a blocking anti-CD40 antibody that potently inhibits primary and secondary antibody responses at pharmacologically relevant concentrations with a favorable pharmacokinetic profile and did not deplete B-cells by antibody dependent cellular cytotoxicity or apoptosis ("non-depleting"). These findings support clinical development of KPL-404 as a potential therapeutic in autoimmune diseases.
- |||| abiprubart (KPL-404) / Kiniksa
New P2 trial: Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Participants With Rheumatoid Arthritis With Inadequate Response or Intolerance to at Least One Biologic Disease-modifying Anti-rheumatic Drug or a Janus Kinase Inhibitor (clinicaltrials.gov) - Jan 20, 2022
P2, N=84, Recruiting, Sponsor: Kiniksa Pharmaceuticals, Ltd.
- ||||| KPL-404 / Kiniksa
P1 data: My guess: KPL-404 “Monoclonal antibody inhibitor of CD40 signaling. KPL-404 is designed to inhibit CD40-CD40L interaction, a key T-cell costimulatory pathway critical for B-cell maturation and immunoglobulin class switching.” It’s in phase 1. (Twitter) - Jan 10, 2022
- KPL-404 / Kiniksa
[VIRTUAL] Safety, Tolerability, Pharmacokinetics, Receptor Occupancy, and Suppression of T-cell-Dependent Antibody Response in a Phase 1 Study with KPL-404, an anti-CD40 Monoclonal Antibody () - Sep 21, 2021 - Abstract #ACRCONVERGENCE2021ACR_CONVERGENCE_1898;
These data support the optionality for studying chronic KPL-404 dosing in patients with subcutaneous and/or intravenous administration. Figure 1.
- || KPL-404 / Kiniksa
Clinical, Journal, IO biomarker: Anti-CD40 antibody KPL-404 inhibits T cell-mediated activation of B cells from healthy donors and autoimmune patients. (Pubmed Central) - Jun 22, 2021
KPL-404 inhibited CD40L-CD40-mediated B cell activation in PBMC cultures from both healthy controls and autoimmune patients. These data support the therapeutic potential of CD40 targeting by KPL-404 Ab for inhibiting B cell responses in SjS and SLE.
- ||| abiprubart (KPL-404) / Kiniksa
Trial completion: Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of KPL-404 in Healthy Subjects (clinicaltrials.gov) - May 3, 2021
P1, N=52, Completed, Sponsor: Kiniksa Pharmaceuticals, Ltd.
These data support the therapeutic potential of CD40 targeting by KPL-404 Ab for inhibiting B cell responses in SjS and SLE. Active, not recruiting --> Completed
- || abiprubart (KPL-404) / Kiniksa
Enrollment closed, Trial completion date, Trial primary completion date: Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of KPL-404 in Healthy Subjects (clinicaltrials.gov) - Feb 3, 2021
P1, N=52, Active, not recruiting, Sponsor: Kiniksa Pharmaceuticals, Ltd.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial completion date: Dec 2020 --> Mar 2021 | Trial primary completion date: Dec 2020 --> Mar 2021
- ||| abiprubart (KPL-404) / Kiniksa
Enrollment open: Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of KPL-404 in Healthy Subjects (clinicaltrials.gov) - Sep 14, 2020
P1, N=60, Recruiting, Sponsor: Kiniksa Pharmaceuticals, Ltd.
Recruiting --> Active, not recruiting | Trial completion date: Dec 2020 --> Mar 2021 | Trial primary completion date: Dec 2020 --> Mar 2021 Active, not recruiting --> Recruiting
- ||| abiprubart (KPL-404) / Kiniksa
New P1 trial: Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of KPL-404 in Healthy Subjects (clinicaltrials.gov) - Aug 6, 2020
P1, N=60, Active, not recruiting, Sponsor: Kiniksa Pharmaceuticals, Ltd.