- |||||||||| Breztri Aerosphere (budesonide/formoterol fumarate/glycopyrronium) / AstraZeneca, FR104 / OSE Immunotherapeutics, Asahi Kasei
Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Fixed-Dose, Subcutaneous (SQ) Administration of VEL-101, an Anti-CD28 Pegylated Monoclonal Antibody Fragment, in Healthy Participants (107-AB, Level 1) - May 6, 2024 - Abstract #ATC2024ATC_2651;
P1
*Purpose: VEL-101, also known as FR104, is a monovalent, humanized anti-CD28 PEGylated monoclonal antibody fragment that selectively blocks CD28 co-stimulation, while sparing CTLA-4 inhibition... IP administration was generally well tolerated, and SQ administration of VEL-101 resulted in serum concentrations yielding detectable CD28 RO at levels compatible for future study in kidney transplant recipients.
- |||||||||| TNX-1500 / Tonix, Massachusetts General Hospital, FR104 / OSE Immunotherapeutics, Asahi Kasei, Antova (ruplizumab) / Biogen
Combined Blockade of the CD154 and CD28 Co-Stimulation Pathways Attenuates Pathogenic Alloimmunity and Prolongs Survival in Cynomolgus Cardiac Allografts (109-AB, Level 1) - May 6, 2024 - Abstract #ATC2024ATC_2451;
*Purpose: TNX-1500 (TNX) is a novel humanized ?CD154 mAb that contains the hu5c8 Fab region and an IgG4 Fc region engineered to modulate Fc?R2 binding to reduce the risk of thromboembolic events seen with ruplizumab (hu5c8 IgG1) in previous clinical trials... Combined blockade of the CD154 and CD28 co-stimulation pathways is associated with durable protection from pathogenic alloimmunity in this stringent model, suggesting a promising approach for clinical translation.
- |||||||||| FR104 / OSE Immunotherapeutics, Asahi Kasei
Enrollment closed: Phase I/II Study of FR104 First Administration In Patient With Renal Transplantation: FIRsT Study (clinicaltrials.gov) - Nov 14, 2023
P1/2, N=10, Active, not recruiting,
Combined blockade of the CD154 and CD28 co-stimulation pathways is associated with durable protection from pathogenic alloimmunity in this stringent model, suggesting a promising approach for clinical translation. Recruiting --> Active, not recruiting
- |||||||||| sirolimus / generics
Journal: CD28 blockade controls T cell activation to prevent graft-versus-host disease in primates. (Pubmed Central) - Sep 28, 2019
While FR104/sirolimus had a salutary effect on GVHD-free survival, overall survival was not improved, due to death in the absence of GVHD in several FR104/sirolimus recipients in the setting of sepsis and a paralyzed INF-γ response. These results therefore suggest that effectively deploying CD28 in the clinic will require close scrutiny of both the benefits and risks of extensively abrogating conventional T cell activation after transplant.
- |||||||||| FR104 / OSE Immunotherapeutics
Journal: Preclinical Testing of Antihuman CD28 Fab' Antibody in a Novel Nonhuman Primate Small Animal Rodent Model of Xenogenic Graft-Versus-Host Disease. (Pubmed Central) - Jun 8, 2017
Our data, thus, suggest that systemic CD28 blockade e.g. with the drug FR104 might also reduce aGvHD in patients after allo-HSCT, while maintaining the protective GvL response. Because human-reactive reagents may not be fully cross-reactive or effective in vivo on NHP immune cells, this NHP xeno-GVHD model provides immunological insights and direct testing on NHP-induced GVHD before committing to the intensive NHP studies that are being increasingly used for detailed evaluation of new immune therapeutic strategies before human trials.
- |||||||||| FR104 / OSE Immunotherapeutics, Asahi Kasei
Trial completion: Safety, Tolerability, PK, PD, and Immunogenicity of Single and Multiple Ascending Intravenous Doses of FR104 (clinicaltrials.gov) - Jul 23, 2016
P1, N=64, Completed,
Because human-reactive reagents may not be fully cross-reactive or effective in vivo on NHP immune cells, this NHP xeno-GVHD model provides immunological insights and direct testing on NHP-induced GVHD before committing to the intensive NHP studies that are being increasingly used for detailed evaluation of new immune therapeutic strategies before human trials. Active, not recruiting --> Completed
- |||||||||| FR104 / OSE Immunotherapeutics, Asahi Kasei
New P1 trial: Safety, Tolerability, PK, PD, and Immunogenicity of Single and Multiple Ascending Intravenous Doses of FR104 (clinicaltrials.gov) - Jun 16, 2016
P1, N=64, Active, not recruiting,
|
