telazorlimab (ISB 830) News

|||||||||| telazorlimab (ISB 830) / Astria Therap, rocatinlimab (KHK4083) / Amgen, amlitelimab IV (SAR445229) / Sanofi
Review, Journal, IO biomarker: OX40 in the Pathogenesis of Atopic Dermatitis-A New Therapeutic Target. (Pubmed Central) - May 5, 2024
As the OX40 pathway is critical for expansion, differentiation, and survival of effector and memory T cells, its targeting might be a promising therapeutic approach to provide sustained inhibition of pathogenic T cells and associated inflammation and broad disease control. Antibodies against OX40 [rocatinlimab (AMG 451/KHK4083) and telazorlimab (GBR 830)] or OX40L [amlitelimab (KY1005)] have shown promising results in early-phase clinical studies of moderate-to-severe AD, highlighting the importance of OX40 signaling as a new therapeutic target in AD.

|||||||||| STAR-0310 / Astria Therap
Development and characterization of STAR-0310: a novel OX40 antagonistic monoclonal antibody (Poster Zone) - Apr 21, 2024 - Abstract #EAACI2024EAACI_2143;
Conclusion STAR-0310, an anti-OX40 antibody, demonstrates the potential for increased half-life, high-potency T cell inhibition, and reduced toxicities with minimized effector (ADCC) functions. These promising preclinical findings support the potential use of STAR-0310 in moderate-to-severe AD and other immunologic diseases.

|||||||||| Review, Journal: An overview of new and emerging antibody therapies for moderate-severe atopic dermatitis in adults. (Pubmed Central) - Dec 6, 2023
Some monoclonal antibodies, such as dupilumab (anti-IL-4?R?) and tralokinumab (anti-IL13) are already approved for the treatment of moderate-to-severe atopic dermatitis, and numerous articles in the literature have demonstrated their efficacy and safety...Data from phase 2b and phase III clinical trials in moderate-to-severe atopic dermatitis in adults indicate that these drugs have a promising efficacy and safety profile. Monoclonal antibodies currently under investigation will be available in the coming years to enrich the therapeutic choice of new alternatives that are valid both in terms of efficacy and safety.

|||||||||| telazorlimab (ISB 830) / Glenmark, IMG-007 / Inmagene
Mitigation and evaluation of agonistic risk of an OX40 antagonistic mab () - Jul 3, 2023 - Abstract #WCD2023WCD_6214;
Our data reported that IMG-007 which possessed excellent binding affinity significantly reduced the agonistic risk of pharmacologically targeting OX40. This study provides a strategy to mitigate agonistic risk of antagonistic anti-OX40 antibody through Fc engineering

||||||||||  telazorlimab (ISB 830) / Glenmark
Trial completion:  OXFORAD TM: Phase 2b Study to Evaluate the Efficacy and Safety of ISB 830 in Adults With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) -  Jun 28, 2022
P2b, N=462, Completed,  Sponsor: Ichnos Sciences SA
This study provides a strategy to mitigate agonistic risk of antagonistic anti-OX40 antibody through Fc engineering Active, not recruiting --> Completed

|||||||||| Dupixent (dupilumab) / Sanofi, Regeneron
Journal: A mathematical model to identify optimal combinations of drug targets for dupilumab poor responders in atopic dermatitis. (Pubmed Central) - Apr 9, 2022
Our model identified IL-13 as a potential predictive biomarker to stratify dupilumab good responders, and simultaneous inhibition of IL-13 and IL-22 as a promising drug therapy for dupilumab poor responders. This model will serve as a computational platform for model-informed drug development for precision medicine, as it allows evaluation of the effects of new potential drug targets and the mechanisms behind patient variability in drug response.

|||||||||| Clinical, P2 data, P3 data, Review, Journal: Review and analysis of biologic therapies currently in phase II and phase III clinical trials for atopic dermatitis. (Pubmed Central) - Apr 8, 2022
Further assessment of tezepelumab and etokimab are needed to assess their safety and efficacy in patients with moderate-to-severe AD. Tralokinumab, lebrikizumab, fezakinumab, nemolizumab, and GBR 830 are effective treatment options for adults with moderate-to-severe AD, but further large-scale studies are needed to confirm their efficacy as monotherapy in children with moderate-to-severe AD.

|||||||||| Xolair (omalizumab) / Roche, Novartis
Review, Journal: Novel Targeted Biological Agents for the Treatment of Atopic Dermatitis. (Pubmed Central) - Jul 28, 2021
Phase II trials of GBR 830 and KHK 4083 are ongoing. In general, further studies are needed to explore new therapeutic targets and improve the efficacy of biological agents.

|||||||||| Dupixent (dupilumab) / Sanofi, Regeneron
[VIRTUAL] A computational model suggested potential therapies for dupilumab poor responders in atopic dermatitis () - Jul 8, 2021 - Abstract #ESDR2021ESDR_132;
The model will serve as a computational platform for model-informed drug development for precision medicine, as it allows to evaluate the validity of potential drug targets, including combinations of multiple targets, in stratified patients. Similar mathematical models and simulation can be also applicable for other diseases and therapies when there are reported clinical efficacies of multiple drugs.

|||||||||| Journal: Biologics for Treatment of Atopic Dermatitis: Current Status and Future Prospect. (Pubmed Central) - May 25, 2021
Dupilumab is the only biologic therapy that is Food and Drug Administration approved for the treatment of moderate-to-severe AD in patients 6 years and older, with consistent long-term efficacy and safety trial data. In this article, we review the mechanisms, safety, and efficacy of dupilumab from recent clinical trials, and we review the current data, mechanism of action, clinical efficacy, and limitations of new biologics currently in phase 2 and 3 clinical trials (lebrikizumab, tralokinumab, nemolizumab, tezepelumab, and ISB 830).

|||||||||| A COMPUTATIONAL MODEL TO INVESTIGATE DRUG TARGETS IN AD PATIENTS WITH HETEROGENOUS RESPONSE TO BIOLOGIC DRUGS () - Apr 23, 2021 - Abstract #ISAD2021ISAD_148;
The mathematical model will serve as a computational platform for model-informed drug development for precision medicine, as it allows us to evaluate the validity of potential drug targets, including combinations of multiple targets, in stratified patients as well as the influence of pathophysiological backgrounds of patients on variability in drug response. Similar mathematical models can be developed for other diseases and drugs by conducting model-based meta-analysis on reported clinical efficacies of multiple drugs.

|||||||||| telazorlimab (ISB 830) / Ichnos Sciences
[VIRTUAL] Telazorlimab in atopic dermatitis: Phase 2b study shows improvement at 16 weeks () - Feb 12, 2021 - Abstract #SID2021SID_472;
In conclusion, telazorlimab improved clinical signs and symptoms of moderate-to-severe AD, with a favorable safety and tolerability profile. Further evaluation of telazorlimab in the treatment of autoimmune disease is warranted.

||||||||||  telazorlimab (ISB 830) / Glenmark
Enrollment closed:  OXFORAD TM: Phase 2b Study to Evaluate the Efficacy and Safety of ISB 830 in Adults With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) -  Jul 13, 2020
P2b, N=468, Active, not recruiting,  Sponsor: Ichnos Sciences SA
Further evaluation of telazorlimab in the treatment of autoimmune disease is warranted. Recruiting --> Active, not recruiting

|||||||||| ISB 830 / Ichnos Sciences
Biomarker, Clinical, Journal, Gene Signature, IO Biomarker: GBR 830, an anti-OX40, improves skin gene-signatures and clinical scores in atopic dermatitis. (Pubmed Central) - May 21, 2020
Recruiting --> Active, not recruiting Two doses of GBR 830, 4-weeks apart, were well-tolerated and induced significant, progressive tissue and clinical changes until Day 71 (42 days after last dose), highlighting the potential of OX40-targeting in AD.

|||||||||| ISB 830 / Ichnos Sciences
Why not give a trial to OX40 antagonist (GBR 830) to contain the cytokine storm? https://t.co/1nGrWB8fFD https://t.co/ipkUcTCPqc (Twitter) - Apr 2, 2020

|||||||||| ISB 830 / Ichnos Sciences
[VIRTUAL] OX40L EXPRESSING NEUTROPHILS INDUCE CD4 T FOLLICULAR AND PERIPHERAL HELPER CELL DIFFERENTIATION IN SYSTEMIC LUPUS ERYTHEMATOSUS (Poster Tour) - Mar 4, 2020 - Abstract #EULAR2020EULAR_831;
Our results disclose an unprecedented phenomenon where cross-talk between TLR7/8-activated neutrophils and CD4 lymphocytes operates through OX40L-OX40 costimulation, and neutrophils promote the differentiation of pro-inflammatory Tfh and Tph, as well as IL21 production. Therefore, OX40L/OX40 should be considered as a potentially therapeutic axis in SLE patients.

||||||||||  telazorlimab (ISB 830) / Glenmark
Trial completion date, Trial primary completion date:  OXFORAD TM: Phase 2b Study to Evaluate the Efficacy and Safety of ISB 830 in Adults With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) -  Jan 7, 2020
P2b, N=468, Recruiting,  Sponsor: Ichnos Sciences SA
Therefore, OX40L/OX40 should be considered as a potentially therapeutic axis in SLE patients. Trial completion date: Apr 2020 --> Aug 2021 | Trial primary completion date: Apr 2020 --> Sep 2020

|||||||||| Review, Journal: What's New in Atopic Dermatitis. (Pubmed Central) - Jul 4, 2019
Nevertheless, because not all patients respond to dupilumab and AD has a heterogeneous phenotype, more treatment options are much needed. This article reviews recent and exciting developments in AD, because ongoing or pipeline clinical trials for AD will ultimately expand and redefine a novel treatment paradigm for this common disease.

||||||||||  telazorlimab (ISB 830) / Glenmark
New P2b trial:  OXFORAD TM: Phase 2b Study to Evaluate the Efficacy and Safety of ISB 830 in Adults With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) -  Jun 26, 2018
P2b, N=392, Recruiting,  Sponsor: Glenmark Pharmaceuticals S.A.

||||||||||  telazorlimab (ISB 830) / Glenmark
Trial completion:  To Assess the Safety and Activity of GBR 830, Compared to Placebo, in Adults With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) -  Aug 7, 2017
P2a, N=64, Completed,  Sponsor: Glenmark Pharmaceuticals S.A.
This article reviews recent and exciting developments in AD, because ongoing or pipeline clinical trials for AD will ultimately expand and redefine a novel treatment paradigm for this common disease. Recruiting --> Completed

||||||||||  telazorlimab (ISB 830) / Glenmark
Trial primary completion date:  To Assess the Safety and Activity of GBR 830, Compared to Placebo, in Adults With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) -  Feb 24, 2017
P2a, N=60, Recruiting,  Sponsor: Glenmark Pharmaceuticals S.A.
Recruiting --> Completed Trial primary completion date: Sep 2017 --> May 2017

||||||||||  telazorlimab (ISB 830) / Glenmark
Enrollment change, Trial primary completion date:  To Assess the Safety and Activity of GBR 830, Compared to Placebo, in Adults With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) -  Jan 24, 2017
P2a, N=60, Recruiting,  Sponsor: Glenmark Pharmaceuticals S.A.
Trial primary completion date: Sep 2017 --> May 2017 N=40 --> 60 | Trial primary completion date: Jan 2017 --> Sep 2017

||||||||||  telazorlimab (ISB 830) / Glenmark
Enrollment open:  To Assess the Safety and Activity of GBR 830, Compared to Placebo, in Adults With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) -  May 10, 2016
P2a, N=40, Recruiting,  Sponsor: Glenmark Pharmaceuticals S.A.
N=40 --> 60 | Trial primary completion date: Jan 2017 --> Sep 2017 Not yet recruiting --> Recruiting

||||||||||  telazorlimab (ISB 830) / Glenmark
New P2a trial:  To Assess the Safety and Activity of GBR 830, Compared to Placebo, in Adults With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) -  Feb 17, 2016
P2a, N=40, Not yet recruiting,  Sponsor: Glenmark Pharmaceuticals S.A.



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