Phase 2b, randomized, double-blinded, placebo-controlled dose range finding study to evaluate the efficacy, safety and tolerability of ISB 830 in adults with moderate to severe atopic dermatitis. The study will be conducted in 2 Parts, with dosing Groups 1-4 comprising Part 1, and dosing Groups 5-6 comprising Part 2. All subjects will receive open-label ISB 830 after a 16 week blinded treatment period.

Start Date31 May 2018

Sponsor / Collaborator

Ichnos Sciences, Inc.Startup

[+1]

NL-OMON44196 / CompletedNot Applicable

A randomized, 2-part, placebo controlled phase 1 study to evaluate safety, tolerability, pharmacokinetics and immunogenicity following single ascending doses (Part 1) and multiple ascending doses (Part 2) of GBR 830 in adult healthy subjects - GBR 830 SAD and MAD study

Start Date05 Jul 2017

Sponsor / Collaborator

Glenmark Pharmaceuticals SA

NL-OMON42954 / CompletedNot Applicable

An open-label, single-dose, parallel-arm study to evaluate the pharmacokinetics and absolute bioavailability of GBR 830 following single dose administration by the subcutaneous (SC) route - GBR 830 pharmacokinetics, absolute bioavailability and safety study

Start Date09 Jan 2017

Sponsor / Collaborator

Glenmark Pharmaceuticals SA

100 Clinical Results associated with Telazorlimab

100 Translational Medicine associated with Telazorlimab

100 Patents (Medical) associated with Telazorlimab

Literatures (Medical) associated with Telazorlimab

01 Feb 2024·The journal of allergy and clinical immunology. Global

Phase 2b randomized trial of OX40 inhibitor telazorlimab for moderate-to-severe atopic dermatitis

Article

Author: Mozaffarian, Neelufar ; Anstett, Victor ; Sher, Lawrence D ; Pulka, Grazyna ; Rewerska, Barbara ; Jabert, Wafaa ; Martinet, Camille ; Blein, Stanislas ; Turrini, Riccardo ; Alpizar, Sady ; Macoin, Julie ; Ca, Vinu ; Doucey, Marie-Agnès ; Pauser, Sylvia ; Machkova, Martina ; Gn, Sunitha ; Konto, Cyril ; Salhi, Yacine ; Gudi, Girish

Background:

Telazorlimab is a humanized anti-OX40 monoclonal antibody being studied for treatment of T-cell-mediated diseases.

Objective:

This randomized, placebo-controlled, phase 2b dose-range finding study investigated efficacy, safety, pharmacokinetics, and immunogenicity of telazorlimab in subjects with atopic dermatitis.

Methods:

In this 2-part study (NCT03568162), adults (≥18 years) with moderate-to-severe disease were randomized to various regimens of subcutaneous telazorlimab or placebo for 16 weeks' blinded treatment, followed by 38 weeks' open-label treatment and 12 weeks' drug-free follow-up. Telazorlimab treatment groups (following a loading dose) in part 1 were 300 mg every 2 weeks; 300 mg every 4 weeks; or 75 mg every 4 weeks. Part 2 evaluated telazorlimab 600 mg every 2 weeks. The primary end point was percentage change from baseline in Eczema Area and Severity Index (EASI) at week 16. Safety assessments included incidence of treatment-emergent adverse events.

Results:

The study randomized 313 subjects in part 1 and 149 in part 2. At 16 weeks, the least squares mean percentage change from baseline in EASI was significantly greater in subjects receiving telazorlimab 300 mg every 2 weeks (part 1) and 600 mg every 2 weeks (part 2) versus placebo (-54.4% vs -34.2% for part 1 and -59.0% vs -41.8% for part 2, P = .008 for both). Telazorlimab was well tolerated, with similar distribution of adverse events between telazorlimab- and placebo-treated subjects in both part 1 and part 2.

Conclusion:

Telazorlimab, administered subcutaneously at 300 mg every 2 weeks or 600 mg every 2 weeks following a loading dose, was well tolerated and induced significant and progressive clinical improvement in adults with moderate-to-severe atopic dermatitis.

17 Feb 2022·The Journal of dermatological treatmentQ4 · MEDICINE

Review and analysis of biologic therapies currently in phase II and phase III clinical trials for atopic dermatitis

Q4 · MEDICINE

Review

Author: Uppal, Shelley K. ; Wu, Jashin J. ; Han, George ; Chat, Vipawee S. ; Kearns, Donovan G.

Biologic medications are recent advances that have clinical significance in the treatment of moderate-to-severe AD. A systemic literature review was performed to examine the efficacy and safety of biologic therapies currently in phase II and phase III of clinical trials for moderate-to-severe AD. Our team searched the databases, PubMed, Google Scholar, and ClinicalTrials.gov, on September 2019 for studies pertaining to the use of biologic drugs in AD. Key words included each drug (lebrikizumab, tralokinumab, fezakinumab, etokimab, nemolizumab, tezepelumab, and GBR 830) or 'biologic drugs' or 'immunotherapies' combined with 'atopic dermatitis.' References within retrieved articles were also reviewed to identify potentially missed studies. A total of 19 articles were included in this review. Lebrikizumab, tralokinumab, fezakinumab, nemolizumab, and GBR 830 lead to statistically significant improvements in disease severity and multiple endpoint outcome scores. Tezepelumab and etokimab, however, did not demonstrate statistically significant changes in primary outcome endpoints. 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.

01 Feb 2022·AllergyQ1 · MEDICINE

A mathematical model to identify optimal combinations of drug targets for dupilumab poor responders in atopic dermatitis

Q1 · MEDICINE

Article

Author: Irvine, Alan D. ; Tanaka, Reiko J. ; Miyano, Takuya

Abstract:

Background:

Several biologics for atopic dermatitis (AD) have demonstrated good efficacy in clinical trials, but with a substantial proportion of patients being identified as poor responders. This study aims to understand the pathophysiological backgrounds of patient variability in drug response, especially for dupilumab, and to identify promising drug targets in dupilumab poor responders.

Methods:

We conducted model‐based meta‐analysis of recent clinical trials of AD biologics and developed a mathematical model that reproduces reported clinical efficacies for nine biological drugs (dupilumab, lebrikizumab, tralokinumab, secukinumab, fezakinumab, nemolizumab, tezepelumab, GBR 830, and recombinant interferon‐gamma) by describing system‐level AD pathogenesis. Using this model, we simulated the clinical efficacy of hypothetical therapies on virtual patients.

Results:

Our model reproduced reported time courses of %improved EASI and EASI‐75 of the nine drugs. The global sensitivity analysis and model simulation indicated the baseline level of IL‐13 could stratify dupilumab good responders. Model simulation on the efficacies of hypothetical therapies revealed that simultaneous inhibition of IL‐13 and IL‐22 was effective, whereas application of the nine biologic drugs was ineffective, for dupilumab poor responders (EASI‐75 at 24 weeks: 21.6% vs. max. 1.9%).

Conclusion:

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.

News (Medical) associated with Telazorlimab

11 Mar 2024

·www.pharmaceutical-technology.com

Sanofi’s amlitelimab shows best-in-class response in atopic dermatitis

Sanofi’s investigational drug amlitelimab is forecast to generate $581m in sales by 2030, as per GlobalData analysis. Credit: Golden Shrimp via Shutterstock. Sanofi has announced encouraging findings from the second part of a study with the OX40 antibody amlitelimab, which showed sustained improvement in treating moderate to severe atopic dermatitis symptoms in previously treated patients. In the second part of the STREAM-AD study, patients initially responding to amlitelimab were re-randomised to either continue treatment or withdraw over 28 weeks. Those continuing treatment maintained high responder rates for Eczema Area and Severity Index (EASI-75) and/or Investigator Global Assessment (IGA 0/1), as did those withdrawn from treatment – 69.2% of patients continued IGA 0/1 and/or EASI-75 response compared to 58.8% in those who had withdrawn. A pooled analysis showed that those who continued treatment maintained an IGA 0/1 response in 71.9% compared to 57% in the treatment-withdrawn group, with EASI-75 response maintained in 69% compared to 61.6% of patients, respectively. Atopic dermatitis-related biomarkers remained reduced at week 52 in both groups, highlighting durable control of the condition post-amlitelimab withdrawal. Results from this part of the study indicate amlitelimab’s potential for durable off-drug efficacy, which means less frequent dosing every 12 weeks could be evaluated, explained chair of the department of dermatology and allergy at the University Hospital Schleswig-Holstein Stephan Weidinger, in the 11 March press release. The 12-week dosing schedule of amlitelimab 250mg with a 500mg loading dose is now being investigated in a larger Phase III clinical program (OCEANA). See Also: AD/PD 2024: BioVie’s novel NE3107 shows promise but confirmatory trial needed Amlitelimab, a human anti-OX40 ligand monoclonal antibody, is under development for the treatment of atopic dermatitis, hidradenitis suppurativa, asthma, alopecia areata, celiac disease and systemic sclerosis. The antibody is forecast to generate $581m in sales by 2030, as per GlobalData analysis. GlobalData is the parent company of Clinical Trials Arena. Another OX40 inhibitor in the atopic dermatitis space is Amgen and Kyowa Kirin’s KHK4083 (rocatinlimab), with Amgen handling the development, production, and marketing for all worldwide markets, excluding Japan. KHK4083 is forecast to generate $960m in 2029, according to GlobalData. In October 2023, Astria Therapeutics signed an exclusive global agreemen t to license Ichnos Sciences’ OX40 portfolio to treat atopic dermatitis in a $305m deal, paying $15m upfront. The portfolio includes monoclonal antibody OX40 antagonists STAR-0310 and telazorlimab. Atopic dermatitis is a long-term chronic form of eczema commonly seen in people with sensitive skin and a malfunctioning immune system. In the announcement accompanying the data, the head of global development, immunology and inflammation at Sanofi, Naimish Patel said: “It’s unprecedented to see this type of durability of clinical response, which we believe could be very meaningful to patients and is the reason why we selected an every 12-week dosing regimen in the AD pivotal programme.”

Phase 3Clinical ResultLicense out/in

12 Oct 2023

·www.fiercebiotech.com

Astria scratches dealmaking itch, paying Ichnos $15M to join eczema race led by Amgen, Sanofi

Astria Therapeutics is years behind the front-runners in the eczema race. Ichnos Sciences has finally found a buyer for its OX40 eczema program. Astria Therapeutics has taken the other side of the deal, paying $15 million upfront to secure a spot at the back of a race led by Amgen and Sanofi. New Jersey-based Ichnos has been talking about partnering its OX40 work for almost as long as it has existed, having made the program available (PDF) for out-licensing the year after it spun out of Glenmark in 2019. Over the years it has sought a partner, Ichnos has seen Sanofi acquire an OX40 candidate in its $1.1 billion takeover of Kymab and Amgen pay Kyowa Kirin $400 million upfront to enter the space. Now, Ichnos has landed a deal—but failed to command the sort of prices paid by those Big Pharmas. The structure of the agreement, which is worth $15 million upfront, $20 million in clinical milestones and $285 million in regulatory and commercial paydays, reflects Astria’s preferred asset. While Ichnos wrapped up a phase 2 trial of its lead OX40-targeting candidate telazorlimab in 2021, that candidate barely gets a mention in Astria’s statement to disclose the deal. Astria is licensing the full OX40 portfolio, but its focus is on STAR-0310, a preclinical program that is forecast to enter human testing early in 2025. The timeline puts Astria years behind the front-runners. Amgen has started seven phase 3 clinical trials of its candidate, rocatinlimab, over the past 16 months, while Sanofi top-lined positive phase 2b data in June. In contrast, the first clinical data on STAR-0310 in healthy volunteers aren't expected until the third quarter of 2025, by which time Amgen could have phase 3 data on rocatinlimab. Astria’s decision to focus on a preclinical program, rather than push telazorlimab into late-phase studies, could give it a differentiated candidate. The biotech sees STAR-0310 as a best-in-class prospect, pointing to its use of half-life extension technology, which could reduce dosing frequency, and early evidence of affinity, safety and tolerability to make its case.

Phase 2AcquisitionLicense out/inPhase 3

11 Oct 2023

·www.biospace.com

ICHNOS SCIENCES ENTERS LICENSING AGREEMENT FOR OX40 ANTAGONIST MONOCLONAL ANTIBODY PORTFOLIO WITH ASTRIA THERAPEUTICS

[11-October-2023] Astria Therapeutics is granted global rights to develop and commercialize OX40 portfolio, comprised of Telazorlimab and its follow-on molecules, for use in inflammatory and immune diseases. NEW YORK, Oct. 11, 2023 /PRNewswire/ -- Ichnos Sciences, a global clinical-stage biotechnology company developing innovative multispecific antibodies for oncology, today announced that the company has entered into an exclusive worldwide licensing agreement for its OX40 antagonist monoclonal antibody portfolio with Astria Therapeutics, a biopharmaceutical company developing therapies for rare allergic and immunological diseases. With the execution of this agreement, Ichnos has successfully licensed its two assets for inflammatory and immunological diseases, a key milestone in the company's prioritization of its pipeline of oncology drug candidates. Within the terms of the agreement, Astria will assume full cost and responsibility for the global development and commercialization of the licensed therapeutic program for all indications. In exchange, Ichnos will receive up to $320 million in upfront, development, regulatory and sales milestone payments in addition to up to low double-digit royalties. Ichnos has also agreed to allow Astria to draw down on its existing investigational drug substance and drug product stocks at normalized costs to facilitate development. Telazorlimab is a novel, humanized IgG1 monoclonal antibody that targets OX40 on T cells responsible for inflammation and immunity diseases. Excessive OX40 signaling, expressed on activated T cells, is the feature of several inflammatory diseases, including atopic dermatitis (AD). Astria plans to develop an affinity-matured version of telazorlimab and apply YTE half-life extension technology to create a product that aims to address the need for a safe, effective, and infrequently administered AD treatment. "As Ichnos continues to grow as a biotechnology company, this agreement enables our team to focus on advancing our robust pipeline of clinical-stage multispecific antibodies in oncology generated by our proprietary BEAT® platform1, as well as continue the discovery and development of our NK-cell engaging programs for solid tumors," said Cyril Konto, M.D., President and CEO of Ichnos. "I am proud of the work achieved by the Ichnos team in successfully completing the Phase 2b with telazorlimab in atopic dermatitis and potentially opening up a new therapeutic class for this disease. Ichnos is confident in Astria Therapeutics' capabilities and vision for pursuing the development of its OX40 program and delivering a potentially life-changing treatment to patients with inflammatory and immune diseases." "We are looking forward to building on the foundational work that Ichnos has done with their OX40 portfolio," said Jill Milne, Ph.D., co-founder and CEO of Astria Therapeutics. "We believe that by using Ichnos' affinity-matured next generation monoclonal antibody OX40 antagonist and applying YTE half-life extension technology, we have the potential to deliver a best-in-class pro atopic dermatitis patients; one that we think can be safe, effective, and long-acting. In addition to OX40 antagonism already being a clinically validated mechanism in atopic dermatitis, we also are excited about the opportunity for potential expansion into additional indications." About Ichnos Sciences Inc. A fully integrated, global biotech with the spirit of a start-up, Ichnos is shifting the way the world thinks about innovation in medicine through its research and development of transformative, disease-centric treatments in oncology. The company, with headquarters in New York, N.Y., is rapidly advancing a clinical-stage pipeline of novel, first-in-class candidates designed to address complex diseases and to treat patients holistically. With its patented BEAT® technology platform and pioneering teams, Ichnos Sciences has a mission to provide breakthrough, curative therapies that will extend and improve lives, writing a new chapter in healthcare. For more information, visit Ichnos.com. CONTACT Hill+Knowlton Strategies HKIchnos@hkstrategies.com 1 BEAT®: Bispecific Engagement by Antibodies based on the TCR

License out/inPhase 2Immunotherapy

100 Deals associated with Telazorlimab

External Link

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dermatitis, Atopic	Phase 2	US	Ichnos Sciences, Inc.Startup	01 Mar 2016
Dermatitis, Atopic	Phase 2	CA	Ichnos Sciences, Inc.Startup	01 Mar 2016
Autoimmune Diseases	Phase 1	NL	Glenmark Pharmaceuticals SA	20 Aug 2014
Rheumatoid Arthritis	Preclinical	US	Ichnos Sciences, Inc.Startup	24 Jan 2021
Systemic Lupus Erythematosus	Preclinical	CH	Ichnos Sciences, Inc.Startup	15 Oct 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03568162 (CTgov)	Phase 2	Dermatitis, Atopic	462	ISB (ISB 830 300 mg q2w)	uobegztklt(xkxoarcfls) = qiajuzfuaq dmiabbzlvn (yyidqwtsot, masoimqrbr - tumhdwpims) View more	-	28 Jun 2022
				ISB (ISB 830 300 mg q4w)	uobegztklt(xkxoarcfls) = mtssofvnmm dmiabbzlvn (yyidqwtsot, oclqrmnmgq - rincknfabp) View more
NCT02683928 (CTgov)	Phase 2	Dermatitis, Atopic	64	GBR 830 (GBR 830)	yvisrocryh(sthteefhen) = exzlwjgulo rqxptyiesq (vnfjivqcyt, aumvofuzqh - pihvwpzsjy) View more	-	18 May 2020
				Placebo (Placebo)	yvisrocryh(sthteefhen) = ezhgbcmnbd rqxptyiesq (vnfjivqcyt, aeghkhkhth - bwzagkvqnk) View more
NCT02683928 (Pubmed) Manual	Phase 2	Dermatitis, Atopic	62	GBR 830	dfgojmwbxa(kjfzkdjaeh) = bdtoqxtgcp kjdixdvdzj (txuyyvqimg ) View more	Positive	01 Aug 2019
				Placebo	dfgojmwbxa(kjfzkdjaeh) = wzskrhspac kjdixdvdzj (txuyyvqimg ) View more

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