Immutep Announces First Participant Dosed in Phase I Study of IMP761, a First in Class Agonist LAG-3 Antibody
Immutep has announced the successful dosing of the first participant in the Phase I clinical trial of IMP761, a first-in-class agonist LAG-3 antibody.
This trial aims to restore immune system balance by enhancing the LAG-3 brake function to address autoimmune diseases. Conducted by the Centre for Human Drug Research (CHDR) in Leiden, Netherlands, the study plans to enroll 49 healthy volunteers. The trial will assess safety, pharmacokinetics, and pharmacodynamics of IMP761 with initial safety data expected by year-end and further data by the first half of CY2025.
Preclinical studies have shown IMP761 to significantly reduce inflammatory cytokines and suppress antigen-specific T cell–mediated immune responses. The trial targets conditions like rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis.
Immutep ha annunciato il successo della somministrazione al primo partecipante nel trial clinico di Fase I per IMP761, un anticorpo agonista LAG-3 di prima classe.
Questo trial mira a ripristinare l'equilibrio del sistema immunitario migliorando la funzione freno del LAG-3 per affrontare le malattie autoimmuni. Condotto dal Centre for Human Drug Research (CHDR) a Leiden, nei Paesi Bassi, lo studio prevede di arruolare 49 volontari sani. La sperimentazione valuterà la sicurezza, la farmacocinetica e la farmacodinamica di IMP761, con i dati iniziali sulla sicurezza attesi entro la fine dell'anno e ulteriori informazioni nella prima metà dell'anno fiscale 2025.
Studi preclinici hanno dimostrato che IMP761 riduce in modo significativo le citochine infiammatorie e sopprime le risposte immunitarie mediate da cellule T specifiche per antigeni. Il trial si concentra su condizioni come l'artrite reumatoide, il diabete di tipo 1 e la sclerosi multipla.
Immutep ha anunciado la dosificación exitosa del primer participante en el ensayo clínico de Fase I de IMP761, un anticuerpo agonista LAG-3 de primera clase.
Este ensayo tiene como objetivo restaurar el equilibrio del sistema inmunológico mejorando la función de freno del LAG-3 para abordar enfermedades autoinmunes. Realizado por el Centre for Human Drug Research (CHDR) en Leiden, Países Bajos, el estudio planea inscribir a 49 voluntarios sanos. La prueba evaluará la seguridad, la farmacocinética y la farmacodinámica de IMP761, con datos iniciales de seguridad esperados para fin de año y más información en la primera mitad del año fiscal 2025.
Los estudios preclínicos han demostrado que IMP761 reduce significativamente las citoquinas inflamatorias y suprime las respuestas inmunitarias mediadas por células T específicas para antígenos. El ensayo se centra en condiciones como la artritis reumatoide, la diabetes tipo 1 y la esclerosis múltiple.
Immutep는 IMP761, 최초의 LAG-3 항체 작용제를 대상으로 하는 제1상 임상 시험의 첫 번째 참가자에게 성공적으로 투약했다고 발표했습니다.
이 시험은 자가면역 질환을 해결하기 위해 LAG-3의 브레이크 기능을 향상시켜 면역 시스템의 균형을 회복하는 것을 목표로 하고 있습니다. 네덜란드 라이덴에 있는 인간 약물 연구 센터(CHDR)에 의해 수행되는 이 연구는 49명의 건강한 자원봉사자를 등록할 계획입니다. 이 시험은 IMP761의 안전성, 약리학적 작용 및 약동학을 평가하며, 초기 안전성 데이터는 연말까지 기대되며 추가 데이터는 2025 회계 연도 상반기까지 제공될 예정입니다.
전임상 연구에서는 IMP761이 염증성 사이토카인을 크게 감소시키고 항원 특이적 T 세포 매개 면역 반응을 억제하는 것으로 나타났습니다. 이 시험은 류마티스 관절염, 제1형 당뇨병 및 다발성 경화증과 같은 질환을 목표로 하고 있습니다.
Immutep a annoncé le dosage réussi du premier participant dans l'essai clinique de phase I de IMP761, un anticorps agoniste LAG-3 de première classe.
Cet essai vise à rétablir l'équilibre du système immunitaire en améliorant la fonction de frein du LAG-3 pour traiter les maladies auto-immunes. Réalisé par le Centre for Human Drug Research (CHDR) à Leyde, aux Pays-Bas, l'étude prévoit d'inscrire 49 volontaires en bonne santé. L'essai évaluera la sécurité, la pharmacocinétique et la pharmacodynamique de l'IMP761, avec des données de sécurité initiales attendues d'ici la fin de l'année et d'autres données dans la première moitié de l'exercice 2025.
Des études précliniques ont montré que l'IMP761 réduit considérablement les cytokines inflammatoires et supprime les réponses immunitaires médiées par des cellules T spécifiques à l'antigène. L'essai cible des conditions telles que l'arthrite rhumatoïde, le diabète de type 1 et la sclérose en plaques.
Immutep hat die erfolgreiche Dosisgabe des ersten Teilnehmers in der Phase-I-Studie von IMP761, einem Antikörper-Ago-nisten der ersten Klasse, angekündigt.
Diese Studie zielt darauf ab, das Gleichgewicht des Immunsystems wiederherzustellen, indem die Bremsfunktion von LAG-3 verbessert wird, um autoimmunerkrankungen zu begegnen. Die Studie wird vom Centre for Human Drug Research (CHDR) in Leiden, Niederlande, durchgeführt und plant, 49 gesunde Freiwillige einzuschreiben. Der Versuch wird die Sicherheit, Pharmakokinetik und Pharmakodynamik von IMP761 untersuchen, wobei die ersten Sicherheitsdaten bis zum Jahresende und weitere Daten in der ersten Hälfte des Geschäftsjahres 2025 erwartet werden.
Vorklinische Studien haben gezeigt, dass IMP761 entzündliche Zytokine signifikant reduziert und antigen-spezifische T-Zell-vermittelte Immunantworten unterdrückt. Der Versuch zielt auf Erkrankungen wie rheumatoide Arthritis, Typ-1-Diabetes und Multiple Sklerose ab.
- First participant successfully dosed in Phase I trial of IMP761
- Initial safety data expected by year-end
- Study to enroll 49 healthy volunteers
- Preclinical studies showed significant reduction in inflammatory cytokines
- Pharmacokinetics and pharmacodynamics data not expected until first half of CY2025
Insights
The dosing of the first participant in the Phase I study of IMP761 marks a significant milestone for Immutep. This first-in-class agonist LAG-3 antibody represents a novel approach to treating autoimmune diseases by enhancing the "brake" function of LAG-3 on T cells. The study's design, including the KLH challenge model, will provide valuable early insights into the drug's pharmacodynamic activity.
Key points to consider:
- The study aims to enroll 49 healthy volunteers, focusing on safety, PK and PD.
- Initial safety data is expected by year-end, with PK/PD data in H1 2025.
- Preclinical studies have shown promising results in reducing inflammatory cytokines and suppressing antigen-specific T cell responses.
From a financial perspective, this news is moderately positive for Immutep. Key considerations include:
- The initiation of a Phase I trial expands Immutep's clinical pipeline, potentially increasing the company's value proposition to investors.
- The novel mechanism of IMP761 could address a significant market need in autoimmune diseases, which represent a multi-billion dollar market opportunity.
- However, investors should note that early-stage clinical trials carry significant risks and it will be years before any potential commercialization.
Media Release
- IMP761 is designed to enhance the “brake” function of LAG-3 on T cells to restore balance to the immune system and address the underlying cause of many autoimmune diseases
- Safety data from this first-in-human study anticipated by year-end and pharmacokinetics and pharmacodynamics data in first half CY2025
SYDNEY, AUSTRALIA, Aug. 14, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces that the first participant has been successfully dosed in the first-in-human Phase I trial of IMP761. This first-in-class agonist LAG-3 antibody is designed to restore balance to the immune system by enhancing the “brake” function of LAG-3 to silence dysregulated self-antigen-specific memory T cells that cause many autoimmune diseases.
The single and multiple ascending dose, placebo-controlled, double-blind Phase I study is being conducted by the Centre for Human Drug Research (CHDR), a world-class institute in Leiden, the Netherlands, specializing in cutting-edge early-stage clinical drug research. The study aims to enrol 49 healthy volunteers, to assess safety, pharmacokinetics (PK) and pharmacodynamics (PD).
CHDR will implement its unique keyhole limpet haemocyanin (KLH) challenge model allowing for the evaluation of IMP761’s pharmacodynamic activity at the earliest stages of clinical development. Immutep anticipates the first safety data from the Phase I study to be available before end of the year with assessment of PK/PD relationships to follow in the first half of CY2025.
The immune checkpoint LAG-3 has been identified as a promising target for agonist LAG-3 immunotherapy to treat rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis, among other autoimmune diseases.1,2,3 In preclinical studies, IMP761 has led to a large decrease in inflammatory cytokines and demonstrated its effectiveness in suppressing antigen-specific T cell–mediated immune responses.4,5
About IMP761
IMP761, a first-in-class immunosuppressive LAG-3 agonist antibody, has the potential to address the root cause of many autoimmune diseases by specifically silencing autoimmune memory T cells that accumulate at disease sites and restoring balance to the immune system. As published in the Journal of Immunology, encouraging pre-clinical in vivo and in vitro studies show IMP761 inhibits peptide-induced T cell proliferation, activation of human primary T cells, and an antigen-specific delayed-type hypersensitivity (DTH) reaction. Additional preclinical data in oligoarticular juvenile idiopathic arthritis (o-JIA) published in Pediatric Research details how IMP761 led to a decrease in a broad spectrum of effector cytokines in just 48 hours. This study also showed children with o-JIA have a skewed LAG-3 metabolism and suggested they can benefit from agonistic LAG-3 activity.
About Immutep
Immutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune disease. We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio harnesses its unique ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com.
Australian Investors/Media:
Catherine Strong, Morrow Sodali
+61 (0)406 759 268; c.strong@morrowsodali.com
U.S. Investors/Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
1. Pedersen, J.M., Hansen, A.S., Skejø, C. et al. Lymphocyte activation gene 3 is increased and affects cytokine production in rheumatoid arthritis. Arthritis Res Ther 25, 97 (2023). https://doi.org/10.1186/s13075-023-03073-z
2. Jones BE, Maerz MD et al. Fewer LAG-3+ T Cells in Relapsing-Remitting Multiple Sclerosis and Type 1 Diabetes. J Immunol. 2022 Feb 1;208(3):594-602. doi: 10.4049/jimmunol.2100850. Epub 2022 Jan 12. PMID: 35022272; PMCID: PMC8820445.
3. Zhou X, Gu Y et al. From bench to bedside: targeting lymphocyte activation gene 3 as a therapeutic strategy for autoimmune diseases. Inflamm Res. 2023 Jun;72(6):1215-1235. doi: 10.1007/s00011-023-01742-y. Epub 2023 Jun 14. PMID: 37314518.
4. Mathieu Angin, Chrystelle Brignone, Frédéric Triebel; A LAG-3–Specific Agonist Antibody for the Treatment of T Cell–Induced Autoimmune Diseases. J Immunol 15 February 2020; 204 (4): 810–818. https://doi.org/10.4049/jimmunol.1900823
5. Sag, E., Demir, S., Aspari, M. et al. Juvenile idiopathic arthritis: lymphocyte activation gene-3 is a central immune receptor in children with oligoarticular subtypes. Pediatr Res 90, 744–751 (2021). https://doi.org/10.1038/s41390-021-01588-2
FAQ
What is the purpose of Immutep's Phase I study of IMP761?
When was the first participant dosed in the IMP761 Phase I study?
What autoimmune diseases could IMP761 potentially treat?
When will the initial safety data from the IMP761 Phase I study be available?
What are the expected timelines for pharmacokinetics and pharmacodynamics data for IMP761?
