Immutep Announces Initial Safety Data from First-in-Human Phase I Trial Evaluating IMP761
Immutep (NASDAQ: IMMP) has reported positive initial safety data from its Phase I trial of IMP761, the world's first LAG-3 agonist antibody. Through the first three of five single ascending dose cohorts in healthy participants, no treatment-related adverse events have been observed. The placebo-controlled, double-blind study is being conducted at the Centre for Human Drug Research in Leiden, Netherlands, involving up to 49 participants.
IMP761 is designed to treat autoimmune diseases by enhancing LAG-3's 'brake' function on T cells to restore immune system balance. Additional safety data and pharmacokinetic/pharmacodynamic relationships assessment are expected in the first half of 2025. The drug shows potential for treating conditions like rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis.
Immutep (NASDAQ: IMMP) ha riportato dati iniziali positivi sulla sicurezza dal suo studio di Fase I di IMP761, il primo anticorpo agonista LAG-3 al mondo. Nei primi tre dei cinque gruppi di dosi ascendenti singole in partecipanti sani, non sono stati osservati eventi avversi correlati al trattamento. Lo studio controllato con placebo e in doppio cieco è condotto presso il Centre for Human Drug Research a Leiden, nei Paesi Bassi, coinvolgendo fino a 49 partecipanti.
IMP761 è progettato per trattare le malattie autoimmuni migliorando la funzione di 'freno' di LAG-3 sulle cellule T per ripristinare l'equilibrio del sistema immunitario. Ulteriori dati sulla sicurezza e la valutazione delle relazioni farmacocinetiche/farmacodinamiche sono attesi nella prima metà del 2025. Il farmaco mostra potenziale nel trattamento di condizioni come l'artrite reumatoide, il diabete di tipo 1 e la sclerosi multipla.
Immutep (NASDAQ: IMMP) ha reportado datos iniciales positivos de seguridad de su ensayo de Fase I de IMP761, el primer anticuerpo agonista de LAG-3 en el mundo. A través de los primeros tres de cinco grupos de dosis ascendentes individuales en participantes sanos, no se han observado eventos adversos relacionados con el tratamiento. El estudio, controlado por placebo y doble ciego, se está llevando a cabo en el Centre for Human Drug Research en Leiden, Países Bajos, involucrando hasta 49 participantes.
IMP761 está diseñado para tratar enfermedades autoinmunitarias al potenciar la función de 'freno' de LAG-3 en las células T para restaurar el equilibrio del sistema inmunológico. Se esperan más datos de seguridad y una evaluación de las relaciones farmacocinéticas/farmacodinámicas en la primera mitad de 2025. El fármaco muestra potencial para tratar condiciones como la artritis reumatoide, la diabetes tipo 1 y la esclerosis múltiple.
Immutep (NASDAQ: IMMP)는 세계 최초의 LAG-3 아고니스트 항체인 IMP761의 1상 시험에서 긍정적인 초기 안전성 데이터를 보고했습니다. 건강한 참가자들 중 5개의 단일 용량 상승 코호트 중 처음 3개의 코호트에서 치료 관련 부작용이 관찰되지 않았습니다. 위약 대조 이중 맹검 연구는 네덜란드 라이덴에 있는 인간 약물 연구 센터에서 진행되며, 최대 49명의 참가자가 참여하고 있습니다.
IMP761은 T 세포에 대한 LAG-3의 '브레이크' 기능을 강화하여 면역 시스템의 균형을 회복함으로써 자가 면역 질환을 치료하도록 설계되었습니다. 추가 안전성 데이터와 약물 동태/약리학적 관계에 대한 평가는 2025년 상반기에 예상됩니다. 이 약물은 류마티스 관절염, 제1형 당뇨병 및 다발성 경화증과 같은 질환을 치료할 가능성을 보여줍니다.
Immutep (NASDAQ: IMMP) a rapporté des données initiales positives concernant la sécurité de son essai de Phase I sur IMP761, le premier anticorps agoniste de LAG-3 au monde. Lors des trois premières cohortes de doses individuelles croissantes parmi des participants sains, aucun événement indésirable lié au traitement n'a été observé. L'étude contrôlée par placebo et en double aveugle est menée au Centre for Human Drug Research à Leiden, aux Pays-Bas, impliquant jusqu'à 49 participants.
IMP761 est conçu pour traiter les maladies auto-immunes en renforçant la fonction de 'frein' de LAG-3 sur les cellules T afin de restaurer l'équilibre du système immunitaire. Des données de sécurité supplémentaires et une évaluation des relations pharmacocinétiques/pharmacodynamiques sont attendues au cours de la première moitié de 2025. Le médicament montre un potentiel pour traiter des conditions telles que l'arthrite rhumatoïde, le diabète de type 1 et la sclérose en plaques.
Immutep (NASDAQ: IMMP) hat positive erste Sicherheitsdaten aus seiner Phase-I-Studie zu IMP761, dem weltweit ersten LAG-3-Agonisten-Antikörper, berichtet. In den ersten drei von fünf einzelnen aufsteigenden Dosis-Kohorten bei gesunden Teilnehmern wurden keine behandlungsbedingten unerwünschten Ereignisse beobachtet. Die placebo-kontrollierte, doppelblinde Studie wird am Centre for Human Drug Research in Leiden, Niederlande, durchgeführt und umfasst bis zu 49 Teilnehmer.
IMP761 ist darauf ausgelegt, Autoimmunerkrankungen zu behandeln, indem es die 'Bremse'-Funktion von LAG-3 auf T-Zellen verstärkt, um das Gleichgewicht des Immunsystems wiederherzustellen. Weitere Sicherheitsdaten und die Bewertung von pharmakokinetischen/pharmakodynamischen Beziehungen werden in der ersten Hälfte von 2025 erwartet. Das Medikament zeigt Potenzial zur Behandlung von Erkrankungen wie rheumatoider Arthritis, Typ-1-Diabetes und multipler Sklerose.
- No treatment-related adverse events observed in Phase I trial
- Successfully completed first three of five dose cohorts
- Preclinical studies showed decrease in inflammatory cytokines
- Complete trial results not available until H1 2025
- Early-stage Phase I trial with no efficacy data yet
Insights
The initial safety data from IMP761's Phase I trial marks a significant milestone in autoimmune disease treatment development. The absence of treatment-related adverse events through three dose cohorts is particularly encouraging for a first-in-human trial. The study's design, incorporating a KLH challenge model, will provide valuable insights into the drug's mechanism of action and its potential immunosuppressive effects.
The LAG-3 agonist approach represents a novel therapeutic strategy. While most autoimmune treatments focus on symptom management, IMP761 targets the root cause by attempting to regulate overactive T cells. The preclinical data showing reduced inflammatory cytokines suggests potential broad applications across multiple autoimmune conditions, including rheumatoid arthritis, Type 1 diabetes and multiple sclerosis.
This initial safety data, while promising, represents just the beginning of IMP761's clinical journey. The completion of three out of five dose cohorts without safety concerns reduces some early-stage development risk, potentially making the asset more attractive for future partnerships or licensing deals. However, investors should note that full safety data and PK/PD relationships won't be available until H1 2025 and efficacy data is still pending.
The autoimmune disease market represents a substantial commercial opportunity, with the global autoimmune treatment market valued at over
- Favourable safety profile for world’s first LAG-3 agonist, IMP761, with no treatment related adverse events to date
- Additional safety data and assessment of PK/PD relationships to follow in first half of CY2025
- 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
SYDNEY, AUSTRALIA, Dec. 17, 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 favourable initial safety data from the placebo-controlled, double-blind first-in-human Phase I study evaluating IMP761. Through the first three of five single ascending dose cohorts in healthy participants, there have been no treatment related adverse events.
Dr. Frédéric Triebel, CSO of Immutep, said: “We are very encouraged by the safety data generated to date for IMP761, the world’s first LAG-3 agonist antibody, in this Phase I setting. Derisking this promising asset in this proof-of-concept study in healthy subjects assessing its safety and immunosuppressive efficacy on an antigen-specific T-cell mediated intra-dermal reaction is an important step for this exciting program in autoimmune diseases. Given that IMP761 is potentially addressing the root cause of many different autoimmune diseases, we are eager to see this study generating more data.”
The trial in up to 49 participants is being conducted by the Centre for Human Drug Research (CHDR) in Leiden, the Netherlands. In addition to the safety analysis, CHDR is implementing its keyhole limpet haemocyanin (KLH) challenge model to evaluate IMP761’s pharmacological activity. Additional safety data and assessment of pharmacokinetic/pharmacodynamic (PK/PD) relationships to follow in the first half of CY2025.
The LAG-3 (lymphocyte-activation gene-3) immune checkpoint has been identified as a promising target for an agonist antibody to treat rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis, among potentially many other autoimmune diseases.1,2,3 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. 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
For more information on the trial, please visit clinicaltrials.gov (NCT06637865).
About IMP761
IMP761, a first-in-class immunosuppressive lymphocyte-activation gene-3 (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.
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
Australian Investors/Media:
Catherine Strong, Sodali & Co
+61 (0)406 759 268; catherine.strong@sodali.com
U.S. Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
FAQ
What are the initial safety results of IMMP's IMP761 Phase I trial?
When will IMMP release complete Phase I trial results for IMP761?
What autoimmune conditions could IMMP's IMP761 potentially treat?
How many participants are enrolled in IMMP's IMP761 Phase I trial?
What makes IMMP's IMP761 unique in the LAG-3 space?
