Immutep Announces Positive Update from Phase I Study of IMP761, a First-in-Class LAG-3 Agonist Antibody for Autoimmune Diseases
MWN-AI** Summary
Immutep Limited (ASX: IMM; NASDAQ: IMMP) announced a positive update regarding its Phase I study of IMP761, a pioneering LAG-3 agonist antibody designed to treat autoimmune diseases. The study, which is placebo-controlled and double-blind, has shown initial pharmacological data highlighting significant T cell suppression and a favorable safety profile at the highest dosing level of 0.9 mg/kg. Notably, there have been no treatment-related adverse events reported in healthy participants, and T cell activity in the skin was suppressed by 80% by day 10 post-neoantigen rechallenge.
Given these encouraging results, Immutep will continue escalating doses to 2.5, 7, and 14 mg/kg to further evaluate the drug's potential efficacy. IMP761 targets the LAG-3 (lymphocyte-activation gene-3) immune checkpoint, which is emerging as a promising therapeutic target for conditions such as rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis—each representing substantial market opportunities.
Dr. Frédéric Triebel, Immutep's Chief Scientific Officer, emphasized the drug's ability to effectively silence dysregulated T cells, a critical factor in autoimmune disease management. The specificity of LAG-3 expression in activated T cells, particularly in chronic inflammation sites, suggests that IMP761 could offer a more targeted treatment alternative with fewer side effects compared to existing therapies.
The Phase I study, conducted by the Centre for Human Drug Research in the Netherlands, will provide further safety and pharmacological activity insights, with additional data expected in the second half of 2025. This research could significantly contribute to addressing the root causes of various autoimmune diseases through innovative therapeutic strategies.
MWN-AI** Analysis
Immutep Limited (ASX: IMM; NASDAQ: IMMP) has announced a promising update from its Phase I study of IMP761, a pioneering LAG-3 agonist antibody targeting autoimmune diseases. Initial results indicate significant T cell suppression at a 0.9 mg/kg dosing level, demonstrating both efficacy and a favorable safety profile. This development is crucial as it positions IMP761 as a potential game-changer in treating conditions such as rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis—each representing multi-billion dollar markets.
The 80% reduction in T cell activity at just the initial dosing underscores the antibody’s potential impact on autoimmune pathologies by specifically silencing dysregulated T cells. As the study progresses to higher dosing levels—2.5, 7, and 14 mg/kg—investors should closely monitor subsequent pharmacological results, set to be released in the latter half of 2025.
From an investment perspective, Immutep presents a high-risk, high-reward opportunity. The successful data from the ongoing study and an established safety profile can drive investor confidence, possibly leading to significant stock appreciation in anticipation of more robust Phase II trial results. However, investors must also be wary of the inherent risks associated with clinical trials and regulatory approvals in the biopharmaceutical sector.
For those considering entry into Immutep's stock, this update suggests a bullish sentiment, especially with the company's focus on an innovative approach to immunotherapy. It’s advisable to keep an eye on market activity and key milestones from the Phase I trial while preparing for potential volatility as further data emerges. Long-term stakeholders may find value in the company’s proactive advancements in addressing unmet medical needs in autoimmune diseases. Ultimately, patient monitoring and strategic timing will be essential to capitalize on Immutep’s trajectory.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
- Initial pharmacological data from placebo-controlled, double-blind Phase I study shows significant T cell suppression and a favourable safety profile at dosing level of 0.9 mg/kg
- The substantial reduction in T cell activity highlights the potential efficacy of IMP761 in treating autoimmune diseases
- Single ascending dose levels will continue with 2.5, 7 and 14 mg/kg
- Additional data from the Phase I to follow in second half of CY2025
SYDNEY, AUSTRALIA, June 23, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces positive initial efficacy data and continued favourable safety data from the placebo-controlled, double-blind first-in-human Phase I study evaluating IMP761, a first-in-class LAG-3 agonist antibody for autoimmune diseases.
Through the highest dosing level to date (0.9 mg/kg of IMP761), there have been no treatment-related adverse events in healthy participants. Additionally, pharmacodynamic data at this dosing level show that the inhibition of T cell infiltration in the skin at day 10 following a neoantigen rechallenge has already reached 80%. Given the encouraging efficacy and safety, Immutep is continuing with single ascending dose levels of 2.5, 7 and 14 mg/kg.
The LAG-3 (lymphocyte-activation gene-3) immune checkpoint has been identified as a promising therapeutic target for rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis in multiple publications. 1 - 3 IMP761 is the first LAG-3 agonist antibody developed to potentially treat these large and growing disorders, each of which represent multi-billion dollar markets, and many other autoimmune diseases. By enhancing the “brake” function of LAG-3 to silence dysregulated self-antigen-specific memory T cells, IMP761 is designed to target the cause of autoimmune diseases and restore balance to the immune system.
Dr. Frédéric Triebel, CSO of Immutep, said: “The early pharmacological data showing substantial T cell suppression at the highest dose level of IMP761 are very promising, especially in conjunction with its continued favourable safety profile, and highlight the potential efficacy of this LAG-3 agonist in treating autoimmune diseases. LAG-3 expression on activated T cells is known to be highly specific to disease sites, and particularly in areas of chronic inflammation. This unique specificity enables the potential for IMP761 to have a more targeted approach with fewer side effects than other therapies. We look forward to evaluating higher dosing levels of IMP761 and hope to further enhance its ability to safely silence the dysregulated T cells responsible for many autoimmune diseases.”
The Phase I trial 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 data from the Phase I to follow in second half of CY2025. 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. 4 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. 5 This study also shows children with o-JIA have a skewed LAG-3 metabolism and suggests they can benefit from agonistic LAG-3 activity.
About Immutep
Immutep is a late-stage biotechnology company developing novel immunotherapies for cancer and autoimmune diseases. The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and its diversified product portfolio harnesses LAG-3’s 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:
Eleanor Pearson, Sodali & Co.
+61 2 9066 4071; eleanor.pearson@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 anticipated outcomes for the ongoing single ascending dose levels of IMP761 beyond the 0.9 mg/kg dose level, and how might they influence Immutep Limited IMMP’s strategy in autoimmune disease treatment?
How does Immutep Limited IMMP plan to leverage the safety profile demonstrated in the Phase I study to attract potential partnerships or investments for further development of IMP761?
Given the promising initial data on T cell suppression, what specific plans does Immutep Limited IMMP have for expanding the study to include a more diverse patient population, especially for autoimmune conditions?
How is Immutep Limited IMMP preparing to utilize the additional data expected in the second half of CY2025 to enhance its market positioning against competitors in the autoimmune therapy sector?
**MWN-AI FAQ is based on asking OpenAI questions about Immutep Limited (NASDAQ: IMMP).
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