Immutep Announces Positive Update on IMP761, a First-in-Class LAG-3 Agonist Antibody for Autoimmune Diseases, from Phase I Study
MWN-AI** Summary
Immutep Limited, an immunotherapy company focused on cancer and autoimmune diseases, has shared positive results from the Phase I clinical trial of IMP761, a first-in-class LAG-3 agonist antibody. The trial, involving healthy participants, has successfully completed the single-ascending dose portion, administering doses of 2.5 and 7 mg per kg. The results illustrate a favorable safety profile, with no significant adverse effects reported apart from mild reactions, and a notable immunosuppressive effect that is dose-dependent.
Significantly, the study demonstrated a sustained reduction in T-cell activity when exposed to a foreign antigen, indicating the potential efficacy of IMP761 in treating various autoimmune conditions, such as rheumatoid arthritis and Type 1 diabetes. Dr. Frédéric Triebel, Immutep's Chief Scientific Officer, highlighted the positive pharmacokinetic/pharmacodynamic relationship observed within the specified dosage, suggesting that IMP761 could provide a targeted approach to managing autoimmune diseases by silencing problematic T cells and restoring immune balance.
As a first LAG-3 agonist antibody, IMP761 commands considerable interest within the medical community, given its significance in treating disorders that impact millions and represent substantial market opportunities. With these promising clinical results, the trial will progress as planned, with further updates anticipated in the first half of CY2026, including data presentations at prominent medical conferences.
Immutep's commitment to advancing immunotherapeutics, especially those utilizing the LAG-3 mechanism, positions the company at the forefront of innovative treatment options aimed at improving patient outcomes in autoimmune diseases. With an increasing focus on their clinical progress, Immutep is poised to harness the potential of IMP761 as a transformative therapy in the field.
MWN-AI** Analysis
Immutep Limited’s recent announcement regarding the positive results from the Phase I study of IMP761, a first-in-class LAG-3 agonist antibody, presents an intriguing investment opportunity amidst its promising implications for autoimmune disease treatment. The successful completion of the single-ascending dose portion, coupled with a favorable safety profile and the demonstration of dose-dependent immunosuppressive effects, positions IMP761 as a potential game-changer in managing conditions like rheumatoid arthritis, type 1 diabetes, and multiple sclerosis.
The robust T-cell suppression noted in the trial could signify a significant therapeutic advancement, which indeed has the potential to capture multi-billion dollar market shares in the autoimmune sector. Investors should consider that the therapeutic landscape is characterized by a pressing need for innovative treatments that address underlying immune dysregulation—an area where IMP761 could excel due to its mechanism of targeting LAG-3.
Moreover, Immutep's upcoming milestones, with further updates expected in H1 CY2026—including data presentations at major medical conferences—could act as significant catalysts for enhancing market sentiment and increasing share value. Ongoing interest from external stakeholders likely underscores the confidence in the program’s potential, enticing both institutional and retail investors.
With a favorable safety profile and encouraging early data, Immutep appears well-positioned to gain traction in the biotech market. However, investors should remain vigilant regarding broader market trends and potential volatility typically associated with clinical-stage companies. In a sector that often experiences fluctuations based on trial results and competitive developments, a careful assessment of risk versus reward is essential. Overall, Immutep presents a compelling case for consideration in a diversified biotech portfolio as it charts a path towards significant regulatory milestones and commercial opportunities.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
- Single-ascending dose portion of study has successfully completed 2.5 and 7 mg / kg levels
- Dose dependent immunosuppressive effect against a strong foreign antigen observed with continued favourable safety profile
- Substantial reduction in T cell activity highlights the potential efficacy of IMP761 in treating autoimmune diseases
- Given encouraging efficacy and safety, the trial will continue as planned and further updates are anticipated in 1H CY2026 including presentation of data at a major medical conference
SYDNEY, AUSTRALIA, Dec. 22, 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 a positive update from the placebo-controlled, double-blind first-in-human Phase I study in healthy participants evaluating IMP761, a first-in-class LAG-3 agonist antibody for autoimmune diseases.
The single-ascending dose escalation portion of the trial has successfully completed the 2.5 and 7 mg / kg dosing levels of IMP761 with continued positive safety and efficacy data. IMP761 was tolerated well with no treatment-related adverse reactions beyond mild intensity. Additionally, evidence of dose dependent immunosuppressive effects with IMP761 was observed with significant, long-lasting inhibition of the three T-cell-mediated intradermal reactions to a strong foreign antigen at day 2, 9 and 23.
Dr. Frédéric Triebel, CSO of Immutep, said: “We are excited to see IMP761 having a long-term immunosuppressive effect after a single injection. A solid pharmacokinetic/pharmacodynamic relationship has now been established between 1 and 7 mg/kg with eight participants per group to cover the variability of the responses. This novel immunotherapy’s significant level of immune suppression combined with its favourable safety provide proof-of-concept data in its potential to silence the dysregulated T cells at the epicenter of many autoimmune diseases. Encouragingly, our clinical progress with IMP761 has corresponded with increased external interest in this program.”
The LAG-3 (lymphocyte-activation gene-3) immune checkpoint has been identified as a promising therapeutic target for many autoimmune diseases, including rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis.1-3 IMP761 is the first LAG-3 agonist antibody developed to potentially treat these large, increasingly prevalent disorders, each of which represent multi-billion dollar markets.
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. LAG-3 expression on activated T cells demonstrates high specificity for disease sites, especially in regions characterised by chronic inflammation. This distinct characteristic of the LAG-3 immune checkpoint suggests IMP761 may enable a more targeted therapeutic approach with fewer adverse effects compared to other treatments.
Given the encouraging efficacy and safety to date, the trial will continue as planned and additional updates are anticipated in the first half of CY2026 including a potential presentation of data at a major medical conference in the field of autoimmune diseases.
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 disease. 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; [email protected]
U.S. Investors/Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; [email protected]
FAQ**
How does Immutep Limited IMMP plan to leverage the positive safety and efficacy data from the IMP761 trial to attract potential partnerships or investment opportunities in the autoimmune disease market?
What specific advancements in the trial methodology did Immutep Limited IMMP implement to ensure robust data collection for the evaluated dose levels of IMP761?
Can Immutep Limited IMMP provide insights into the anticipated mechanism of action for IMP761 in silencing dysregulated T cells and how this differentiates the drug from existing immunotherapies for autoimmune diseases?
What are the key milestones on the timeline leading up to the presentation of data in 1H CY2026, specifically regarding Immutep Limited IMMP’s plans for further clinical trials or regulatory submissions following the current Phase I study?
**MWN-AI FAQ is based on asking OpenAI questions about Immutep Limited (NASDAQ: IMMP).
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