Immutep Receives Regulatory Clearance for Phase I Study of First-in-Class LAG-3 Agonist Antibody Designed to Treat Autoimmune Diseases
Immutep (ASX: IMM; NASDAQ: IMMP) has received regulatory clearance in the Netherlands to initiate a Phase I study of IMP761, the world's first therapeutic LAG-3 agonist antibody for autoimmune diseases. The study, expected to enroll 49 healthy volunteers starting Q3 CY2024, will assess safety, pharmacokinetics, and pharmacodynamics.
IMP761 aims to restore immune system balance by enhancing LAG-3's 'brake' function to silence self-antigen-specific memory T cells, which cause many autoimmune diseases. The antibody has shown promise in preclinical studies for suppressing T cell-mediated immune responses and reducing inflammatory cytokines.
The trial, conducted by the Centre for Human Drug Research in Leiden, will use a unique KLH challenge model to evaluate IMP761's pharmacological activity. First data is anticipated before the end of 2024.
- Received regulatory clearance for Phase I study of IMP761, the first LAG-3 agonist antibody for autoimmune diseases
- IMP761 showed effectiveness in preclinical studies in suppressing T cell-mediated immune responses
- Study to begin enrolling participants in Q3 CY2024 with first data expected by year-end
- Unique KLH challenge model to be used for early evaluation of pharmacological activity
- None.
Insights
Immutep's announcement of regulatory clearance for a Phase I study of its LAG-3 agonist antibody, IMP761, marks a significant step in the realm of autoimmune disease treatment. The focus on LAG-3, a checkpoint molecule, is indeed promising. Unlike antagonists used in cancer therapy, this agonist approach aims to silence self-antigen-specific memory T cells responsible for various autoimmune conditions.
For retail investors, understanding the concept of agonist vs. antagonist antibodies is crucial. Antagonists block receptor activity, often used in oncology to boost immune response against tumors. Conversely, agonists enhance receptor activity to dampen the immune response in autoimmune diseases. This novel approach, leveraging the body's own mechanisms to restore immune balance, could significantly impact the industry if successful.
While Phase I trials primarily focus on safety and dosage, the use of CHDR's KLH challenge model to assess pharmacokinetics and pharmacodynamics offers an early glimpse into the drug's effectiveness. Investors should keep a close watch on the upcoming enrollment and subsequent data expected by the end of the year.
An important takeaway is the potential market size for autoimmune diseases. Conditions like rheumatoid arthritis, Type 1 diabetes and multiple sclerosis affect millions worldwide, representing a
From a financial perspective, the regulatory clearance for Immutep's IMP761 Phase I trial is a notable development. Biopharmaceutical companies often experience stock price fluctuations based on clinical trial milestones. The news itself may offer a short-term boost to stock price due to increased investor confidence in Immutep's pipeline and innovation in autoimmune therapies.
Investors should consider the company’s financial health and ability to sustain long-term research and development. Biotech firms typically operate at a loss during early-stage trials, relying heavily on cash reserves and funding to advance their pipelines. Key figures to watch in Immutep’s financial reports include their cash burn rate, partnerships and any strategic collaborations that may provide additional funding or resources.
Looking ahead, the potential success of IMP761 can open doors to lucrative markets. However, early-stage trials carry inherent risks and setbacks can impact stock performance. Investors should balance optimism with caution, monitoring regulatory updates, clinical results and financial statements.
Media Release
- Study expected to enrol first participants during Q3 CY2024
SYDNEY, AUSTRALIA, July 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 it has received regulatory clearance from the ethics and competent authority in the Netherlands to initiate the first-in-human Phase I study of IMP761.
IMP761 is the world’s first therapeutic LAG-3 agonist antibody and as such is uniquely positioned in the treatment landscape for autoimmune diseases. The immune checkpoint LAG-3 has been identified as a promising target for agonist immunotherapy to treat rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis, among other autoimmune diseases.1,2,3 IMP761 is designed to restore balance to the immune system by enhancing the “brake” function of LAG-3 to silence unregulated self-antigen-specific memory T cells. These T cells accumulate at disease sites and are the underlying cause of many autoimmune diseases.
Professor Bent Deleuran, MD, Department of Biomedicine, Aarhus University (DK) stated, “Immune checkpoint molecules such as LAG-3 play pivotal roles in determining the outcome of antigen activation, and as a result hold significant potential in the treatment of autoimmune diseases. In preclinical studies, the agonistic LAG-3 antibody IMP761 has shown, both in vitro and in vivo, to be highly effective in suppressing antigen-specific T cell–mediated immune responses and driving a meaningful decrease in inflammatory cytokines. It is exciting to see IMP761 move into the clinical setting to evaluate the potential of this new immunotherapy to address autoimmune diseases.”
“The regulatory and ethical clearance for the first-in-human trial of IMP761 is a significant milestone for Immutep and marks an important step in the development of this novel autoimmune disease approach,” said Dr. Frédéric Triebel, Immutep’s CSO. “Blocking LAG-3 with an antagonist antibody in cancer patients unleashes the power of the anti-tumor T cell responses, but also leads to autoimmunity in a fraction of the patients. This has put LAG-3 at the center of autoimmune disorders as a co-inhibitory receptor that downplays the T cell receptor response. Using IMP761, an agonist LAG-3 antibody, to reinforce this physiological upstream control of the T cell response represents a new approach to silence the few aggressive T cells that lead to autoimmune diseases,” added Dr. Triebel.
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, with the objective of assessing safety, pharmacokinetics (PK) and pharmacodynamics (PD). CHDR will implement its unique keyhole limpet haemocyanin (KLH) challenge model allowing for the evaluation of IMP761’s pharmacological activity at the earliest stages of clinical development.
Immutep anticipates that CHDR will enrol first participants into the Phase I study during Q3 of CY2024 with first data being available before end of the year.
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.
FAQ
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