Immutep Announces First Clinical Data from 90mg Dosing of Efti
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The data from the AIPAC-003 trial indicating that a 90mg dose of eftilagimod alpha (efti) in combination with paclitaxel is safe and well-tolerated in metastatic breast cancer (MBC) patients is a significant development. The observed 50% overall response rate and 100% disease control rate are particularly promising, given that these patients had exhausted all endocrine therapies, including CDK4/6 inhibitors. It is crucial to note that the therapeutic landscape for MBC, especially HR-positive/HER2-negative subtypes, is highly competitive, with several established and emerging treatments. The efficacy of efti in this context suggests a potential for it to become an important addition to the treatment regimen, which could improve patient outcomes and survival rates.
From a clinical perspective, understanding the mechanism of action of efti, which involves modulating the LAG-3 pathway, is essential. This pathway plays a role in regulating the immune response to cancer cells. Efti's ability to enhance the immune response while being combined with chemotherapy could potentially offer a dual attack on cancer cells, leveraging the body's own defenses alongside conventional cytotoxic agents. Continued monitoring for any delayed adverse events and long-term outcomes will be vital for assessing the true clinical benefit of this treatment combination.
The early results from the AIPAC-003 trial are noteworthy for several reasons. Firstly, the data suggest that the 90mg dosage of efti, which is three times higher than the previously highest tested dose, does not increase the severity of adverse events, an important consideration for patient quality of life. Secondly, the dose-dependent effect observed with efti in MBC treatment could indicate that higher doses may lead to enhanced therapeutic efficacy, which is a valuable insight for future clinical research and drug development strategies.
Moreover, the alignment with the FDA’s Project Optimus initiative highlights the trial's focus on determining the optimal biological dose, which is a key factor in the development and approval process for new treatments. The initiative aims to refine dosing strategies to improve patient outcomes and reduce toxicities. The ongoing Phase II portion of the trial will be particularly telling, as it will provide comparative data on the safety and efficacy of the 90mg dose versus the 30mg dose. This could have significant implications for the efti program's trajectory and its potential market positioning.
The impact of these trial results on the business side is multifaceted. For Immutep Limited, positive early-stage trial results can lead to increased investor confidence and potentially boost the company's stock market performance. The data may also position Immutep favorably for strategic partnerships or licensing deals, which are common in the biotech industry, especially for companies with promising oncology pipelines.
However, it is also important to manage expectations, as the biotech sector is known for its volatility and investment is often speculative, hinging on the outcomes of clinical trials. The long-term business impact will depend on the completion of the Phase II/III trials, regulatory approval processes and the ability of Immutep to effectively commercialize efti if it is approved. Additionally, the competitive landscape, including the presence of other treatments and the rate of innovation in the MBC treatment space, will influence the market potential of efti. Stakeholders should watch for further updates and the eventual outcomes of the ongoing trials for a clearer picture of the business implications.
- Data from the safety lead-in of the AIPAC-003 trial shows 90mg efti in combination with paclitaxel is safe and well tolerated
- Encouraging initial efficacy in six metastatic breast cancer patients, who exhausted all endocrine therapy including CDK4/6 inhibitors, demonstrated by a
50% overall response rate, including one complete response, and a100% disease control rate
SYDNEY, AUSTRALIA, March 05, 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 safety and initial efficacy data from the first ever 90mg dosing of eftilagimod alpha (efti) in combination with weekly paclitaxel in patients from the safety lead-in (N=6) of the AIPAC-003 Phase II/III trial.
Updated safety data from patients with HR-positive/HER2-negative/low metastatic breast cancer (MBC) treated with this innovative immuno-oncology (IO)-chemotherapy combination reveal no treatment-emergent serious adverse events. Additionally, all treatment-emergent adverse events during the safety observation period to date have been of mild severity.
Initial efficacy reports show these six MBC patients, who exhausted all endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors, exhibited encouraging results achieving a
Acknowledging the early nature of these results, efti with paclitaxel historically has shown a dose-dependent effect in MBC and has in some cases also led to stable disease patients becoming partial responders after six months. The biologically active 30mg efti dose, previously the highest dose of efti ever tested, has demonstrated a stronger immune response and greater efficacy than lower dosing levels (1mg, 6mg) in multiple clinical trials.
The ongoing randomized Phase II portion of the trial, which will include up to 58 evaluable patients, is focused on whether 90mg efti dosing is safe and more efficacious than 30mg dosing. This portion of the trial has enrolled 23 patients to date. Importantly, the determination of the optimal biological dose in AIPAC-003 is directly tied to the FDA’s Project Optimus initiative and is relevant for the entire efti program.
Further updates from AIPAC-003 will be provided in CY2024. For more information on the trial, please visit clinicaltrials.gov (NCT05747794).
About Eftilagimod Alpha (Efti)
Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.
Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).
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, Citadel-MAGNUS
+61 (0)406 759 268; cstrong@citadelmagnus.com
U.S. Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
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