First Patient Dosed in Trial Evaluating Efti and the Anti-PD-L1 Therapy BAVENCIO® in Metastatic Urothelial Cancer

Rhea-AI Summary

Immutep Limited (IMM) Announces Enrollment of First Patient in INSIGHT-005 Phase I Trial for Urothelial Carcinoma Treatment

Oncology Doctor

The commencement of the INSIGHT-005 Phase I trial marks a significant stride in the realm of immuno-oncology, particularly for metastatic urothelial carcinoma, a prevalent form of bladder cancer with considerable mortality rates. The combination of eftilagimod alpha (efti) and avelumab, an anti-PD-L1 monoclonal antibody, is noteworthy for its chemotherapy-free approach, which could potentially offer a less toxic and more tolerable treatment alternative for patients ineligible for or unresponsive to traditional platinum-based chemotherapy.

The previous INSIGHT-004 trial's promising outcomes, particularly in patients with low and negative PD-L1 expression, suggest that efti may enhance the immune system's ability to combat cancer cells in conjunction with established therapies like avelumab. This could have significant implications for treatment protocols and patient quality of life if the results are corroborated by the INSIGHT-005 study.

Given the current standards of care, the integration of efti into treatment regimens could represent a paradigm shift, potentially expanding the therapeutic options available to oncologists and their patients. However, it is crucial to await the data on safety and efficacy from this early-stage trial before considering any changes to clinical practice.

Medical Research Analyst

The initiation of the INSIGHT-005 trial underscores the importance of collaborative research in advancing cancer treatment. The study's design, focusing on a patient population with high unmet needs, is strategic and could, if successful, lead to rapid adoption in clinical settings. The partnership between Immutep and Merck KGaA leverages both companies' expertise and resources, potentially accelerating the development of eftilagimod alpha.

From a research perspective, the trial's results will provide valuable insights into the mechanistic synergies between LAG-3 immunotherapies and immune checkpoint inhibitors. Understanding how efti's immune activation properties can complement avelumab's blockade of PD-L1 could inform the development of new combination therapies for various cancers.

Moreover, the trial's outcomes may have broader implications for the field of immunotherapy, as they could validate the efficacy of LAG-3 targeted treatments beyond the specific context of urothelial carcinoma. This could catalyze further research and investment into LAG-3 as a therapeutic target.

Financial Analyst

For investors, the initiation of the INSIGHT-005 trial is a critical milestone for Immutep, as clinical advancements often serve as inflection points for a biotech company's valuation. The market's response to this news will likely reflect the potential commercial implications of a successful trial, given the sizeable addressable market for bladder cancer treatments.

While the trial is in its early stages, positive data could lead to increased investor confidence and potentially partnerships or licensing deals, which are common in the biotech industry for promising therapies. Conversely, any setbacks could have a proportionately negative impact on investor sentiment and the company's market valuation.

It is important to note that the biotech sector is inherently high-risk with volatile stock movements, often tied to the outcomes of clinical trials. Investors should monitor the progress of the INSIGHT-005 trial closely, as it could significantly influence Immutep's financial trajectory and strategic positioning within the immuno-oncology market.

Media Release

SYDNEY, AUSTRALIA, Jan. 04, 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 that the first patient has been enrolled and safely dosed in the INSIGHT-005 Phase I trial. The investigator-initiated study jointly funded with Merck KGaA, Darmstadt, Germany, will evaluate eftilagimod alpha (“efti”) in combination with BAVENCIO® (avelumab) in up to 30 patients with metastatic urothelial carcinoma.

This chemotherapy-free immuno-oncology (IO) combination has already shown promising signals of efficacy and a favorable safety profile in advanced solid tumors, including several IO insensitive indications, in the INSIGHT-004 Phase I trial. Encouragingly, responses were achieved even in cancer patients with low and negative PD-L1 expression, who typically would not be expected to respond to anti-PD-(L)1 therapy.

INSIGHT-005 looks to build on these clinical results and is focused on an area of high unmet need: metastatic urothelial carcinoma patients that are not eligible for platinum-based chemotherapy or progressing during or after platinum-based chemotherapy. The trial will assess the safety and efficacy of efti and avelumab, an anti PD-L1 monoclonal antibody owned by Merck KGaA, Darmstadt, Germany, that is widely recognized in international guidelines as the standard of care for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are progression-free following platinum-based chemotherapy.

Immutep CSO, Frédéric Triebel, M.D., Ph.D., “Immunotherapy has made great strides in improving clinical outcomes for patients with bladder cancer, including avelumab that has set a new standard of care for many metastatic urothelial carcinoma patients, and we are pleased to commence patient enrollment in the INSIGHT-005 study that we hope will build upon this progress. The chemotherapy-free IO combination utilizing efti and avelumab has already generated encouraging efficacy and safety in difficult-to-treat advanced solid tumors, and this trial will help further elucidate how efti’s unique immune system activation may complement and enhance the ability of immune checkpoint inhibitors like avelumab to fight cancer.”

INSIGHT-005 will be conducted by the Institute of Clinical Cancer Research IKF at Krankenhaus Nordwest in Frankfurt and other German cancer centers, including Helios Klinikum Bad Saarow with Dr. Med. Daniel Pink, as part of the investigator-initiated INSIGHT platform for studies investigating efti in different combination treatments and routes of administration. INSIGHT currently consists of 5 different arms from stratums A to E (INSIGHT-005 is Stratum E).

Urothelial carcinoma is the most common type of bladder cancer. For 2023, it was estimated there would be 82,290 new cases of bladder cancer and 16,710 deaths in the US alone.¹

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. Investors/Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com

¹ US National Cancer Institute: https://seer.cancer.gov/statfacts/html/urinb.html

FAQ

What is the latest announcement from Immutep Limited (IMM)?

Immutep Limited (IMM) has announced the enrollment of the first patient in the INSIGHT-005 Phase I trial for the treatment of urothelial carcinoma.

What is the purpose of the INSIGHT-005 Phase I trial?

The INSIGHT-005 Phase I trial aims to evaluate eftilagimod alpha in combination with BAVENCIO in up to 30 patients with metastatic urothelial carcinoma.

What are the key goals of the INSIGHT-005 Phase I trial?

The trial will assess the safety and efficacy of eftilagimod alpha and avelumab, an anti-PD-L1 monoclonal antibody, in patients who are not eligible for platinum-based chemotherapy or have progressed during or after platinum-based chemotherapy.

Who is funding the INSIGHT-005 Phase I trial?

The INSIGHT-005 Phase I trial is jointly funded by Immutep Limited and Merck KGaA, Darmstadt, Germany.

What is the significance of the INSIGHT-005 Phase I trial for cancer patients?

The trial aims to build on the promising signals of efficacy and a favorable safety profile of the chemotherapy-free immuno-oncology combination in advanced solid tumors, including IO insensitive indications.

What is the estimated number of new bladder cancer cases in the US for 2023?

For 2023, it was estimated there would be 82,290 new cases of bladder cancer and 16,710 deaths in the US alone.