Immutep Receives Constructive Regulatory Feedback on TACTI-004 Registrational Trial in Metastatic Non-Small Cell Lung Cancer
- The PEI's support for Immutep's Phase III trial is a positive indication for the company's future prospects. The acknowledgment of the good safety profile of efti in combination with anti-PD-1 therapy is also a favorable point for Immutep's development of LAG-3 immunotherapies.
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Insights
The feedback from the Paul-Ehrlich-Institut regarding Immutep's planned Phase III trial for eftilagimod alpha in the treatment of metastatic non-small cell lung cancer represents a significant step in the development of new cancer therapies. The endorsement of a registrational trial, especially in a first-line setting, suggests that efti may offer a novel approach to NSCLC treatment, potentially improving the standard of care.
Combining efti with anti-PD-1 therapy and possibly without the need for chemotherapy, could have a profound impact on patient quality of life and treatment outcomes. The PEI's acknowledgement of efti's safety profile is crucial, as adverse effects are a major consideration in cancer treatment regimens. The trial design's focus on PD-L1 expression levels is indicative of a personalized medicine approach, tailoring therapies based on individual tumor characteristics, which could enhance treatment efficacy.
The positive regulatory feedback from the PEI can be a potential catalyst for Immutep's stock value. Investors often look for such milestones when evaluating biotech companies, as they can precede market approval and commercialization. The decision to move into a Phase III trial indicates a level of confidence in eftilagimod alpha that might attract partnership opportunities, licensing deals, or even acquisition interest.
However, the costs associated with a Phase III trial are substantial and the company's financial position will be scrutinized. The ability to secure funding without significant dilution to existing shareholders will be key. Additionally, the market opportunity for NSCLC treatments is large and if efti proves effective, it could capture a significant market share, especially if it offers advantages over existing therapies.
Immutep's ongoing discussions with the FDA and other European regulators are critical, as alignment on trial design and endpoints can streamline the path to potential approval. The selection of the control arm and patient population based on PD-L1 expression levels is an important strategic decision that will influence the trial's relevance and the drug's positioning in the market. The fact that the PEI has positively acknowledged the safety profile of efti in combination with anti-PD-1 therapy is promising, as safety is a major concern in clinical trials and can significantly impact a drug's market potential.
Furthermore, the CEO's reference to 'mature data' from the TACTI-002 Phase II trial and 'emerging data' from the INSIGHT-003 study suggests that the company has a robust evidence base to support the advancement of eftilagimod alpha. The success of the Phase III trial could lead to a new, effective treatment option for NSCLC patients, which would be a notable achievement in the field of oncology.
Media Release
SYDNEY, AUSTRALIA, Dec. 21, 2023 (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 constructive feedback has been received from the Paul-Ehrlich-Institut (“PEI”), a German regulatory authority and part of the Committee for Medicinal Products for Human Use (CHMP), regarding the planned TACTI-004 Phase III trial of eftilagimod alpha (“efti”) for first line treatment of metastatic non-small cell lung cancer (NSCLC).
The PEI is supportive of Immutep moving into a registrational trial in first line NSCLC and evaluating efti in combination with an anti-PD-1 therapy in a chemotherapy-free regimen or as a triple combination approach that includes chemotherapy. Also, the PEI acknowledged the good safety profile of efti in combination with anti-PD-1 therapy.
Among the other items discussed at the meeting were general aspects of the trial design, including selection of the control arm and the potential patient population as defined by level of PD-L1 expression. Additional interactions with the U.S. Food and Drug Administration (FDA), other local European regulators, as well as with other stakeholders and potential partners are ongoing. Immutep plans to announce its final trial design for TACTI-004 in Q1 of CY2024.
Immutep CEO, Marc Voigt, commented: “We appreciate the valuable feedback from the PEI and look forward to additional discussions with other regulatory agencies in the coming months. Immutep is uniquely positioned to address multiple patient populations within non-small cell lung cancer as defined by their level of PD-L1 expression, including high, low, and negative expressors, with either efti combined with anti-PD-1 therapy or a triple combination approach including chemotherapy. Our confidence in efti’s ability in this important indication stems from the mature data in the large TACTI-002 Phase II trial, and the emerging data from the triple combination INSIGHT-003 study.”
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
FAQ
What is the feedback received by Immutep from the Paul-Ehrlich-Institut regarding the planned TACTI-004 Phase III trial of eftilagimod alpha for first line treatment of metastatic non-small cell lung cancer?
When does Immutep plan to announce its final trial design for TACTI-004?
What is the CEO's comment on the feedback from the PEI?
What is the significance of the PEI's support for Immutep's Phase III trial?
What is the significance of the acknowledgment of the good safety profile of efti in combination with anti-PD-1 therapy?
