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Immutep Limited (NASDAQ: IMMP) is a globally active biotechnology company focusing on the development of innovative immunotherapy products for cancer and autoimmune diseases. Listed on both the Australian Stock Exchange and the Nasdaq Global Market in the U.S., Immutep is at the forefront of personalized bio-therapeutic treatment options.
At the core of Immutep's research and development is the LAG-3 immune control mechanism, crucial for the regulation of the T cell immune response. The company's flagship product, IMP321, a T cell immunostimulatory factor (APC activator), has completed Phase II clinical trials for cancer chemo-immunotherapy. This product is designed to enhance the body's immune response to cancer, providing a novel treatment option for patients.
In addition to IMP321, Immutep is advancing several other LAG-3 related products. These include IMP701, a blocking anti-LAG-3 antibody for cancer currently in Phase I clinical trials, and CVac, a personalized immunocellular therapeutic being investigated for the treatment of epithelial cancer. The development of these products is supported through partnerships with large pharmaceutical companies, aiming to accelerate the availability of these innovative treatments.
Immutep's operations are headquartered in Australia, with the majority of its revenue derived from product sales. The company remains committed to maximizing shareholder value through its technological expertise and robust pipeline of products.
For investors, Immutep represents a significant opportunity in the biotechnology sector, with its cutting-edge research and promising clinical advancements poised to make a substantial impact on cancer and autoimmune disease treatment.
Immutep announced a Phase III clinical trial collaboration with MSD to evaluate eftilagimod alfa (efti) combined with KEYTRUDA® (pembrolizumab) and chemotherapy in treating first-line metastatic non-small cell lung cancer (NSCLC).
The TACTI-004 trial will involve 750 patients regardless of PD-L1 expression. Under the agreement, Immutep will conduct the trial, and MSD will supply KEYTRUDA. Immutep retains commercial rights to efti.
Past trials have shown promising efficacy and safety of the combination therapy. This trial aims to confirm these benefits and potentially set a new standard of care for NSCLC.
Immutep presented promising data from the safety lead-in phase of their AIPAC-003 Phase II/III trial at the ESMO Breast Cancer Congress 2024. The trial, combining 90mg efti with paclitaxel, showed a 50% overall response rate and a 100% disease control rate in six metastatic breast cancer patients. Notably, one patient achieved a complete response which is ongoing with efti monotherapy. The combination has been well tolerated with no severe adverse events. Higher efti concentrations were observed, remaining pharmacologically active up to 96 hours post-administration. The randomized Phase II portion continues, with more data expected in 2024.
Immutep has reported positive initial clinical data from the Phase II EFTISARC-NEO trial, combining efti with radiotherapy and pembrolizumab in soft tissue sarcoma patients. The trial showed very good pathologic responses rarely seen with standard therapies, with 67% of patients having near-complete responses. This novel triple combination was well tolerated, with no new safety concerns.
Immutep provides an update on its product candidates development, including positive clinical data in breast cancer and head and neck squamous cell carcinoma patients, progress in various phase II and III trials, appointment of a new director, and financial summary. The Company remains well-funded with a cash balance of approximately $95.4 million as of March 31, 2024.
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