Immutep (formerly known as Prima Biomed) Limited (ASX: IMM; NASDAQ: IMMP) is thrilled to announce it has received a positive response from the US Food and Drug Administration (FDA) regarding its late-stage clinical development plans for its pioneering soluble LAG-3 protein and MHC Class II agonist, eftilagimod alpha (“efti”), to treat 1st line non-small cell lung cancer (NSCLC). This revolutionary immunotherapeutic could pave the way for a new era of cancer treatment.
At the 37th Annual Society of Immunotherapy of Cancer (SITC) Meeting in November 2022, a late-breaking oral abstract presentation showcased encouraging data from the Phase II TACTI-002, Part A (N=114) trial in 1st line NSCLC patients, regardless of PD-L1 expression.
In response to these positive results, the FDA has expressed support for a registrational trial to evaluate efti in combination with an anti-PD-1 therapy. This is an exciting step forward in the fight against cancer.
At the meeting, we discussed the toxicological package and trial design, with a focus on first-line non-small cell lung cancer patients with a Tumor Proportion Score (TPS) PD-L1 of greater than 1%. This trial, dubbed TACTI-004 (Two ACTive Immunotherapies), has already received Fast Track designation. We also discussed its potential patient population, as well as statistics and general aspects of the trial design.
Marc Voigt, CEO of Immutep, was thrilled to receive positive feedback from the FDA following their meeting and discussed the compelling clinical data generated by efti in combination with anti-PD-1 therapy. This is an essential step in the late-stage development process for 1st line non-small cell lung cancer, and it’s a huge step forward in finding a unique immuno-oncology approach to help those suffering from this devastating disease.
Dr. Frédéric Triebel, CSO of Immutep expressed his enthusiasm for the successful dialogue with the FDA, paving the way for the utilization of efti in non-small cell lung cancer. This collaboration represents a major breakthrough in the development of revolutionary immunotherapy treatments for a wide range of cancer patients, as well as a significant opportunity to provide more effective, tolerable, and long-lasting relief.
About Eftilagimod Alpha (Efti)
Immutep’s Efti is a groundbreaking soluble LAG-3 protein and MHC Class II agonist designed to kickstart both innate and adaptive immunity for the treatment of cancer. This first-in-class antigen presenting cell (APC) activator binds to MHC (major histocompatibility complex) Class II molecules on APC, prompting the activation and proliferation of a powerful suite of immune cells, including CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. In addition, Efti ramping up the expression of essential molecules like IFN-ƴ and CXCL10, creating an even more formidable immune response that can take on cancer.
Efti is being evaluated as a potential treatment for solid tumors, including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and HER2–/HR+ metastatic breast cancer.
Due to its favorable safety profile, Efti can be combined with anti-PD-[L]1 immunotherapy and/or chemotherapy, making it a highly attractive treatment option. The US Food and Drug Administration has granted Fast Track Designation to Efti in 1st line HNSCC and 1st line NSCLC, further emphasizing its potential.
About Immutep
Immutep is an ambitious biotechnology company with a mission to revolutionize cancer and autoimmune disease treatment. Using their cutting-edge LAG-3-related immunotherapy products, they are striving to bring innovative solutions to the market that will benefit both patients and shareholders. With their focus on research and development, Immutep is on a path to make a lasting impact in the healthcare industry.
Immutep’s groundbreaking lead product candidate, eftilagimod alpha (“efti” or “IMP321”), is a first-in-class soluble LAG-3 fusion protein (LAG-3Ig) that activates antigen presenting cells (APCs). This revolutionary development is being explored in cancer treatment and is being trialled in multiple clinical studies.
As well as this, the company is also developing IMP761, an agonist of LAG-3 targeted at autoimmune diseases. Not only that, but Immutep has licensed additional LAG-3 product candidates, such as antibodies for immune response modulation, to major pharmaceutical firms for further development.