The FDA and IRB Approves the Initiation of Phase IIb TACTI-003 Trial by Immutep Limited (NASDAQ: IMMP) in the United States

It is imperative to harness and strengthen the power of the body’s immune system. This means embracing therapeutic intervention, perhaps through the use of immunotherapy treatments. Within its operations of developing novel LAG-3 related to such treatments, Immutep Limited (NASDAQ: IMMP) has announced the approval by the FDA for the commencement of a phase IIb TACTI-003 trial in the United States.

Phase IIb TACTI-003 will be evaluating the efficacy of the company’s lead product candidate, eftilagimod alpha, as first-line therapy for patients with Head and Neck Squamous Cell Carcinoma (HNSCC). It will have a combination of MSD’s KEYTRUDA® (pembrolizumab). This lead product received a Fast Track designation from the FDA to treat 1st line HNSCC patients in April. 

The randomized, controlled clinical study will take place across Europe, Australia, and the US is up to 35 clinical sites. The estimate to have 130 patients in cohort A. They will receive either efti plus pembrolizumab or pembrolizumab alone. In comparison, another 24 patients in cohort B will receive a combination of efti and pembrolizumab. However, the recruitment of trial subjects is expected to take off any time within this quarter. Meanwhile, Immutep is working on increasing its recruitment sites. 

Immutep’s Collaboration with Cardiff University

The globally active biotechnology company is also premier in the development of LAG-3 related immunotherapeutic products. It has established a collaboration with Cardiff University, a UK Russell Group University, to advance the discovery and development of a new cohort of small molecule anti-LAG-3 therapies. Meanwhile, the primary aim is to avail oral treatment to cancer patients at a lower cost than the current anti-LAG-3 antibodies.

With the recent endorsement of LAG-3 by the pharma industry, “… Never has there been a more exciting time to explore new ideas to control the interaction between LAG-3 and MHC class II molecules….” Immutep CEO Marc Voigt added that they could already see some thrilling early results from the joint efforts. 

This is not the first collaboration Cardiff University has in respect of the anti-LAG-3 therapies. It has another with Monash University and has demonstrated a profound impact on the LAG-3 landscape. 

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