Two ACTive Immunotherapies-003 (TACTI-003) is an active trial that has completed patient recruitment and is being conducted in collaboration with MSD (Merck & Co., Inc., Kenilworth, NJ, USA). TACTI-003 is a randomised, controlled Phase IIb clinical trial in First Line Head and Neck Cancer (1L HNSCC), which is evaluating the safety and efficacy of eftilagimod alfa (efti) in combination with MSD’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as a first line therapy in unresectable recurrent or metastatic HNSCC patients with PD-L1 positive (CPS ≥1) tumours (Cohort A) and PD-L1 negative (CPS <1) tumours (Cohort B). The primary endpoint is Overall Response Rate (ORR) according to RECIST 1.1. Secondary endpoints include OS and Progression Free Survival (PFS). Efti was granted Fast Track designation by the FDA for the treatment of 1L HNSCC in April 2021.

Two ACTive Immunotherapies-002 (TACTI-002) is a completed trial that was conducted in collaboration with MSD (Merck & Co., Inc., Kenilworth, NJ, USA). TACTI-002 is an all-comer study in terms of PD-L1 status evaluating the combination of eftilagimod alfa (efti) with MSD’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with first and second line non-small cell lung cancer (1L and 2L NSCLC, Parts A and B) and second line head & neck squamous cell carcinoma (2L HNSCC, Part C). This Phase II, Simon’s two-stage, non-comparative, open-label, single-arm, multicentre clinical study recruited patients across Australia, Europe, and the US, and completed enrolment in November 2021. Efti has received Fast Track status from the United States Food and Drug Administration (FDA) in 1L HNSCC and in combination with pembrolizumab in 1L NSCLC.

AIPAC-003 (Active Immunotherapy and PAClitaxel) is an active trial that has completed patient recruitment. This is an integrated Phase II/III trial to evaluate eftilagimod alfa (“efti”) in combination with paclitaxel for the treatment of metastatic HER2-neg/low breast cancer (MBC) and triple-negative breast cancer, an aggressive cancer with limited treatment options. Depending on the Phase II results, potential regulatory actions and resources, a randomized, double-blinded, placebo-controlled Phase III portion will then follow.

EFTISARC-NEO is an active trial that has completed patient recruitment. This open-label Phase II trial is evaluating efti in combination with pembrolizumab and radiotherapy in soft tissue sarcoma (STS) patients in the neoadjuvant (prior to surgery) setting. The investigator-initiated study is primarily funded by the Maria Skłodowska-Curie National Research Institute of Oncology with an approved grant from the Polish government awarded by the Polish Medical Research Agency program.

IMP761 is a first-in-class immunosuppressive lymphocyte-activation gene-3 (LAG-3) agonist antibody being evaluated in a placebo-controlled, double-blind first-in-human Phase I study. The study is actively recruiting participants and is being conducted by the Centre for Human Drug Research (CHDR), a world-class institute in Leiden, The Netherlands, specializing in cutting-edge early-stage clinical drug research. The study aims to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) in healthy volunteers.

IMP731 is Immutep’s LAG-3 depleting antibody that eliminates T cells to combat autoimmune diseases. This clinical-stage asset has been tested in a Phase II in active ulcerative colitis and a Phase I/Ib trial in psoriasis.