Purple Biotech Launches Phase 2 Trial for NT219 in Head and Neck Cancer Treatment

Purple Biotech has initiated a Phase 2 trial to evaluate NT219 in patients with head and neck cancer. The trial will assess the efficacy of NT219 when combined with pembrolizumab or cetuximab. NT219 targets oncogenic pathways IRS1/2 and STAT3, promoting degradation and inhibiting phosphorylation. The trial will also identify potential biomarkers for NT219.

Purple Biotech (NASDAQ/TASE: PPBT) has initiated a Phase 2 clinical study of NT219 in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). The study, conducted at the University of Colorado Anschutz Medical Campus, will evaluate NT219 in combination with either pembrolizumab or cetuximab [1]. NT219 is a novel small molecule that targets the IRS1/2 and STAT3 pathways, promoting degradation and inhibiting phosphorylation, respectively [2].

The Phase 2 trial employs a Simon 2-stage design with two treatment arms, initially enrolling 10 patients per arm with potential expansion to 29 patients per arm. The trial builds on promising Phase 1 results, which showed two partial responses and five stable disease cases when NT219 was combined with cetuximab [3]. The study aims to assess the efficacy of NT219 in combination with either pembrolizumab or cetuximab, both of which are standard-of-care treatments for R/M SCCHN patients.

The trial also focuses on identifying potential biomarkers for NT219, which could improve patient selection and increase response rates. The $5 billion projected market size for SCCHN treatments by 2030 indicates substantial commercial potential if NT219 demonstrates efficacy in this Phase 2 study [1].

References:
[1] https://www.stocktitan.net/news/PPBT/purple-biotech-announces-initiation-of-phase-2-study-of-nt219-in-u5sq2764o7cj.html
[2] https://www.gurufocus.com/news/2930633/purple-biotech-ppbt-kicks-off-phase-2-trial-for-nt219-in-head-and-neck-cancer-ilppbt-stock-news
[3] https://www.tipranks.com/news/the-fly/purple-biotech-announces-initiation-of-phase-2-study-of-nt219-thefly