Purple Biotech Presents Data of its Phase 1 Head & Neck Cancer of NT219 in combination with Cetuximab at ESMO TAT Congress 2024

NT219 was well tolerated

Anti-tumor activity at relevant higher dose levels observed with 29% Objective Response Rate (ORR) and 71% Disease Control Rate (DCR)

REHOVOT, Israel, Feb. 27, 2024 (GLOBE NEWSWIRE) --   Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, today announced clinical results from its Phase 1/2 dose escalation study of NT219 in combination with cetuximab in the treatment of patients with recurrent/metastatic head and neck cancer (R/M SCCHN).

The data were presented at the European Society of Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Congress 2024 in Paris on Monday, February 26, 2024 by Dr. Ari Rosenberg,  Assistant Professor of Medicine at the University of Chicago, clinical investigator in the study, and member of Purple Biotech’s Head & Neck Cancer Scientific Advisory Board, in an oral presentation titled “Interim results of a Phase 1/2 trial of NT219 in combination with cetuximab in patients with advanced/metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)”.

The Phase 1/2 dose escalation study (NCT04474470) evaluated NT219 as a monotherapy in various indications and in combination with cetuximab in the treatment of R/M SCCHN and colorectal cancer.

As of cut-off date of January 25, 2024:

• Seventeen patients with R/M SCCHN were enrolled in the combination arm of NT219 + cetuximab. The median number of prior lines of therapy was 2 and 94% of the patients received prior immunotherapy.
   
• Safety profile was well tolerated and manageable including at 100 mg/kg. Most frequent treatment emergent adverse events (AEs) were infusion related reactions and nausea, and no treatment-related Grade 4/5 AEs were observed.
   
• Pharmacokinetic analysis demonstrated dose dependent increase in NT219 plasma concentrations.
   
• Fifteen patients were evaluable for efficacy, 7 of whom were at the relevant highest dose levels of 50 and 100 mg/kg in which anti-tumor activity was observed. Out of these 7 patients, 2 had confirmed partial responses and 3 stable diseases (all patients with partial response and stable disease have HPV negative disease), representing a 29% ORR and 71% DCR. Median follow-up across all dose levels is 9.4 months (95% CI: 3.4-10.0, 8 out of 15 patients remaining in follow up).

The Company recently reported NT219’s recommended Phase 2 dose of 100 mg/kg.