Purple Biotech Advances NT219 in the Treatment of Head and Neck Cancer, Reaching Recommended Phase 2 Dose
REHOVOT, Israel, Feb. 01, 2024 - Purple Biotech Ltd. (Purple Biotech or the Company) (NASDAQ/TASE: PPBT), a pioneer in developing groundbreaking therapies that target the tumor microenvironment, has recently achieved a significant milestone in the treatment of head and neck cancer. The company has confirmed that the recommended Phase 2 dose (RP2D) for NT219, in combination with cetuximab, has been determined to be 100mg/kg. This breakthrough announcement is based on Purple Biotech’s successful Phase 1/2 dose escalation study (NCT04474470).
NT219, a first-in-class small molecule dual inhibitor of IRS1/2 and STAT3, holds remarkable potential in overcoming tumor immune evasion and defeating drug resistance. The tumor microenvironment often aids in the tumor’s ability to evade the immune system, making it difficult for standard treatments to effectively combat cancer. Purple Biotech’s innovative approach harnesses the power of the tumor microenvironment to address these challenges.
The Phase 1/2 dose escalation study consisted of carefully monitoring and evaluating patient responses at different dosage levels of NT219 in combination with cetuximab. By systematically increasing the dosage, the study aimed to identify the RP2D that achieves optimal efficacy and safety profiles. The results were both promising and encouraging.
Having defined the optimal dosage, Purple Biotech has achieved a critical milestone in its mission to revolutionize the treatment of head and neck cancer. This significant breakthrough positions NT219 and cetuximab combination therapy as a potential game-changer in addressing the unmet medical needs in this challenging disease.
Dr. Marianne Rodriguez, Chief Medical Officer at Purple Biotech, expressed her excitement regarding the study findings. Determining the recommended dose for NT219 in combination with cetuximab marks a notable achievement for Purple Biotech, she stated. By leveraging the untapped potential of the tumor microenvironment and targeting regulatory proteins involved in tumor immune evasion, we have the opportunity to transform the treatment landscape of head and neck cancer.
The Phase 1/2 dose escalation study for NT219 was designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of this novel therapeutic combination. As the study continues, Purple Biotech’s research team remains optimistic about providing patients and physicians with an innovative treatment strategy that addresses tumor resistance and significantly improves patient outcomes.
With this breakthrough, Purple Biotech has demonstrated its dedication to advancing precision medicine solutions for cancer treatment. By harnessing the tumor microenvironment’s potential, the company is revolutionizing the approach to tackle resistance mechanisms and immune evasion, paving the way for a new era in cancer therapeutics.

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