REHOVOT, Israel - Purple Biotech Ltd. (NASDAQ/TASE: PPBT), a clinical-stage company focused on developing novel cancer therapies, has established the recommended Phase 2 dose (RP2D) for its drug candidate NT219 at 100mg/kg when combined with cetuximab for treating head and neck cancer. This determination follows the results from the Phase 1/2 dose escalation study, which evaluated the safety, pharmacokinetics, pharmacodynamics, and efficacy of the drug combination in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).
The study revealed that NT219, in combination with cetuximab, exhibited dose-dependent anti-tumor activity with confirmed partial responses and no reported dose-limiting toxicities. The RP2D was selected based on these findings and the pharmacokinetics of NT219 across all dose levels. As the Phase 1 dose escalation study concludes, the remaining patient data is expected to be reported in the first half of 2024.
Looking ahead, Purple Biotech plans to initiate a Phase 2 Proof of Concept study for NT219 in the treatment of recurrent and/or metastatic SCCHN. Detailed clinical results from the dose escalation phase of the study are slated to be presented at the European Society of Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Congress 2024 in Paris on February 26, 2024.
NT219 is characterized as a small molecule dual inhibitor of IRS1/2 and STAT3, targeting key pathways involved in tumor growth, drug resistance, and immune evasion. By inhibiting these pathways, NT219 has the potential to prevent the development of resistance to multiple approved therapies.
Purple Biotech's CEO, Gil Efron, expressed optimism about the drug's progress, stating the company's goal to establish NT219 as a standard of care for SCCHN patients who have not responded to first-line treatments.
The company's broader oncology pipeline includes additional drug candidates such as CM24 and IM1240, with ongoing development efforts and clinical studies.
The information in this article is based on a press release statement.
InvestingPro Insights
As Purple Biotech Ltd. (NASDAQ/TASE: PPBT) advances its clinical trials for NT219, investors and stakeholders may find the financial health and market performance of the company to be of particular interest. According to real-time data from InvestingPro, Purple Biotech holds a market capitalization of $16.73 million USD. The company's P/E ratio stands at -0.63, highlighting that it is not currently profitable. This is further emphasized by a negative operating income of $22.47 million USD over the last twelve months as of Q3 2023.
Two InvestingPro Tips that could be pertinent to the company's current situation are:
1. Purple Biotech is quickly burning through cash, which may raise concerns about long-term financial sustainability.
2. The company does not pay a dividend to shareholders, which is common for clinical-stage biotech companies that are focused on reinvesting earnings into research and development.
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