Phase 2 Dose Established for Purple Biotech's NT219

Purple Biotech, a clinical-stage company, is developing innovative treatments designed to tackle the challenge of tumor immune evasion and drug resistance. Their focus is on first-in-class therapies that leverage the tumor microenvironment to enhance the effectiveness of cancer treatments.

One of their leading candidates, NT219, is a novel small molecule that degrades Insulin Receptor Substrates 1/2 (IRS) and inhibits the phosphorylation of Signal Transducer and Activator of Transcription 3 (STAT3). These pathways are crucial in the development and progression of cancer, as well as in the development of resistance to various therapies. NT219's dual action on these pathways makes it a promising agent in the fight against cancer.

In a recent Phase 1/2 study, Purple Biotech identified 100mg/kg as the recommended Phase 2 dose for NT219 when combined with cetuximab for treating head and neck cancer. The study was an open-label dose escalation designed to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of the combination therapy in patients with previously treated recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). The data showed dose-dependent anti-tumor activity with confirmed partial responses and no dose-limiting toxicities reported.

The company is now preparing for a Phase 2 Proof of Concept study for NT219 in the treatment of R/M SCCHN. The results from the dose escalation portion of the study are expected to be presented at the ESMO TAT Congress 2024 in Paris, highlighting the interim outcomes of the Phase 1/2 trial.

Purple Biotech's pipeline also includes CM24, a humanized monoclonal antibody that targets CEACAM1, an immune checkpoint protein that aids in tumor immune evasion and survival. The company is advancing CM24 in combination with anti-PD-1 checkpoint inhibitors for the treatment of pancreatic ductal adenocarcinoma (PDAC) and has partnered with Bristol Myers Squibb for Phase 2 clinical trials.

Additionally, Purple Biotech is developing a preclinical platform of conditionally-activated tri-specific antibodies designed to engage both T cells and NK cells, aiming to induce a strong, localized immune response within the tumor microenvironment. Their technology is innovative in that it confines therapeutic activity to the local tumor area, potentially increasing the therapeutic window for patients.

IM1240, another asset in their pipeline, is a tri-specific antibody targeting the Tumor Associated Antigen (TAA) 5T4, which is expressed in various solid tumors and is associated with advanced disease and poor outcomes. The company's headquarters are located in Rehovot, Israel.

As a clinical-stage company, Purple Biotech is committed to advancing its pipeline and bringing new therapeutic options to patients in need. Their approach to cancer treatment, targeting both the tumor and its microenvironment, positions them at the forefront of innovative oncology research.