On February 27, 2024 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, reported 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) (Press release, Purple Biotech, FEB 27, 2024, View Source [SID1234640530]).

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The data were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 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.

"We were encouraged to see anti-tumor activity in HPV negative patients," said Dr. Michael Schickler, Purple Biotech’s Head of Clinical and Regulatory Affairs. "There is an unmet medical need for patients in second- and third-line R/M SCCHN, most of them having HPV negative disease, with relatively short survival of less than nine months. NT219 should continue to be tested to establish better treatment options for this patient population."

"These positive data support our path forward for NT219 as we plan to initiate a Phase 2 study in combination with cetuximab in head and neck cancer in the first half of 2024," stated Gil Efron, Chief Executive Officer of Purple Biotech. "We thank the study participants, their families, and clinical researchers for participating in this important study."

About NT219

NT219 is a first-in-class, small molecule that promotes Insulin Receptor Substrates 1/2 (IRS) degradation and inhibits Signal Transducer and Activator of Transcription 3 (STAT3) phosphorylation, two major complementary signaling pathways that play a key role in the tumor and its microenvironment. IRS1/2 acts as scaffolds, organizing signaling complexes that mediate mitogenic, metastatic, angiogenic, and anti-apoptotic signals from IGF1R and other oncogenes, consisting of an important driver in multiple cancers and is highly involved in triggering drug resistance. STAT3 is a transcription factor that is broadly hyperactivated in many cancers, promoting proliferation, survival, angiogenesis, metastasis, and tumor immune evasion. Feedback activation of STAT3 plays a prominent role in mediating drug resistance to various anti-cancer therapies. As an inhibitor of both IRS1/2 and STAT3, NT219 has the potential to prevent the development of resistance to multiple approved therapies.