On December 6, 2021 Purple Biotech (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies by overcoming tumor immune evasion and drug resistance, reported the initiation of Part 2 of its ongoing Phase 1/2 clinical trial of NT219, a novel small molecule inhibiting simultaneously IRS1/2 and STAT3, for the treatment of multiple cancers (Press release, Purple Biotech, DEC 6, 2021, View Source [SID1234596503]). Part 2 is a dose escalation study of NT219, beginning with 6mg/kg, in combination with the standard dose of cetuximab (ERBITUX), in patients with recurrent or metastatic squamous cell carcinoma of head and neck cancer (SCCHN) or colorectal adenocarcinoma.
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The monotherapy portion of the study, Part 1, is progressing as planned, and is now dosing patients with advanced solid tumors in the 24mg/kg cohort. To date, no drug limiting toxicities have been observed in the trial, and NT219 has been found to be well-tolerated with minimal serious adverse events.
Initial efficacy data previously reported from the first dose level in Part 1, and additional efficacy signals in the following two cohorts, support the immediate extension of the study to Part 2 of the study, dosing NT219 at its recommended Phase 2 dose in combination with cetuximab in patients with recurrent or metastatic SCCHN, as well as the potential expansion of the clinical program to new indications, which is anticipated to commence during the second half of 2022.
Additional preliminary efficacy data from Part 1 of the trial is expected to be presented at a medical meeting in the first half of 2022.
"The advancement of our ongoing Phase 1/2 clinical trial to Part 2 represents an important achievement for our NT-219 clinical development program," said Michael Schickler, Ph.D., Head of Clinical and Regulatory Affairs of Purple Biotech. "We are encouraged by the initial signals of efficacy, as well as safety trends, observed in Part 1 of the study to date. We look forward to the availability of additional preliminary efficacy data from Part 1 of the study in the first half of 2022, as well as to the further advancement of our development program to Part 2 of the study, and to the potential expansion of the clinical program into other unmet cancer indications, in the second half of 2022."