Spectrum, Hanmi Pharmaceutical’s U.S. partner, said Tuesday that it plans to publish the trial results for Poziotinib, a non-small-cell lung cancer treatment, on Nature Medicine, an international medical journal.
The report will entail preclinical and clinical trials regarding Poziotinib for EGFR and HER2 exon 20 mutated non-small cell lung cancer conducted at MD Anderson Cancer Center in the U.S. Epidermal growth factor receptor (EGFR) is a transmembrane protein. Mutations affecting EGFR expression could lead to cancer.
MD Anderson Cancer Center will implement a 3D modeling of the exon 20 mutation and describe the superior pharmacodynamic principles of Poziotinib. According to 3D modeling studies, the exon 20 mutation has a size restriction on the drug-binding site, which is not likely to be effective in the case of conventional drugs with large binding sites or inflexibility. Hanmi’s medicine is small in size and flexible and has excellent efficacy to do so, however.
Also, Poziotinib showed superior pharmacological activity in patient-derived xenograft and genetically engineered mice (GEM) models compared to conventional EGFR TKI therapies. The study also confirmed an overall response rate (ORR) of 64 percent in 11 patients, and although the data is 6.6 months before the time of publication in the journal, the team has still not obtained a median for progression-free survival (PFS).
The center had previously presented an updated data at the World Conference on Lung Cancer (WCLC) in 2017.
“We are pleased to publish the clinical results of Poziotinib in a prestigious international journal,” Spectrum CEO Joe Turgeon said. “In the absence of a therapeutic alternative to the exon 20 mutated non-small cell lung cancer patient, this publication has shown the potential of Poziotinib as a promising treatment.”
Spectrum will work closely with its partners, medical staff and licensing authorities to spur the development of Poziotinib, Turgeon added.
MD Anderson Cancer Center has almost completed enrolling patients for the EGFR cohort study related to the phase 2 clinical trials. Spectrum is currently recruiting patients participating in phase 2 clinical trials in more than 20 U.S. institutions and plans to expand to other countries, including the United States.
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