Pasithea Therapeutics announces in vivo preclinical efficacy data for PAS-004

Pasithea Therapeutics announced positive preclinical results from two in vivo studies evaluating the anti-tumor efficacy of PAS-004 in NRAS mutation cancer xenograft models. In the first study, PAS-004 exhibited dose-dependent anti-tumor efficacy in the lung cancer NCI-H1299 cell-line-derived xenograft model. PAS-004 at dose levels of 10 mg/kg and 5 mg/kg, once daily, significantly inhibited tumor growth as compared to vehicle control. The anti-tumor efficacy of PAS-004, when taken at equivalent doses was shown to be superior to that of binimetinib and selumetinib. In the second study, PAS-004 exhibited dose-dependent anti-tumor efficacy in the liver cancer xHepG2 cell-line-derived xenograft model. PAS-004 at dose levels of 10 mg/kg and 5 mg/kg, once daily, produced signigicant antitumor activities as compared to vehicle control. The anti-tumor efficacy of PAS-004, when taken at equivalent doses was shown to be similar to that of binimetinib and superior to that of selumetinib. These studies were conducted to provide further support of PAS-004 ahead of the Company’s planned first-in-human Phase 1 open-label dose escalation trial in patients with MAPK pathway-driven advanced solid tumors harboring RAS, RAF or NF1 mutations or patients who have failed BRAF/MEK inhibition. The Phase I study is expected to start as early as the first quarter of 2024, following acceptance of the Company’s Investigational New Drug Application with the FDA.