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Qualigen Therapeutics will acquire intellectual property rights to the family of RAS-targeting small molecules and pay royalties to Louisville upon commercialization.
The study will evaluate the safety, tolerability and clinical activity of JSI-1187 in patients with relapsed, refractory solid tumors containing mutations in the MAPK pathway.
Early sub-protocol results presented at AACR meeting hint at better outcomes for Mektovi-treated cases with NRAS codon 61 tumor mutations.
In a study published in the Journal of Clinical Oncology, partial responses were observed in patients with BRAF V600-mutated and KRAS-mutated solid tumors.
The study will evaluate the effects of investigational drug IN10018 as a monotherapy and in combination with a MEK inhibitor.
The findings should spur cancer centers to review testing rates and address barriers, said experts from Hackensack University, Cota Healthcare, and Guardant Health.
Keytruda and Ibrance demonstrate activity in molecularly defined populations, while a new cohort will explore Gilotrif in tumors with NRG1 fusions.
The assay can identify KRAS, NRAS, PIK3CA, BRAF, and EGFR gene mutations, as well as 19 gene rearrangements of the ALK, ROS1, RET, NTRK1, and MET genes from FFPE.
The draft document, which includes recommendations on which molecular tests labs should perform, on what samples, and with what analytical specifications, is available for comment until April 22.