• Intellikine Inc., of La Jolla, Calif., said it treated the first patient in a Phase I study of INKN1117, a selective, orally available, small-molecule inhibitor of the PI3K-alpha isoform, in patients with advanced solid malignancies. The trial will consist of a dose-escalation phase, followed by expansion cohorts in breast cancer patients as well as in patients with other cancers whose tumors are characterized by a mutation of the PIK3CA gene.

• Thallion Pharmaceuticals Inc., of Montreal, said it is resuming patient enrollment in its Phase II SHIGATEC trial of Shigamabs in Shigatoxin-producing E. coli. The firm suspended testing in July after a preliminary product out-of-specification finding was observed during routine stability testing of the anti-Stx1 monoclonal antibody part of the drug. The 42-patient study is comparing a low dose of Shigamabs vs. standard of care in the first cohort, while the second cohort will compare standard of care combined with high dose of Shigamabs vs. standard of care combined with placebo. The primary endpoints are safety and tolerability. Secondary endpoints include pharmacokinetics and objective measures of efficacy using single and composite endpoints.