Product Pipeline

Pathway Therapeutics is developing multiple programs targeting PI3K/mTOR kinase family members important in cancer, inflammation, and respiratory diseases.

The most advanced program, which is in Phase 1 testing, is a PI3K alpha/mTOR inhibitor for solid tumors. Pathway Therapeutics is also developing PI3K delta inhibitors for hematological malignancies, inflammatory and respiratory diseases.

PWT33597 (PI3K alpha/mTOR)

PWT33597 demonstrates excellent in vitro selectivity for its targets, with negligible activity against other lipid kinases, protein kinases and other pharmacologically relevant targets at biologically active concentrations. The compound achieves good distribution into tumors, robust pathway inhibition and excellent oral efficacy in multiple xenograft across varying genetic backgrounds. PWT33597 has an excellent DMPK and safety profile and is an attractive candidate for use as single agent and combination therapy.

The first clinical study for PWT33597 is a dose escalation study to evaluate the safety, tolerability and pharmacokinetics in patients with advanced solid tumors. The Phase 1 study will also evaluate pharmacodynamic correlation between PWT33597 exposure and markers of the PI3K/mTOR pathway in tumors and surrogate tissues. After the maximum tolerated dose, has been reached, the Phase 1 program will be expanded to measure activity in specific tumor types with PI3K/mTOR pathway dysregulation.

PI3K delta

PI3K delta, expressed exclusively in leukocytes, is a clinically validated target for hematological malignancies. PI3K delta is also strongly implicated in multiple inflammatory/autoimmune, allergic, and respiratory disorders. Using a proprietary scaffold and with clear insight into structure activity relationship, Pathway has developed potent (low nM) and selective (>100X) PI3K delta inhibitors with good PK/ADME properties. Pathway is rapidly progressing its PI3K delta inhibitor program which is currently in pre-clinical development.