Sensei Biotherapeutics announced that the first patient was dosed in its Phase 1b/2 study (FTH‑PIK‑101, NCT07558733) of PIKTOR, an all‑oral combination of serabelisib and sapanisertib that targets the PI3K/AKT/mTOR pathway in HR⁺/HER2⁻ advanced breast cancer.
PIKTOR became Sensei’s lead program after the company acquired Faeth Therapeutics in February 2026. In a prior Phase 1b trial of PIKTOR plus paclitaxel, the combination achieved an overall response rate of 47 % in response‑evaluable patients and 71 % in those with PI3K‑pathway mutations, including three complete responses in endometrial cancer patients.
The first‑in‑human dosing milestone advances Sensei’s pipeline by providing the first safety, tolerability and preliminary efficacy data in a patient population with limited treatment options. The dual PI3Kα/mTORC1/2 inhibition strategy is designed to overcome resistance seen with single‑node inhibitors, and the trial targets a large cohort of tumors that frequently harbor PI3K‑pathway alterations.
Sensei’s financial position underscores the importance of this development. The company has reported no revenue and significant net losses, but it secured a $200 million private‑placement financing in February 2026 to fund its clinical programs, including the PIKTOR breast cancer trial.
Chief Operating Officer Anand Parikh noted that “In our earlier trial, patients who had exhausted multiple lines of therapy, including chemotherapy, responded to the PIKTOR plus paclitaxel combination, and several had complete responses.” He added that “PIK‑101 now takes that same oral combination into breast cancer, where a large share of tumors carry the pathway alterations that PIKTOR is designed to target.”
The milestone positions Sensei to evaluate a potentially transformative therapy in a high‑need patient population, while the recent financing provides the necessary capital to advance the program through later‑stage development.
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