Keeping the Faeth in PIKTOR - NDR Download

Research evidence excerpt

Keeping the Faeth in PIKTOR - NDR Download

June 18, 2026

●The breast cancer Ph1b/2 study is guided to readout in 2027. An

ORR of 30% would be considered good in this setting and Faeth is

deliberately combining with palbociclib and fulvestrant to demonstrate

comparability with gedatolisib, which was combined with the same

drugs.

●While palbociclib and fulvestrant are two of the current backbones

of breast cancer therapy targeting CDK4/6 and estrogen receptor

signaling, respectively, Faeth believes these drugs might be overhauled

in the future. As such, this combination might not necessarily be taken

into a pivotal Ph3 trial.

●Faeth is also working with the same CRO that Celcuity used for

its VIKTORIA-1 study of gedatolisib in HR+/HER2- breast cancer.

Anecdotoally, mgmt. sensed excitement for an oral option from its

interactions with the CRO and investigators.

PIKTOR inhibitors were developed independently, so some contribution

of parts questions remain to be addressed

●Sapanisertib (mTOR) and serabelisib (PI3Kα) came to Faeth from

Intellikine by way of Takeda. Past development attempts were

conducted by independent clinical development teams. The two drugs

were never put together and were also dosed at higher doses and

frequencies vs. PIKTOR.

●In breast cancer, sapanisertib has demonstrated efficacy in

combination with fulvestrant in a fulvestrant-controlled trial.

Serabelisib was trialed as monotherapy and showed some early

evidence of activity. As such, Faeth believes it has a good basis to

address the contribution of components in breast cancer.

●Sapanisertib has shown efficacy in combination with paclitaxel in

a randomized Ph2 in ovarian cancer, which helps the PIKTOR +

paclitaxel combination in endometrial to an extent. Faeth is planning