Friday, Aadi Bioscience Inc AADI released results from a planned interim analysis on the first third of participants in the ongoing tumor-agnostic PRECISION1 trial of nab-sirolimus in patients with TSC1 or TSC2 inactivating alterations.
H.C. Wainwright notes that nab-sirolimus achieved a 26% and 11% investigator-assessed objective response rate (ORR) in tumors-harboring TSC1 and TSC2 inactivating alterations, respectively; this is significantly lower than what was observed in the exploratory analysis of data from the AMPECT trial, wherein nine of 14 (64%) mTORi-naive TSC1/TSC2+ PEComa patients achieved a response.
Nevertheless, it’s important to highlight the highly advanced condition of these patient groups, potentially affecting the response rate negatively. H.C. Wainwright currently lacks information regarding the specific tumor types in which the responses were observed.
The drug candidate also achieved an ORR of 44% (4/9) in PEComa patients harboring TSC1 or TSC2 inactivating alterations previously exposed to mTOR inhibitors.
After reviewing the preliminary interim data from TSC1 and TSC2-altered solid tumors, alongside the historical benchmarks for tumor-agnostic approvals, and considering the probability of FYARRO being designated for later-line patients upon potential approval in a tumor-agnostic manner, H.C. Wainwright has downgraded the stock from Buy to Neutral.
Price Action: AADI shares are down 56.70% at $2.3250 on the last check Friday.