Why Is Anti-Cancer Focused Aadi Bioscience Stock Trading Lower Today?

Aadi Bioscience Inc AADI shares are trading lower after the company 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. 

The interim analysis includes data from the first third of trial participants (n=40) with a minimum of 4.5 months of follow-up, including investigator-assessed response and safety analyzed separately in each TSC1 and TSC2 arms. 

Efficacy of nab-sirolimus in patients with tumors harboring pathogenic inactivating alteration in TSC1

• A 26% Overall Response Rate (ORR), including five partial responses (PR) with four confirmed responses and one unconfirmed response (uPR).
• All responses were ongoing at the time of data cutoff. The patient with uPR remains on treatment and is awaiting a confirmatory scan.
• Nine patients had stable disease (SD), 3 of which were greater than or equal to six months in duration, resulting in a clinical benefit rate of 42%.
• 60% of responders experienced > 50% tumor reduction.

Efficacy of nab-sirolimus in patients with tumors harboring pathogenic inactivating alteration in TSC2

• An 11% ORR, including 2 PRs with one confirmed and one uPR.
• Twelve patients had SD, 3 of which were greater than or equal to six months, resulting in a clinical benefit rate of 28%.
• Responses were seen in one epithelial carcinoma and one sarcoma.

No new safety signals were observed, and no grade-four treatment-related events or deaths occurred.

Eighty patients are enrolled in the PRECISION1 trial, supporting the two-thirds interim analysis expected in Q3 of 2024. The ORR analysis in this cohort will be based on an independent radiological review with at least six months of follow-up for all patients. 

The trial is expected to be completed by the end of 2024, with results anticipated in early 2025.

Price Action: AADI shares are down 56.24% at $2.35 during the premarket session on the last check Friday.