Not even a year since it named Dave Lennon as CEO, Aadi Bioscience is facing major headwinds as it pulls back from a series of trials of its only cancer asset and cuts a majority of its staffers.
The California biotech said it is ending a mid-stage trial of its cancer candidate, dubbed nab-sirolimus, in people with solid tumors who have TSC1 or TSC2 inactivating alterations.
The 120-subject Phase 2 PRECISION1 study “fell short of delivering what we believe would be required to support an accelerated approval,” the company said in a Tuesday release. The 25 subjects “who are still benefiting” from the drug will be able to move to an expanded access program.
The company’s shares $AADI dropped 27% premarket Wednesday.
Aadi is also pausing enrollment in separate Phase 2 trials of nab-sirolimus in advanced or recurrent endometrioid-type endometrial cancer (EEC) and neuroendocrine tumors. The trials will still dose the 20 EEC patients and 10 NET subjects already enrolled in the studies. The EEC study aimed to have a total of 29 patients, while the NET trial had a 21-patient target.
A complete analysis of PRECISION1 will be shared at a later date, Aadi said. Initial efficacy analyses of the other two trials are expected later this year.
Nab-sirolimus is an mTOR inhibitor. TSC1 and TSC2 inactivation upregulates the mTOR pathway, which plays an important role in the proliferation and survival of cancer cells.
In an effort to save cash, the company plans to cut its R&D workforce by 80%. It had 48 full-time employees in R&D as of June. These changes should extend the company’s cash runway into at least the second half of 2026. It had $78.6 million in cash, equivalents and short-term investments at the end of June.
In October, Lennon joined as CEO from his former role as chief exec at the tissue therapeutics startup Satellite Bio.
Nab-sirolimus won FDA approval in November 2021 and has the brand name Fyarro for a type of ultra-rare sarcoma called advanced malignant PEComa. The drug made $6.2 million in the second quarter, up 15% from the first three months of the year, according to the company.