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Aadi Bioscience, Inc. (NASDAQ: AADI) is a commercial-stage precision oncology company focused on the development and commercialization of therapies for cancers with alterations in the mTOR pathway. The company's lead asset, FYARRO® (sirolimus albumin-bound nanoparticles for injectable suspension), is an mTOR inhibitor targeting cancers driven by genetic alterations in mTOR pathway genes. Aadi is committed to bringing transformational therapies to cancer patients with mTOR pathway driver alterations such as those in the TSC1 or TSC2 genes.
Aadi Bioscience has received FDA approval for FYARRO® for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). FYARRO® is designed to improve delivery, stability, solubility, and targeting compared to traditional mTOR inhibitors and is being evaluated in various clinical trials. The company's innovative approach combines nanoparticle albumin-bound (nab) technology with the potent mTOR inhibitor, sirolimus.
The company's clinical pipeline includes the Phase 2 PRECISION1 trial, a tumor-agnostic registration-intended study exploring nab-sirolimus in patients with solid tumors harboring TSC1 or TSC2 inactivating alterations. The trial is expected to complete enrollment by the end of 2024, with interim analysis anticipated in Q3 2024.
In addition to PRECISION1, Aadi is conducting two other Phase 2 trials: one in advanced or recurrent endometrioid-type endometrial cancer (EEC) in combination with letrozole, and another in neuroendocrine tumors (NETs). Endometrial cancer is a common type of gynecologic cancer, and nab-sirolimus has shown promise in combination therapies for these difficult-to-treat cancers.
Financially, Aadi's Q1 2024 revenue from FYARRO® sales reached $5.4 million, reflecting a strong market presence as the preferred treatment for malignant PEComa. The company's robust financial position, with $88.3 million in cash and short-term investments as of March 2024, is expected to fund operations into Q4 2025.
Headquartered in Los Angeles, Aadi Bioscience is led by a team of industry veterans with extensive experience in developing and commercializing blockbuster oncology products. The company's mission is to unlock the full potential of mTOR inhibition and bring hope to patients with genetically-defined cancers.
Aadi Bioscience, a biopharmaceutical company, announced the acceptance of abstracts for the 2023 ASCO Annual Meeting from June 2-6 in Chicago. The presentations will highlight updates from the PRECISION 1 Phase 2 study and combination data from an ongoing trial involving nab-sirolimus and pazopanib. Key poster details include:
- Title: Phase 2 multicenter trial of nab-sirolimus for patients with TSC1 or TSC2 gene alterations. Date: June 3, 2023, 8:00 AM-11:00 AM.
- Title: Phase I study of nab-sirolimus with pazopanib in advanced soft tissue sarcoma. Date: June 3, 2023, 1:15 PM-4:15 PM.
Aadi's FDA-approved product, FYARRO, targets advanced PEComa. The company aims to advance precision therapies for cancers driven by mTOR pathway alterations.
Aadi Bioscience (NASDAQ: AADI) announced three poster presentations at the 2023 American Association for Cancer Research (AACR) Annual Meeting, which runs from April 14-19 in Orlando, FL. The presentations include updates on the ongoing PRECISION 1 trial, which studies nab-sirolimus in patients with TSC1 or TSC2 gene alterations. Key highlights feature the anti-tumor efficacy of nab-sirolimus combined with KRAS inhibitors in xenograft models, and a biomarker analysis from the AMPECT trial correlating responses to nab-sirolimus with TSC1 and TSC2 mutations. The sessions are scheduled for April 17 and 18, showcasing the advancements in precision therapies for genetically defined cancers, reinforcing Aadi's commitment to innovative treatment solutions.
Aadi Bioscience, Inc. (NASDAQ: AADI) announced its participation at the American Association for Cancer Research (AACR) Annual Meeting 2023, scheduled from April 14-19, 2023 in Orlando, FL. The company will present three posters focusing on innovative cancer therapies linked to mTOR pathway genes. Key presentations include:
- Title: "Phase 2, multicenter, open-label basket trial of nab-sirolimus for patients with inactivating alterations in TSC1 or TSC2 (PRECISION I)" on April 17, 2023.
- Title: "Synergistic anti-tumor activity of nab-sirolimus in combination with KRAS inhibitors" on April 18, 2023.
- Title: "Biomarker analysis from AMPECT" on April 19, 2023.
Post-presentation, materials will be available on Aadi's investor relations page.
Aadi Bioscience (AADI) reported total revenue of $15.2 million from FYARRO® sales in FY 2022. The fourth quarter generated $5.2 million, showing a 23% sequential growth. The company announced a net loss of $60.5 million for 2022, improved from $110.1 million in 2021. A $72.5 million financing closed in Q4 extended the cash runway to 2025. The PRECISION 1 trial is progressing, with preliminary data expected in Q2 2023. Aadi also signed a collaboration with Mirati Therapeutics for a Phase 1/2 trial starting in Q2 2023.
Aadi Bioscience, Inc. (NASDAQ: AADI) has appointed Dr. Mohammad Hirmand to its Board of Directors. Dr. Hirmand brings over 20 years of experience in biotechnology and previously served as EVP and CMO at Turning Point Therapeutics, acquired by Bristol Myers Squibb for $4.1 billion in August 2022. His expertise in oncology and previous roles at Medivation and Peloton Therapeutics are expected to enhance Aadi's strategic direction, especially in advancing its FYARRO therapy beyond its current use for PEComa. The company is also conducting the PRECISION-1 trial for nab-sirolimus in mTOR-driven solid tumors.
Aadi Bioscience (NASDAQ: AADI) presented clinical data from its PRECISION 1 and AMPECT trials at the Society of Gynecological Oncology Annual Meeting 2023 in Tampa, FL, held from March 25-28, 2023. The company showcased two posters highlighting significant findings related to nab-sirolimus for treating solid tumors with mTOR pathway gene alterations. The PRECISION I trial focuses on a tumor-agnostic approach for patients with TSC1 or TSC2 alterations, while the AMPECT trial provides insights into responses in patients with primary uterine PEComa. Aadi continues its commitment to developing precision therapies for genetically defined cancers.
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