TSC2

Kazia Therapeutics licenses paxalisib to Sovargen for intractable seizures in rare central nervous system diseases

Retrieved on: 
Thursday, March 21, 2024
TSC, PI3K, TSC1, Epilepsy, Brain, FCD, Central nervous system, Patient, CNS, Seizure, KZIA, TSC2, Pharmaceutical industry

Paxalisib is an oral dual inhibitor targeting both PI3K and mTOR within this pathway, and it is distinguished by its ability to penetrate the brain.

Key Points: 
  • Paxalisib is an oral dual inhibitor targeting both PI3K and mTOR within this pathway, and it is distinguished by its ability to penetrate the brain.
  • Although FCD T2 and TSC are rare orphan diseases, they represent a high medical unmet need with significant market opportunity.
  • The licensing agreement includes all countries worldwide, excluding mainland China, Hong Kong, Macao and Taiwan, which Kazia retains.
  • Our license with Sovargen provides us the ability to explore the impact of paxalisib outside of our area of expertise where there is substantial patient need and market opportunity.

Aadi Bioscience Presents New Subgroup Analysis of Patients with Advanced Malignant PEComa of Gynecologic Origin Treated with nab-Sirolimus at Society of Gynecologic Oncology (SGO)

Retrieved on: 
Sunday, March 17, 2024
TSC1, Ovarian cancer, AADI, Endometrial cancer, Perivascular epithelioid cell tumour, EEC, Cervical cancer, Patient, Neoplasm, Cancer, Trial of the century, University, SGO, MD, Malignancy, Society, Safety, Gynecologic Oncology (journal), TSC2, FDA, Glomus tumor, Aadi, Pharmaceutical industry

LOS ANGELES, March 17, 2024 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage precision oncology company focused on developing and commercializing therapies for cancers with alterations in the mTOR pathway, today announced patients in the AMPECT trial whose malignant perivascular epithelioid cell tumor (PEComa) had gynecologic origins experienced efficacy and safety consistent with the overall study population. The AMPECT trial formed the basis for the FDA approval of the company's nab-sirolimus, FYARRO®, for advanced malignant PEComa regardless of mutational status. This new subgroup analysis will be presented during an oral plenary at the Society of Gynecologic Oncology (SGO) Annual Meeting in San Diego, CA on March 17, 2024.

Key Points: 
  • The AMPECT trial formed the basis for the FDA approval of the company's nab-sirolimus, FYARRO®, for advanced malignant PEComa regardless of mutational status.
  • This new subgroup analysis will be presented during an oral plenary at the Society of Gynecologic Oncology (SGO) Annual Meeting in San Diego, CA on March 17, 2024.
  • "Overactivation of the mTOR pathway has been implicated in gynecological cancers," said Loretta Itri, MD, Chief Medical Officer at Aadi.
  • "nab-Sirolimus is a nanoparticle albumin-bound (nab) mTOR inhibitor under investigation in TSC1- and TSC2-mutated tumors as well as other mTOR-driven tumors.

Aadi Bioscience Announces Poster Presentations at the 2024 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium

Retrieved on: 
Friday, January 26, 2024
Patient, PST, Prostate cancer, Carcinoma, Bladder cancer, ASCO, Team Impulse, Society, TSC1, Urethra, GU, TSC2, Progress, Kidney cancer, Cancer

LOS ANGELES, Jan. 26, 2024 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for patients with mTOR pathway alterations, today announced poster presentations at the 2024 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, taking place January 25-27, 2024, in San Francisco, CA.

Key Points: 
  • LOS ANGELES, Jan. 26, 2024 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for patients with mTOR pathway alterations, today announced poster presentations at the 2024 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, taking place January 25-27, 2024, in San Francisco, CA.
  • Abstract and poster presentation details are below:
    Date/Time: January 26, 2024 – 11:30 – 1:00 pm; 5:45 – 6:45 pm PST
    In a large real-world database of patients with advanced cancer, 1,828 (4.0%) of the 46,068 patients with GU cancers had at least one inactivating alteration in TSC1 or TSC2
    TSC1 and/or TSC2 inactivating alterations were present in 9.2% of patients with bladder cancer, 6.4% of patients with kidney cancer, and 0.6% of patients with prostate cancer
    Aadi is also presenting an encore Trials-in-Progress (TiP) poster from the ongoing PRECISION 1 study.
  • Session Title: Trials in Progress Poster Session C: Renal Cell Cancer: Adrenal, Penile, Urethral and Testicular Cancers
    Date/Time: January 27, 2024 – 7:00 – 8:00 am; 11:30 am – 1:00 pm PST

Aadi Bioscience Announces Poster Presentations at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium

Retrieved on: 
Friday, January 19, 2024
MSI, Patient, Pancreas, Cancer, Research, MSS, ASCO, Diagnosis, Lunch, Team Impulse, Society, TMB, TSC1, NET, Gastrointestinal tract, Liver, TSC2, Progress, Colorectal cancer, GI, Pharmaceutical industry

LOS ANGELES, Jan. 19, 2024 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for patients with mTOR pathway alterations, today announced poster presentations at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium, taking place January 18-20, 2024, in San Francisco, CA. 

Key Points: 
  • LOS ANGELES, Jan. 19, 2024 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for patients with mTOR pathway alterations, today announced poster presentations at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium, taking place January 18-20, 2024, in San Francisco, CA.
  • Abstract and poster presentation details are below:
    In a large real-world database of patients with advanced cancer, 1,898 (1.4%) of the 138,671 patients with GI cancers harbored at least one known or likely inactivating alteration in TSC1 or TSC2
    TSC1 and/or TSC2 inactivating alterations were present in 6.8% of liver cancers, 1.6% of colorectal cancers, and 0.5% of pancreatic cancers
    Most TSC1 and/or TSC2 inactivating alterations in liver and pancreatic cancers occurred in the context of low TMB and MSS tumors; whereas increased TMB and MSI signatures were enriched in colorectal cancer with TSC1 and/or TSC2 alterations
    Limitations of this exploratory, real-world study include the timing of sampling (at initial diagnosis vs disease progression) and the absence of clinically matched outcomes data.
  • More research is needed to understand the clinical and prognostic implications of these data
    Aadi is also presenting Trials-in-Progress (TiP) posters from its PRECISION 1 and NET clinical studies.
  • Session Title: Trials in Progress Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
    Title: "A phase 2, study of nab-sirolimus in patients with well-differentiated and advanced/metastatic neuroendocrine tumors of the gastrointestinal tract, lunch, or pancreas"
    Session Title: Trials in Progress Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Aadi Bioscience Reports Interim Results from PRECISION1 Trial of nab-Sirolimus Demonstrating Anti-Tumor Activity in Solid Tumors with TSC1 or TSC2 Inactivating Alterations

Retrieved on: 
Thursday, December 14, 2023
Webcast, ID, Safety, Telephone, TSC1, Aadi, Patient, LOS, TSC2, Death, UPR, AADI, ORR, Pneumonitis, Cancer, CMO, Neoplasm, Pharmaceutical industry, Medical imaging, MD

LOS ANGELES, Dec. 14, 2023 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for genetically defined cancers with alterations in mTOR pathway genes, today reported results from a planned interim analysis on the first third of participants in the ongoing tumor-agnostic PRECISION1 trial evaluating nab-sirolimus in patients with TSC1 or TSC2 inactivating alterations. 

Key Points: 
  • "Our tumor agnostic PRECISION1 trial is designed to elucidate the impact of nab-sirolimus on cancers expressing inactivating alterations of TSC1 or TSC2, regardless of tumor type.
  • Nine different tumor types were enrolled in the TSC1 arm and 13 tumor types were enrolled in the TSC2 arm.
  • 80 patients are currently enrolled in the PRECISION1 trial, supporting the two-thirds interim analysis expected in the third quarter of 2024.
  • The Aadi management team is hosting a conference call and webcast today at 5:00 pm ET (2:00 pm PT) to discuss the interim results from the PRECISION1 trial.

Aadi Bioscience Announces Poster Presentations on Nab-Sirolimus at the International Gynecologic Cancer Society (IGCS) 2023 Annual Global Meeting

Retrieved on: 
Thursday, October 19, 2023
PTEN, Research design, Pathology, EEC, Emotional dysregulation, TSC1, Multicenter Automatic Defibrillator Implantation Trial, Letrozole, Safety, Patient, TSC2, Pharmaceutical industry, Vaccine

LOS ANGELES, Oct. 19, 2023 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for patients with mTOR pathway alterations, today announced e-poster presentations at the International Gynecologic Cancer Society (IGCS) 2023 Annual Global Meeting, taking place November 5-7, 2023, in Seoul, Korea.

Key Points: 
  • LOS ANGELES, Oct. 19, 2023 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for patients with mTOR pathway alterations, today announced e-poster presentations at the International Gynecologic Cancer Society (IGCS) 2023 Annual Global Meeting, taking place November 5-7, 2023, in Seoul, Korea.
  • Abstract and e-poster presentation details are below:
    This is a Phase 2 open-label, multi-institutional study to evaluate the efficacy and safety of nab-sirolimus and letrozole in patients with advanced or recurrent endometrioid endometrial carcinoma, exploring the potential for this combination to produce additive anti-tumor activity in patients with endometrioid-type endometrial carcinoma (EEC)
    Dysregulation of mTOR signaling is implicated in the pathology of EEC, in which >80% harbor PTEN or PI3K/AKT/mTOR pathway alterations
    In preclinical models, intravenous nab-sirolimus demonstrates significantly higher tumor growth inhibition, intra-tumoral drug accumulation, and greater mTOR target suppression compared with oral inhibitors
    An encore presentation titled, "Phase 2, Multicenter, Open-label Basket Trial of nab-Sirolimus for Malignant Solid Tumors Harboring Pathogenic Inactivating Alterations in TSC1 and TSC2 (PRECISION1)" will be displayed as an e-poster during the meeting.

Aadi Bioscience Announces Poster Presentations at 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

Retrieved on: 
Thursday, October 12, 2023
TSC1, Tempus, Cancer, Foundation Medicine, Biomarker, Breast cancer, Drug resistance, Prevalence, AACR, NGS, PI3K, Abstract (summary), LOS, Genome, TSC2, BRCA, Database, Research design, Neoplasm, Multicenter Automatic Defibrillator Implantation Trial, Conference, AKT, Patient, Poster, Medical imaging, Pharmaceutical industry, Vaccine

LOS ANGELES, Oct. 12, 2023 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for patients with mTOR pathway alterations, today announced details of four poster presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place October 11-15, 2023, in Boston, MA. 

Key Points: 
  • Next-generation sequencing data from Foundation Medicine's genomic database of patients primarily with advanced cancer were analyzed using the FoundationInsights™ web-based platform.
  • In a large RW database of patients with advanced cancer, inactivating TSC1 and TSC2 variants occurred in 1.9% of patients.
  • The frequency of TSC1 and/or TSC2 alterations and tumor types were generally consistent between tumor tissue samples and liquid biopsies.
  • Consistency between primary vs metastatic samples suggests TSC1 and TSC2 alterations may not be acquired, although samples were not longitudinal.

Aadi Bioscience Announces Poster Presentations at the North American Neuroendocrine Tumor Society (NANETS) 2023 Multidisciplinary NET Medical Symposium

Retrieved on: 
Thursday, October 5, 2023
TSC1, NETS, Mtori, Pancreas, Gastrointestinal tract, Safety, TSC2, Disease, Research design, Lung, Multicenter Automatic Defibrillator Implantation Trial, Patient, Pharmaceutical industry

LOS ANGELES, Oct. 5, 2023 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for patients with mTOR pathway alterations, today announced that two posters will be presented at the upcoming North American Neuroendocrine Tumor Society (NANETS) Multidisciplinary NET Medical Symposium, taking place October 4-6, 2023, in Montreal, Canada.

Key Points: 
  • LOS ANGELES, Oct. 5, 2023 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for patients with mTOR pathway alterations, today announced that two posters will be presented at the upcoming North American Neuroendocrine Tumor Society (NANETS) Multidisciplinary NET Medical Symposium, taking place October 4-6, 2023, in Montreal, Canada.
  • Details of the poster presentations are below:
    Title: "Phase 2 study of nab-sirolimus in patients with well-differentiated and advanced or metastatic neuroendocrine tumors of the gastrointestinal tract, lung, or pancreas"
    The PI3K/AKT/mTOR pathway has been implicated in the pathogenesis and progression of NETs, though the use of oral mTORis as a treatment for NETs is limited by low bioavailability and the heterogeneity of the disease
    The efficacy and safety of nab-sirolimus in patients with advanced or metastatic NETs will be evaluated in this phase 2, multicenter, open-label, single-arm, US-based study
    The study, NET-202 (NCT05997056), will enroll up to 21 efficacy evaluable patients at approximately three US centers.
  • Enrollment for the study is planned to begin in the third quarter of 2023, with completion expected within 12–18 months
    An encore presentation titled, "Phase 2, Multicenter, Open-label Basket Trial of nab-Sirolimus for Malignant Solid Tumors Harboring Pathogenic Inactivating Alterations in TSC1 and TSC2 (PRECISION1)" will also be presented on Thursday, October 5, 2023.

Aadi Bioscience Announces Poster Presentations at 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

Retrieved on: 
Wednesday, September 20, 2023
Abstract, AACR, Genome, AADI, Patient, TSC2, Team Impulse, Foundation Medicine, Conference, TSC1, Breast cancer, Pharmaceutical industry

LOS ANGELES, Sept. 20, 2023 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for patients with mTOR pathway alterations, today announced that four abstracts have been selected for presentation at the upcoming 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place October 11-15, 2023 in Boston, MA.

Key Points: 
  • LOS ANGELES, Sept. 20, 2023 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for patients with mTOR pathway alterations, today announced that four abstracts have been selected for presentation at the upcoming 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place October 11-15, 2023 in Boston, MA.
  • The presentations include four posters: a Trials-in-Progress (TiP) update from the PRECISION1 trial in TSC1/2 alterations, two real-world clinical genomic analyses, and one preclinical study of nab-sirolimus combinations in breast cancer xenograft models.
  • Title: "Inactivating TSC1 and TSC2 alterations, co-mutations, and genomic instability in advanced cancers: Analysis of a real-world (RW) patient (pt) population using the Foundation Medicine genomic database"

Aadi Bioscience Announces Financial Results for the Second Quarter 2023 and Provides Corporate Update

Retrieved on: 
Wednesday, August 9, 2023
TIP, NETS, Interim, Initiation, TSC1, Telephone, Mirati Therapeutics, Glomus tumor, Everolimus, Pancreas, ID, AADI, Lung, Sirolimus, ASCO, Endometrial cancer, TSC2, Patient, Investment, Cancer, Webcast, CFO, Growth, EEC, GI, Letrozole, Pharmacology, Safety, Pharmaceutical industry, Cryptocurrency, Aadi

LOS ANGELES, Aug. 9, 2023 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for genetically defined cancers with alterations in mTOR pathway genes, today provided a corporate update and announced financial results for the second quarter of 2023.

Key Points: 
  • LOS ANGELES, Aug. 9, 2023 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for genetically defined cancers with alterations in mTOR pathway genes, today provided a corporate update and announced financial results for the second quarter of 2023.
  • FYARRO net product sales were $6.2 million in the second quarter, reflecting growth of approximately 6% over Q1 2023 and 80% over the prior year quarter.
  • The Aadi management team is hosting a conference call and webcast today at 8:30 am ET (5:30 am PT) to provide a corporate update and discuss results for the second quarter 2023.
  • Participants may access a live webcast of the call on the "Investors & News" page of the Aadi Bioscience website at aadibio.com .