1. LOS ANGELES, Oct. 22, 2021 (GLOBE NEWSWIRE) -- Aadi Bioscience, Inc. ("Aadi") (NASDAQ:AADI), a clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today announced the publication of "nab-Sirolimus for Patients with Malignant Perivascular Epithelioid Cell Tumors", detailing its AMPECT study of investigational ABI-009 in the American Society of Clinical Oncology's Journal of Clinical Oncology. The authors concluded that investigational nab-sirolimus (ABI-009, formerly known as nab-rapamycin), if approved, may represent an important new treatment option in malignant PEComa, a rare cancer and aggressive form of sarcoma, with no currently approved treatment…

    LOS ANGELES, Oct. 22, 2021 (GLOBE NEWSWIRE) -- Aadi Bioscience, Inc. ("Aadi") (NASDAQ:AADI), a clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today announced the publication of "nab-Sirolimus for Patients with Malignant Perivascular Epithelioid Cell Tumors", detailing its AMPECT study of investigational ABI-009 in the American Society of Clinical Oncology's Journal of Clinical Oncology. The authors concluded that investigational nab-sirolimus (ABI-009, formerly known as nab-rapamycin), if approved, may represent an important new treatment option in malignant PEComa, a rare cancer and aggressive form of sarcoma, with no currently approved treatment.

    The content of the publication included the primary analysis, which occurred 6 months after the last patient on the AMPECT study initiated treatment, as well as a 1.5-year follow-up after the primary analysis with a data cutoff of November 23, 2020. In the trial, 34 patients were treated with ABI-009. In the 31 evaluable patients, the overall independently assessed response rate was 39% (12 of 31; with a 95% confidence interval, 22% to 58%) with 1 complete and 11 partial responses. In addition, 52% (16 of 31) of patients had stable disease. The responses were durable and median duration of response was not reached after a median follow-up for response of 2.5 years, and 7 of 12 responders with treatment ongoing (range 5.6-47.2+ months). Responses were of rapid onset (67% by week 6). The safety profile was found to be acceptable with most treatment-related adverse events characterized as low grade and manageable for long-term treatment.

    Andrew Wagner, M.D., Ph.D., a senior oncologist at the Dana-Farber Cancer Institute and Principal Investigator of the study, said, "We are excited to publish the data obtained from this trial. nab-Sirolimus delivered highly durable responses in patients with advanced PEComa. Most of the responding patients rapidly achieved a response by their first assessment at 6 weeks following initiation of therapy and these patients have stayed on therapy for extended periods with an acceptable safety profile. We are encouraged by the outcomes in this first-ever prospective clinical trial in patients with this extremely rare disease".

    Neil Desai, Ph.D., co-author of the article and Founder, Chief Executive Officer and President of Aadi Bioscience, said, "The Aadi Bioscience team is extremely grateful to the patients, families, and clinical trial teams who help expand the boundaries of available care through their participation in clinical trials. The publication of these results is an important milestone not only for malignant PEComa patients but also for the ongoing development of nab-sirolimus across the planned investigation in TSC1 and TSC2 indications and other combination strategies."

    A New Drug Application for investigational ABI-009 is under review by the U.S. Food and Drug Administration for treatment of patients with PEComa and has a Prescription Drug User Fee Action target date of November 26, 2021. If approved, ABI-009 will be known as FYARRO.

    About Aadi Bioscience and FYARRO™

    Aadi is a clinical-stage biopharmaceutical company developing precision therapies for genetically-defined cancers. Aadi's primary goal is to bring transformational therapies to cancer patients with mTOR pathway driver alterations such as alterations in TSC1 or TSC2 genes, where other mTOR inhibitors have not or cannot be effectively exploited due to problems of pharmacology, effective drug delivery, safety, or effective targeting to the disease site. Aadi's lead product candidate is FYARROTM (sirolimus albumin-bound nanoparticles for injectable suspension; nab-sirolimus; ABI-009), an mTOR inhibitor bound to human albumin that has demonstrated significantly higher tumor accumulation, greater mTOR target suppression, and increased tumor growth inhibition over other mTOR inhibitors in preclinical models1.

    Aadi's registration trial of FYARRO in advanced malignant PEComa (the "AMPECT trial") demonstrated meaningful clinical efficacy in malignant PEComa2, a type of cancer with the highest known alteration rate of TSC1 or TSC2 genes. FYARRO has received Breakthrough Therapy, Fast-Track and Orphan Designations from the U.S. Food and Drug Administration (FDA). A rolling New Drug Application (NDA) submission was completed in May 2021 for this indication and the FDA accepted the NDA in July 2021 and granted Aadi Priority Review status with a Prescription Drug User Fee Act ("PDUFA") target action date of November 26, 2021.

    Based on the AMPECT trial and emerging data for FYARRO in other solid tumors with TSC1 or TSC2 inactivating alterations3, and following discussions with the FDA, Aadi plans to initiate a tumor-agnostic registrational trial in mTOR inhibitor-naïve solid tumors harboring TSC1 or TSC2 inactivating alterations by the end of 2021. Aadi also has ongoing studies to evaluate dosing of FYARRO in combination regimens. FYARRO is an investigational drug that has not been approved by the FDA for commercial distribution in the United States. More information is available on the Aadi website at  www.aadibio.com.

    Forward-Looking Statements

    Aadi Bioscience, Inc. ("Aadi", "The Company") cautions you that certain statements included in this press release that are not a description of historical facts are forward-looking statements. These statements are based on Aadi's current beliefs and expectations. Forward-looking statements include statements regarding: FYARRO, including expectations regarding the clinical responses and safety profile, regulatory approval and commercialization, and the timing of the initiation of additional clinical trials. Actual results could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: risks related to Aadi's ability to obtain, or the timeline to obtain, regulatory approval from the FDA and other regulatory authorities for FYARRO in advanced malignant PEComa; risks related to Aadi's ability to successfully commercialize, including the timing of a commercial launch of FYARRO in advanced malignant PEComa; uncertainties associated with the clinical development and regulatory approval of FYARRO, including potential delays in the commencement, enrollment and completion of clinical trials; the risk that interim results of clinical trials may not be reproduced and do not necessarily predict final results; the risk that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; the risk that unforeseen adverse reactions or side effects may occur in the course of developing and testing FYARRO; risks associated with the failure to realize any value from FYARRO in light of inherent risks and difficulties involved in successfully bringing product candidates to market; risks related to Aadi's estimates regarding future expenses, capital requirements and need for additional financing; and risks related to the impact of the COVID-19 outbreak on Aadi's operations, the biotechnology industry and the economy generally.

    Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" and elsewhere in Aadi's reports and other documents that Aadi has filed, or will file, with the SEC from time to time and available at www.sec.gov.

    All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Aadi undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

    FYARRO™ is a trademark of Aadi Bioscience, Inc.

    References:

    1 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics 2021 Abstract: https://aadibio.com/wp-content/uploads/2021/10/ABI-009-Poster-091321-Final-Oral.pdf

    2 ASCO 2020 Abstract: https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.11516?af=R

    ASCO 2021 Abstract: https://meetings.asco.org/abstracts-presentations/197602

    Contacts

    Investors:



    Irina Koffler

    LifeSci Advisors LLC

    ikoffler@lifesciadvisors.com



    Primary Logo

    View Full Article Hide Full Article
  2. LOS ANGELES, Oct. 19, 2021 (GLOBE NEWSWIRE) -- Aadi Bioscience, Inc. ("Aadi"), a privately-held clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today announced that Founder, Chief Executive Officer and President, Neil Desai, Ph.D., will present at H.C. Wainwright's 2nd Annual Precision Oncology Conference, which will be held virtually.

    Presentation Information:

    Date: Wednesday, October 20, 2021

    Time: 1 pm ET

    To Listen to the Presentation:

    The live webcast can be accessed here: https://journey.ct.events/view/ceb3457a-5338-4644-94da-75d0fb24b8f0. A replay will also be available at this link for 90 days and posted on Aadi's website within the…

    LOS ANGELES, Oct. 19, 2021 (GLOBE NEWSWIRE) -- Aadi Bioscience, Inc. ("Aadi"), a privately-held clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today announced that Founder, Chief Executive Officer and President, Neil Desai, Ph.D., will present at H.C. Wainwright's 2nd Annual Precision Oncology Conference, which will be held virtually.

    Presentation Information:

    Date: Wednesday, October 20, 2021

    Time: 1 pm ET

    To Listen to the Presentation:

    The live webcast can be accessed here: https://journey.ct.events/view/ceb3457a-5338-4644-94da-75d0fb24b8f0. A replay will also be available at this link for 90 days and posted on Aadi's website within the Investors & News/Events & Presentations section.

    About Aadi Bioscience and FYARRO™

    Aadi is a clinical-stage biopharmaceutical company developing precision therapies for genetically-defined cancers. Aadi's primary goal is to bring transformational therapies to cancer patients with mTOR pathway driver alterations such as alterations in TSC1 or TSC2 genes, where other mTOR inhibitors have not or cannot be effectively exploited due to problems of pharmacology, effective drug delivery, safety, or effective targeting to the disease site. Aadi's lead product candidate is FYARROTM (sirolimus albumin-bound nanoparticles for injectable suspension; nab-sirolimus; ABI-009), an mTOR inhibitor bound to human albumin that has demonstrated significantly higher tumor accumulation, greater mTOR target suppression, and increased tumor growth inhibition over other mTOR inhibitors in preclinical models1.

    Aadi's registration trial of FYARRO in advanced malignant PEComa (the "AMPECT trial") demonstrated meaningful clinical efficacy in malignant PEComa2, a type of cancer with the highest known alteration rate of TSC1 or TSC2 genes. FYARRO has received Breakthrough Therapy, Fast-Track and Orphan Designations from the U.S. Food and Drug Administration (FDA). A rolling New Drug Application (NDA) submission was completed in May 2021 for this indication and the FDA accepted the NDA in July 2021 and granted Aadi Priority Review status with a Prescription Drug User Fee Act ("PDUFA") target action date of November 26, 2021.

    Based on the AMPECT trial and emerging data for FYARRO in other solid tumors with TSC1 or TSC2 inactivating alterations3, and following discussions with the FDA, Aadi plans to initiate a tumor-agnostic registrational trial in mTOR inhibitor-naïve solid tumors harboring TSC1 or TSC2 inactivating alterations by the end of 2021. Aadi also has ongoing studies to evaluate dosing of FYARRO in combination regimens. FYARRO is an investigational drug that has not been approved by the FDA for commercial distribution in the United States. More information is available on the Aadi website at  www.aadibio.com.

    Forward-Looking Statements

    Aadi Bioscience, Inc. ("Aadi", "The Company") cautions you that certain statements included in this press release that are not a description of historical facts are forward-looking statements. These statements are based on Aadi's current beliefs and expectations. Forward-looking statements include statements regarding: FYARRO, including expectations regarding the clinical responses and safety profile, regulatory approval and commercialization, and the timing of the initiation of additional clinical trials. Actual results could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: risks related to Aadi's ability to obtain, or the timeline to obtain, regulatory approval from the FDA and other regulatory authorities for FYARRO in advanced malignant PEComa; risks related to Aadi's ability to successfully commercialize, including the timing of a commercial launch of FYARRO in advanced malignant PEComa; uncertainties associated with the clinical development and regulatory approval of FYARRO, including potential delays in the commencement, enrollment and completion of clinical trials; the risk that interim results of clinical trials may not be reproduced and do not necessarily predict final results; the risk that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; the risk that unforeseen adverse reactions or side effects may occur in the course of developing and testing FYARRO; risks associated with the failure to realize any value from FYARRO in light of inherent risks and difficulties involved in successfully bringing product candidates to market; risks related to Aadi's estimates regarding future expenses, capital requirements and need for additional financing; and risks related to the impact of the COVID-19 outbreak on Aadi's operations, the biotechnology industry and the economy generally.

    Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" and elsewhere in Aadi's reports and other documents that Aadi has filed, or will file, with the SEC from time to time and available at www.sec.gov.

    All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Aadi undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

    FYARRO™ is a trademark of Aadi Bioscience, Inc.

    References:

    1 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics 2021 Abstract: https://aadibio.com/wp-content/uploads/2021/10/ABI-009-Poster-091321-Final-Oral.pdf

    2 ASCO 2020 Abstract: https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.11516?af=R

    ASCO 2021 Abstract: https://meetings.asco.org/abstracts-presentations/197602

    Contacts

    Investors:



    Irina Koffler

    ikoffler@lifesciadvisors.com 



    Primary Logo

    View Full Article Hide Full Article
  3. - Poster Presentation to go Live on October 7, 2021 at 9 a.m. ET and on Demand at the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics -

    LOS ANGELES, Oct. 06, 2021 (GLOBE NEWSWIRE) -- Aadi Bioscience, Inc. ("Aadi") (NASDAQ:AADI), a clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today announced it will present a poster at the Virtual International Conference on Molecular Targets and Cancer Therapeutics to be held this year from October 7th -10th.

    The Company will present preclinical data evaluating nab-sirolimus (ABI-009) in PTEN-deleted and TSC2-deleted cancer models in comparison with other mTOR inhibitors…

    - Poster Presentation to go Live on October 7, 2021 at 9 a.m. ET and on Demand at the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics -

    LOS ANGELES, Oct. 06, 2021 (GLOBE NEWSWIRE) -- Aadi Bioscience, Inc. ("Aadi") (NASDAQ:AADI), a clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today announced it will present a poster at the Virtual International Conference on Molecular Targets and Cancer Therapeutics to be held this year from October 7th -10th.

    The Company will present preclinical data evaluating nab-sirolimus (ABI-009) in PTEN-deleted and TSC2-deleted cancer models in comparison with other mTOR inhibitors sirolimus and everolimus and evaluating their effects on important downstream targets S6 and 4EBP1.

    Learn more about Aadi's development of therapies that target the genetic drivers of cancers of the mTOR pathway at www.aadibio.com.

    Aadi's presentation at the 2021 AACR-NCI-EORTC International Conference:

    All times noted are U.S. Eastern Time (ET).

    Presentation Title: nab-Sirolimus improves mTOR pathway suppression and antitumor activity versus oral mTOR inhibitors in PTEN null bladder cancer (UMUC3) and TSC2 null liver cancer (SNU398) xenografts

    Author: Shihe Hou, Ph.D., Aadi Bioscience, Inc.

    Session: mTOR/PI3-kinase, P138

    Session Date/Time: Thursday, October 7, 9:00 a.m. and on-demand throughout conference

    The poster will be posted to the Events and Presentations section of Aadi Bioscience's website after 9 am ET on October 7th.

    About Aadi Bioscience and FYARRO™

    Aadi is a clinical-stage biopharmaceutical company developing precision therapies for genetically-defined cancers. Aadi's primary goal is to bring transformational therapies to cancer patients with mTOR pathway driver alterations such as alterations in TSC1 or TSC2 genes, where other mTOR inhibitors have not or cannot be effectively exploited due to problems of pharmacology, effective drug delivery, safety, or effective targeting to the disease site. Aadi's lead product candidate is FYARRO™ (sirolimus albumin-bound nanoparticles for injectable suspension; nab-sirolimus; ABI-009), an mTOR inhibitor bound to human albumin that has demonstrated significantly higher tumor accumulation, greater mTOR target suppression, and increased tumor growth inhibition over other mTOR inhibitors in preclinical models2.

    Aadi's registration trial of FYARRO in advanced malignant PEComa (the "AMPECT trial") demonstrated meaningful clinical efficacy in malignant PEComa1, a type of cancer with the highest known alteration rate of TSC1 or TSC2 genes. FYARRO has received Breakthrough Therapy, Fast-Track and Orphan Designations from the U.S. Food and Drug Administration (FDA). A rolling New Drug Application (NDA) submission was completed in May 2021 for this indication and the FDA accepted the NDA in July 2021 and granted Aadi Priority Review status with a Prescription Drug User Fee Act ("PDUFA") target action date of November 26, 2021.

    Based on the AMPECT trial and emerging data for FYARRO in other solid tumors with TSC1 or TSC2 inactivating alterations3, and following discussions with the FDA, Aadi plans to initiate a tumor-agnostic registrational trial in mTOR inhibitor-naïve solid tumors harboring TSC1 or TSC2 inactivating alterations by the end of 2021. Aadi also has ongoing studies to evaluate dosing of FYARRO in combination regimens. FYARRO is an investigational drug that has not been approved by the FDA for commercial distribution in the United States. More information is available on the Aadi website at www.aadibio.com.

    Forward-Looking Statements

    Aadi Bioscience, Inc. ("Aadi", "The Company") cautions you that certain statements included in this press release that are not a description of historical facts are forward-looking statements. These statements are based on Aadi's current beliefs and expectations. Forward-looking statements include statements regarding: FYARRO, including expectations regarding the clinical responses and safety profile, regulatory approval and commercialization, and the timing of the initiation of additional clinical trials. Actual results could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: risks related to Aadi's ability to obtain, or the timeline to obtain, regulatory approval from the FDA and other regulatory authorities for FYARRO in advanced malignant PEComa; risks related to Aadi's ability to successfully commercialize, including the timing of a commercial launch of FYARRO in advanced malignant PEComa; uncertainties associated with the clinical development and regulatory approval of FYARRO, including potential delays in the commencement, enrollment and completion of clinical trials; the risk that interim results of clinical trials may not be reproduced and do not necessarily predict final results; the risk that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; the risk that unforeseen adverse reactions or side effects may occur in the course of developing and testing FYARRO; risks associated with the failure to realize any value from FYARRO in light of inherent risks and difficulties involved in successfully bringing product candidates to market; risks related to Aadi's estimates regarding future expenses, capital requirements and need for additional financing; and risks related to the impact of the COVID-19 outbreak on Aadi's operations, the biotechnology industry and the economy generally.

    Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" and elsewhere in Aadi's reports and other documents that Aadi has filed, or will file, with the SEC from time to time and available at www.sec.gov.

    All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Aadi undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

    FYARRO™ is a trademark of Aadi Bioscience, Inc.

    References:

    ASCO 2020 Abstract: https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.11516?af=R

    2 AACR 2019 Abstract: https://cancerres.aacrjournals.org/content/79/13_Supplement/348

    ASCO 2021 Abstract: https://meetings.asco.org/abstracts-presentations/197602

    Contacts

    Investors:



    Investors:

    Irina Koffler

    ikoffler@lifesciadvisors.com



    Primary Logo

    View Full Article Hide Full Article
  4. LOS ANGELES, Sept. 20, 2021 (GLOBE NEWSWIRE) -- Aadi Bioscience, Inc. ("Aadi") (NASDAQ:AADI), a clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today announced the appointment of Brendan Delaney to the role of Chief Operating Officer (COO). Brendan has had an established career in oncology-focused commercial leadership roles, launching multiple groundbreaking new products and building effective and cohesive commercial teams. Most recently Brendan was Chief Commercial Officer at Constellation Pharmaceuticals, which was acquired by MorphoSys AG for $1.4 billion prior to a commercial launch of pelabresib a first-in-class BETi inhibitor with blockbuster…

    LOS ANGELES, Sept. 20, 2021 (GLOBE NEWSWIRE) -- Aadi Bioscience, Inc. ("Aadi") (NASDAQ:AADI), a clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today announced the appointment of Brendan Delaney to the role of Chief Operating Officer (COO). Brendan has had an established career in oncology-focused commercial leadership roles, launching multiple groundbreaking new products and building effective and cohesive commercial teams. Most recently Brendan was Chief Commercial Officer at Constellation Pharmaceuticals, which was acquired by MorphoSys AG for $1.4 billion prior to a commercial launch of pelabresib a first-in-class BETi inhibitor with blockbuster potential across multiple hematology indications. Prior to this, as Chief Commercial Officer at Immunomedics, Inc. Brendan led the launch of TRODELVY®, the first TROP-2 directed antibody-drug conjugate for the treatment of triple-negative breast cancer which was acquired by Gilead Sciences, Inc. for $21 billion.

    "Brendan and I collaborated closely when I was Executive Chairman of Immunomedics to bring TRODELVY to market, and I am delighted to be reunited with Brendan in his new capacity as Aadi becomes a fully integrated biopharmaceutical company," stated Behzad Aghazadeh, Ph.D., Managing Partner and Portfolio Manager, Avoro Capital and member of Aadi's Board of Directors. "Brendan has a stellar track record of bringing orphan oncology drugs to market, leading commercial teams at three major oncology companies that have now been acquired. Aside from being an invaluable addition to the Company at this time, Brendan will also establish Aadi's presence on the East Coast since he is based in the tri-state area."

    "We are delighted that Brendan has accepted the role of COO. His commercial expertise will be critical as we get ready to launch ABI-009 for malignant PEComa and expand our focus to the broader applications of this exciting product," stated Neil Desai, Chief Executive Officer of Aadi. "In his role as COO we will be able to leverage his extensive leadership experience to build out across various functions in this important growth phase of the Company."

    Mr. Delaney began his career at Bristol-Myers, Genentech and Chiron in roles of increasing responsibility in oncology marketing and strategy, and led global branding, strategy and franchises in Novartis' oncology division for blockbuster brands. At Immunomedics, Mr. Delaney led the build-out of the marketing, sales, market access and commercial operations teams related to TRODELVY. Prior to his Chief Commercial Officer roles at Constellation and Immunomedics, Mr. Delaney was Vice President, U.S. Commercial Hematology Oncology of Celgene Corporation, prior to its acquisition by Bristol-Myers Squibb in 2019.

    Mr. Delaney commented, "I am thrilled to join Aadi at this pivotal time ahead of the November 26, 2021 Prescription Drug User Fee Act (PDUFA) target date of its investigational candidate, ABI-009 for PEComa. I look forward to leveraging my commercialization expertise to bring this promising investigational candidate to market, and to maximize the utility of the nab-sirolimus technology platform in tumor agnostic indications – such as in patients with solid tumors harboring TSC1 or TSC2 inactivating alterations, for which we plan to initiate a registrational trial by year-end."

    Mr. Delaney has an M.B.A. from the Stern School of Business at New York University and a B.A. in Biology from Rutgers University.

    About Aadi Bioscience and FYARRO™

    Aadi is a clinical-stage biopharmaceutical company developing precision therapies for genetically-defined cancers. Aadi's primary goal is to bring transformational therapies to cancer patients with mTOR pathway driver alterations such as alterations in TSC1 or TSC2 genes, where other mTOR inhibitors have not or cannot be effectively exploited due to problems of pharmacology, effective drug delivery, safety, or effective targeting to the disease site. Aadi's lead product candidate is FYARROTM (sirolimus albumin-bound nanoparticles for injectable suspension; nab-sirolimus; ABI-009), an mTOR inhibitor bound to human albumin that has demonstrated significantly higher tumor accumulation, greater mTOR target suppression, and increased tumor growth inhibition over other mTOR inhibitors in preclinical models2.

    Aadi's registration trial of FYARRO in advanced malignant PEComa (the "AMPECT trial") demonstrated meaningful clinical efficacy in malignant PEComa1, a type of cancer with the highest known alteration rate of TSC1 or TSC2 genes. FYARRO has received Breakthrough Therapy, Fast-Track and Orphan Designations from the U.S. Food and Drug Administration (FDA). A rolling New Drug Application (NDA) submission was completed in May 2021 for this indication and the FDA accepted the NDA in July 2021 and granted Aadi Priority Review status with a Prescription Drug User Fee Act ("PDUFA") target action date of November 26, 2021.

    Based on the AMPECT trial and emerging data for FYARRO in other solid tumors with TSC1 or TSC2 inactivating alterations3, and following discussions with the FDA, Aadi plans to initiate a tumor-agnostic registrational trial in mTOR inhibitor-naïve solid tumors harboring TSC1 or TSC2 inactivating alterations by the end of 2021. Aadi also has ongoing studies to evaluate dosing of FYARRO in combination regimens. FYARRO is an investigational drug that has not been approved by the FDA for commercial distribution in the United States. More information is available on the Aadi website at www.aadibio.com.

    Forward-Looking Statements

    Aadi Bioscience, Inc. ("Aadi", "The Company") cautions you that certain statements included in this press release that are not a description of historical facts are forward-looking statements. These statements are based on Aadi's current beliefs and expectations. Forward-looking statements include statements regarding: FYARRO, including expectations regarding the clinical responses and safety profile, regulatory approval and commercialization, and the timing of the initiation of additional clinical trials. Actual results could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: risks related to Aadi's ability to obtain, or the timeline to obtain, regulatory approval from the FDA and other regulatory authorities for FYARRO in advanced malignant PEComa; risks related to Aadi's ability to successfully commercialize, including the timing of a commercial launch of FYARRO in advanced malignant PEComa; uncertainties associated with the clinical development and regulatory approval of FYARRO, including potential delays in the commencement, enrollment and completion of clinical trials; the risk that interim results of clinical trials may not be reproduced and do not necessarily predict final results; the risk that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; the risk that unforeseen adverse reactions or side effects may occur in the course of developing and testing FYARRO; risks associated with the failure to realize any value from FYARRO in light of inherent risks and difficulties involved in successfully bringing product candidates to market; risks related to Aadi's estimates regarding future expenses, capital requirements and need for additional financing; and risks related to the impact of the COVID-19 outbreak on Aadi's operations, the biotechnology industry and the economy generally.

    Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" and elsewhere in Aadi's reports and other documents that Aadi has filed, or will file, with the SEC from time to time and available at www.sec.gov.

    All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Aadi undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

    FYARRO™ is a trademark of Aadi Bioscience, Inc.

    References:

    ASCO 2020 Abstract: https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.11516?af=R

    2 AACR 2019 Abstract: https://cancerres.aacrjournals.org/content/79/13_Supplement/348

    ASCO 2021 Abstract: https://meetings.asco.org/abstracts-presentations/197602

    Contacts

    Investors:



    Investors:

    Irina Koffler

    ikoffler@lifesciadvisors.com 



    Primary Logo

    View Full Article Hide Full Article
  5. LOS ANGELES, Sept. 13, 2021 (GLOBE NEWSWIRE) -- Aadi Bioscience, Inc. ("Aadi") (NASDAQ:AADI), a clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today announced the appointment of Emma Reeve to its Board of Directors as Audit Committee Chair. Ms. Reeve brings over 25 years of value creation in pharmaceutical, medical device and bio-pharma service companies and a successful track record of transitioning companies from private to public. She currently sits on the boards of PTC Therapeutics (NASDAQ:PTCT) and privately-held Ribon Therapeutics and is Audit Committee Chair at both companies, and was recently appointed to the board of Editas Medicine (NASDAQ…

    LOS ANGELES, Sept. 13, 2021 (GLOBE NEWSWIRE) -- Aadi Bioscience, Inc. ("Aadi") (NASDAQ:AADI), a clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today announced the appointment of Emma Reeve to its Board of Directors as Audit Committee Chair. Ms. Reeve brings over 25 years of value creation in pharmaceutical, medical device and bio-pharma service companies and a successful track record of transitioning companies from private to public. She currently sits on the boards of PTC Therapeutics (NASDAQ:PTCT) and privately-held Ribon Therapeutics and is Audit Committee Chair at both companies, and was recently appointed to the board of Editas Medicine (NASDAQ:EDIT). Most recently, Ms. Reeve was Chief Financial Officer of Constellation Pharmaceuticals, a development-stage oncology company, which went public in 2018 and raised over $600 million in public and private financings during her tenure. Ms. Reeve was a key member of the team that sold the company to MorphoSys AG for a total consideration of approximately $1.7 billion in 2021.

    "We welcome Ms. Reeve to our Board at this pivotal time for Aadi as we are emerging post-IPO and transitioning to become a fully integrated biopharmaceutical company," stated Caley Castelein, M.D., Aadi Board Chairman. "As Aadi prepares for the potential commercialization of its investigational candidate, nanoparticle albumin-bound mTOR inhibitor, FYARRO™ (sirolimus albumin-bound nanoparticles for injectable suspension, nab-sirolimus ABI-009) for PEComa, and advances its registrational trial in patients harboring TSC1 and TSC2 inactivating alterations, the addition of Emma's expertise in transitioning and growing a newly public oncology company will be invaluable to Aadi and her appointment will complement our recently appointed Board."

    Ms. Reeve stated, "Aadi has executed an impressive debut to access the public markets and is facing an exciting inflection point with the upcoming November 26 target action date under PDUFA for FYARRO in PEComa as well as its pursuit of the tumor agnostic approach in TSC1 and TSC2 alterations. I am delighted to join its Board to maximize the Company's opportunity to help patients with genetically-driven cancers during this important growth period for the organization. I look forward to collaborating with Aadi's talented and driven team."

    Ms. Reeve holds a Bachelor's of Science from the University of London Imperial College and is a Chartered Accountant (ACA).

    About Aadi Bioscience and FYARRO™

    Aadi is a clinical-stage biopharmaceutical company developing precision therapies for genetically-defined cancers. Aadi's primary goal is to bring transformational therapies to cancer patients with mTOR pathway driver alterations such as alterations in TSC1 or TSC2 genes, where other mTOR inhibitors have not or cannot be effectively exploited due to problems of pharmacology, effective drug delivery, safety, or effective targeting to the disease site. Aadi's lead product candidate is FYARRO™ (sirolimus albumin-bound nanoparticles for injectable suspension; nab-sirolimus; ABI-009), an mTOR inhibitor bound to human albumin that has demonstrated significantly higher tumor accumulation, greater mTOR target suppression, and increased tumor growth inhibition over other mTOR inhibitors in preclinical models2.

    Aadi's registration trial of FYARRO in advanced malignant PEComa (the "AMPECT trial") demonstrated meaningful clinical efficacy in malignant PEComa1, a type of cancer with the highest known alteration rate of TSC1 or TSC2 genes. FYARRO has received Breakthrough Therapy, Fast-Track and Orphan Designations from the U.S. Food and Drug Administration (FDA). A rolling New Drug Application (NDA) submission was completed in May 2021 for this indication and the FDA accepted the NDA in July 2021 and granted Aadi Priority Review status with a Prescription Drug User Fee Act ("PDUFA") target action date of November 26, 2021.

    Based on the AMPECT trial and emerging data for FYARRO in other solid tumors with TSC1 or TSC2 inactivating alterations3, and following discussions with the FDA, Aadi plans to initiate a tumor-agnostic registrational trial in mTOR inhibitor-naïve solid tumors harboring TSC1 or TSC2 inactivating alterations by the end of 2021. Aadi also has ongoing studies to evaluate dosing of FYARRO in combination regimens. FYARRO is an investigational drug that has not been approved by the FDA for commercial distribution in the United States. More information is available on the Aadi website at  www.aadibio.com.

    Forward-Looking Statements

    Aadi Bioscience, Inc. ("Aadi", "The Company") cautions you that certain statements included in this press release that are not a description of historical facts are forward-looking statements. These statements are based on Aadi's current beliefs and expectations. Forward-looking statements include statements regarding: FYARRO, including expectations regarding the clinical responses and safety profile, regulatory approval and commercialization, and the timing of the initiation of additional clinical trials. Actual results could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: risks related to Aadi's ability to obtain, or the timeline to obtain, regulatory approval from the FDA and other regulatory authorities for FYARRO in advanced malignant PEComa; risks related to Aadi's ability to successfully commercialize, including the timing of a commercial launch of FYARRO in advanced malignant PEComa; uncertainties associated with the clinical development and regulatory approval of FYARRO, including potential delays in the commencement, enrollment and completion of clinical trials; the risk that interim results of clinical trials may not be reproduced and do not necessarily predict final results; the risk that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; the risk that unforeseen adverse reactions or side effects may occur in the course of developing and testing FYARRO; risks associated with the failure to realize any value from FYARRO in light of inherent risks and difficulties involved in successfully bringing product candidates to market; risks related to Aadi's estimates regarding future expenses, capital requirements and need for additional financing; and risks related to the impact of the COVID-19 outbreak on Aadi's operations, the biotechnology industry and the economy generally.

    Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" and elsewhere in Aadi's reports and other documents that Aadi has filed, or will file, with the SEC from time to time and available at www.sec.gov.

    All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Aadi undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

    FYARRO™ is a trademark of Aadi Bioscience, Inc.

    References:

    ASCO 2020 Abstract: https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.11516?af=R

    2 AACR 2019 Abstract: https://cancerres.aacrjournals.org/content/79/13_Supplement/348

    ASCO 2021 Abstract: https://meetings.asco.org/abstracts-presentations/197602

    Contacts

    Investors:



    Investors:

    Irina Koffler

    ikoffler@lifesciadvisors.com



    Primary Logo

    View Full Article Hide Full Article