Quantumleap Healthcare Collaborative

Oral Paclitaxel combination regimen has graduated in this Phase 2 trial in the triple negative breast cancer subgroupBUFFALO, N.Y., Dec. 20, 2022 (GLOBE NEWSWIRE) -- Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions announced that collaborators at the Quantum Leap Healthcare Collaborative reported today that the Company’s oral paclitaxel plus encequidar in combination with a PD-1 inhibitor and carboplatin has graduated in the triple-negative subgroup of high-risk early-stage breast cancer. Oral paclitaxel, relative to intravenous paclitaxel, was associated with less neuropathy and was not associated with an increase in febrile neutropenia. Quantum Leap Healthcare Collaborative anticipates presenting these results at upcoming national meetings in Q2 of 2023. “We are very pleased that the Oral Paclitaxel combination regimen graduated from this prestigious program which has brought exciting and innovative treatments to neoadjuvant breast cancer patients. This study confirms our finding of less neuropathy for Oral Paclitaxel compared to intravenous paclitaxel in our metastatic breast cancer study. It’s reassuring to see that Oral Paclitaxel regimen was not associated with increased febrile neutropenia relative to the intravenous paclitaxel regimen in a well-conducted U.S. study,” said Dr. Johnson Lau, Chief Executive Officer of Athenex. “We will explore different opportunities to maximize the value of Oral Paclitaxel.” Please refer to https://www.quantumleaphealth.org/ for more information. About Quantum Leap Healthcare Collaborative Quantum Leap Healthcare Collaborative is a 501c(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Our mission is to integrate high-impact research with clinical processes and systems technology, resulting in improved data management and information systems, greater access to clinical trial matching and sponsorship, and greater benefit to providers, patients and researchers. Our goal is to improve and save lives. Quantum Leap provides operational, financial, and regulatory oversight to I-SPY. For more information, visit https://www.quantumleaphealth.org/. About the I-SPY TRIALs The I-SPY TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis 2) (I-SPY 2 TRIAL) was designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The trial is a unique collaborative effort by a consortium that includes the Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from 16 major U.S. cancer research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations. For more information, visit www.ispytrials.org. About Athenex, Inc. Founded in 2003, Athenex, Inc. is a global clinical-stage biopharmaceutical company dedicated to becoming a leader in the discovery, development, and commercialization of next generation cell therapy drugs for the treatment of cancer. In pursuit of this mission, Athenex leverages years of experience in research and development, clinical trials, regulatory standards, and manufacturing. The Company’s current clinical pipeline is derived mainly from the following core technologies: (1) Cell therapy, based on NKT cells and (2) Orascovery, based on a P-glycoprotein inhibitor. Athenex’s employees worldwide are dedicated to improving the lives of cancer patients by creating more active, accessible, and tolerable treatments. For more information, please visit www.athenex.com. Forward-Looking Statements Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. These forward-looking statements are typically identified by terms such as “explore,” “will,” “may,” “believe,” and similar expressions. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: our history of operating losses and our need and ability to raise additional capital to continue as a going concern; the development stage of our primary clinical candidates and related risks involved in drug development, clinical trials, regulation, uncertainties around regulatory reviews and approvals, including the further development of oral paclitaxel; the preclinical and clinical results for Athenex’s drug candidates, which may not support further development of such drug candidates; the Company’s ability to successfully demonstrate the safety and efficacy of its drug candidates and gain approval of its drug candidates on a timely basis, if at all; risks related to counterparty performance, including our reliance on third parties for success in certain areas of Athenex’s business; intellectual property risks, and the other risk factors set forth from time to time in our SEC filings, copies of which are available for free in the Investor Relations section of our website at http://ir.athenex.com/phoenix.zhtml?c=254495&p=irol-sec or upon request from our Investor Relations Department. All information provided in this release is as of the date hereof, and we assume no obligation and do not intend to update these forward-looking statements, except as required by law. Athenex Contacts Daniel Lang, MD Athenex, Inc. Email: danlang@athenex.com

Oral Paclitaxel combination regimen has graduated from this Phase 2 trial in the triple negative breast cancer subgroup SAN FRANCISCO, Dec. 20, 2022 /PRNewswire/ -- Quantum Leap Healthcare Collaborative (QLHC) today announced that a regimen including oral paclitaxel plus encequidar (Athenex) in combination with a PD-1 inhibitor and carboplatin has graduated in the triple-negative subset of high-risk early-stage breast cancer. The oral paclitaxel, relative to intravenous paclitaxel, was associated with less neuropathy and was not associated with an increase in febrile neutropenia. We anticipate that these results will be presented at upcoming national meetings in Q2 of 2023. "It is important for us to seek out optimal combinations of therapies and find ways to reduce toxicity. We are excited to continue working on this and other combinations," said Laura Esserman, MD, the lead investigator for the I-SPY 2 study and founder of QLHC. The I-SPY 2 TRIAL, sponsored by QLHC, is a standing Phase 2 randomized, controlled, multicenter platform with an innovative Bayesian adaptive randomization design aimed to rapidly screen and identify promising new treatments in specific subgroups of adults with newly-diagnosed, high-risk (high likelihood of recurrence), locally-advanced breast cancer (Stage 2/3) based on molecule characteristics (biomarker signatures). The biomarker rich I SPY 2 TRIAL will continue to investigate the personalized combination of agents to optimize efficacy and toxicity. About Quantum Leap Healthcare Collaborative Quantum Leap Healthcare Collaborative is a 501c(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Our mission is to integrate high-impact research with clinical processes and systems technology, resulting in improved data management and information systems, greater access to clinical trial matching and sponsorship, and greater benefit to providers, patients and researchers. Our goal is to improve and save lives. Quantum Leap provides operational, financial, and regulatory oversight to I-SPY. For more information, visit . About the I-SPY TRIALs The I-SPY TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis 2) (I-SPY 2 TRIAL) was designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The trial is a unique collaborative effort by a consortium that includes the Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from 16 major U.S. cancer research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations. For more information, visit . SOURCE Quantum Leap Healthcare Collaborative

BUFFALO, N.Y., Dec. 20, 2022 (GLOBE NEWSWIRE) -- Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions announced that collaborators at the Quantum Leap Healthcare Collaborative reported today that the Company’s oral paclitaxel plus encequidar in combination with a PD-1 inhibitor and carboplatin has graduated in the triple-negative subgroup of high-risk early-stage breast cancer. Oral paclitaxel, relative to intravenous paclitaxel, was associated with less neuropathy and was not associated with an increase in febrile neutropenia. Quantum Leap Healthcare Collaborative anticipates presenting these results at upcoming national meetings in Q2 of 2023. “We are very pleased that the Oral Paclitaxel combination regimen graduated from this prestigious program which has brought exciting and innovative treatments to neoadjuvant breast cancer patients. This study confirms our finding of less neuropathy for Oral Paclitaxel compared to intravenous paclitaxel in our metastatic breast cancer study. It’s reassuring to see that Oral Paclitaxel regimen was not associated with increased febrile neutropenia relative to the intravenous paclitaxel regimen in a well-conducted U.S. study,” said Dr. Johnson Lau, Chief Executive Officer of Athenex. “We will explore different opportunities to maximize the value of Oral Paclitaxel.” Please refer to for more information. About Quantum Leap Healthcare Collaborative Quantum Leap Healthcare Collaborative is a 501c(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Our mission is to integrate high-impact research with clinical processes and systems technology, resulting in improved data management and information systems, greater access to clinical trial matching and sponsorship, and greater benefit to providers, patients and researchers. Our goal is to improve and save lives. Quantum Leap provides operational, financial, and regulatory oversight to I-SPY. For more information, visit . About the I-SPY TRIALs The I-SPY TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis 2) (I-SPY 2 TRIAL) was designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The trial is a unique collaborative effort by a consortium that includes the Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from 16 major U.S. cancer research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations. For more information, visit . About Athenex, Inc. Founded in 2003, Athenex, Inc. is a global clinical-stage biopharmaceutical company dedicated to becoming a leader in the discovery, development, and commercialization of next generation cell therapy drugs for the treatment of cancer. In pursuit of this mission, Athenex leverages years of experience in research and development, clinical trials, regulatory standards, and manufacturing. The Company’s current clinical pipeline is derived mainly from the following core technologies: (1) Cell therapy, based on NKT cells and (2) Orascovery, based on a P-glycoprotein inhibitor. Athenex’s employees worldwide are dedicated to improving the lives of cancer patients by creating more active, accessible, and tolerable treatments. For more information, please visit . Forward-Looking Statements Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. These forward-looking statements are typically identified by terms such as “explore,” “will,” “may,” “believe,” and similar expressions. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: our history of operating losses and our need and ability to raise additional capital to continue as a going concern; the development stage of our primary clinical candidates and related risks involved in drug development, clinical trials, regulation, uncertainties around regulatory reviews and approvals, including the further development of oral paclitaxel; the preclinical and clinical results for Athenex’s drug candidates, which may not support further development of such drug candidates; the Company’s ability to successfully demonstrate the safety and efficacy of its drug candidates and gain approval of its drug candidates on a timely basis, if at all; risks related to counterparty performance, including our reliance on third parties for success in certain areas of Athenex’s business; intellectual property risks, and the other risk factors set forth from time to time in our SEC filings, copies of which are available for free in the Investor Relations section of our website at or upon request from our Investor Relations Department. All information provided in this release is as of the date hereof, and we assume no obligation and do not intend to update these forward-looking statements, except as required by law. Athenex Contacts Daniel Lang, MD Athenex, Inc. Email: danlang@athenex.com