On October 25, 2021 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, reported the appointment of Loretta M. Itri, M.D., FACP, to the role of Chief Medical Officer (CMO) (Press release, Aadi Bioscience, OCT 25, 2021, View Source [SID1234591887]). Dr. Itri’s extensive career spans clinical and regulatory global-leadership roles at both major pharmaceutical and biopharmaceutical companies. Most recently, Dr. Itri was Chief Medical Officer at Immunomedics, Inc, where she oversaw the development program and approval of TRODELVY, the first TROP-2 directed antibody-drug conjugate for the treatment of unresectable locally advanced or metastatic triple-negative breast and urothelial cancers. Immunomedics was subsequently acquired by Gilead Sciences, Inc.

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"We are fortunate at Aadi to be able to tap into the experience of another valued former colleague from Immunomedics," stated Behzad Aghazadeh, Ph.D., Managing Partner and Portfolio Manager, Avoro Capital and member of Aadi’s Board of Directors. "Loretta’s insight and experience was critical to Immunomedics gaining FDA approval for TRODELVY. I am excited that she will be lending her extensive development experience to Aadi as we advance nab-sirolimus (ABI-009) forward."

"We are thrilled to have Loretta join Aadi as CMO," stated Neil Desai, Ph.D., Founder, President and Chief Executive Officer of Aadi. "Her deep drug development experience in targeted oncology therapeutics will be crucial as we drive forward our registrational study in TSC1 and TSC2 inactivating alterations. Her unparalleled expertise and track record in designing and executing clinical studies will be invaluable as we broaden the applications of our mTOR inhibitor."

Prior to joining Immunomedics, Dr. Itri was the Executive Vice President of Global Health Sciences and Regulatory Affairs at The Medicines Company (acquired by Novartis) where she oversaw the development and regulatory approval of a variety of products, including the early development of inclisiran, and other cardiovascular drugs and antibiotics. Before that, she was President of Pharmaceutical Development and Chief Medical Officer at Genta, Inc., playing a vital role in the development of diverse therapeutic agents that helped treat conditions such as breast cancer and chronic lymphocytic leukemia.

Dr. Itri has also previously served as Senior Vice President of Medical and Regulatory Affairs at Johnson & Johnson’s Pharmaceutical Research Institute, where she oversaw the development and approval of several therapeutic products, including Procrit, Cladribine, and Tramadol. In addition, she served as Senior Vice President of Clinical Affairs and Chief Medical Officer for Ortho Biotech Inc., where she was responsible for the hematology, oncology and immunology product lines. Dr. Itri began her career at Hoffmann-La Roche, where she served in various positions of increasing responsibility, including most recently as Assistant Vice President of Clinical Development in immunology, virology, hematology, and oncology.

Dr. Itri commented, "I feel fortunate to be joining Aadi at this critical time and ahead of the November 26, 2021 PDUFA target date of its investigational candidate for PEComa. I look forward to leveraging my drug development expertise to further advance and expand the opportunities for ABI-009. I believe that ABI-009 represents both a significant advance for patients with PEComa and potentially also a transformative medicine for patients with solid tumors harboring TSC1 or TSC2 inactivating alterations. With an outstanding group of new colleagues at Aadi, I look forward to initiating our registrational trial PRECISION-1 in this population."

Dr. Itri received her M.D. from New York Medical College, completed her medical residency at SUNY-Stony Brook and her fellowship in medical oncology at Memorial Sloan-Kettering Cancer Center where she was an adjunct attending physician for more than 15 years. Dr. Itri has served as a member of the National Cancer Institute Board of Scientific Counselors in both the Division of Cancer Treatment and the Division of Cancer Prevention and Control. She is the author or co-author of numerous articles in peer-reviewed journals, book chapters and abstracts related to the clinical development of therapeutic agents.

On October 25, 2021 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, reported that Company management will participate in a fireside chat and one-on-one investor meetings during the virtual portion of the Jefferies London Healthcare Conference, taking place November 18-19, 2021 (Press release, AC Bioscience, OCT 25, 2021, View Source [SID1234591903]).

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During the fireside chat, Prof. Andrea Pfeifer, CEO, AC Immune SA, will discuss the Company’s corporate strategy while highlighting its precision medicine approach, clinical stage vaccine programs in neurodegenerative diseases, and data from the Lauriet Phase 2 trial evaluating semorinemab in mild-to-moderate Alzheimer’s disease.

The fireside chat will be available on-demand for attendees during the virtual conference beginning on November 18, 2021. A replay of the fireside chat will also be available on the Events Page of AC Immune’s website following the conference’s conclusion.

On October 25, 2021 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that Juventas Cell Therapy Ltd. ("Juventas") has completed a Series C financing round through which it raised more than RMB410 million (approximately $63 million (USD)) (Press release, CASI Pharmaceuticals, OCT 25, 2021, View Source [SID1234591919]). Juventas states that the funds will be used to pursue a new drug application in China and launch implementation of a commercialization and international research and development plan for CNCT19.

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CASI shares global co-commercial and profit-sharing rights with Juventas and indirectly owns a 12.0098% equity stake in Juventas on a fully diluted basis following completion of the Series C financing round. The Juventas’ financing was led by CICC Capital.

Dr. Wei-Wu He, CEO and Chairman of CASI comments: "CASI, through its commercialization of Evomela in China, has built a robust commercial team in the hematology-oncology market. Juventas is a leading cell therapy innovator in China. The collaboration between CASI and Juventas will speed up the adoption of CAR-T therapy in China, helping thousands of patients in need of this breakthrough therapy."

About CNCT19

CNCT19 targets CD19, a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies. CD19- targeted CAR constructs from several different institutions have demonstrated consistently high antitumor efficacy in children and adults with relapsed B-cell acute lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), and B-cell non-Hodgkin lymphoma (B-NHL). CD19 antigen is the most frequently used target in the CAR-T cell therapy clinical trials for hematological malignancies such as leukemia and lymphoma. Juventas is responsible for the development of CNCT19. CASI and Juventas will co-commercialize CNCT19 under the direction of the program’s joint steering committee.

On October 25, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported that new data being presented at the American Society for Radiation Oncology (ASTRO) 2021 Annual Meeting suggest the company’s Decipher Prostate genomic classifier identifies patients with clinically high-risk prostate cancer who may require treatment intensification beyond standard-of-care therapy (Press release, Veracyte, OCT 25, 2021, View Source [SID1234591888]).

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The findings, from a pre-specified analysis of biopsy samples taken from prostate cancer patients with clinically high-risk disease who were enrolled in multiple phase 3, prospective, randomized studies, show that Decipher Prostate test scores are independently associated with distant metastases (DM), prostate cancer-specific mortality (PCSM) and overall survival (OS) in this patient population. After a median follow up of 11 years, men with disease classified as Decipher high-risk experienced substantially less favorable outcomes compared to men with disease classified as Decipher low-risk.

"Clinically high-risk prostate cancer is a heterogenous disease, and having reliable information about individual patients’ prognoses based on their unique tumor biology can help improve shared decision-making," said Paul L. Nguyen, M.D., of the Dana-Farber Brigham Cancer Center, who presented the data during an ASTRO media briefing today. "The findings we’re sharing at ASTRO are particularly exciting because they are the first to validate use of a gene expression classifier in pre-treatment prostate cancer biopsy samples collected during prospective, randomized clinical trials."

For the analysis, Dr. Nguyen and colleagues obtained Decipher Prostate scores for 265 biopsy samples from the NRG/RTOG 9202, 9413 and 9902 phase 3 randomized trials. After multi-variable analyses adjusting for age, prostate-specific antigen (PSA) levels, Gleason score, cT-stage, trial and randomized treatment arm, researchers found that Decipher Prostate scores were independently associated with distant metastases (HR 1.24), prostate cancer-specific mortality (1.27) and overall survival (1.12). The cumulative incidence of DM at 10 years was 26%, 15% and 6% for men who were Decipher high-risk, intermediate-risk and low-risk, respectively. Among the subset of patients with a Decipher Prostate score >0.85 (within the "high-risk" range of 0.6-1.0), DM was 29% at 5 years and 41% at 10 years.

"This analysis provides the first clinical evidence that the Decipher Prostate classifier can help physicians and patients make critical, personalized treatment decisions in the post-biopsy, clinically high-risk prostate cancer setting," said Elai Davicioni, Ph.D., Veracyte’s senior vice president of scientific and clinical operations, Urologic Cancers. "It adds another important piece to the extensive and growing body of clinical data supporting use of the classifier to help inform treatment decisions across the patient’s prostate cancer journey."

Treatment intensification for men with clinically high-risk prostate cancer and Decipher scores above 0.85 is being studied in the currently enrolling, prospective, phase 3 randomized trial NRG-GU009 (PREDICT-RT), which also studies treatment de-intensification by halving the duration of hormonal therapy in men with Decipher scores 0.85 or less. Along with PREDICT-RT, the Decipher Prostate genomic classifier is currently being investigated in seven National Cancer Institute-sponsored, phase 3, prospective, randomized controlled clinical trials; 13 phase 2/3 prospective trials; and more than 20 retrospective studies of phase 3 randomized controlled trials. Many of these trials require Decipher Prostate testing for study inclusion.

About Decipher Prostate

Decipher Prostate (Decipher Prostate Biopsy and Decipher Prostate RP) is a 22-gene, whole-transcriptome-developed genomic test intended to help inform treatment decisions for men with localized prostate cancer at initial diagnosis and after surgical removal of the prostate. The test reports the Decipher Score, which prognosticates a patient’s risk of metastasis within five years and provides risk estimates of prostate cancer-specific outcomes. Decipher Prostate can help guide physicians to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes.

On October 25, 2021 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that it will release its third quarter 2021 financial results and operational highlights before open of U.S. markets on Wednesday, November 3, 2021 (Press release, Autolus, OCT 25, 2021, View Source [SID1234591904]).

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Management will host a conference call and webcast at 8:30 am ET/1:30 pm GMT to discuss the company’s financial results and provide a general business update. To listen to the webcast and view the accompanying slide presentation, please go to the events section of Autolus’ website.

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 6984737. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 6984737.