Larotrectinib Sulfate

SHANGHAI, Nov. 20, 2023 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces the formation of its Clinical Advisory Board. This highly regarded panel of experts will provide invaluable guidance and insights for the global clinical development of company's innovative product candidates. "As we embark on this exciting journey to advance our differentiated CAR T-cell therapies, I am delighted to welcome our esteemed Clinical Advisory Board members. Their collective expertise and dedication to advancing cancer treatment align perfectly with CARsgen's vision and clinical development activities. We are confident that their knowledge and experience will contribute to the strategic planning and execution of our clinical development endeavors, ultimately helping us to make a meaningful difference for cancer patients worldwide. Together, we are committed to making cancer curable." Raffaele Baffa, MD, PhD, Chief Medical Officer of CARsgen Therapeutics, remarked. The newly appointed members of the Clinical Advisory Board, listed below in alphabetical order by last name, include: Dr. David S. Hong is the Douglas E Johnson Endowed Professor in and Deputy Chair of the Department of Investigational Cancer Therapeutics at the University of Texas MD Anderson Cancer Center, and Clinical Medical Director of its Clinical Translational Research Center. Dr. Hong was a pioneering driver in forming one of the largest and most innovative Phase I clinical trial units in the world, with over 1,200 patients enrolled in clinical trials in 2022 and over 280 active ongoing clinical trials. Dr. Hong has been the Principal Investigator of ~110 research protocols and published over 400 articles in peer-reviewed journals such as New England Journal of Medicine, Lancet Oncology, etc. Dr. Hong was heavily involved in the early development of many oncology drugs including cabozantinib, siltuximab, dabrafenib, trametinib, regorafenib, lenvatinib, larotrectinib, tisotumab vendotin, tepotinib, and sotorasib. Dr. C. Ola Landgren is Professor of Medicine, Chief of the Myeloma Division, Director of Sylvester Myeloma Institute, Paul J. DiMare Endowed Chair in Immunotherapy, Leader of the Experimental Therapeutics Program, and Co-Leader of the Translational and Clinical Oncology (TCO) Program at NCI-designated Sylvester Comprehensive Cancer Center, University of Miami. Prior to joining University of Miami, he served as Chief of the Myeloma Service at Memorial Sloan Kettering Cancer Center in New York City, and prior to that he was the Chief of the Multiple Myeloma Section at the National Cancer Institute in Bethesda, Maryland. Dr. Landgren is a board-certified hematologist-oncologist and he has published more than 500 papers and chapter books with a primary focus on multiple myeloma, MGUS (monoclonal gammopathy of undetermined significance), and smoldering myeloma. Dr. Landgren's research focuses the mechanisms underlying progression from precursor disease to frank malignancy, underlying mechanisms of disease response/resistance, role of minimal residual disease (MRD) negativity, biological mechanisms associated with sustained MRD negativity, identification of novel treatment targets, early drug development, and identification of novel biomarkers. Dr. Sattva S. Neelapu is a tenured Professor and Deputy Chair in the Department of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center. His research is focused on clinical and translational development of novel immunotherapies for B-cell malignancies. His work on the pivotal clinical trial of axicabtagene ciloleucel, CD19 targeted CAR T-cell therapy in aggressive B cell lymphomas, led to its FDA approval as the first CAR T-cell therapy for lymphoma. His laboratory is focused on developing CAR T-cell therapies against novel targets, understanding mechanisms of resistance to CAR T-cell therapy, and developing allogeneic cell therapy approaches. He has authored or co-authored over 275 publications. Dr. Noopur Raje is a Professor of Medicine at Harvard Medical School, the Director of the Center for Multiple Myeloma, and the Rita Kelley Chair in Oncology at Massachusetts General Hospital Cancer Center, Harvard Medical School. Dr. Raje's research focuses primarily on developing novel therapeutic strategies for the treatment of multiple myeloma and related plasma cell disorders. Her laboratory efforts are aimed at identifying cellular signaling pathways that contribute to the survival and proliferation of myeloma cells in the bone environment. Her expertise in cellular therapies has led to FDA approval of the first in class CAR T-cell product, idecabtagene vicleucel in myeloma. She has received several awards and has published widely on multiple myeloma. Dr. Paul G. Richardson is the RJ Corman Professor of Medicine at Harvard Medical School and the clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute. Dr. Richardson has led the development of several first-generation novel drugs used in multiple myeloma for over 20 years, including the combination of lenalidomide (Revlimid) and bortezomib (Velcade), with the development of the combination of lenalidomide and bortezomib with dexamethasone as frontline therapy in myeloma being one of his important contributions; the subsequent development of this combination with other agents such as daratumumab has been key for improving therapy in newly diagnosed multiple myeloma. He has also had a leadership role in the development of ixazomib, elotuzumab, daratumumab, isatuximab and pomalidomide, as well as more recently melflufen, and belantamab mafodotin. His current research efforts have been in the development of the potent and orally bioavailable CelMods, including mezigdomide. He has published extensively, having authored, or co-authored, over 460 original articles and 340 reviews, chapters, and editorials in peer-reviewed journals. His work has been recognized with multiple awards, including the Robert A. Kyle lifetime achievement award in 2017 and the Warren Alpert Prize in 2012, as well as the Ernest Beutler award in 2016. Dr. Josep Tabernero, Head of the Medical Oncology Department at the Vall d'Hebron University Hospital, Director of the Vall d'Hebron Institute of Oncology (VHIO) and Professor of Medicine at UVic-UCC. Dr. Tabernero has been Principal Investigator of several Phase I pharmacodynamic studies and translational projects with tumor-directed targeted therapies and immune-based therapies. Dr. Tabernero's research aims at potentiating molecular therapies targeting specific oncoproteins and accelerating more effective personalized cancer medicines for patients displaying genetic lesions or pathway disregulation. Dr. Tabernero's extensive publication record and leadership roles in prestigious organizations like ESMO highlight his contributions to the field. The formation of this Clinical Advisory Board marks a significant step forward for CARsgen as it continues to pioneer CAR T-cell therapies with the potential to transform cancer treatment. These accomplished experts will play a pivotal role in advising the company's efforts to develop effective therapies for patients worldwide. About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company with operations in China and the U.S. and is focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. CARsgen has established a comprehensive CAR T-cell research and development platform, encompassing target discovery, innovative CAR T-cell development, clinical trials, and commercial-scale production. CARsgen has internally developed novel technologies and a product pipeline with global rights to address major challenges of CAR T-cell therapies, such as improving the safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs. CARsgen's vision is to become a global biopharmaceutical leader that brings innovative and differentiated cell therapies to cancer patients worldwide and makes cancer curable. Forward-looking Statements All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, . No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release. Contact CARsgen For more information, please visit Public Relations: PR@carsgen.com Investor Relations: IR@carsgen.com View original content to download multimedia: SOURCE CARsgen Therapeutics Company Codes: HongKong:2171

WHIPPANY, N.J.--(BUSINESS WIRE)-- Bayer is voluntarily recalling one lot of Vitrakvi® (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottles to the consumer/user level. The product is being recalled due to microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing. Risk Statement: Given that Vitrakvi® is indicated for the treatment of solid tumors that are NTRK gene fusion positive, it is expected that patients on Vitrakvi® may be immunocompromised. Although there is little data in the literature on human pathology caused by Penicillium brevicompactum, there are cases of invasive disease caused by similar Penicillium species, particularly in patients with underlying immunosuppression. Therefore, there is a reasonable probability that ingestion of Penicillium brevicompactum in patients on Vitrakvi® with underlying immunosuppression may result in invasive fungal infections of the blood or pneumonia that can be life-threatening. To date, Bayer has not received any adverse events related to this recall. The impacted lot of Vitrakvi® is packaged in a 100mL glass bottle with NDC# 50419-392-01 and is identified with Lot# 2114228 and an expiration date of February 29, 2024. Lot# 2114228 was distributed to wholesale distributors and specialty pharmacies nationwide between January 3, 2023, and February 13, 2023. Product bottle and carton label images and information on the lot number that falls under this recall is available at: Vitrakvi Recall Lot # Photos 11.17.23.pdf (bayer.com) Bayer notified all distributors and pharmacies of this recall on November 8, 2023. Bayer has engaged Qualanex to manage the recall of the product down to the consumer level. Qualanex has notified Vitrakvi® distributors via a recall notification letter and will arrange for the return of the recalled lot from distributors, specialty pharmacies, and consumers. Consumers with general questions regarding this recall can contact Qualanex via e-mail at Recall@qualanex.com or toll free at 888-280-2043, Monday-Friday between the hours of 7 a.m. and 4 p.m. Central Standard Time. Consumers who have the recalled Vitrakvi® product should immediately stop use of this particular lot of product and contact their physician or healthcare provider if they have any questions, concerns or have experienced any problems related to Vitrakvi® Oral Solution 20 mg/mL. Patients or prescribers who have questions regarding the recall can contact Bayer Medical Information Call Center at 888-842-2937, Monday-Friday between the hours of 8:30 a.m. and 8:00 p.m. Eastern Standard Time. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. © 2023 Bayer BAYER, the Bayer Cross and Vitrakvi are registered trademarks of Bayer. Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward- looking statements or to conform them to future events or developments. PP-VIT-US-1391 11/23 View source version on businesswire.com: Contacts Company Contact: Name: Carolyn Nagle Email: carolyn.nagle@bayer.com Mobile: (201) 419-0337 Source: Bayer View this news release online at: