BioSyngen Pte Ltd.

Genmab-Pfizer’s cervical cancer treatment is under EMA review. Credit: Jo Panuwat D / Shutterstock.com. The European Medicines Agency (EMA) has validated the marketing authorisation application (MAA) for review of Genmab and Pfizer ’s tisotumab vedotin to treat recurrent or metastatic cervical cancer. The antibody-drug conjugate (ADC) would become the first treatment option in the European Union for adult cervical cancer patients whose disease has advanced on or following systemic therapy. The MAA submission is based on results from the randomised, international Phase III innovaTV 301 trial. The trial enrolled 502 patients who had received no more than two systemic regimens previously for recurrent or metastatic cervical cancer. Tisotumab vedotin demonstrated improved overall survival, progression-free survival and objective response rates. See Also: Regeneron’s linvoseltamab application accepted for review Biosyngen’s liver cancer therapy receives fast track designation The findings are compared to those obtained from chemotherapy treatments. The primary goal of the study was to assess overall survival, while secondary outcomes included progression-free survival and quality-of-life measures. Data from the innovaTV 204 Phase II single-arm trial of tisotumab vedotin monotherapy was also included in the application. The safety profile observed in the innovaTV 301 trial aligns with the known safety information provided in the US prescribing details. Genmab CEO Jan van de Winkel stated: “The validation of our application is an important milestone supporting our commitment to bringing a new therapeutic option for recurring or metastatic cervical cancer to more patients. “There continues to be a need for therapeutic options for these patients, and we’re dedicated to delivering potentially improved outcomes to women diagnosed with this devastating disease.” Tisotumab vedotin combines Genmab’s human monoclonal antibody targeting tissue factor with the ADC technology of Pfizer. Pfizer Oncology chief development officer Roger Dansey stated: “The milestone signifies our progress in exploring the availability of tisotumab vedotin for more patients with recurrent or metastatic cervical cancer. “We remain dedicated to collaborating closely with regulatory authorities, while we navigate the process to potentially deliver a new therapeutic option to people facing this debilitating disease.”

BST02 is being developed to treat liver cancer, including hepatocellular carcinoma and cholangiocarcinoma. Credit: Peakstock / Shutterstock.com. The US Food and Drug Administration (FDA) has granted fast track designation (FTD) to Biosyngen’s T cell therapy BST02 for treating liver cancer, including hepatocellular carcinoma and cholangiocarcinoma. The designation will accelerate the clinical trial process and marketing registration for BST02. BST02 utilises adoptive immune cell therapy technology, expanding the patient’s own tumour-infiltrating lymphocytes. This approach offers potential benefits over standard tumour-infiltrating lymphocyte (TIL) therapies, including the ability to be cryopreserved and transported and a reduced requirement for high doses of interleukin-2. In October 2023, the company received FDA approval to commence the Phase I/II clinical trials of the cell therapy. The China National Drug Administration’s Center for Drug Evaluation granted approval for the trial in December. See Also: Vivet wins $5.3m grant to develop gene therapy for rare metabolic disorder CMS sets up negotiating framework for expensive sickle cell disease gene therapies This marks a significant milestone as BST02 becomes the first TIL cell therapy drug for liver cancer to enter clinical stages globally. The FTD for BST02 follows a similar designation for another Biosyngen product, BRG01, in July 2023. Biosyngen aims to continue its research efforts to improve patient outcomes worldwide. Biosyngen co-founder and CEO Michelle Chen expressed her gratitude to the FDA for recognising the company’s fourth product. She highlighted the company’s commitment to advancing cancer cell therapy across the globe and offering new treatments for a diverse patient population. Chen reaffirmed the company’s dedication to using its advanced technology platforms to deliver accessible therapies for patients around the world. In September 2023, the company received FDA IND clearance for a Phase I/II trial of its therapy, BRL03, to treat lung cancer, gastric cancer and other advanced solid tumours. BRL03 is the first T cell receptor product developed by the company to enter the clinics. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Cell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. By Cytiva Thematic By downloading this case study, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy

SINGAPORE, Feb. 1, 2024 /PRNewswire/ -- Biosyngen is proud to announce that its latest groundbreaking product, BST02, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of all types of liver cancer, including hepatocellular carcinoma and cholangiocarcinoma. Continue Reading Fast track is a process designed to facilitate development, and accelerate the review of drugs to treat serious or life-threatening conditions and fill an unmet medical need. This designation is anticipated to expedite the advancement of clinical trials and the registration of pharmaceutical products for marketing purposes. BST02 has received approval from the FDA for Phase I/II clinical trial in October 2023 and has also been approved by the Center for Drug Evaluation (CDE) of the China National Drug Administration in January, 2024. This marks the first TIL cell therapy drug for liver cancer to progress to the clinical stage globally. Furthermore, another product from Biosyngen, BRG01, was granted fast track designation in July 2023. Michelle Chen, co-founder and CEO of Biosyngen, expressed gratitude towards the FDA for acknowledging the company's fourth product. She emphasized the company's commitment to advancing cell therapy for cancer globally and providing innovative treatment solutions for diverse patient populations. Michelle reiterated Biosyngen's dedication to leveraging its advanced technology platforms to offer more effective and accessible treatment options for patients worldwide. BST02, a T cell therapy based on the expansion of the patient's own tumor infiltrating lymphocytes, falls within the category of adoptive immune cell therapy technology. It holds promise for the treatment of all types of liver cancer, offering new hope for patients. In contrast to traditional TIL therapies, BST02 offers numerous benefits, including the ability to overcome distance constraints due to its cryopreserved form and the reduced need for high doses of interleukin-2. Biosyngen is dedicated to the R&D of innovative pharmaceutical products aimed at addressing unmet clinical need in oncology. Moving forward, Biosyngen intends to maintain its emphasis on conducting research in this domain for the betterment of patients globally. SOURCE Biosyngen