![]() ![]() Based on progression-free survival (PFS) and positive efficacy signals observed in the interim analysis, the trial is now expected to enroll a total of 120 patients compared to the initial forecast of 150 patients. In November 2022, Transgene announced that following a prespecified interim analysis of its randomized, Phase II clinical study comparing TG4001 in combination with avelumab vs avelumab alone in patients with HPV16-positive anogenital tumors ( NCT: 03260023), the Independent Data Monitoring Committee (IDMC) has recommended the study continue. With TG4001, Transgene aims to bring a new solution to patients with HPV-positive anogenital cancers who currently have very limited second-line treatment options. TG4001: Positive result from interim analysis of randomized Phase II trial in HPV-positive anogenital cancers Key achievements in 2022 and expected near-term news flow “Based on the potential of TG4050, TG4001 and TG6050, I believe that Transgene has a very exciting future and is well positioned to deliver for all of its key stakeholders.” “The progress we have made in 2022 has positioned Transgene to deliver multiple major milestones in the next 18 months, including launching potentially registrational trials for our two most advanced therapeutic vaccine candidates, as well as a Phase I study with our high-potential oncolytic virus, TG6050, given by intravenous administration. This multi-armed oncolytic virus has been designed to address major solid tumor indications, such as lung cancer, and will begin a Phase I in the months ahead. ![]() In addition, we announced the launch of a new oncolytic virus, TG6050. ![]() The ability to administer our oncolytic viruses intravenously significantly expands the range of solid tumors they can be used to treat and the market opportunity they can access. We presented new positive data from the Phase I trial evaluating our oncolytic virus TG6002 administered intravenously, showing in all patients its ability to reach the tumor, multiply and express its payload. “Turning to the oncolytic virus platform, we have achieved two important milestones. For TG4001, our most advanced product, the positive outcome of the interim analysis of the Phase II trial in HPV-positive cancers has allowed us to reduce the total number of patients to be randomized in the ongoing study. Positive data from this Phase II trial could be used for a potential registration of TG4050. ![]() These very encouraging data have led us to start the planning of Phase II trial. “With regard to our therapeutic cancer vaccine pipeline, we presented new Phase I results for TG4050 demonstrating the full clinical and commercial potential of this highly innovative neoantigen vaccine in patients with head and neck cancer. I am confident that Transgene is at the forefront of helping to realize the potential of these exciting treatment modalities. This trend backs us in our strategy and validates our technological and medical choices. We also are very encouraged by the growing industry interest in therapeutic cancer vaccines and oncolytic viruses that have the potential to become new standards of care for the treatment of solid tumors. Hedi Ben Brahim, CEO of Transgene, commented: “ I am extremely happy with the multiple positive milestones that Transgene has delivered in 2022 and I would like to thank all our employees and partners for their commitment and support. Transgene (Euronext Paris: TNG) (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today publishes its financial results for 2022 and provides an update on its product pipeline. STRASBOURG, France-( BUSINESS WIRE)-Regulatory News: €26.8 million in cash and cash equivalents as of Decem– Financial visibility until early 2024.Ĭonference call in English scheduled today at 6:00 p.m. Launch of the new multi-armed TG6050 aimed at a major solid tumor indication. Oncolytic viruses: New clinical data confirm the potential for Invir.IO® oncolytic viruses to be given via intravenous administration. Transgene is preparing for a registration targeting study. TG4001: Positive interim analysis supports continuation of the ongoing randomized Phase II clinical trial. Preparing for a Phase II trial in head and neck cancer, which purpose is to provide data for a potential registration. TG4050: New Phase I data confirm the strong clinical and commercial potential of this highly innovative personalized immunotherapy. Positive data on key clinical candidates delivered in 2022 – Promising outlook for 2023 as industry interest in therapeutic cancer vaccines and oncolytic viruses gains significant momentum ![]()
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