Salute e Benessere
Biosyngen's first-in-class CAR-T asset targeting solid tumors has entered pivotal phase II trial, Phase I trial data debut at ESMO 2024 Annual Congress
Safety and efficacy of a novel CAR-T cell therapy (BRG01) targeting the Epstein-Barr Virus envelope glycoprotein in advanced metastatic nasopharyngeal cancer (NPC) patients
899P
The presentation highlights that the Phase I clinical trial of BRG01 has successfully completed dose-limiting toxicity (DLT) observations and efficacy evaluations in nine patients,
Preliminary data indicates that BRG01 demonstrates exceptional safety and preliminary efficacy. In terms of safety, The most common grade 3 adverse events were transient leukopenia related to the lymphodepletion regimen.
In terms of efficacy, disease control and response rates exhibited a clear dose-dependent relationship. Higher doses led to more significant effects,
Patients treated with BRG01 have shown demonstrating significantly extended antitumor effects compared to the current standard treatment, checkpoint inhibitors like PD-1 antibodies.
Additionally, BRG01 exhibited remarkable antiviral efficacy,
Professor Zhang Li , the principal investigator (PI) of this clinical trial, and Director of the Phase I Unit at Sun Yat-sen University Cancer Center, stated, "BRG01 has the potential to be a 'first-in-class' T cell therapy for EBV-positive tumors. Its unique mechanism and robust Phase I data instill confidence in its Phase II clinical performance. We look forward to establishing its clinical efficacy through further studies, offering new hope for more patients."
As previously reported,
These data not only underscore the potential of BRG01 in treating cancer but also highlights its dual advantages in antiviral therapy, establishing a solid foundation for future clinical applications. This is likely a key factor in the Center for Drug Evaluation, NMPA and FDA's decision to advance BRG01 to Phase II trials.
BRG01 is an autologous T cell immunotherapy that expresses a chimeric receptor targeting EBV antigens through genetic modification. It represents Biosyngen's global innovation in next-generation CAR-T cell therapy specifically for EBV. The therapy received clinical trial approval from the CDE in December 2022 and the FDA in February 2023 . Subsequently, it was granted by the FDA in June and July 2023 , respectively, marking rapid simultaneous progress in both the U.S. and China .
Biosyngen's commitment to solid tumor cell therapies extends beyond BRG01. The company is emerging as All related product pipelines have achieved simultaneous regulatory submissions and approvals in both the U.S. and China ,
Regarding the initial release of BRG01's Phase I clinical data, Dr. Michelle Chen , co-founder and CEO of Biosyngen, stated, "BRG01 is the result of years of hard work by our team and a testament to the recognition of our core technology and research capabilities. Biosyngen is committed to developing innovative drugs that address unmet clinical needs in oncology. In the future, "
With Biosyngen's efficient execution and rapid research advancements, we have reason to be optimistic about achieving further clinical breakthroughs in solid tumor cell therapies in a shorter timeframe, bringing new hope to patients.
Photo - https://mma.prnewswire.com/media/2508496/image.jpg
Photo - https://mma.prnewswire.com/media/2508497/image.jpg
Photo - https://mma.prnewswire.com/media/2508498/image.jpg
Photo - https://mma.prnewswire.com/media/2508499/image.jpg
Logo - https://mma.prnewswire.com/media/2462064/Biosyngen_Logo.jpg
View original content:https://www.prnewswire.co.uk/news-releases/biosyngens-first-in-class-car-t-asset-targeting-solid-tumors-has-entered-pivotal-phase-ii-trial-phase-i-trial-data-debut-at-esmo-2024-annual-congress-302251738.html