CD30 CAR-T Cell Therapy! Singapore Tesha Bio-Innovative Therapy is eligible for EU Priority Drug (PRIME): Treatment of Lymphoma (cHL)!

19, 2021 // -- Tessa Therapeutics is a Singapore-based international biotechnology company dedicated to the development of next-generation cell therapies for cancer treatment.
recently announced that the European Medicines Agency (EMA) has granted its CD30 directed self-embedded antigen-treated antigen-treated T-cell (CD30 CAR-T) therapy priority drug qualification (PRIME) for the treatment of recurring or refractic classic Hodgkin's lymphoma (R/R cHL).
last year, the U.S. Food and Drug Administration (FDA) awarded the self-called CD30 CAR-T cell therapy R/R cHL Advanced Regenerative Medicine (RMAT) qualification.
clinical data show that this autobiographical CD30 CAR-T cell therapy has significant efficacy, good safety, and very limited toxicity in patients with R/R cHL who have previously been treated in a variety of options, and can meaningfully address the unseeded medical needs currently present in the treatment of R/R cHL.
PRIME is a rapid approval program launched by EMA in March 2016 to optimize development plans, accelerate the evaluation and review of key drugs in the field of pharmaceutical shortages, and benefit patients as early as possible.
's finalists for PRIME's experimental drugs will receive strong support from the EMA in clinical trials and drug development, including early interaction and dialogue and accelerated evaluation pathways to accelerate the development and approval of truly innovative drugs to meet the medical needs of promising new drugs.
a PRIME-qualified drug, there must be preliminary clinical evidence and non-clinical evidence that the drug substantially improves the condition compared to existing therapeutic drugs.
EMA granted PRIME, based on data from 2 Phase I/II clinical trials.
two trials, conducted by Baylor College of Medicine (NCT02917083) and the University of North Carolina's Lindbergh Comprehensive Cancer Center (NCT02690545), assessed the efficacy and safety of CD30 CAR-T therapy for patients with relapsed or resuscable CD30 positive cHL.
these studies show that at the highest dose levels, about 60 percent of patients have completely disappeared tumors, and there are no other car-T therapies associated with severe toxicity.
the results were published in the Journal of Clinical Oncology (Ramos et al., 2020).
based on these data, Tessa plans to conduct a multi-center, critical study in the United States in 2021.
The EMA has recognized the potential therapeutic effect of our in-body CD30 CAR-T therapy on patients with classic Hodgkin's lymphoma (cHL)," said Jeffrey H. Buchalter, President and CEO of Tessa Therapeutics.
, which was RMAT certified by the U.S. Food and Drug Administration (FDA) in 2020, now wants to work closely with regulators in the U.S. and Europe to accelerate the clinical development and registration path of the therapy.
Therapeutics Ltd is a Singapore-based international biotechnology company that specializes in the research, clinical development and marketing of cellular immunotherapy for cancer.
specializes in solid tumors through the company's unique virus-specific T-cell platform (VST platform).
, the company is also committed to optimizing the treatment process, reducing costs and providing patients with safe, effective and affordable treatments.
VST platform strength is the effectiveness and safety, can treat nasopharyngeal cancer, oral and pharynx cancer, cervical cancer, liver cancer, lung cancer, stomach cancer, head and neck cancer, breast cancer, etc. , Tesha company's many introphy therapy and allogeneic therapy clinical trials are under way.
() Original source: Tessa Therapeutics Receives PRIME Designation from European Medicine Agency for CD30 CAR-T Therapy