Tessa Therapeutics Receives EMA PRIME Designation for CD30 CAR-T Therapy in Relapsed/Refractory Classical Hodgkin Lymphoma

January 19, 2021 / Bioon -- Tessa Therapeutics, an international biotechnology company headquartered in Singapore, is dedicated to developing next-generation cell therapies for the treatment of cancer. The company recently announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to its CD30-directed autologous chimeric antigen receptor T-cell (CD30 CAR-T) therapy for the treatment of relapsed or refractory classical Hodgkin lymphoma (R/R cHL). Last year, the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to this autologous CD30 CAR-T cell therapy for the treatment of R/R cHL.

Clinical data demonstrate that this autologous CD30 CAR-T cell therapy exhibits significant efficacy, a favorable safety profile, and minimal toxicity in patients with relapsed/refractory classical Hodgkin lymphoma (R/R cHL) who have previously received multiple lines of therapy, thereby meaningfully addressing the current unmet medical needs in the treatment of R/R cHL.

PRIME is a priority medicines scheme launched by the European Medicines Agency (EMA) in March 2016, designed to optimize development plans and accelerate the assessment and review of key medicines in areas of unmet medical need, thereby enabling patients to benefit as early as possible. Investigational medicines selected for the PRIME scheme receive enhanced support from the EMA in clinical trials and drug development, including early interactions and dialogue as well as accelerated assessment pathways, to expedite the development and approval of truly innovative therapies and meet the healthcare needs for promising new drugs. To qualify for PRIME, medicines must have preliminary clinical and non-clinical evidence demonstrating that they offer a substantial therapeutic advantage over existing treatments.

The EMA granted PRIME designation based on data from two Phase I/II clinical trials. These two trials, conducted by Baylor College of Medicine (NCT02917083) and the University of North Carolina Lineberger Comprehensive Cancer Center (NCT02690545), respectively, evaluated the efficacy and safety of CD30 CAR-T therapy in patients with relapsed or refractory CD30-positive classical Hodgkin lymphoma (cHL).These studies indicate that at the highest dose level, approximately 60% of patients achieved complete tumor regression, without the severe toxicities associated with several other CAR-T therapies.These results were published in the Journal of Clinical Oncology (Ramos et al., 2020). Based on these data, Tessa Therapeutics plans to conduct a multicenter pivotal study in the United States in 2021.

Jeffrey H. Buchalter, President and Chief Executive Officer of Tessa Therapeutics, stated, “We are delighted that the EMA has acknowledged the potential therapeutic benefit of our autologous CD30 CAR-T therapy for patients with classical Hodgkin lymphoma (cHL). Having received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) in 2020, we now look forward to working closely with regulatory authorities in the United States and Europe to accelerate the clinical development and registration pathway for this therapy.”

Tessa Therapeutics Pte Ltd is a Singapore-based international biotechnology company specializing in the research, clinical development, and commercialization of cellular immunotherapies for cancer. Leveraging its proprietary Virus-Specific T-cell (VST) platform, the company focuses on solid tumors. Additionally, Tessa Therapeutics is committed to optimizing treatment processes and reducing costs to provide patients with safe, effective, and affordable therapies.

The VST platform’s strengths lie in its efficacy and safety, offering treatment for nasopharyngeal carcinoma, oropharyngeal carcinoma, cervical cancer, liver cancer, lung cancer, gastric cancer, head and neck cancer, breast cancer, and other malignancies. Multiple clinical trials of Tessa Therapeutics’ autologous and allogeneic therapies are currently underway. (Bioon.com)

Original Source: Tessa Therapeutics Receives PRIME Designation from European Medicines Agency for CD30 CAR-T Therapy