CYTEA|BIO, a MedXCell pipeline company, is proud to announce the submission of briefing documents to EMA and FDA for Innovative Glioblastoma Multiforme Treatment

Montreux, Switzerland | July 27, 2023 –
CYTEA|BIO, a pre-clinical stage biotech company developing therapeutic antibody-effector cell constructs, is proud to announce the submission of documents for a pre-IND meeting to the regulatory authorities.
CYTEA|BIO, has taken a significant step towards addressing the urgent medical need for effective glioblastoma multiforme (GBM) treatments. The company has submitted Briefing Documents to both European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) regulatory bodies seeking advice for the completion of pre-clinical and manufacturing development of the company’s first oncology treatment for glioblastoma multiforme, based on the proprietary PIN™ platform, utilizing monoclonal antibody-armed Natural Killer (NK) effector cells.
This advice will enable completion of pre-clinical studies and chemistry, manufacturing and control (CMC) development to position CYTEA|BIO to enroll first patients in a clinical study in 2025.

GBM, the most aggressive form of brain cancer, remains a devastating pathology with alarmingly poor patient prognosis. With the average age at diagnosis being less than 60 years and average survival rates extending for barely one year from diagnosis, there is an urgent and pressing need for novel and innovative therapies to help manage this life-threatening disease.

CYTEA|BIO is a pre-clinical stage biotech company developing therapeutic antibody-effector cell constructs by combining Fc-engineered targeting ligands with unmodified allogeneic effector cells via natural receptors. The patented Pin™ platform enables practically limitless combinations of effector mechanisms and targeting ligands, building new and innovative therapies without need for drug discovery, with unrivalled efficacy, safety and manufacturing / regulatory economics. The company is the first pipeline company of MedXCell.
MedXCell is a European cell therapy venture builder with offices in Switzerland, France and the US. MedXCell focuses on technologies, techniques or novel applications in major diseases such as cancer, autoimmune, neurological and degenerative disorders, with the aim to turn promising academic ideas into commercially viable propositions.

For more information, please contact:

Lionel Brodard, CFO