AvenCell Therapeutics, a leading clinical-stage cell therapy company, has announced that the European Medicines Agency (EMA) has approved its Clinical Trial Application (CTA) for AVC-201.
AVC-201 is a novel allogeneic CD123-directed switchable CAR-T investigational therapy for the treatment of relapsed/refractory Acute Myeloid Leukemia (AML) and other CD123 positive hematological malignancies.
This therapy is the world’s first CRISPR-engineered switchable allogeneic CAR-T designed to fully avoid rejection by both the innate and adaptive host immune system.
The phase 1 study, which includes up to 35 patients, will be conducted at multiple sites in Germany. The primary objective of the trial is to assess the safety profile of AVC-201 and to determine the maximum tolerated dose. Secondary measures will include efficacy, safety, and CAR-T persistence.
Andrew Schiermeier, AvenCell’s President & CEO, expressed excitement about building on the early success and promising activity and safety of their ongoing switchable autologous clinical program in AML (AVC-101). He believes that their allogeneic technology is the most scientifically-compelling in the industry.
The application of both platform technologies allows the company to separate the manufacture of cells from the ultimate patients and cancer indications they will be targeted to. This approach allows for future flexibility, massive scaling of supply, and meaningful reductions in cost of goods, all of which will dramatically advance the field of cell therapy for patients.
AvenCell Therapeutics was launched in 2021 by Blackstone Life Sciences, Cellex Cell Professionals, and Intellia Therapeutics, and incorporated the clinical-stage biopharmaceutical company GEMoaB GmbH.
The company is headquartered in Cambridge, Massachusetts with additional R&D and manufacturing operations in Dresden, Germany.