On January 25, 2022 Cartesian Therapeutics, a fully integrated clinical-stage biotechnology company pioneering RNA cell therapy in and beyond oncology, reported that it has dosed the first patient in a Phase 1/2a multicenter clinical study evaluating Descartes-25 in patients with multiple myeloma (Press release, Cartesian Therapeutics, JAN 25, 2022, View Source [SID1234606767]). To the company’s knowledge, Descartes-25 is the first off-the-shelf RNA cell therapy to enter clinical trials for any cancer and marks the company’s fifth FDA Investigational New Drug (IND) allowance in five years. Descartes-25 is produced at Cartesian’s wholly owned cGMP manufacturing facility with the company’s proprietary RNA Armory cell manufacturing platform. This platform now includes an internally developed, Part 1271-compliant Master Cell Bank of human umbilical cord Mesenchymal Stem Cells (MSC) that was used to engineer Descartes-25.
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Descartes-25 is designed to deliver two complementary antitumor proteins directly to the tumor: a novel three-arm bispecific antibody that binds B-cell Maturation Antigen (BCMA) with femtomolar avidity and the potent antitumor cytokine interleukin-12 (IL-12). Descartes-25 cells are further engineered with a membrane-bound homing protein that directs the cells to the tumor microenvironment for local delivery of their antitumor cargo. In preclinical models, Descartes-25’s IL-12 synergistically potentiates its BCMA bispecific antibody to eliminate myeloma with unprecedented activity.
"Patients with relapsed and/or refractory multiple myeloma have few treatment options remaining," said Kenneth Anderson, M.D., Kraft Family Professor of Medicine at Harvard Medical School and Director of the Jerome Lipper Multiple Myeloma Center and LeBow Institute for Myeloma Therapeutics. "A cell therapy that locally delivers a combination of a BCMA-bispecific antibody and IL-12, without using lymphodepleting chemotherapy, is an elegant and highly innovative approach. If approved, it will be a welcome addition to our toolkit for treating this currently incurable disease."
"We designed Descartes-25 to be highly potent and well tolerated by focusing on creating the ideal pharmacokinetic profile: continuous, measured, and local delivery of a synergistic combination of antitumor agents," said Murat Kalayoglu, M.D., Ph.D., President and Chief Executive Officer at Cartesian. "I am proud of our integrated team of scientists and physicians for their hard work and rapid clinical translation of this first-in-class therapy."
"With Descartes-25, Cartesian scientists used RNA Armory technology to convert stem cells into a targeted combination therapy," said Chief Scientific Officer Michael Singer, M.D., Ph.D. "Therefore Descartes-25 is not just a potent antitumor therapy. It’s also a blueprint for future RNA cell therapies to deliver three or more rationally selected and spatially targeted combination therapeutics for a diverse array of diseases."
About the Phase 1/2a Clinical Trial
The Phase 1/2a study (NCT05113342) is an open-label, multicenter, dose escalation trial for Descartes 25 in patients with relapsed and/or refractory multiple myeloma. The study aims to enroll twenty patients who have previously failed two or more lines of treatment to determine the safety and preliminary efficacy of Descartes-25. For more information visit View Source
About RNA Armory
The RNA Armory is Cartesian’s proprietary cell engineering platform that generates large-scale, potent RNA cell therapies with extended protein expression. The RNA Armory is currently focused on RNA engineering two types of cells, T-cells and Mesenchymal Stem Cells (MSCs). Our CAR T-cell programs harness the safety of RNA and autologous engineering to target autoimmune diseases and frontline cancer – without lymphodepletion. Our off-the-shelf MSC programs leverage these cells’ clinical safety record and excellent capacity for protein secretion to deliver synergistic combinations of therapies. For more information visit View Source