First Car-T for an Autoimmune Disease Enters Clinic
Maryland-Based Cartesian Therapeutics Initiates CAR-T Clinical Trial in Myasthenia Gravis
Gaithersburg, MD, November 5, 2019 – see full press release
Founded in 2016 by a pair of MD/PhD scientists and serial life sciences entrepreneurs, Cartesian Therapeutics is out to rapidly translate discoveries into clinical trials, and trials into approved cell and gene therapies for cancer and autoimmune diseases. Just three years after launching, Cartesian now has a third program in clinical development and is on its way to accomplishing that vision.
The company announced today that it has initiated a Phase 1/2 clinical trial (NCT04146051) of its lead CAR-T candidate, Descartes-08, in patients with generalized myasthenia gravis (GMG). Not only is this an important milestone for Cartesian, but to the company’s knowledge, this is the first CAR-T investigational candidate to enter clinical development for an autoimmune disease.
The selective targeting found in Cartesian’s technology would be a first in GMG and could potentially help patients discontinue use of ISTs. The trial will be lead by Volkan Granit, MD, the trial’s principal investigator and Assistant Professor of Neurology at the University of Miami Miller School of Medicine.
“Patients with severe GMG have limited treatment options and are often dependent on nonselective, chronic immunosuppressive therapies (ISTs) that have long-term toxicities,” said Granit. “Cartesian’s CAR-T technology selectively targets the primary culprit in the disease: antibody-producing plasma cells. Such selective targeting would be a first in GMG and could help patients discontinue use of chronic ISTs.”
“Unlike conventional CAR-T, which has the potential for uncontrolled proliferation and ensuing severe toxicity, Descartes-08 is engineered to have a defined and predictable half-life, enabling repeat dosing to maximize potency while minimizing risk of toxicity,” said Metin Kurtoglu, MD, PhD, Chief Medical Officer at Cartesian. “Descartes-08’s enhanced safety features enable use for of a wide range of diseases, from multiple myeloma and other cancers to autoimmune diseases.”
Cartesian’s integrated approach is designed to promote cross-disciplinary collaboration by maintaining discovery, cGMP manufacturing, and clinical operations all happen under one roof. All investigational therapies are manufactured at Cartesian’s wholly-owned, state-of-the-art cGMP manufacturing facility in Gaithersburg, MD.
“Cartesian’s fully integrated approach to R&D and a laser focus on internal cGMP manufacturing have enabled it to quickly translate three promising programs to clinical development,” said John LaMattina, Pfizer’s former President of Global R&D and a Senior Advisor to Cartesian. “I am impressed by the team’s rapidly expanding pipeline of innovative cell and gene therapies. Development of a potent yet safer CAR-T allows for potential treatment of a wide range of autoimmune diseases. It also enables use of CAR-T earlier in the treatment paradigm for multiple myeloma and other cancers.”
Cartesian was founded by Dr. Murat Kalayoglu (CEO) and Dr. Michael Singer (CSO) whose last venture, Topokine Therapeutics, was acquired by Allergan in April, 2016. Their mission with Cartesian is to develop potent yet safer cell and gene therapies designed to benefit the broadest range of patients with cancer and autoimmune diseases. In addition to the expertise and track record of success of its Founders, a broad and exclusive patent license from the National Cancer Institute (NCI) provides the company with a commanding IP position.
Cartesian has also built a high caliber leadership team that includes the former Director of the National Cancer Institute (NCI) (Dr. John Niederhuber), the former President of Pfizer R&D (Dr. John LaMattina), and three prominent physician-scientists recognized for their work in immunotherapy of multiple myeloma (Drs. Ken Anderson, Ola Landgren and Ivan Borrello).