On September 18, 2017 Formula Pharmaceuticals, Inc. ("Formula") reported the opening of the first clinical trial for allogeneic Cytokine Induced Killer (C.I.K.) cell-based Chimeric Antigen Receptor (CAR) cancer immunotherapy (Press release, Formula Pharmaceuticals, SEP 18, 2017, View Source [SID1234520545]).
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This open-label, dose-escalating clinical Phase 1/2a trial will evaluate the safety, pharmacokinetics (PK), and antitumor activity of modified allogeneic C.I.K. cells administered to pediatric and adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL). This clinical trial, sponsored by Fondazione Matilde Tettamanti and supported in part by Formula in accordance with the Italian/EU regulations on investigator-initiated trials, will be conducted at the MBBM Foundation/San Gerardo Hospital in Monza, Italy, and the Azienda Ospedaliera Papa Giovanni XXIII in Bergamo, Italy, both of which are affiliated with the University of Milan-Bicocca.
"We are very proud to have led the C.I.K. CAR program from the bench to the clinic and look forward to demonstrating the therapeutic potential of this platform for patients with persistent unmet need," commented Prof. Andrea Biondi, Director of the Pediatric and Pediatric Hematologic Oncology Clinic at the University of Milan-Bicocca, MBBM Foundation/San Gerardo Hospital, and Scientific Director at the Fondazione M. Tettamanti in Monza, Italy. "We look forward to expanding our close collaboration with Formula into additional hematologic cancer applications."
"This clinical trial is the first to evaluate non-virally transfected, allogeneic C.I.K. CAR in patients with cancer and is designed to demonstrate important clinical proof of concept for our entire platform," said Maurits Geerlings, MD, president and CEO of Formula. "We are honored to support Fondazione M. Tettamanti in reaching this important milestone."
Formula’s product pipeline is based on a proprietary non-viral, allogeneic C.I.K. CAR technology platform, which has the potential to overcome practical, therapeutic and commercial limitations related to existing CAR-T approaches that involve autologous blood, viral transfection and restricted immune effector functionality. Formula’s C.I.K. CAR technology activates T cell and Natural Killer cell functionality within one effector cell population, sourced from healthy donor or cord blood. With this approach, the Company is developing off-the-shelf CAR immunotherapies for various hematologic and solid tumor indications.