BERWYN, Pa.--(BUSINESS WIRE)--Formula Pharmaceuticals, Inc. (“Formula”) announced today the opening of the first clinical trial for allogeneic Cytokine Induced Killer (C.I.K.) cell-based Chimeric Antigen Receptor (CAR) cancer immunotherapy.
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.
About Formula Pharmaceuticals, Inc.
Formula Pharmaceuticals is a privately held, immuno-oncology-focused company located in Berwyn, Pennsylvania that is pioneering a novel approach to CAR immunotherapy for oncology and autoimmune diseases. Formula’s technology platform offers important opportunities to overcome the limitations of existing CAR approaches, with the objectives of significantly increasing patient access, clinical benefit potential, and cost-effectiveness of manufacturing. Formula develops C.I.K. CAR therapies in hematologic and solid tumor indications on its own and in partnership with others. For more information visit www.formulapharma.com.
About Fondazione Matilde Tettamanti:
The Tettamanti Foundation is a non-profit scientific institution founded in 1987. In 1994, it established the Tettamanti Research Center. The Foundation has supported the publication of more than 400 scientific papers in the most authoritative international journals, based on work of over 35 researchers, technicians, research fellowships, scholars and doctoral students at the Milan-Bicocca University, under leadership of scientific director Prof. Andrea Biondi. The institution’s five separate Research Units address different, complementary and interactive contexts in pediatric leukemia (molecular genetics, immunotherapy, molecular therapy, stem cells and cellular signals) with the aim of transferring new knowledge “from the bench to the clinic" as quickly as possible. In addition, with 15 technicians and biologists, the entire multidisciplinary diagnostic pathway is applied for children and adolescents treated in the Pediatric Clinic of the University of Milano-Bicocca, MBBM Foundation/San Gerardo Hospital in Monza, which accounts for about 20 percent of children and adolescents with leukemia in Italy. For more information, visit www.fondazionetettamanti.it.