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.
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.
Privately held Formula Pharmaceuticals is pioneering a novel approach to CAR immunotherapy for oncology and autoimmune diseases.
The company's technology platform offers 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.
The Tettamanti Foundation is a non-profit scientific institution that established the Tettamanti Research Center in 1994. The foundation has supported the publication of more than 400 scientific papers 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% of children and adolescents with leukemia in Italy.
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