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Increased incidental detection of clonal hematopoiesis and new considerations for mutations in myelodysplastic precursors herald improved precision medicine strategies.
The trial is evaluating BP1002 to treat lymphoma and chronic lymphocytic leukemia patients whose tumors overexpress the protein BCL-2.
The company has used its semi-closed electroporation system to manufacture autologous CAR T cells to treat ovarian cancer and leukemia patients in two trials.
Using OneThree's AI platform, Jubilant has identified biomarker-defined cancer indications that it hopes to pursue for JBI-802 in human trials next year.
The agency recommended the combination for previously untreated CLL patients with certain genetic mutations, including those with a 17p deletion or TP53 mutation.
The decision comes after EMA's CHMP determined that the submitted evidence was not strong enough to demonstrate the drug's benefit in this setting.
The Phase I/II trial will assess the safety and efficacy of the CAR T cell therapy MB-102 for patients with three types of hematologic malignancies.
The company will seek FDA approval in advanced systemic mastocytosis, a disorder that can turn into cancer in 7 percent of children and 30 percent of adults.
The agency has granted priority review to Pfizer's sNDA application and is slated to issue a decision by January 2020.
The program is in its third year monitoring individuals with these mutations to try to detect disease early, understand their risk, and develop preventive treatments.