On May 17, 2023 Modiblast GmbH, a preclinical-stage biopharmaceutical company developing novel immunomodulatory cancer therapies, reported that its lead development program MB101 has passed a recent scientific advice and pre-CTA meeting with the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) – Germany’s Federal Institute for Drugs and Medical Devices – without objections. Achieving this milestone significantly increases the chances to get final regulatory approval and expedites the transition of the Company’s lead development program into a planned Phase 1/2 clinical trial in acute myeloid leukemia (AML) and Myelodysplastic syndromes (MDS).
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"Today’s news is a significant step forward for Modiblast and paves the way for a swift transition into clinical-stage development once the necessary funding can be secured. The meeting outcome validates that Modiblast has addressed all safety aspects sufficiently to initiate a clinical study, that our preclinical data package is considered adequate, and that the study design is well substantiated. I want to thank all our collaborators and clinical partners that have contributed to achieving this milestone," commented Prof. Dr. rer. nat. Helga Schmetzer, Managing Director and Founder of Modiblast.
Modiblast’s therapeutic approach combines two crucial factors to turn ‘foe’ into ‘friend’. A myeloid differentiation factor fosters the creation of dendritic cell progenitor cells and hematological recovery. The patented combination with a danger signal and maturation factor drives the formation of dendritic cells (DCs). Both signals combined trigger the reprogramming of cancer blast into dendritic cells of leukemic origin, or DCleu, and boost the creation of healthy DC. Our first program, MB101, aims for a fixed-dose combination of granulocyte-macrophage colony stimulation factor (GM-CSF), and prostaglandin E1 (PGE1) as a ‘danger signal’.
(Press release, Modiblast, MAY 17, 2023, https://www.modiblast.com/modiblast-mb101-program-passes-bfarm-scientific-advice-and-pre-cta-meeting-without-objections/ [SID1234662144])