Modiblast MB101 program passes BfArM scientific advice and pre-CTA meeting without objections

Oberhaching/Munich, Germany – Modiblast GmbH, a preclinical-stage biopharmaceutical company developing novel immunomodulatory cancer therapies, today announced 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). 

“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’. 

About Modiblast 

Modiblast pursues a novel in vivo cell reprogramming approach to treat hematological malignancies and other cancers. Our proprietary strategy aims to drive innate & adaptive immune responses and establish memory cells. With our lead pipeline program progressing towards a first clinical trial in AML, we are in the process of raising a seed round. Our long-term vision is to establish a cancer backbone therapy capable of prolonging phases in remission. We aim to enable patients to self-administer this novel drug combination at home, drastically improving their quality of life. 

Contact 

Modiblast GmbH 

Prof. Dr. rer. nat. Helga Schmetzer 
CEO/CSO 
contact@modiblast.com  

Media Relations 

Valency Communications 
Mario Brkulj 
mbrkulj@valencycomms.eu