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Researchers from Duke-NUS Medical School and Monash University collaborates in optimizing culture conditions for cell therapy.                   

Researchers from Duke-NUS Medical School in Singapore and Monash University in Australia have developed an algorithm that can predict what molecules are required to keep cells healthy in laboratory cultivation.

They developed a computational approach called EpiMogrify, that can predict the molecules needed to signal stem cells to change into specific tissue cells, which can help accelerate treatments that require growing patient cells in the lab.

EpiMogrify was able to successfully identify molecules to add to cell culture media to maintain healthy nerve cells, called astrocytes, and heart cells called cardiomyocytes. They also used their model to successfully predict molecules that induce stem cells to turn into astrocytes and cardiomyocytes.

The researchers have already filed for a patent on their computational approach and the cell culture factors it predicted for maintaining and controlling cell fate.

(资料来源:亚洲BioSpectrum,2020年)


FDA approves  orphan drug designation to natural killer cell therapy for multiple myeloma

The Food and Drug Administration (FDA) has recently granted orphan drug designation to oNKord, an investigational natural killer cell-based therapy, for the treatment of multiple myeloma.

oNKord (Glycostem Therapeutics) is an allogeneic natural killer cell product derived ex vivo from CD34-positive hematopoietic stem and progenitor cells from partially HLA-matched umbilical cord blood units.

The FDA grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The grant enables the company to qualify for various incentives, including tax credits for qualified clinical trials and market exclusivity upon receiving regulatory approval.

(资料来源:Healio,2020年)


FDA puts Voyager Gene Therapy study on hold. 

The Food and Drug Administration (FDA) paused Voyager’s study of gene therapy treatment until more information on its manufacturing processes. No other details were revealed by Voyager about the delay. 

The gene therapy candidate is a focused treatment for Huntington’s disease. Voyager was set to commence clinical trials and would have trailed a treatment from rival UniQure by just a few months, if not for the sudden halt by the FDA. 

Voyager said in a statement that they would promptly address the FDA’s concerns to accelerate work on Huntington’s disease candidate.

(资料来源:Biopharma Dive,2020年)