January 4, 2022Matthew Fowler
CYNK-001 was recently granted fast track designation by the FDA for the treatment of patients with acute myeloid leukemia.
The FDA granted fast track designation to CYNK-001, a cryopreserved human placental hematopoietic stem cell-derived natural killer (NK) cell therapy that is not genetically modified, for the treatment of patients with acute myeloid leukemia (AML), according to a press release from the biotechnical company developing the agent, Celularity Inc.
CYNK-001 is the only cryopreserved allogeneic, off-the-shelf NK cell therapy that incorporates CD56-positive and CD3-negative NK cells expanded from human placental CD34-positive cells and is being developed as one of Celularity’s placental-derived allogeneic cell therapies. The therapy is being developed for the treatment of hematologic malignancies, solid tumors, and infectious diseases.
“We believe that the unique properties of our cell source, including the ability to proliferate and maintain activity, could be the key to improving response rates and durability for patients,” Robert Hariri, MD, PhD, founder, chairperson, and chief executive officer of Celularity, said in a press release. “We are pleased to receive this fast-track designation from the FDA for AML supporting continued development of our placental-derived NK cell platform. CYNK-001 previously received orphan drug designation for malignant gliomas and fast track designation for glioblastoma multiforme.”
I'm currently reading Philipp Dettmer's excellent book, Immune. In it, he explains that unlike other immune cells, natural killer cells identify infected/corrupt cells by (among other things) detecting the absence of MHC Class I molecules on the surface of the cell, which are normally in abundance on all healthy nucleated cells in the human body.
In a footnote, he explains that infected red blood cells are safe(r?) from NK cells because they don't have MHC Class I molecules anyway.
What's not explained (as far as I can tell; I haven't quite finished the book) is how the NK cell knows the absence of MHC I on a red blood cell is normal. Is there some other marker that says "I'm a red blood cell" or is there more to activating NK cells than the reduction of this molecule? Or can the NK cells simply not trigger apoptosis in red blood cells for some reason?
I'm not sure if I am missing something or my understanding is just fundamentally incorrect and I should go back and re-read a few chapters.
Celularity Announces FDA Clearance of Investigational New Drug Application (IND) for Natural Killer Cell Therapy CYNK-101 in First-line Advanced Her2/neu Positive Gastric and Gastroesophageal Junction Cancer
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100% objective response rate with a 42% complete response rate in 12 patients, according to investigator assessment, after the 1st of 2 planned cycles at the recommended phase 2 dose of 108 cord blood-derived natural killer (cbNK) cells/kg pre-complexed with AFM13
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No cases of serious adverse events such as cytokine release syndrome, neurotoxicity syndrome or graft-versus-host disease were observed
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Affimed to host virtual investor event on December 9th to discuss the results
New England Journal of Medicine
- pubmed = https://pubmed.ncbi.nlm.nih.gov/34469647/,
- DOI = 10.1056/NEJMoa2102715
How much should we be concerned about this? https://pubmed.ncbi.nlm.nih.gov/11237929/
"Fish oil caused a significant reduction (mean decline: 48%) in NK cell activity that was fully reversed by 4 wk after supplementation had ceased".
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