Here are my recommended weekly reads for The Niche readership for early February 2021 including COVID-19 and stem cell lawsuit updates, papers, and more. How many papers do you end up reading each week or month these days? More or less than before the pandemic?
New Regenerative Medicine INDs; Korea rejects COVID one
IPSC-related IND. Factor Bioscience spins out a new cell therapy player with eyes on the clinic within 2 years, EndPoints
“The company will be unveiling a CD19-targeted CAR-T and CAR-NK, Fiore said, with ROR1 as its next target…The CEO says Exacis’ approach is what differentiates it from others in the crowded cell therapy field, beginning with mRNA technology in-licensed from Factor. The process starts with induced pluripotent stem cells (iPSC), which are blood or skin cells that have been engineered back into an embryonic-like stem cell state. They’re created with mRNA reprogramming, and then edited to avoid host immune surveillance, add a CAR and enhance the cells for potency against tumors.”
Organicell IND for COPD. Organicell Announces FDA Approval of IND Application for the Use of Zofin™ in the Treatment of Chronic Obstructive Pulmonary Disease (COPD). A perinatal cellular medicine product.
Korea says no on COVID-19 cell therapy IND that FDA cleared. Korean regulators rejected an IND-like application from Nature Cell for a stem cell study in COVID-19 patients, citing too little data (HT, Leigh Turner). Notably, Nature Cell received an FDA IND clearance for a study of the same product. I believe the FDA has cleared way too many INDs of cellular medicines for COVID-19, including especially from stem cell clinic firms.
Stem Cell Clinic Lawsuit Updates
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