The Niche reads: COVID, new INDs, clinic suits, papers

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?

COVID-19 updates

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.”

Vertex IND for Diabetes. Vertex Announces FDA Clearance of Investigational New Drug (IND) Application for VX-880, a Novel Cell Therapy for the Treatment of Type 1 Diabetes (T1D)

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.

duan et al current biology 2021 fig 1b, The Niche recommended reads
Lamin-B does not disperse during mitoses of adult GSCs. Duan et al current biology 2021 fig 1b, “Shown are representative nuclear images of wild-type GSCs and somatic mitotic cells in adult ovaries stained with antibodies against lamin-B (red), and H3S10p (white). Stages of mitosis are labeled on the left. Asterisks indicate locations of lamin-B looped structures (centrosomes). Scale bars: 5 μm.”


Stem Cell Clinic Lawsuit Updates

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