Precision BioSciences Inc (DTIL), a clinical biotech firm, recently announced that FDA has accepted its application for PBCAR19B as an Investigation New Drug (IND). PBCAR19B is tailored to be the next generation drug having stealth cell and CD19 capabilities and will target patients suffering from Non-Hodgkin Lymphoma(NHL).
The company was very pleased to receive the initial IND clearance regarding their drug PBCAR19B, which has shown in its clinical studies that it delays both T cell and natural cell-mediated allogeneic rejection. The company believes that the ability to reduce rejection by both cell types holds new endeavors. By bringing PBCAR19 B into the fold may cause two favorable outcomes.
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One able to develop persistence for the drug and the second durable clinical responses.
As always, the Phase 1 study will be non-randomized, open-label and a single dose designed to test the safety and clinical activity of PBCAR19B in patients with NHL. The key reason for this study is to test how much dosage a patient can withstand and any toxicities that might come into play once the dosage is taken.
The company had also developed an in-vivo chronic Hep-B Virus program under the tutelage of Gilead Sciences. The mutual agreement between the two firms was ended in June 2020. The company is currently exploring partnership or alternatives opportunities for the development of Hepatitis B Virus therapies.