Wednesday, March 6, 2019 Daily Archives

Xenetic buying Scripps-developed XCART technology

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The currently marketed CAR-T therapies cannot discriminate between healthy and malignant B-cells says Xenetic Biosciences, which is buying a technology to enhance the safety and efficacy of such products. The XCART technology platform, developed by the Scripps Research Institute in collaboration with the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, will be used by Xenetic Biosciences to develop cell-based therapeutics for the treatment of B-cell Non-Hodgkin lymphomas. The two chimeric antigen receptor (CAR) T-cell products on the market – Kymriah (tisagenlecleucel) and…

March 6, 2019

FDA commissioner resignation ‘a great day for rogue stem cell clinics’

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Scott Gottlieb will step down from his position as commissioner of the US FDA next month. He issued more cell and gene therapy guidance in his two-year tenure than had appeared in the previous ten. In May 2017, the US Senate confirmed Dr Scott Gottlieb as commissioner of the US Food and Drug Administration (FDA). This week, nearly two years on, and Gottlieb announced he is to step down from the role in the next month. Among Gottlieb’s achievements are…

March 6, 2019

Autolus: ‘Fully-enclosed and machine-made’ CAR-Ts to lower COGS

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Having begun to build out its CAR-T network, Autolus says its fully contained, semi-automated manufacturing process will increase efficiencies and reduce costs. Last June, Autolus Therapeutics raised $150 million (€132 million) in its initial public offering (IPO) with the intention of using some of the funds to support the manufacturing of its personalized Chimeric Antigen Receptor (CAR) T-cell therapy pipeline. In January, the UK-headquartered firm began building out a commercial manufacturing facility in Enfield, London, and signed a long-term full…

March 6, 2019