While the political landscape takes shape before the US presidential elections, the cell therapy industry is facing potential shifts in regulatory framework that could allow developers earlier market access by bypassing certain clinical trials. Specifically, the proposed US REGROW bill -- which has gained renewed bipartisan interest but elicited concern from many cell therapy developers -- is unlikely to pass in Congress’s current session, but has success potential postelection, political consultants told BioPharm Insight. Experts added that the bill, if passed, will bring an increased risk of adverse events to patients, which will impact safety perceptions of the whole industry. In turn, this could derail development of other regenerative medicines.
Legislative pathway modifications aside, cell therapy is a fast-growing industry seeing a wave of emerging therapies with potential to bring forth new treatment options in several therapeutic areas. Among those harnessing the body’s immune system, undoubtable interest is being garnered in oncology with chimeric antigen receptor (CAR) modified T cells targeting the CD19 antigen. While the most substantial clinical benefit until now with CAR-Ts has been seen in relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), early phase clinical studies are currently assessing the therapy’s potential in additional hematological malignancies...
This report includes coverage on major recent developments and important upcoming catalysts in the cell therapy area based on our discussions with key opinion leaders. It also includes sales forecasts for notable cell therapies in development and analytics on licensing deals in the space.
Companies included in this report: Adaptimmune, Argos Therapeutics, Immune Design, Juno Therapeutics, and Kite Pharma.
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