Positive topline data from Phase II trial of Vaxart’s norovirus vaccine pill

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Positive topline data from Phase II trial of Vaxart’s norovirus vaccine pill Vaxart has announced that both groups dosed with the oral bivalent vaccine candidate showed increased antibody responses to norovirus.

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Kymriah is expected to continue as the dominant CAR-T therapy

Novartis’s Kymriah and Gilead’s Tecartus are the only marketed cell therapy products approved for the treatment of ALL as of 2022. Both products are CD19-directed autologous CAR-T therapies approved for use in R/R settings. Per GlobalData estimates, Kymriah is expected to continue as the dominant CAR-T therapy through to 2031. Label expansion of Kymriah into the 1L, which has a high patient number, will strongly drive sales. Tecartus fails to compete with Kymriah due to later market entry for pediatric and young adult patients. The success of CAR-Ts in ALL has fueled R&D investment into this class of therapy, with more CAR-Ts in development than all other cell and gene therapy (CGT) classes combined. Pipeline CAR-Ts will likely require a novel target, increased efficacy, lower price, or simplified manufacture to penetrate the crowded CAR-T market. There is a high level of unmet need for patients who relapse or fail to respond to first-line combination chemotherapy regimens; this is partially addressed by already marketed CAR-Ts. CGTs may provide a curative treatment for patients with R/R T-ALL; however, no such agents are in Phase III trials.

Editorial clinicaltrialsarena@globaldata.com

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