in

MEI Pharma, Kyowa Kirin Cull Development Of Blood Cancer Drug Outside Japan, Look For Strategic Alternatives – MEI Pharma (NASDAQ:MEIP)

MEI Pharma, Kyowa Kirin Cull Development Of Blood Cancer Drug Outside Japan, Look For Strategic Alternatives - MEI Pharma (NASDAQ:MEIP)
MEI Pharma Kyowa Kirin Cull Development Of Blood Cancer Drug

  • MEI Pharma Inc MEIP and Kyowa Kirin Co Ltd are discontinuing global development of zandelisib outside of Japan for B-cell malignancies. 
  • Kyowa Kirin continues the ongoing clinical trials, including the Phase 2 MIRAGE study evaluating Japanese patients with relapsed or refractory indolent B-cell non-Hodgkin lymphomas.
  • Recently, the companies reported topline data from a MIRAGE study demonstrating a 75.4% objective response rate, and 24.6% of patients achieved a complete response.
  • The move follows the most recent guidance from a late November meeting with the FDA that provided further guidance regarding the design and statistical analysis for the Phase 3 COASTAL trial. 
  • The company believes the clinical development cannot be completed within a time supporting further investment.
  • In March, the FDA informed that a randomized clinical trial is “needed to adequately assess drug efficacy and safety of PI3K inhibitor drug candidates, including zandelisib.” 
  • Following the zandelisib update, MEI Pharma will focus on developing two earlier clinical-stage assets, voruciclib (B-cell malignancies) and ME-344 (solid tumors). 
  • It plans to initiate a staggered workforce reduction, initially representing approximately 30% of the current workforce.
  • Following workforce reductions, MEI expects its existing cash, cash equivalents, and marketable securities will be sufficient to fund operations through clinical data milestones for voruciclib and ME-344. 
  • The company further announced that it had engaged Torreya Partners as a financial advisor to help explore additional strategic opportunities.
  • Price Action: MEIP shares are down 45.40% at $0.21 during the premarket session on the last check Tuesday.

Written by biedex markets