NexImmune gains aftermarket on IND clearance for NEXI-003 to treat HPV-related cancers

Jul. 14, 2022 4:22 PM ETNexImmune, Inc. (NEXI)By: Jessica Kuruthukulangara, SA News Editor
  • NexImmune (NASDAQ:NEXI) stock jumped 23% postmarket on Thursday after the firm received investigational new drug clearance by FDA for its first cellular therapy candidate for solid tumors.
  • NEXI-003, an autologous antigen-specific T cell product, is being developed for patients with relapsed or refractory HPV-related cancers.
  • The IND clearance allows NEXI to begin phase 1 clinical trial to evaluate NEXI-003 for treatment of HPV-related cancers.
  • The proposed study is a 2-part, multicenter, open-label, dose-finding, first-in-human study to evaluate safety and clinical activity of NEXI-003.
  • "The dose escalation phase will consist of multiple safety cohorts investigating increasing doses of NEXI-003 followed by an expansion phase that will enroll 24-36 patients overall," NEXI said in a statement.
  • After initial data and recommended phase 2 dose has been confirmed, NEXI plans to expand the NEXI-003 development program to include other HPV-related cancers and evaluate potential SOC combination options.
  • NEXI stock has fallen 69% YTD.

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