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A Phase 3 open-label hybrid control design registration trial of MDNA55 in rGBM patients with no mutation in 1DH1/1DH2 genes

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Trial Profile

A Phase 3 open-label hybrid control design registration trial of MDNA55 in rGBM patients with no mutation in 1DH1/1DH2 genes

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 30 Aug 2026

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At a glance

  • Drugs Bizaxofusp (Primary)
  • Indications Glioblastoma; Glioma
  • Focus Registrational; Therapeutic Use
  • Acronyms LIGHT
  • Sponsors Medicenna Therapeutics

Most Recent Events

  • 14 Aug 2026 According to a Medicenna Therapeutics media release, company continues to pursue partnership opportunities for bizaxofusp, phase 3-ready for recurrent glioblastoma (rGBM). Updated and new clinical data are expected to be presented in an oral presentation at an upcoming medical conference.
  • 13 Feb 2026 According to a Medicenna Therapeutics media release, phase 3 ready asset for rGBM, bizaxofusp, to-date, has been tested in 118 patients with high grade gliomas (including 112 patients with rGBM)
  • 22 May 2024 According to a Medicenna Therapeutics media release, the company will be presenting an abstract, offering new data analyses for bizaxofusp (formerly known as MDNA55), a Phase-3 ready immunotherapy for recurrent glioblastoma, as a poster at the 2024 ASCO Annual Meeting.

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