A Phase 3 open-label hybrid control design registration trial of MDNA55 in rGBM patients with no mutation in 1DH1/1DH2 genes
Latest Information Update: 23 May 2024
At a glance
- Drugs Bizaxofusp (Primary)
- Indications Glioblastoma
- Focus Registrational; Therapeutic Use
- Acronyms LIGHT
- Sponsors Medicenna Therapeutics
- 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.
- 14 Feb 2024 According to a Medicenna Therapeutics media release, the company to seek alignment with the European Medicines Agency (EMA) for the Phase 3 registration trial of bizaxofusp incorporating an ECA. The proposed Phase 3 trial design incorporating a hybrid external control arm has been supported by the FDA. Data from this trial will be used to file for approval in the EU and USA.
- 22 Jun 2022 According to a Medicenna Therapeutics media release, design of this trial highlighted in a peer-reviewed manuscript published in The Lancet Oncology.