Clinical trialsCompany release

TuHURA wins FDA IND clearance for VISTA antibody TBS-2025 in relapsed AML

🇺🇸 TuHURA Biosciences, Inc./NV (HURA) · Fri 13 Nov 2026

The US regulator has allowed a Phase 1b study of TBS-2025 in relapsed or refractory mutant NPM1 acute myeloid leukaemia, as TuHURA reports third-quarter results with $1.9 million in cash.

TuHURA Biosciences said on 13 November 2026 that the US Food and Drug Administration has issued a "study may proceed" notice and cleared its investigational new drug (IND) application for TBS-2025. The VISTA-targeting antibody will be tested in a Phase 1b trial in patients with relapsed or refractory acute myeloid leukaemia (AML) carrying a mutant NPM1 gene.

The announcement came with the company's third-quarter 2026 results and corporate update. TuHURA also gave an early read on IFx-2.0 combined with Keytruda in metastatic Merkel cell carcinoma. In this open-label study, the first three patients treated showed responses.

On finances, TuHURA reported cash of $1.9 million at the end of the quarter. The company said its operations are being funded through a loan facility provided by its largest shareholder.

The summary available does not include further details on the trial design, enrolment targets, timelines or the quarter's financial results beyond the cash position. Context: an IND clearance allows a sponsor to begin clinical testing of an unapproved product in the US, but does not indicate efficacy or safety.

What it means for your team

  • The IND clearance lets TuHURA begin human testing of TBS-2025 in a genetically defined AML population, a setting to watch for VISTA-directed approaches.
  • The Merkel cell carcinoma data are early, open-label and based on three patients, so they should be read with caution.
  • With $1.9 million in cash and funding dependent on a loan from its largest shareholder, the company's ability to run trials rests on continued financing, a point for partners and counterparties to note.

Company's press release (SEC filing): TuHURA Biosciences, Inc./NV ↗

Article written by VigiEye from the official source (TuHURA Biosciences, Inc./NV). Claims are the company's own. AI-assisted; check the source before acting.

More Clinical trials All →