TuHURA Biosciences files FDA IND for TBS-2025 VISTA antibody in AML, blood cancers

TuHURA Biosciences, Inc.

TuHURA Biosciences, Inc.

HURA

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  • Tuhura Biosciences filed an IND with the FDA for TBS-2025, a VISTA-inhibiting antibody, in molecularly defined AML subsets.
  • The FDA declined a requested meeting, opting to provide written feedback on the proposed Phase 1b/2 AML plan next month.
  • Tuhura targets starting the Phase 1b/2 trial in 2H 2026, including monotherapy in relapsed/refractory AML with potential expansion for accelerated approval.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Tuhura Biosciences Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: 202606150745PR_NEWS_USPR_____LA83185) on June 15, 2026, and is solely responsible for the information contained therein.