IFx-Hu2.0
- Generic Name
- IFx-Hu2.0
- Drug Type
- Biotech
- Background
IFx-Hu2.0 is an investigational cancer vaccine. It is composed of plasmid DNA encoding the streptococcal membrane protein, Emm55, contained within a cationic polymer.
TuHURA Biosciences Appoints Former J&J Oncology Executive Craig Tendler to Board of Directors
• TuHURA Biosciences has appointed Craig L. Tendler, M.D., former Vice President of Oncology Clinical Development at Johnson & Johnson, to its Board of Directors effective March 10, 2025.
• Dr. Tendler brings extensive experience overseeing 30 major drug approvals and 13 FDA Breakthrough Designations, including transformational treatments for hematologic malignancies, prostate, lung, and bladder cancers.
• The appointment comes as TuHURA prepares to advance its lead candidate IFx-2.0, designed to overcome resistance to checkpoint inhibitors, into a Phase 3 registrational trial in Q2 2025.
Tyra Biosciences' TYRA-300 Shows Promise in Bladder Cancer and Achondroplasia
• Tyra Biosciences reported positive interim Phase 1/2 data for TYRA-300 in metastatic urothelial cancer (mUC), with a 54.5% confirmed partial response rate in FGFR3+ patients.
• The FDA cleared the IND for TYRA-300's Phase 2 study in pediatric achondroplasia (BEACH301), with the first patient expected to be dosed in Q1 2025.
• TYRA-300 is also on track for a Phase 2 IND submission for non-muscle invasive bladder cancer (NMIBC) by the end of 2024, expanding its clinical development.
• The company appointed Doug Warner, MD, as Chief Medical Officer and reported a cash position of $360.1 million, expected to last through at least 2026.
Kintara Therapeutics Announces Corporate Updates and REM-001 Clinical Study Progress
• Kintara Therapeutics is set to hold a special meeting on September 20, 2024, to approve its merger with TuHURA Biosciences, aiming to enhance its oncology pipeline.
• The REM-001 study has enrolled four patients with cutaneous metastatic breast cancer, showing no treatment-related safety issues and progressing towards Phase 3 dose assessment.
• Kintara emphasizes that the merger with TuHURA is crucial for continued operation and funding of the REM-001 study, urging stockholders to vote in favor.
FDA Grants Fast Track Status to BBO-8520 for KRAS G12C-Mutated NSCLC
• The FDA has granted fast track designation to BBO-8520, an oral agent under investigation for treating KRAS G12C-mutated metastatic non-small cell lung cancer.
• This designation aims to expedite the development and review of BBO-8520, addressing an unmet need in previously treated NSCLC patients.
• The decision was based on the drug's potential to improve outcomes in this specific genetic subgroup of lung cancer, where treatment options are limited.
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.
© Copyright 2025. All Rights Reserved by MedPath