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TuHURA Biosciences Achieves a Major Milestone in Cancer Treatment

TuHURA Biosciences, Inc. (NASDAQ: HURA), a leading Phase 3 immuno-oncology company, has recently announced a significant achievement in its ongoing efforts to develop innovative cancer therapies. On December 15, 2025, TuHURA disclosed that Kintara's REM-001 clinical trial, aimed at treating metastatic cutaneous breast cancer, successfully met its primary safety endpoint. This milestone facilitates the distribution of shares to holders of the Contingent Value Rights (CVR) associated with Kintara, paving the way for potential advancements in cancer treatment.

Achieving Primary Safety Endpoint

The REM-001 trial enrolled ten patients suffering from metastatic cutaneous breast cancer. Following a rigorous eight-week follow-up period, the trial demonstrated not only the safety of the treatment but also suggested signs of clinical efficacy. These encouraging results are critical in the context of cancer therapies, where safety and efficacy are paramount. The trial's success is a testament to TuHURA's commitment to combatting cancer and overcoming the barriers patients often face with conventional therapies.

Contractual Milestone and Share Release

As outlined in the Contingent Value Rights Agreement finalized on October 18, 2024, the completion of this clinical trial's primary endpoint triggers the release of 1,539,958 shares of TuHURA’s common stock to former shareholders of Kintara Therapeutics. This stock distribution is expected to occur within ten business days, enabling CVR holders to benefit from their investment effectively. By achieving this milestone, TuHURA not only honors its previous commitments but also reinforces investor confidence in its mission.

TuHURA's Innovative Approach

Founded with a vision to revolutionize cancer treatment, TuHURA Biosciences is at the forefront of developing therapies that address both primary and acquired resistance to cancer immunotherapy. The company’s flagship innate immune agonist, IFx-2.0, aims to enhance the effectiveness of existing checkpoint inhibitors by addressing the hurdles resistant cancers often present. This innovation is critical in the broader fight against cancer, where many therapies fail due to the body's immune evasion mechanisms.

TuHURA is currently leading a Phase 3 registration trial for IFx-2.0 in conjunction with Keytruda® (pembrolizumab) for treating advanced Merkel Cell Carcinoma, showcasing the company's proactive approach to integrating its novel therapies into established treatment protocols.

Future Directions

In addition to IFx-2.0, TuHURA is propelling forward with the TBS-2025, a product acquired during its merger with Kineta Inc. on June 30, 2025. TBS-2025 is a VISTA inhibiting monoclonal antibody that is transitioning into Phase 2 development for treating mutNPM1 r/r AML. Such advancements signify TuHURA's adaptability and innovative strategies in the rapidly evolving landscape of cancer treatment.

Furthermore, the company is leveraging its Delta Opioid Receptor technology to create novel bi-specific antibody drug conjugates aimed at Myeloid Derived Suppressor Cells. This strategic focus is designed to neutralize their immune-suppressing activities, ultimately combating the challenges posed by tumor microenvironments and preventing T cell exhaustion—a significant obstacle in cancer therapy.

Conclusion

In conclusion, TuHURA Biosciences' recent milestone symbolizes a step forward in the field of immuno-oncology. With the successful trial of Kintara's REM-001 and the subsequent share release to CVR holders, TuHURA is poised to impact cancer treatment significantly. Investors and stakeholders are encouraged to stay tuned as the company continues to innovate and lead in this critical area of medical science. For more information on TuHURA’s endeavors, visit their website at www.tuhurabio.com and connect through their social media platforms.