Kintara Therapeutics and TuHURA Biosciences Update on Corporate and Clinical Progress and Near Term Goals

Kintara Therapeutics and TuHURA Biosciences recently announced significant corporate and clinical progress. Kintara, a company specializing in solid tumor cancer treatments, and TuHURA, an immune-oncology firm, have made notable advancements and shared their anticipated milestones for the near future.

In April 2024, Kintara and TuHURA entered into a merger agreement. Under this agreement, Kintara's subsidiary, Kayak Mergeco, Inc., will merge with TuHURA, making TuHURA a wholly-owned subsidiary of Kintara. This merger is expected to finalize in the third quarter of 2024. Following the merger, Kintara's existing shareholders will own about 5.5% of the combined company's common stock, which includes a contingent value right linked to the enrollment of at least 10 patients in the REM-001 study by December 31, 2025.

TuHURA plans to initiate a Phase 3 trial for its IFx-2.0 personalized cancer vaccine in combination with Keytruda® for advanced Merkel cell carcinoma in the second half of 2024. This trial will proceed under the FDA's accelerated approval pathway. Moreover, TuHURA's bifunctional Antibody Drug Conjugates (ADCs) present potential partnering opportunities, adding value to their pipeline.

In connection with the merger, TuHURA has secured $31 million in subscribed financing, extending their financial runway into late 2025. Additionally, Kintara received a 180-day extension from Nasdaq until December 9, 2024, to comply with the minimum bid price requirement for continued listing on the Nasdaq Capital Market.

On the clinical front, Kintara is progressing with the enrollment, dosing, and expansion of clinical sites for its open-label 15-patient REM-001 study in cutaneous metastatic breast cancer (CMBC). As of June 26, 2024, four patients have been dosed. Memorial Sloan Kettering Cancer Center and Montefiore Medical Center are among the institutions participating in the study. The majority of the study's costs are covered by a $2.0 million Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH).

In March 2024, Kintara expanded the inclusion criteria for the REM-001 study to include patients who have been receiving pembrolizumab (KEYTRUDA®) for at least three months. This change is expected to accelerate enrollment significantly.

Looking ahead, Kintara and TuHURA have outlined several key milestones. By the third quarter of 2024, they aim to close the merger. In the fourth quarter of 2024, they plan to complete the enrollment and 8-week follow-up of 10 patients in the REM-001 study. Additionally, TuHURA intends to commence its Phase 3 trial for the IFx-2.0 vaccine in the second half of 2024.

Kintara, based in San Diego, is committed to developing innovative cancer therapies for patients with unmet medical needs. Their lead program, REM-001 Therapy, focuses on treating CMBC and other potential indications using a proprietary photodynamic therapy platform. REM-001 Therapy, consisting of a laser light source, a light delivery device, and the REM-001 drug product, has shown an 80% complete response rate in evaluable CMBC lesions and has an established safety profile from approximately 1,100 patients across multiple studies.

TuHURA Biosciences, a Phase 3 registration-stage immuno-oncology company, is developing novel technologies to combat resistance to cancer immunotherapy. Their lead candidate, IFx-2.0, aims to overcome primary resistance to checkpoint inhibitors. TuHURA is also working on bi-functional ADCs targeting Myeloid Derived Suppressor Cells to enhance the efficacy of cancer treatments.