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Kintara Therapeutics Inc. (KTRA) news has centered on the issuer's biotechnology and immuno-oncology disclosure stream as recent records identify the company as TuHURA Biosciences, Inc. TuHURA is a Phase 3 immuno-oncology company developing therapeutics intended to overcome resistance to cancer immunotherapy.
Recurring developments include clinical-development leadership and strategy for the VISTA-inhibiting antibody TBS-2025 in blood-related cancers, innate immune agonist product candidates, Delta Opioid Receptor technology, antibody-drug conjugate work targeting Myeloid Derived Suppressor Cells, and updates on capital structure, material agreements, shareholder voting, governance, operating results, and risk factors.
TuHURA Biosciences and Kintara Therapeutics (Nasdaq: KTRA) announced that Kineta Inc. has reopened enrollment for the VISTA-101 Phase 1/2 clinical trial evaluating KVA12123 in patients with advanced solid tumor cancer. The trial has enrolled 30 out of 39 projected patients, including a monotherapy arm and a combination arm with Merck's KEYTRUDA®. Kineta expects full enrollment by the end of 2024.
KVA12123 has shown promising initial results, including partial response and stable disease in combination cohorts and durable stable disease in monotherapy cohorts. The drug has demonstrated a favorable safety profile with no dose-limiting toxicities or cytokine release syndrome. TuHURA is currently in due diligence for the potential acquisition of KVA12123 from Kineta, following a $5 million nonrefundable payment and an exclusive negotiation agreement.
TuHURA Biosciences has entered into an Exclusivity and Right of First Offer Agreement with Kineta for the potential acquisition of the anti-VISTA antibody KVA12123 and related assets. KVA12123 targets VISTA, a checkpoint on quiescent T-cells, to reverse immune suppression and remodel the tumor microenvironment. This inhibitor is currently in Phase 1/2 clinical trials, showing favorable safety and tolerability. Concurrently, TuHURA secured a $5 million investment from an existing shareholder to support its Phase 3 trial and ADC development. The agreement includes a payment of $2.5 million at signing, with an additional $2.5 million due by July 15, 2024, and a 90-day exclusivity period.
Kintara Therapeutics and TuHURA Biosciences have announced significant corporate and clinical advances. In April 2024, both companies entered a merger agreement where TuHURA will become a wholly-owned subsidiary of Kintara, expected to close in Q3 2024. Kintara's existing stockholders will own roughly 5.5% of the combined company's stock, including a contingent value right linked to the REM-001 study milestones.
TuHURA is set to advance a Phase 3 trial for its IFx-2.0 personalized cancer vaccine in the second half of 2024. Moreover, TuHURA's ADCs offer potential partnering opportunities. A $31 million financing will support the merger, extending financial runway into late 2025. Kintara also received a 180-day Nasdaq compliance extension to December 9, 2024.
On the clinical front, Kintara has advanced its REM-001 study for cutaneous metastatic breast cancer, having dosed four patients as of June 26, 2024. The study is supported by a $2 million NIH grant. Near-term milestones include closing the merger in Q3 2024 and commencing TuHURA's Phase 3 trial in 2H 2024.
TuHURA Biosciences and Kintara Therapeutics have announced positive results from a Phase 1b trial of their personalized cancer vaccine, IFx-2.0. The trial targeted patients with advanced Merkel Cell Carcinoma (MCC) and Cutaneous Squamous Cell Carcinoma (cSCC) who were resistant to immune checkpoint inhibitors (ICIs). The vaccine was well-tolerated and showed promising efficacy, with 80% of ICI-naïve patients achieving a durable response.
Data from the study were presented at the 2024 ASCO Annual Meeting. The trial's success has led to the planning of a Phase 3 trial, expected to start in the second half of 2024, using IFx-2.0 in combination with Keytruda to improve tumor response rates.
Additionally, TuHURA has entered into an all-stock transaction with Kintara and secured a $31 million financing to advance their oncology pipeline. The combined company will focus on personalized cancer vaccines and bi-functional Antibody Drug Conjugates (ADCs), operating under the name TuHURA Biosciences and trading on Nasdaq under the ticker HURA.
Kintara Therapeutics (Nasdaq: KTRA) announced its fiscal Q3 2024 financial results ending March 31, 2024. Key developments include a definitive merger agreement with TuHURA Biosciences. Post-merger, Kintara stockholders will own 2.85% to 5.45% of the combined company. The merger is expected to close in Q3 2024. Kintara expanded the inclusion criteria for its REM-001 study and initiated a study in CMBC patients, funded by a $2M NIH grant. Financially, Kintara saw a net loss of $2M ($0.05/share) compared to $3.3M ($1.94/share) in Q3 2023, attributed to lower R&D costs. Cash and equivalents were $6.35M, up from $1.54M in June 2023.
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