公司动态 - TuHURA Biosciences被纳入罗素3000指数和罗素2000指数 该调整于2025年6月27日收盘后生效 [1] - 公司CEO表示 入选罗素指数标志着上市首年取得重大进展 并强调2025年剩余时间是关键阶段 将继续推进IFx-2.0的III期加速批准试验 并计划将收购Kineta获得的新型抗VISTA抗体推进至II期临床试验 [2] 产品管线 - 主导产品IFx-2.0旨在克服对检查点抑制剂的原发性耐药 目前正在进行III期注册试验 作为Keytruda的辅助疗法用于晚期或转移性默克尔细胞癌的一线治疗 [11] - 抗VISTA抗体TBS-2025已完成I/II期剂量递增试验 单药治疗组(n=24)和联合pembrolizumab组(n=16)在1000mg剂量下均表现出良好耐受性 数据显示超过90%的受体占有率 [8] - 公司正在利用Delta阿片受体技术开发首创的双特异性抗体药物偶联物 靶向髓源性抑制细胞以抑制其免疫抑制作用 [12] 技术平台 - VISTA是髓系细胞高表达的免疫检查点 在肿瘤微环境中驱动免疫抑制 与大多数研究中患者总生存期降低相关 [6] - TBS-2025是一种工程化IgG1单抗 具有延长半衰期 能在酸性和中性pH下结合独特表位 每两周静脉注射一次 [7] 行业背景 - 罗素3000指数是按市值加权的股票指数 跟踪美国最大的3000只股票 其成分股每年重组一次 超过10万亿美元资产以罗素美国指数为基准 [3][4] - 罗素指数成员资格主要由客观的市值排名和风格属性决定 被投资经理和机构投资者广泛用于指数基金和主动投资策略的基准 [3][4]

Acquisition adds Phase 2 ready novel VISTA inhibiting monoclonal antibody (mAb) to TuHURA's late-stage immuno-oncology pipelineTuHURA planning to initiate a Phase 2 randomized trial involving VISTA inhibiting antibody in 2nd Half 2025Completion of the acquisition unlocks the fourth tranche of funds from $12.5 million aggregate PIPE financing announced June 3, 2025TAMPA, Fla., June 30, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immuno-oncology company developing novel t ...

TAMPA, Fla. and SEATTLE, June 23, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced with Kineta, Inc. (OTC Pink:KANT) ("Kineta"), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, that TuHURA stockholders approved all of the proposals set forth at the C ...

NEW YORK, June 9, 2025 /PRNewswire/ -- Halper Sadeh LLC, an investor rights law firm, is investigating the following companies for potential violations of the federal securities laws and/or breaches of fiduciary duties to shareholders relating to:TuHURA Biosciences, Inc. (NASDAQ: HURA)'s merger with Kineta, Inc. If you are a TuHURA shareholder, click here to learn more about your legal rights and options.Vigil Neuroscience, Inc. (NASDAQ: VIGL)'s sale to Sanofi. Under the terms of the proposed transaction, V ...

Secures $12.5 million of commitments in a private offeringSecures an additional $3.0 million through payment of cash exercise price of warrantsFunding provides capital for: Initiation of planned Phase 3 accelerated approval trial of IFx-2.0 targeting 40% enrollment by 2-2025 year end Acquisition of and initiating a Phase 2 trial in NPM1 mutated AML, a novel VISTA inhibiting antibody through closing of Kineta merger Advancing first-in-class immune modulating bi-specific, and bi-functional Antibody Drug Conju ...

Phase 3 IFx-Hu2.0 trial as an adjunctive therapy with Keytruda® (pembrolizumab) in checkpoint inhibitor (CPI)-naïve patients with advanced or metastatic Merkel cell carcinoma (MCC) detailed in Trial in Progress Poster at ASCOPhase 3 trial of IFx-Hu2.0 to be conducted under Accelerated Approval Pathway and Special Protocol Assessment (SPA) agreement with U.S. Food and Drug Administration (FDA)TAMPA, Fla., June 2, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immune-oncolog ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39473 TUHURA BIOSCIENCES, INC. (Exact Name of Registrant as Specified in its Charter) Nevada 99-0360497 ( State or other jurisdiction of incorporation or organization) 10500 University Center Dr., Suite 110 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Nevada 001-37823 99-0360497 (Commission File Number) (IRS Employer (State or Other Jurisdiction of Incorporation) Identification No.) FORM 8-K 10500 University Center Dr., Suite 110 Tampa, Florida 33612 (Address of Principal Executive Offices, including zip code) CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Registrant's Telephone Number, Including Area Code: (813) 875-6600 Date of Report (Date of ...

Anticipates initiating the Company's Phase 3 accelerated approval trial of IFx-Hu2.0 as adjunctive therapy with Keytruda® (pembrolizumab) as a first-line therapy for advanced and metastatic Merkel cell carcinoma (MCC), conducted under Special Protocol Assessment (SPA) agreement with U.S. Food and Drug Administration (FDA), in Q2 2025Initiated a Phase 1b/2a trial of IFx-Hu2.0 as adjunctive therapy with pembrolizumab in first-line Merkel cell carcinoma of unknown primary origin (MCCUP) Targeting to close the ...

公司动态 - TuHURA Biosciences宣布启动IFx-Hu2 0的1b/2a期临床试验 该试验旨在评估IFx-Hu2 0与Keytruda®联合通过介入放射学治疗深部肿瘤的安全性和可行性 试验对象为无皮肤肿瘤的MCCUP患者[1] - 公司计划在2025年第二季度后期开始加速批准的3期试验入组 该试验针对CPI初治的转移性MCC患者[1] - 1b/2a期试验将入组9名非皮肤MCC患者 每种病灶类型(肝 肺 腹膜后)各3名 患者将每周接受一次IFx-Hu2 0(0 1 mg)注射 持续3周 并在首次注射后48小时内开始pembrolizumab治疗[4] - 公司预计1b/2a期试验数据将在2025年第四季度末或2026年第一季度初公布[4] 产品研发 - IFx-Hu2 0是公司主导的先天免疫激动剂 旨在克服对Keytruda®等检查点抑制剂的主要耐药性 在之前的1期和1b期试验中 已证明在黑色素瘤和晚期MCC中能产生系统性抗肿瘤免疫反应[1] - 公司正在准备启动IFx-2 0的3期加速批准试验 这是一项随机 安慰剂对照研究 比较Keytruda®加IFx-2 0与Keytruda®加安慰剂在晚期MCC一线治疗中的效果[5] - 3期试验的主要终点是约24周时的总体缓解率(ORR) 次要终点是无进展生存期(PFS)[5] - 公司与FDA达成协议 若PFS结果良好且不影响总生存期 可能无需进行批准后确认性试验[6][7] 市场潜力 - 约30%的MCC患者没有原发性皮肤病灶 因此该试验可能扩大IFx-Hu2 0的潜在受益患者群体[2] - 若在深部肿瘤中证明安全可行 公司计划将试验扩展到其他对CPI反应不佳的非MCC癌症[3] - 公司认为IFx-Hu2 0克服CPI耐药的机制与癌症类型无关 已在三种无关皮肤癌中证明有效[3] 公司背景 - TuHURA Biosciences是一家专注于免疫肿瘤学的3期临床阶段公司 致力于开发克服癌症免疫治疗主要和获得性耐药的新技术[8] - 除先天免疫激动剂外 公司还利用Delta阿片受体技术开发双特异性抗体药物偶联物 靶向髓源性抑制细胞以抑制其对肿瘤微环境的免疫抑制作用[10]