Kazia Therapeutics强调最近的进展并提供业务更新-动脉网

Kazia Therapeutics Highlights Recent Progress and Provides Business Update

CISION 等信源发布 2025-05-15 19:59

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可切换为仅中文

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Awarded research grant from The Michael J. Fox Foundation for Parkinson's Research (MJFF) to fund research between The

获得来自迈克尔·J. 福克斯帕金森研究基金会（MJFF）的研究资助，用于资助以下研究

Hebrew University of Jerusalem

耶路撒冷希伯来大学

(

Hebrew University

希伯来大学

) and Kazia to explore the therapeutic potential of paxalisib as a treatment for Parkinson's disease (PD)

）和Kazia探索paxalisib作为帕金森病（PD）治疗的治疗潜力

Launched clinical trial evaluating the combination of paxalisib and immunotherapy in patients with advanced breast cancer

启动了评估帕克萨利西布与免疫疗法联合应用于晚期乳腺癌患者的临床试验

Reached alignment with the FDA on key aspects of the design of a proposed registrational/pivotal phase 3 study of paxalisib for treatment of glioblastoma (GB), including patient population, primary endpoint, and comparator arm

就帕克萨利西布治疗胶质母细胞瘤（GB）的拟定注册/关键性3期研究设计的关键方面，包括患者人群、主要终点和对照组，与FDA达成了一致。

Raised

升起

$3 million

300万美元

in capital during the first quarter of 2025, which included

2025年第一季度在首都，其中包括

$1 million

100万美元

in non-dilutive funding

非稀释性资金

SYDNEY

悉尼

，

May 15, 2025

2025年5月15日

/PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ:

/PRNewswire/ -- Kazia Therapeutics Limited (纳斯达克:

KZIA

克齐亚

) ('Kazia' or the 'Company'), an oncology-focused drug development company, today announced a summary of its recent progress across its business and also provided a business update.

)（“Kazia”或“公司”），一家专注于肿瘤学的药物开发公司，今天宣布了其业务近期进展的摘要，并提供了业务更新。

'During the first quarter of 2025, we made significant progress both with respect to our clinical programs and corporate strategy,' said

“在2025年第一季度，我们在临床项目和公司战略方面都取得了显著进展，”

John Friend

约翰·弗兰德

, M.D., Chief Executive Officer of Kazia Therapeutics. 'We recently advanced paxalisib into multiple new clinical trials, reached the last patient follow-up in a Phase 1 trial of EVT801 for the treatment of solid tumours, and raised

，医学博士，Kazia Therapeutics首席执行官。“我们最近将paxalisib推进到多个新的临床试验中，在EVT801治疗实体瘤的I期试验中达到了最后一位患者的随访，并筹集了资金。”

$3 million

300万美元

in new capital, including

在新首都，包括

$1 million

100万美元

in non-dilutive funding.'

非稀释性资金。

'Looking ahead, we anticipate a busy year for Kazia, as both paxalisib and EVT801 continue to advance across multiple clinical trials based on strong investigator interest. We are excited about the potential of our advanced-stage pipeline candidates to address significant areas of unmet need within oncology, and we look forward to providing additional updates on our progress throughout 2025.' .

“展望未来，我们预计Kazia将迎来繁忙的一年，因为paxalisib和EVT801在多个临床试验中继续取得进展，得到了研究者们的强烈兴趣。我们对处于晚期阶段的候选药物有望满足肿瘤学领域重大未满足需求的潜力感到兴奋，并期待在2025年全年分享更多关于我们进展的更新。”

Pipeline - paxalisib

管道 - paxalisib

在

February 20, 2025

2025年2月20日

, the Company announced a research grant awarded from The Michael J. Fox Foundation for Parkinson's Research (MJFF) to fund research between The

，公司宣布获得迈克尔·J. 福克斯帕金森研究基金会（MJFF）颁发的研究资助，用于支持与 The 之间的研究合作

Hebrew University of Jerusalem

耶路撒冷希伯来大学

(

Hebrew University

希伯来大学

) and Kazia to explore the therapeutic potential of paxalisib as a treatment for Parkinson's disease (PD). The grant will fund collaborative preclinical studies at Professor

）和Kazia探索paxalisib作为治疗帕金森病（PD）的治疗潜力。该笔拨款将资助在教授处进行的协作性临床前研究。

Ronit Sharonʼs

罗尼特·沙龙的

lab (

实验室 (

Hebrew University

希伯来大学

) aimed at establishing an operational link between a specific pathway in the pathophysiology of PD and paxalisib. The research will assess the impact of paxalisib on mouse survival, motor and non-motor performances, as well as specific biochemical, pathological and molecular disease biomarkers that will be determined in brains of treated mice.

）旨在建立帕金森病（PD）病理生理学中特定通路与paxalisib之间的功能性联系。研究将评估paxalisib对小鼠存活率、运动和非运动表现的影响，以及在治疗小鼠大脑中测定的特定生化、病理和分子疾病生物标志物的变化。

Data from this research is expected to provide valuable insights into its potential activity for the treatment of PD..

这项研究的数据预计将为其治疗PD的潜在活性提供有价值的见解。

在

February 2025

2025年2月

, Kazia executed an agreement to evaluate paxalisib in the next-Generation aGile Genomically Guided Glioma platform (5G) study. The 5G study is an academic trial conducted by the Drug Development Unit – Investigator Initiated Team and sponsored by the Institute of Cancer Research,

Kazia签署了一项协议，以在下一代aGile基因组指导胶质瘤平台（5G）研究中评估paxalisib。5G研究是由药物开发部门——研究者发起团队进行的一项学术试验，并由癌症研究所赞助。

London

伦敦

and fully funded by Cancer Research UK and the Australian charity, Minderoo Foundation. Every patient in this study will have their genome sequenced, enabling researchers to target their treatment with greater precision. Patients with PI3k/mTOR related mutations will be enrolled to receive paxalisib once a day..

由英国癌症研究中心和澳大利亚慈善机构Minderoo基金会全额资助。这项研究中的每位患者都将进行基因组测序，使研究人员能够更精确地针对他们的治疗。与PI3k/mTOR相关的突变患者将被纳入研究，每天接受一次paxalisib治疗。

在

January 30, 2025

2025年1月30日

, the Company announced the regulatory approval and launch of a clinical trial evaluating the combination of paxalisib and immunotherapy in patients with advanced breast cancer. This novel treatment combination offers what is believed to be a unique approach to targeting this highly aggressive and treatment-resistant type of breast cancer.

公司宣布已获得监管批准并启动了一项临床试验，评估paxalisib与免疫疗法联合用于晚期乳腺癌患者的治疗。这种新颖的治疗组合被认为提供了一种独特的方法，针对这种高度侵袭性和治疗抵抗性的乳腺癌类型。

The ABC-Pax (Advanced Breast Cancer – Paxalisib) study is the first known trial conducted to assess the safety and efficacy of paxalisib in combination with KEYTRUDA® (pembrolizumab) or LYNPARZA® (olaparib) in women with triple negative breast cancer. ABC-Pax is a multi-center, open-label phase .

ABC-Pax（晚期乳腺癌 – Paxalisib）研究是首个已知的试验，旨在评估Paxalisib与KEYTRUDA®（派姆单抗）或LYNPARZA®（奥拉帕尼）联合使用在三阴性乳腺癌女性中的安全性和有效性。ABC-Pax是一项多中心、开放标签的阶段研究。

study that will enroll 24 patients who will receive the combination therapy for up to 12 months. Currently the study is open and actively screening patients at The Royal Brisbane and Women's Hospital, Gold Coast University Hospital and Sunshine Coast University Hospital in

这项研究将招募24名患者，他们将接受长达12个月的联合治疗。目前，该研究正在开放，并在皇家布里斯班和妇女医院、黄金海岸大学医院以及阳光海岸大学医院积极筛选患者。

Queensland, Australia

澳大利亚昆士兰州

with plans to open up to 4 additional sites in

计划开设多达4个额外的站点

Australia

澳大利亚

。

打开

December 31, 2024

2024年12月31日

, the Company provided a regulatory update on paxalisib for the treatment of glioblastoma (GBM) following its Type C clinical meeting with the United States Food and Drug Administration (FDA). The FDA's current position is that data on overall survival (OS) would generally not be appropriate for accelerated approval but could be considered to support a traditional/standard approval.

公司在美国食品和药物管理局 (FDA) 的C类临床会议后，提供了关于paxalisib治疗胶质母细胞瘤 (GBM) 的监管更新。FDA的目前立场是，总生存期 (OS) 的数据通常不适合用于加速批准，但可以考虑作为支持传统/标准批准的依据。

The FDA further commented that the secondary endpoint OS data from the GBM-AGILE study are supportive and informative for designing and executing a pivotal registrational study in pursuit of a standard approval. Importantly, the Company aligned with the FDA on key aspects of the design of a proposed registrational/pivotal phase 3 study, including patient population, primary endpoint, and the comparator arm to be used..

FDA进一步评论称，GBM-AGILE研究的次要终点OS数据对于设计和执行一项旨在获得标准批准的关键注册研究具有支持性和信息性。重要的是，公司在拟议的注册/关键III期研究的设计方面与FDA达成了一致，包括患者人群、主要终点以及将使用的对照组。

The study will be a randomized, controlled study of paxalisib versus standard of care (SOC) in patients with newly diagnosed unmethylated glioblastoma to determine Overall Survival as well as other parameters of clinical efficacy, safety and tolerability. Approximately 366 patients will be enrolled over 14 months into the study with a 1:1 treatment ratio between the paxalisib and SOC (temozolomide) arm.

该研究将是一项随机、对照研究，针对新诊断的未甲基化胶质母细胞瘤患者，比较帕克西利比（paxalisib）与标准治疗（SOC）的总生存期以及其他临床疗效、安全性和耐受性参数。大约366名患者将在14个月内按1:1的治疗比例分配到帕克西利比组和标准治疗（替莫唑胺）组。

We anticipate engaging roughly 50 clinical sites across the globe (.

我们预计将与全球大约50个临床站点合作。

North America

北美

, UK,

，英国，

Europe

欧洲

，

Asia-Pacific

亚太地区

) for this study. The Kazia team is exploring various bids from Contract Research Organizations (CROs) in parallel to discussions with strategic partners and cooperative groups to participate or fully fund the trial.

）用于本研究。Kazia团队正在探索来自合同研究组织（CROs）的各种投标，同时与战略合作伙伴和合作小组进行讨论，以参与或全额资助该试验。

Pipeline – EVT801

管道 – EVT801

在

November 2024

2024年11月

, the last patient completed follow-up in a Phase 1 study (NCT05114668) evaluating EVT801 for the treatment of patients with histologically-confirmed advanced or metastatic solid tumours, unresponsive to standard treatment, or for whom no standard treatment is available or appropriate. We anticipate receiving the final data in 2Q2025 and presenting data later this year at an international medical congress. .

，最后一名患者在一项一期研究（NCT05114668）中完成了随访，该研究评估了EVT801用于治疗组织学确认的晚期或转移性实体瘤患者，这些患者对标准治疗无反应，或没有可用或适当的标准治疗。我们预计将在2025年第二季度收到最终数据，并在今年晚些时候的国际医学大会上展示数据。

Corporate

企业

在

May 12, 2025

2025年5月12日

, the Company received a notification (the Notification) from the Listing Qualifications Staff of the Nasdaq Stock Market LLC (Nasdaq) notifying the Company that that from

，公司收到了纳斯达克股票市场有限责任公司（纳斯达克）上市资格工作人员的通知（通知），告知公司从

March 28, 2025

2025年3月28日

至

May 9, 2025

2025年5月9日

, the Company's Market Value of Listed Securities (MVLS) was below the minimum of

，公司上市证券的市场价值（MVLS）低于最低限度

$35 million

3500万美元

. The Notification has no immediate impact on the Company's operations or listing and Kazia's American Depositary Shares (ADSs) will continue to trade on the Nasdaq Capital Market under the ticker 'KZIA'. In accordance with Nasdaq Listing Rule 5810(c)(3)(C), the Company has 180 calendar days to regain compliance with the MVLS Requirement.

通知不会立即影响公司的运营或上市，Kazia的美国存托股份（ADS）将继续在纳斯达克资本市场以“KZIA”代码进行交易。根据纳斯达克上市规则5810(c)(3)(C)，公司有180个日历日来重新符合最低公众持股量（MVLS）要求。

The Notification states that, to regain compliance with the MVLS Requirement, the Company's MVLS must close at $35 million or more for a minimum of ten consecutive business days during the compliance period ending on November 10, 2025. Kazia has no intention of delisting and is currently exploring options to regain compliance, which include raising additional capital and possible merger and acquisition-related strategies.

通知称，为重新符合 MVLS 要求，公司必须在 2025 年 11 月 10 日结束的合规期内，连续至少十个交易日的 MVLS 收盘达到 3,500 万美元或以上。Kazia 不打算退市，目前正在探索重新符合要求的选择，其中包括筹集额外资本以及可能与并购相关的策略。

While the Company is exercising diligent efforts to maintain the listing of its ADS on Nasdaq, there can be no assurance that the Company will be able to regain or maintain compliance with the applicable continued listing standards set forth in the Nasdaq Listing Rules..

尽管公司正在尽心尽力保持其ADS在纳斯达克的上市地位，但无法保证公司能够重新符合或保持纳斯达克上市规则中规定的适用持续上市标准。

Effective April 17, 2025, Kazia changed the ratio of its ADSs to Ordinary Shares from one ADS representing one hundred Ordinary Shares to one ADS representing five hundred Ordinary Shares. This adjustment, equivalent to a one-for-five reverse ADS split, was necessary to maintain compliance with Nasdaq's minimum bid price requirement..

自2025年4月17日起，Kazia将其ADS与普通股的比例从1个ADS代表100股普通股更改为1个ADS代表500股普通股。这一调整相当于1对5的ADS反向分拆，是为确保符合纳斯达克最低出价要求所必需的。

On March 31, 2025, the Company announced the sale of all intellectual property and trademarks rights to Cantrixil for USD $1 million. In March 2021, Vivesto licensed the exclusive global development and commercialization rights for Cantrixil from Kazia Therapeutics. Having decided not to pursue the development of Cantrixil in ovarian cancer, as originally anticipated under the license, Vivesto is currently exploring Cantrixil preclinically for the treatment of hematological cancers..

2025年3月31日，公司宣布以100万美元的价格出售Cantrixil的所有知识产权和商标权。2021年3月，Vivesto从Kazia Therapeutics获得了Cantrixil的全球独家开发和商业化权利许可。在决定不再按照原许可预期推进Cantrixil在卵巢癌领域的开发后，Vivesto目前正在探索Cantrixil在血液癌症治疗中的临床前研究。

On February 26, 2025, CEO Dr John Friend bought 8,000 ADSs (split adjusted). The ADSs were bought at a split-adjusted price of $4.2465 per ADS for a total transaction of $33,972.

2025年2月26日，首席执行官约翰·弗兰德博士购买了8,000股美国存托股份（ADS，经拆股调整）。每股ADS的购买价格为经拆股调整后的4.2465美元，总交易金额为33,972美元。

On January 14, 2025, the Company announced the closing of a registered direct offering with existing fundamental healthcare investor, Alumni Capital LP. The gross proceeds to the Company from the offering were approximately $2.0 million, before deducting the placement agent's fees and other offering expenses payable by the Company..

2025年1月14日，公司宣布与现有基础医疗保健投资者Alumni Capital LP完成了一项注册直接发行。在扣除配售代理费用和公司应支付的其他发行费用之前，此次发行给公司带来的总收益约为200万美元。

About Kazia Therapeutics Limited

关于Kazia治疗有限公司

Kazia Therapeutics Limited (NASDAQ:

Kazia Therapeutics Limited (纳斯达克:

KZIA

克齐亚

) is an oncology-focused drug development company, based in Sydney, Australia. Our lead program is paxalisib, an investigational brain penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of brain cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in this disease.

）是一家专注于肿瘤学的药物开发公司，总部位于澳大利亚悉尼。我们的主要项目是paxalisib，一种研究性脑渗透PI3K / Akt / mTOR通路抑制剂，正在开发用于治疗多种类型的脑癌。Paxalisib于2016年底从基因泰克获得许可，已经在该疾病中进行了十项临床试验。

A completed Phase 2/3 study in glioblastoma (GBM-Agile) was reported in 2024 and discussions are ongoing for designing and executing a pivotal registrational study in pursuit of a standard approval. Other clinical trials involving paxalisib are ongoing in brain metastases, diffuse midline gliomas, and primary CNS lymphoma, with several of these trials having reported encouraging interim data.

2024年报道了一项已完成的胶质母细胞瘤（GBM-Agile）二期/三期研究，目前正就设计和执行一项关键注册研究进行讨论，以寻求标准批准。其他涉及帕克萨利司的临床试验正在脑转移、弥漫性中线胶质瘤和原发性中枢神经系统淋巴瘤中进行，其中几项试验已报告了令人鼓舞的中期数据。

Paxalisib was granted Orphan Drug Designation for glioblastoma by the FDA in February 2018, and Fast Track Designation (FTD) for glioblastoma by the FDA in August 2020. Paxalisib was also granted FTD in July 2023 for the treatment of solid tumour brain metastases harboring PI3K pathway mutations in combination with radiation therapy.

2018年2月，Paxalisib获得FDA授予的用于治疗胶质母细胞瘤的孤儿药资格，并于2020年8月获得FDA授予的胶质母细胞瘤快速通道资格（FTD）。2023年7月，Paxalisib还获得了与放射治疗联合用于携带PI3K通路突变的实体瘤脑转移治疗的快速通道资格（FTD）。

In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA for diffuse intrinsic pontine glioma in August 2020, and for atypical teratoid / rhabdoid tumours in June 2022 and July 2022, respectively. Kazia is also developing EVT801, a small molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021.

此外，paxalisib于2020年8月获得FDA授予的罕见儿科疾病认定和孤儿药认定，用于治疗弥漫性内生性桥脑胶质瘤，并于2022年6月和2022年7月分别获得用于非典型畸胎样/横纹肌样肿瘤的认定。Kazia还在开发EVT801，这是一种VEGFR3的小分子抑制剂，于2021年4月从Evotec SE获得许可。

Preclinical data has shown EVT801 to be active against a broad range of tumour types and has provided evidence of synergy with immuno-oncology agents. A Phase I study has been completed and preliminary data was presented at 15th Biennial Ovarian Cancer Research Symposium in September 2024. For more information, please visit www.

临床前数据表明，EVT801对多种肿瘤类型具有活性，并提供了与免疫肿瘤药物协同作用的证据。I 期研究已经完成，初步数据在2024年9月举行的第15届卵巢癌研究双年研讨会上公布。欲了解更多信息，请访问 www。

Forward-Looking Statements

前瞻性声明

This announcement may contain forward-looking statements, which can generally be identified as such by the use of words such as 'may,' 'will,' 'estimate,' 'future,' 'forward,' 'anticipate,' or other similar words. Any statement describing Kazia's future plans, strategies, intentions, expectations, objectives, goals or prospects, and other statements that are not historical facts, are also forward looking statements, including, but not limited to, statements regarding: the timing for results and data related to Kazia's clinical and preclinical trials, Kazia's strategy and plans with respect to its programs, including paxalisib and EVT801, potential results of research between .

本公告可能包含前瞻性陈述，这些陈述通常可以通过使用诸如“可能”、“将”、“估计”、“未来”、“前瞻”、“预期”或其他类似词语来识别。任何描述Kazia未来计划、战略、意图、期望、目标或前景的陈述，以及其他非历史事实的陈述，也属于前瞻性陈述，包括但不限于以下方面的陈述：与Kazia临床和临床前试验相关的结果和数据的时间安排，Kazia针对其项目（包括paxalisib和EVT801）的战略和计划，以及研究之间的潜在结果。

Hebrew University

希伯来大学

and Kazia regarding the therapeutic potential of paxalisib for the treatment of Parkinson's disease, the potential benefits of paxalisib as an investigational PI3K/mTOR inhibitor, timing for any regulatory submissions or discussions with regulatory agencies, the potential market opportunity for paxalisib and Kazia's intent and efforts to regain and/or maintain compliance with the applicable Nasdaq continued listing requirements and standards.

关于paxalisib治疗帕金森病的治疗潜力，paxalisib作为一种研究性PI3K/mTOR抑制剂的潜在益处，任何监管提交或与监管机构讨论的时间安排，paxalisib的潜在市场机会，以及Kazia意图和努力重新获得和/或维持符合纳斯达克适用的持续上市要求和标准。

Such statements are based on Kazia's current expectations and projections about future events and future trends affecting its business and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, including risks and uncertainties: associated with clinical and preclinical trials and product development, related to regulatory approvals, related to the impact of global economic conditions, and related to Kazia's ability to regain and/or maintain compliance with the applicable Nasdaq continued listing requirements and standards.

此类声明基于Kazia对未来事件和未来影响其业务的趋势的当前预期和预测，并受到某些风险和不确定性的制约，这些风险和不确定性可能导致实际结果与前瞻性声明中预期的结果存在重大差异，包括与临床和临床前试验及产品开发相关的风险和不确定性、与监管审批相关的风险和不确定性、与全球经济状况的影响相关的风险和不确定性，以及与Kazia恢复和/或维持遵守适用的纳斯达克持续上市要求和标准的能力相关的风险和不确定性。

These and other risks and uncertainties are described more fully in Kazia's Annual Report, filed on form 20-F with the SEC, and in subsequent filings with the United States Securities and Exchange Commission. Kazia undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law.

这些以及其他风险和不确定性在Kazia的年度报告中有所描述，该报告以20-F表格形式提交给美国证券交易委员会（SEC），并在随后提交给美国证券交易委员会的文件中进行了更新。除非适用法律要求，Kazia无义务公开更新任何前瞻性声明，无论是由于新信息、未来事件或其他原因。

You should not place undue reliance on these forward-looking statements, which apply only as of the date of this announcement..

您不应过分依赖这些前瞻性声明，它们仅适用于本公告发布之日。

This announcement was authorized for release by Dr

本公告经博士授权发布。

John Friend

约翰·弗兰德

, CEO

，首席执行官

SOURCE Kazia Therapeutics Limited

来源：Kazia治疗有限公司

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