Racura Oncology has dosed the first patient in the HARNESS-1 Phase 1a/b trial of RC220 in combination with osimertinib for EGFR-mutant non-small cell lung cancer. The study will assess safety, pharmacokinetics, ctDNA dynamics and early clinical activity of RC220 as a strategy to address therapeutic TKI resistance..

Racura Oncology 已在 HARNESS-1 I a/b 期临床试验中完成首例患者给药，该试验评估 RC220 联合奥希替尼治疗 EGFR 突变非小细胞肺癌。本研究将评估 RC220 的安全性、药代动力学、ctDNA 动态变化及早期临床活性，旨在应对治疗性 TKI 耐药问题。

SYDNEY

悉尼

,

，

June 25, 2026

2026年6月25日

/PRNewswire/ -- Racura Oncology Limited (ASX: RAC), a clinical-stage biopharmaceutical company developing new small molecule based approaches to cancer treatment, today announced that the first patient has been dosed with RC220 in HARNESS-1, a Phase 1a/b clinical trial evaluating RC220 in combination with osimertinib in patients with epidermal growth factor receptor-mutant (EGFR-mutant) non-small cell lung cancer (NSCLC).

/美通社/ -- 临床阶段生物制药公司Racura Oncology Limited（澳大利亚证券交易所代码：RAC）致力于开发基于小分子的新型癌症治疗方法，该公司今日宣布，在HARNESS-1临床试验中，首位患者已接受RC220给药。HARNESS-1是一项1a/b期临床试验，旨在评估RC220与奥希替尼联合用于表皮生长因子受体突变（EGFR突变）非小细胞肺癌（NSCLC）患者的疗效和安全性。

The first patient received RC220 at 50 mg/m.

首位患者接受了50 mg/m²的RC220治疗。

2

2

by intravenous infusion. No adverse events were observed.

通过静脉输注。未观察到不良事件。

HARNESS-1 is designed to test whether RC220, Racura's proprietary formulation of (E,E)-bisantrene, can be safely combined with osimertinib (Tagrisso

HARNESS-1 旨在测试 Racura 公司专有配方 (E,E)-比生蒽（RC220）能否与奥希替尼（Tagrisso）安全联用

®

®

; AstraZeneca), a third-generation EGFR tyrosine kinase inhibitor (TKI) and standard-of-care therapy for EGFR-mutant NSCLC to delay or prevent TKI treatment resistance. Although EGFR TKIs have transformed outcomes for many patients with EGFR-driven lung cancer, acquired treatment resistance remains a central therapeutic challenge..

；阿斯利康），一种第三代EGFR酪氨酸激酶抑制剂（TKI），是用于延缓或预防EGFR突变非小细胞肺癌（NSCLC）对TKI治疗产生耐药性的标准治疗方案。尽管EGFR TKIs已显著改善了许多EGFR驱动型肺癌患者的预后，但获得性治疗耐药性仍然是核心治疗挑战。

Daniel Tillett, Ph.D., Chief Executive Officer of Racura Oncology, said:

Racura Oncology 首席执行官丹尼尔·蒂利特博士表示：

'Dosing the first patient in HARNESS-1 is an important milestone for Racura and for the clinical development of RC220. The scientific rationale for this trial is grounded in the urgent need to address TKI therapeutic resistance in EGFR-mutant NSCLC. RC220 gives us the opportunity to explore whether targeting G4-DNA and RNA structures, including MYC-associated growth pathways, can delay EGFR TKI resistance arising and support a new therapeutic combination for patients treated with osimertinib.

在HARNESS-1研究中为首名患者给药是Racura公司以及RC220临床开发的重要里程碑。本试验的科学依据源于解决EGFR突变非小细胞肺癌（NSCLC）中酪氨酸激酶抑制剂（TKI）治疗耐药性的迫切需求。RC220为我们提供了探索靶向G4-DNA和RNA结构（包括与MYC相关的生长通路）能否延缓EGFR TKI耐药性产生，并为接受奥希替尼治疗的患者支持一种新型联合治疗方案的机会。

We are grateful to Associate Professor Surein Arulananda and the Monash Health team for enrolling and treating the first participant, and to the patients and families who make this research possible.'.

我们感谢苏雷因·阿鲁兰南达副教授和莫纳什健康团队招募并治疗了首位参与者，也感谢使这项研究成为可能的患者及其家属。

Scientific Rationale

科学依据

EGFR-mutant NSCLC is a molecularly stratified lung adenocarcinoma subtype driven by constitutive EGFR kinase signaling and initial sensitivity to EGFR inhibition. However, responses to EGFR tyrosine kinase inhibitors, including osimertinib, are typically limited by acquired resistance, arising through heterogeneous mechanisms such as secondary EGFR alterations, bypass receptor tyrosine kinase activation, MAPK/PI3K pathway reactivation, oncogenic fusions, lineage plasticity, epithelial-to-mesenchymal transition and histologic transformation..

EGFR突变型非小细胞肺癌是一种分子分层的肺腺癌亚型，由组成性EGFR激酶信号传导驱动，并对EGFR抑制具有初始敏感性。然而，对包括奥希替尼在内的EGFR酪氨酸激酶抑制剂的反应通常因获得性耐药而受限，其耐药机制具有异质性，例如继发性EGFR改变、旁路受体酪氨酸激酶激活、MAPK/PI3K通路再激活、致癌融合、谱系可塑性、上皮-间质转化以及组织学转化。

RC220 is being developed to target the non-canonical G-quadruplex DNA and RNA structures enriched in oncogenic regulatory regions, including promoters, untranslated regions and highly transcribed loci. Stabilization of these structures can disrupt transcriptional and post-transcriptional control networks that sustain malignant proliferation, including silencing the c-MYC-regulated growth and survival pathways..

RC220 正在开发中，旨在靶向富含于致癌调控区域（包括启动子、非翻译区和高转录位点）的非经典 G-四链体 DNA 和 RNA 结构。稳定这些结构可以破坏维持恶性增殖的转录和转录后调控网络，包括沉默由 c-MYC 调控的生长和生存通路。

HARNESS-1 is designed to evaluate the safety and tolerability of RC220 with continued osimertinib-mediated EGFR suppression, while generating pharmacokinetic, pharmacodynamic, molecular response and translational biomarker data.

HARNESS-1 研究旨在评估在持续奥希替尼介导的 EGFR 抑制背景下，RC220 的安全性和耐受性，同时生成药代动力学、药效学、分子反应及转化生物标志物数据。

HARNESS-1 Trial Design

HARNESS-1 试验设计

HARNESS-1 is a multi-center Phase 1a/b clinical study in patients with EGFR-mutant NSCLC receiving osimertinib. The study includes an observational screening stage using ctDNA to help identify eligible patients and characterize tumor molecular status before treatment.

HARNESS-1 是一项针对接受奥希替尼治疗的 EGFR 突变非小细胞肺癌（NSCLC）患者的多中心 Ia/b 期临床研究。该研究包含一个使用循环肿瘤 DNA（ctDNA）的观察性筛查阶段，以帮助识别符合入排标准的患者，并在治疗前表征肿瘤的分子状态。

The Phase 1a dose-escalation stage will evaluate RC220 administered by intravenous infusion on Day 1 of each 21-day cycle in combination with standard-of-care maintenance osimertinib. The first three dose levels will use single-patient cohorts at 50 mg/m

1a期剂量递增阶段将评估在每个21天周期的第1天通过静脉输注给予RC220，并与标准治疗维持用药奥希替尼联合使用的情况。前三个剂量水平将采用单患者队列，剂量为50 mg/m²

2

2

, 100 mg/m

，100 毫克/平方米

2

2

and 150 mg/m

和 150 mg/m

2

2

, before progressing to larger cohorts to identify the maximum tolerated dose and an appropriate dose for further study. Between 12 and 40 patients are expected to participate in the dose-escalation stage.

，然后进入更大规模的患者队列研究，以确定最大耐受剂量和适合进一步研究的剂量。预计将有12至40名患者参与剂量递增阶段。

Following review of available safety and pharmacokinetic data, the study is expected to advance into a double-blind, randomized Phase 1b expansion stage. In this dose expansion stage, 40 patients will receive one of two RC220 dose levels in combination with osimertinib. Patients will be monitored for safety, pharmacokinetics and early signals of clinical activity, including progression-free survival, overall survival, ctDNA dynamics and changes in cancer-specific mutations..

在对现有安全性和药代动力学数据进行审查后，该研究预计将进入双盲、随机化的1b期扩展阶段。在此剂量扩展阶段，40名患者将接受两种RC220剂量水平中的一种，并与奥希替尼联合用药。将对患者的安全性、药代动力学以及早期临床活性信号进行监测，包括无进展生存期、总生存期、循环肿瘤DNA（ctDNA）动态变化以及癌症特异性突变的变化。

The first patient was treated by Principal Investigator Associate Professor Surein Arulananda and his team at Monash Health in Clayton, Victoria. Additional clinical trial sites are expected to open in the coming months to support patient recruitment and study progress.

首位患者由首席研究员苏雷恩·阿鲁拉南达副教授及其团队在维多利亚州克莱顿的莫纳什健康中心接受治疗。预计在未来几个月内将开设更多临床试验站点，以支持患者招募和研究进展。

Clinical Trial Information

临床试验信息

Further details about HARNESS-1, including open and recruiting sites, are available through the Australian and New Zealand Clinical Trial Registry at

关于HARNESS-1的更多详情，包括开放和正在招募的研究中心，可通过澳大利亚和新西兰临床试验注册平台获取，网址为

www.anzctr.org.au

www.anzctr.org.au

under trial code ACTRN12626000325303. Clinical trial inquiries may be directed to Racura Oncology at

试验代码为 ACTRN12626000325303。临床试验相关问询可联系 Racura Oncology，地址如下：

[email protected]

[email protected]

.

。

About RC220 & (E,E)-bisantrene

关于RC220和(E,E)-比生托仑

RC220 is a proprietary formulation of (E,E)-bisantrene designed to overcome drug solubility issues that prevent safe peripheral intravenous infusion. (E,E)-bisantrene, is a clinical validated small molecule anticancer agent that primarily functions via G4-DNA and RNA binding, leading to potent transcriptional silencing of the important cancer growth regulator c-MYC..

RC220 是一种专有配方的 (E,E)-比生蒽，旨在克服药物溶解度问题，从而实现安全的外周静脉输注。(E,E)-比生蒽是一种经临床验证的小分子抗癌药物，主要通过结合 G4-DNA 和 RNA 发挥作用，从而强效沉默重要的癌症生长调节因子 c-MYC 的转录。

About Racura Oncology

关于Racura肿瘤学

Racura Oncology (ASX: RAC) is a Phase 3 clinical-stage biopharmaceutical company with a mission to silence cancer. Our lead asset, (E,E)-bisantrene, is a small molecule anticancer agent that primarily functions via G4-DNA and RNA binding, leading to potent silencing of the important cancer growth regulator MYC..

Racura Oncology（澳交所代码：RAC）是一家处于III期临床阶段的生物制药公司，其使命是抑制癌症。我们的核心资产(E,E)-bisantrene是一种小分子抗癌药物，主要通过结合G4-DNA和RNA发挥作用，从而强效沉默重要的癌症生长调节因子MYC。

Racura is advancing RC220 to address the high unmet needs of patients across multiple oncology indications, including a Phase 3 clinical program in acute myeloid leukemia (AML), a Phase 1 program in mutant epidermal growth factor receptor non-small cell lung cancer (EGFRm NSCLC), and a Phase 1 program in combination with the anthracycline doxorubicin, where we aim to deliver both cardioprotection and enhanced anticancer activity for solid tumor patients..

Racura 正在推进 RC220 的研发，以满足多种肿瘤适应症中患者尚未得到充分满足的高需求，其中包括针对急性髓系白血病（AML）的 III 期临床项目、针对突变型表皮生长因子受体非小细胞肺癌（EGFRm NSCLC）的 I 期临床项目，以及与蒽环类药物多柔比星联合应用的 I 期临床项目，旨在为实体瘤患者提供心脏保护并增强抗癌活性。

Learn more at

了解更多，请访问

www.racuraoncology.com

www.racuraoncology.com

.

。

Forward-Looking Statements

前瞻性陈述

Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this release include, without limitation, statements regarding expectations regarding clinical development and regulatory strategy and the Company's ability to deliver meaningful value to patients and shareholders.

本新闻稿中的某些陈述属于《1933年证券法》第27A条、《1934年证券交易法》第21E条以及《1995年私人证券诉讼改革法》所定义的“前瞻性陈述”，涉及风险和不确定性。本新闻稿中的前瞻性陈述包括但不限于，关于临床开发和监管策略的预期，以及公司为患者和股东创造有意义价值的能力的陈述。

These statements relate to future events, future expectations, plans and prospects. Although Racura believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements.

这些陈述涉及未来事件、未来预期、计划和前景。尽管Racura认为在作出之日，此类前瞻性陈述中所反映的预期是合理的，但实际结果可能与这些前瞻性陈述所表达或暗示的结果存在重大差异。

Racura has attempted to identify forward-looking statements by terminology including 'believes', 'estimates', 'anticipates', 'expects', 'plans', 'projects', 'intends', 'potential', 'may', 'could', 'might', 'will', 'should', 'approximately' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements.

Racura 已尝试通过使用包括“相信”、“估计”、“预期”、“期望”、“计划”、“预测”、“打算”、“潜在”、“可能”、“能够”、“或许”、“将”、“应当”、“大约”或其他传达未来事件或结果不确定性的词语来识别前瞻性陈述。

These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including market and other conditions. Any forward-looking statements contained in this press release speak only as of its date. Racura undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except as required by law..

这些陈述仅为预测，涉及已知和未知的风险、不确定性及其他因素，包括市场状况和其他条件。本新闻稿中包含的任何前瞻性陈述仅在其发布之日有效。除非法律另有要求，Racura 没有义务更新本新闻稿中包含的任何前瞻性陈述，以反映在其发布之后发生的事件或情况，或反映意外事件的发生。

SOURCE Racura Oncology Limited

来源：Racura Oncology Limited

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