Iomab-B led bone marrow transplant improved survival in patients with high-risk relapsed or refractory acute myeloid leukemia including those with a TP53 mutation

Iomab-B领导的骨髓移植提高了高危复发或难治性急性髓系白血病患者（包括TP53突变患者）的生存率

Iomab-B safely delivered radiation to the target bone marrow at greater amounts than achievable with total body irradiation while sparing healthy non-target organs and enabled 100% access to bone marrow transplant

Iomab-B安全地将辐射传递到目标骨髓，其辐射量超过全身照射所能达到的量，同时保留了健康的非目标器官，并使100%的人能够获得骨髓移植

Novel linker technology supports Actinium's Antibody Radiation Conjugate pipeline expansion in solid tumor indications

新型接头技术支持Actinium抗体辐射缀合物管道在实体瘤适应症中的扩展

NEW YORK, June 10, 2024 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies, today highlighted data from multiple abstracts that were presented at the 2024 Society of Nuclear Medicine & Molecular Imaging (SNMMI) Annual Meeting being held June 8 – 11, 2024, in Toronto, Canada.

2024年6月10日，纽约/PRNewswire/--Actinium Pharmaceuticals，Inc.（纽约证券交易所美国证券交易所：ATNM）（Actinium或该公司），抗体辐射偶联物（ARCs）和其他靶向放射疗法开发的领导者，今天强调了2024年6月8日至11日在加拿大多伦多举行的2024年核医学与分子成像学会（SNMMI）年会上提交的多篇摘要的数据。

The presentations featured results from the Phase 3 SIERRA trial of Iomab-B, a CD45 targeting ARC with the Iodine-131 payload, intended for conditioning to prepare patients with active relapsed or refractory acute myeloid leukemia (r/r AML) for a potentially curative bone marrow transplant (BMT). The Phase 3 SIERRA trial enrolled 153 r/r AML patients.

这些演讲展示了Iomab-B（一种具有碘-131有效载荷的CD45靶向ARC）的3期SIERRA试验的结果，该试验旨在为活动性复发或难治性急性髓细胞白血病（r/r AML）患者进行调理，以备潜在的治愈性骨髓移植（BMT）。SIERRA 3期试验招募了153名r/r AML患者。

Iomab-B achieved the primary endpoint of durable Complete Remission (dCR) with high statistical significance (p<0.0001). Additionally, Actinium's novel linker technology was highlighted in a presentation demonstrating high tumor uptake and in vivo stability in preclinical models with significantly lower kidney and liver uptake compared to standard DOTA linkers..

Iomab-B达到了持久完全缓解（dCR）的主要终点，具有很高的统计学意义（p＜0.0001）。此外，Actinium的新型接头技术在一次演讲中得到了强调，该演讲证明了与标准DOTA接头相比，肾脏和肝脏摄取显着降低的临床前模型中的高肿瘤摄取和体内稳定性。。

Actinium's Iomab-B SNMMI presentations and highlights:

Actinium的Iomab-B SNMMI演示和亮点：

Survival Outcomes and Dosimetric Analysis of Iomab-B (131I-apamistamab) Followed by Allogeneic Hematopoietic Cell Transplant for Patients with TP53 Mutated Relapsed/Refractory AML

Iomab-B（131I apamistamab）联合异基因造血细胞移植治疗TP53突变复发/难治性AML患者的生存结果和剂量学分析

37 patients (24%) enrolled on SIERRA had a TP53 mutation with 27 patients receiving Iomab-B (either through randomization or cross over) and 10 patients on the control arm

SIERRA登记的37名患者（24%）患有TP53突变，其中27名患者接受了Iomab-B（通过随机化或交叉），10名患者接受了对照组

For patients with TP53 mutation who received Iomab-B, the median OS was 5.49 months compared to a median 1.66 months in pts who did not receive Iomab-B (HR=0.23; 95% CI [0.10, 0.52])

对于接受Iomab-B治疗的TP53突变患者，中位OS为5.49个月，而未接受Iomab-B治疗的患者中位OS为1.66个月（HR=0.23；95%CI[0.10，0.52]）

These results support Iomab-B's differentiated mechanism of action to overcome the negative impact of TP53 mutation typically associated with a dismal prognosis in these patients

这些结果支持Iomab-B的分化作用机制，以克服TP53突变的负面影响，这些突变通常与这些患者的预后不佳有关

Exploratory Analysis of Bone Marrow Dosimetry from the Randomized Phase 3 SIERRA Trial of Iomab-B (131I-apamistamab) Prior to HCT in Relapsed/Refractory Acute Myeloid Leukemia

HCT治疗复发/难治性急性髓细胞白血病之前Iomab-B（131I apamistamab）随机3期SIERRA试验骨髓剂量测定的探索性分析

Iomab-B safely delivers high doses of myeloablative targeted radiation to the diseased bone marrow at greater amounts than what would be achieved with total body irradiation

Iomab-B安全地向患病骨髓提供高剂量的清髓靶向辐射，其剂量大于全身照射所能达到的剂量

Myeloablative doses were safely delivered to patients irrespective of age, performance status and other metrics

无论年龄、表现状态和其他指标如何，清髓剂量都可以安全地传递给患者

A median of 16Gy of radiation was delivered to the bone marrow while normal healthy organs received significantly less exposure, including the heart (2.6 Gy), lungs (2.5 Gy), small intestine (2.4 Gy), stomach (3.6 Gy), kidneys (4.1 Gy) and the whole body (3.3 Gy)

中位辐射量为16Gy，而正常健康器官的辐射量明显减少，包括心脏（2.6 Gy）、肺（2.5 Gy）、小肠（2.4 Gy）、胃（3.6 Gy）、肾脏（4.1 Gy）和全身（3.3 Gy）

Mathematical Modeling of Exposure Measurements Following High-Dose Targeted Therapy Using 131I-apamistamab: Analysis From the Large Multicenter Phase III SIERRA Trial

使用131I apamistamab进行高剂量靶向治疗后暴露测量的数学模型：来自大型多中心III期SIRRA试验的分析

SIERRA patients received up to 1,030 mCi (range: 300-1,030) of Iodine-131 via Iomab-B

SIERRA患者通过Iomab-B接受了高达1030 mCi（范围：300-1030）的碘131

Iomab-B is administered via a single infusion 12 days prior to BMT

Iomab-B在BMT前12天通过单次输注给药

Data from SIERRA show that the median time for patients to reach the release criteria was 5 days, including in patients receiving greater than 800 mCi

SIERRA的数据显示，患者达到释放标准的中位时间为5天，包括接受超过800 mCi的患者

Actinium's Proprietary Linker Technology SNMMI presentation and highlights:

Actinium专有链接器技术SNMMI演示和亮点：

Evaluation of novel DOTA-based linkers for improved targeted radiotherapy delivery to solid tumors

新型基于DOTA的接头用于改善实体瘤靶向放射治疗的评估

Novel linkers showed significantly lower kidney and liver uptake compared to standard DOTA linkers

与标准DOTA接头相比，新型接头显示出明显更低的肾脏和肝脏摄取

SPECT/CT imaging showed high tumor uptake and in vivo stability in preclinical models

SPECT/CT成像在临床前模型中显示出高肿瘤摄取和体内稳定性

Successful design, efficient conjugation and pharmacological properties support further advancement of these novel linkers

成功的设计，有效的结合和药理特性支持这些新型接头的进一步发展

Actinium has two wholly owned U.S. patents covering its novel bifunctional linker technology with each having a patent term extending into 2043 and a pending international patent application

Actinium拥有两家全资美国公司。S、 涵盖其新型双功能连接器技术的专利，每项专利的专利期限延长至2043年，并正在申请国际专利

Sandesh Seth, Actinium's Chairman and CEO, said, 'At this year's SNMMI, we are proud to highlight Actinium's broad ARC pipeline and capabilities. Building on our leadership position in hematology focused ARCs through Iomab-B and Actimab-A, we are excited to highlight the potential to treat patients with high-risk relapsed or refractory AML and overcome TP53 mutations or extensive prior therapy including Venetoclax.

Actinium董事长兼首席执行官桑德什·塞思（SandeshSeth）说，“在今年的SNMMI上，我们很自豪地强调了Actinium广泛的ARC管道和能力。基于我们通过Iomab-B和Actimab-A在以血液学为重点的ARCs中的领导地位，我们很高兴强调治疗高危复发或难治性AML患者并克服TP53突变或包括Venetoclax在内的广泛先前治疗的潜力。

Hematology represents an area with potential for significant growth for the field of nuclear medicine and there is great excitement from the community around our efforts. Consistent with our vision to build a leading specialty radiotherapeutics company, we are also eager to highlight our novel linker technology for solid tumor ARCs.

血液学代表了核医学领域具有显着增长潜力的领域，社区对我们的努力感到非常兴奋。与我们建立领先的专业放射治疗公司的愿景一致，我们也渴望突出我们针对实体瘤电弧的新型接头技术。

Finally, SNMMI provides the opportunity to showcase our proprietary Actinium-225 cyclotron-based manufacturing technology that has the potential to produce highly pure medical grade Actinium-225 at a scale and cost that is not currently achievable, which has been met with great enthusiasm given the industry emphasis on Actinium-225 supply.'.

最后，SNMMI提供了展示我们专有的基于锕-225回旋加速器的制造技术的机会，该技术有可能以目前无法实现的规模和成本生产高纯度医用级锕-225，鉴于行业对锕-225供应的重视，这一点得到了极大的热情。”。

About the SNMMI Annual Meeting

关于SNMMI年会

The SNMMI Annual Meeting is recognized as the premier educational, scientific, research, and networking event in nuclear medicine and molecular imaging. The four-day event, taking place each June, provides physicians, technologists, pharmacists, laboratory professionals, and scientists with an in-depth view of the latest research and development in the field as well as providing insights into practical applications for the clinic..

SNMMI年会被公认为核医学和分子成像领域最重要的教育、科学、研究和网络活动。这项为期四天的活动每年6月举行，为医生、技术人员、药剂师、实验室专业人员和科学家提供该领域最新研究和开发的深入见解，并为临床实际应用提供见解。。

About Actinium Pharmaceuticals, Inc.

关于Actinium Pharmaceuticals，Inc。

Actinium develops targeted radiotherapies to meaningfully improve survival for people who have failed existing oncology therapies. Advanced pipeline candidates Iomab-B (pre-BLA & MAA (EU)), an induction and conditioning agent prior to bone marrow transplant, and Actimab-A (National Cancer Institute CRADA pivotal development path), a therapeutic agent, have demonstrated potential to extend survival outcomes for people with relapsed and refractory acute myeloid leukemia.

锕开发有针对性的放射疗法，以有意义地提高现有肿瘤治疗失败的人的生存率。骨髓移植前的诱导和调理剂Iomab-B（pre-BLA＆MAA（EU））和治疗剂Actimab-A（National Cancer Institute CRADA pivotal development path）已证明有潜力延长复发和难治性急性髓细胞白血病患者的生存结果。

Actinium plans to advance Iomab-B for other blood cancers and next generation conditioning candidate Iomab-ACT to improve cell and gene therapy outcomes. Actinium holds more than 230 patents and patent applications including several patents related to the manufacture of the isotope Ac-225 in a cyclotron..

Actinium计划推进Iomab-B治疗其他血癌，下一代调理候选Iomab ACT改善细胞和基因治疗结果。锕拥有230多项专利和专利申请，其中包括与在回旋加速器中制造同位素Ac-225有关的多项专利。。

For more information, please visit: https://www.actiniumpharma.com/

有关更多信息，请访问：https://www.actiniumpharma.com/

Forward-Looking Statements

前瞻性声明

This press release may contain projections or other 'forward-looking statements' within the meaning of the 'safe-harbor' provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update.

本新闻稿可能包含1995年《私人证券诉讼改革法案》中“安全港”条款所指的关于公司未来事件或未来财务表现的预测或其他“前瞻性声明”，公司没有义务更新这些预测或声明。

These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the 'SEC'), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time..

这些声明基于管理层目前的预期，并可能导致实际结果与预期或估计的未来结果存在重大差异的风险和不确定性，包括与初步研究结果相关的风险和不确定性，这些结果与最终结果、开发中药物潜在市场的估计、临床试验、FDA和其他政府机构的行动、监管许可、对监管事项的回应、市场对锕产品和服务的需求和接受程度、临床研究组织的表现以及锕提交给证券交易委员会（“SEC”）的文件中不时详述的其他风险有关，包括但不限于其最新的10-K表格年度报告、随后的10-Q表格和8表格季度报告-K，每一个都是不时修订和补充的。。

Investors:investorrelations@actiniumpharma.com

投资者：investorrelations@actiniumpharma.com

SOURCE Actinium Pharmaceuticals, Inc.

来源Actinium Pharmaceuticals，Inc。