FLORHAM PARK, N.J., June 04, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for iopofosine I 131, a potential first-in-class, novel cancer targeting agent utilizing a phospholipid ether as a radioconjugate monotherapy, for the treatment of relapsed/refractory Waldenstrom macroglobulinemia (r/r WM)..

弗洛勒姆帕克，新泽西州，2025年6月4日（环球新闻社）-- Cellectar生物科学公司（纳斯达克股票代码：CLRB），一家专注于发现和开发癌症治疗药物的晚期临床生物制药公司，今天宣布，美国食品和药物管理局（FDA）已授予iopofosine I 131突破性疗法认定。Iopofosine I 131是一种潜在的首创新型癌症靶向药物，利用磷脂醚作为放射性偶联单药疗法，用于治疗复发/难治性华氏巨球蛋白血症（r/r WM）。

WM is the dominant subtype of lymphoplasmacytic lymphoma and remains incurable with available therapies according to the International Waldenstrom’s Macroglobulinemia Foundation. Approved WM treatment options are limited, underscoring the need for new therapies with novel mechanisms of action.

WM是淋巴浆细胞淋巴瘤的主要亚型，根据国际Waldenstrom巨球蛋白血症基金会的说法，目前可用的治疗方法仍无法治愈该病。已批准的WM治疗方案有限，凸显了对具有新作用机制的疗法的需求。

“The FDA’s Breakthrough Therapy Designation underscores the potential of iopofosine I 131 as it may offer substantial improvement on at least one clinically significant endpoint over available therapies to address the substantial unmet medical need in this life-threatening cancer,” said James Caruso, president and chief executive officer of Cellectar.

“FDA的突破性疗法认定强调了碘泊膦酸I 131的潜力，因为它可能在至少一个临床重要终点上比现有疗法有显著改善，以满足这种致命癌症中未被满足的重大医疗需求，”Cellectar总裁兼首席执行官詹姆斯·卡鲁索表示。

“With robust clinical data, a favorable safety profile, expedited review designations in the United States and Europe and a compelling commercial market potential, we believe iopofosine I 131 represents an attractive candidate for potential collaborations or partners seeking impactful innovation and accelerated development pathways.”.

“凭借强大的临床数据、良好的安全性、在美国和欧洲获得的加速审评资格，以及引人注目的商业市场潜力，我们认为碘泊膦酸I 131是一个有吸引力的候选方案，适合寻求有影响力创新和加速开发途径的潜在合作或合作伙伴。”

Data from the Phase 2 CLOVER WaM study (NCT02952508), including the overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2% (95% CI, 0.42 to 0.67), which exceeded the agreed-upon primary endpoint of a 20% MRR, were presented as a podium presentation during the 66th Annual American Society of Hematology Conference in December 2024 by Sikander Ailawadhi, M.D., Professor of Medicine, Mayo Clinic..

2024年12月，在第66届美国血液学会年会上，梅奥诊所医学教授Sikander Ailawadhi博士通过讲台报告形式公布了二期CLOVER WaM研究（NCT02952508）的数据，其中包括83.6%的总缓解率（ORR）和58.2%的主要缓解率（MRR）（95%置信区间，0.42至0.67），超过了预设的20% MRR的主要终点。

As previously announced, the FDA also granted iopofosine I 131 Fast Track Designation and Orphan Drug Designation. The European Medicines Agency (EMA) granted Orphan Drug Designation to iopofosine I 131 for treatment of r/r WM, as well as PRIME Designation for WM.

正如之前宣布的，FDA还授予了碘磷索I 131快速通道资格和孤儿药资格。欧洲药品管理局（EMA）也授予了碘磷索I 131用于治疗复发/难治性WM的孤儿药资格，以及WM的PRIME资格。

Separately, the company announced that it has provided the EMA with a data package that includes extensive supportive preclinical, regulatory and manufacturing data, as well as safety and efficacy data from the CLOVER WaM Phase 2b clinical trial. The EMA will review the package to determine whether there is enough clinical evidence to address the required criteria for Cellectar to apply for a fast-track, conditional marketing authorization approval.

此外，该公司宣布已向欧洲药品管理局（EMA）提交了一份数据包，其中包括广泛的支持性临床前、监管和生产数据，以及来自CLOVER WaM 2b期临床试验的安全性和有效性数据。欧洲药品管理局将审查该数据包，以确定是否有足够的临床证据满足Cellectar申请快速通道、附条件上市许可所需的标准。

In late July 2025 the company expects a recommendation from the EMA on whether Cellectar should file a Medical Authorization Application (MAA)..

2025年7月下旬，该公司预计EMA将给出是否应提交医疗授权申请（MAA）的建议。

About Breakthrough Therapy Designation

关于突破性疗法指定

Breakthrough Therapy Designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening diseases with preliminary clinical evidence that the investigational therapy may offer substantial improvement on at least one clinically significant endpoint over available therapies.

突破性疗法指定是FDA的一个项目，旨在加速针对严重或危及生命的疾病的药物的开发和审查，初步临床证据表明，与现有疗法相比，该研究性疗法可能在至少一个具有临床意义的终点上提供显著改善。

The designation provides increased interactions with the FDA and supports the possibility of receiving a six-month priority review of a New Drug Application..

该指定提供了与FDA的更多互动，并支持有可能在六个月内获得新药申请的优先审查。

About Cellectar Biosciences, Inc.

关于Cellectar生物科学公司

Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects..

Cellectar Biosciences是一家处于后期临床阶段的生物制药公司，专注于独立发现和开发用于治疗癌症的专有药物，并通过研发合作进行相关工作。该公司的核心目标是利用其专有的磷脂药物偶联™（PDC）递送平台，开发下一代靶向癌细胞的治疗方法，因减少脱靶效应而带来更高的疗效和更好的安全性。

The company’s product pipeline includes: iopofosine I 131, a PDC designed to provide targeted delivery of iodine-131 (radioisotope); CLR 121225, an actinium-225 based program being targeted to several solid tumors with significant unmet need, such as pancreatic cancer; and CLR 121125, an iodine-125 Auger-emitting program targeted in other solid tumors, such as triple negative breast, lung and colorectal, as well as proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets..

公司的产品管线包括：iopofosine I 131，一种旨在实现碘-131（放射性同位素）靶向递送的PDC；CLR 121225，一个基于锕-225的项目，针对多种具有显著未满足需求的实体瘤，如胰腺癌；以及CLR 121125，一个碘-125 Auger发射项目，针对其他实体瘤，如三阴性乳腺癌、肺癌和结直肠癌，还包括专有的临床前PDC化疗项目和多个合作的PDC资产。

In addition, iopofosine I 131 has been studied in Phase 2b trials for relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) lymphoma, and the CLOVER-2 Phase 1b study, targeting pediatric patients with high-grade gliomas, for which Cellectar is eligible to receive a Pediatric Review Voucher from the FDA upon approval.

此外，碘泊膦 I 131 已在针对复发或难治性多发性骨髓瘤 (MM) 和中枢神经系统 (CNS) 淋巴瘤的 2b 期试验中进行了研究，并开展了 CLOVER-2 的 1b 期研究，针对患有高级别胶质瘤的儿童患者，Cellectar 在获得 FDA 批准后有资格获得儿科审查凭证。

The FDA has also granted iopofosine I 131 six Orphan Drug, four Rare Pediatric Drug and two Fast Track Designations for various cancer indications..

FDA还授予了碘泊膦酸I 131六个孤儿药、四个罕见儿科药物和两个快速通道资格，用于各种癌症适应症。

For more information, please visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: X, LinkedIn, and Facebook.

欲了解更多信息，请访问 www.cellectar.com 或通过关注公司的社交媒体渠道参与对话：X、LinkedIn 和 Facebook。

Forward Looking Statements Disclaimer

前瞻性声明免责声明

This news release contains forward-looking statements. You can identify these statements by our use of words such as 'may,' 'expect,' 'believe,' 'anticipate,' 'intend,' 'could,' 'estimate,' 'continue,' 'plans,' or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made.

本新闻稿包含前瞻性声明。您可以通过我们使用的诸如“可能”、“预期”、“相信”、“预计”、“意图”、“可能”、“估计”、“继续”、“计划”或它们的否定词或其他相关词汇来识别这些声明。这些声明仅为估计和预测，受已知和未知的风险及不确定性影响，可能导致实际未来的经历和结果与声明内容存在重大差异。

These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to identify suitable collaborators, partners, licensees or purchasers for our product candidates and, if we are able to do so, to enter into binding agreements with regard to any of the foregoing, or to raise additional capital to support our operations, or our ability to fund our operations if we are unsuccessful with any of the foregoing.

这些声明基于我们对未来结果的当前信念和期望。药物发现和开发涉及高度风险。可能导致这种重大差异的因素包括但不限于：与为我们产品候选物找到合适的合作者、合作伙伴、被许可方或购买者相关不确定性，以及如果我们能够做到这一点，能否就上述任何一项达成具有约束力的协议，或筹集额外资金以支持我们的运营，或者如果我们未能成功完成上述任何一项，我们是否有能力为我们的运营提供资金。

A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2024, and our Form 10-Q for the quarter ended March 31, 2025. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements..

关于我们业务的风险和不确定性的完整描述包含在我们向证券交易委员会提交的定期报告中，包括截至2024年12月31日的年度Form 10-K报告以及截至2025年3月31日的季度Form 10-Q报告。这些前瞻性陈述仅于本日期作出，我们拒绝承担更新任何此类前瞻性陈述的义务。

Source: Cellectar Biosciences, Inc.

来源：Cellectar Biosciences, Inc.

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