TEL AVIV, Israel, April 17, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced a poster presentation on apheresis center efficiency and CXCR4 antagonists including APHEXDA (motixafortide) in patients with multiple myeloma.

以色列特拉维夫，2024年4月17日/PRNewswire/--BioLineRx Ltd.（纳斯达克：BLRX）（TASE：BLRX），一家商业阶段的生物制药公司，致力于在肿瘤学和罕见疾病中改变生命的疗法，今天宣布了一份关于多发性骨髓瘤患者单采中心效率和CXCR4拮抗剂（包括阿哌昔达（莫西福肽））的海报。

The poster will be presented at the American Society for Apheresis (ASFA) 2024 Annual Meeting, taking place April 17-19, 2024, in Las Vegas, Nevada..

该海报将于2024年4月17日至19日在内华达州拉斯维加斯举行的美国单采血液学会（ASFA）2024年年会上发布。。

Autologous stem cell transplantation (ASCT) is part of the standard of care treatment paradigm for multiple myeloma and prolongs survival for patients with this cancer type.1 Historically, depending on induction regimens and mobilization strategies, approximately 50% to 75% of patients required more than one apheresis session to collect a target number of cells.2,3.

自体干细胞移植（ASCT）是多发性骨髓瘤标准治疗模式的一部分，可以延长这种癌症患者的生存期[1]。历史上，根据诱导方案和动员策略，大约50%至75%的患者需要一次以上的单采治疗来收集目标数量的细胞[2,3]。

The model in the poster at ASFA analyzed the number of apheresis days needed to collect ≥6 million CD34+ cells/kg using different mobilization regimens based on product-specific Phase 3 studies. A direct comparison was used between daily filgrastim alone and in combination with APHEXDA based on the Phase 3 GENESIS trial that supported the U.S.

ASFA海报中的模型分析了根据产品特定的3期研究，使用不同的动员方案收集≥600万个CD34+细胞/kg所需的单采天数。根据支持美国的3期GENESIS试验，对每日单独使用非格司亭和与阿非克斯达联合使用进行了直接比较。

Food and Drug Administration (FDA) approval of APHEXDA. In the absence of head-to-head Phase 3 studies, an indirect comparison was made between daily filgrastim, plerixafor in combination with filgrastim, and APHEXDA in combination with filgrastim. The calculations were based on data from the MOZOBIL® (plerixafor) US Prescribing Information and local laboratory assessments in the GENESIS trial.4.

食品和药物管理局（FDA）批准APHEXDA。在没有头对头的3期研究的情况下，对每日非格司亭，plerixafor联合非格司亭和APHEXDA联合非格司亭进行了间接比较。这些计算是基于GENESIS试验中MOZOBIL®（plerixafor）美国处方信息和当地实验室评估的数据。

'Variability in the time to mobilize sufficient stem cells for ASCT is a significant operational challenge for apheresis centers that can cause suboptimal experiences for patients, as well as delays in care and cost impact,' said Edmund K. Waller, MD, PhD, FACP, Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University.

埃默里大学Winship癌症研究所血液学和医学肿瘤学系FACP医学博士EdmundK.Waller说：“动员足够干细胞进行ASCT的时间变化是单采中心面临的重大运营挑战，可能会给患者带来不理想的体验，以及护理延误和成本影响。”。

'Research of this type supports clinical and institutional decision making and we look forward to presenting the model at the poster session at ASFA.'.

“这种类型的研究支持临床和机构决策，我们期待着在ASFA的海报会议上展示该模型。”。

Poster Presentation at the ASFA 2024 Annual Meeting The Resorts World, Las Vegas, NVPoster Session DetailsPoster: Number P-28. See abstract in Journal of Clinical Apheresis. Title: Enhancing Apheresis Center Efficiency with CXCR4 Antagonists: Evidence from the Phase 3 TrialsAuthors: Edmund K. Waller, MD, PhD, FACP, Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GADate: April 17-19, 2024.

ASFA 2024年年会上的海报展示NVPoster会议详情，拉斯维加斯度假村世界，邮编：P-28。见《临床单采血液学杂志》摘要。标题：用CXCR4拮抗剂提高单采中心的效率：来自3期试验的证据作者：埃德蒙·沃勒，医学博士，博士，FACP，埃默里大学温希普癌症研究所血液学和医学肿瘤学系，亚特兰大，加达特：2024年4月17日至19日。

About Multiple Myeloma Multiple myeloma is an incurable blood cancer that affects some white blood cells called plasma cells, which are found in the bone marrow. When damaged, these plasma cells rapidly spread and replace normal cells in the bone marrow. According to the American Cancer Society, in 2024, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and nearly 13,000 people will die from the disease in the U.S.5 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems, or infections. .

关于多发性骨髓瘤多发性骨髓瘤是一种无法治愈的血癌，会影响骨髓中发现的一些称为浆细胞的白细胞。当受损时，这些浆细胞迅速扩散并取代骨髓中的正常细胞。据美国癌症协会估计，到2024年，美国将有超过35000人被诊断出患有多发性骨髓瘤，近13000人将死于该疾病。S、 虽然一些被诊断患有多发性骨髓瘤的人最初没有症状，但大多数患者被诊断出的症状可能包括骨折或疼痛，红细胞计数低，疲劳，钙水平高，肾脏问题或感染。。

About the GENESIS Trial GENESIS (NCT 03246529) is a 2-part, Phase-3, randomized, double-blind, placebo-controlled, multicenter study evaluating the safety and efficacy of APHEXDA (motixafortide) plus filgrastim (G-CSF), compared to placebo plus filgrastim, for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients.

关于GENESIS试验GENESIS（NCT 03246529）是一项由两部分组成的3期随机双盲安慰剂对照多中心研究，评估了阿非昔达（莫西沙福肽）加非格司亭（G-CSF）与安慰剂加非格司亭相比的安全性和有效性，用于动员造血干细胞用于多发性骨髓瘤患者的自体移植。

Part 1 was a single center, lead-in, open-label study involving 12 patients treated with motixafortide plus filgrastim designed to ascertain the dose. Part 2 involved 122 patients who were randomized 2:1 in a double-blind, placebo-controlled, multicenter study. The primary objective of the study was to evaluate if one dose of motixafortide plus filgrastim is superior to placebo plus filgrastim in the ability to mobilize ≥ 6 million CD34+ cells in up to two apheresis sessions.

第一部分是一项单中心，引入，开放标签的研究，涉及12名接受莫替卡福肽加非格司亭治疗的患者，旨在确定剂量。第二部分涉及122名患者，他们在一项双盲，安慰剂对照，多中心研究中以2:1的比例随机分组。这项研究的主要目的是评估一剂莫替卡福肽加非格司亭是否优于安慰剂加非格司亭，在多达两次单采过程中动员≥600万个CD34+细胞的能力。

A key secondary objective of the study was to evaluate if one dose of motixafortide plus filgrastim is superior to placebo plus filgrastim in the ability to mobilize ≥ 6 million CD34+ cells in one apheresis session. The study showed that APHEXDA combined with filgrastim (G-CSF) significantly enhanced the rate of mobilizing ≥6 × 106 CD34+ cells/kg in up to 2 apheresis days compared to placebo + filgrastim.

该研究的一个关键次要目标是评估一剂莫替卡福肽加非格司亭在一次单采过程中动员≥600万个CD34+细胞的能力是否优于安慰剂加非格司亭。该研究表明，与安慰剂+非格司亭相比，APHEXDA联合非格司亭（G-CSF）在长达2天的单采血液中显着提高了动员≥6×106个CD34+细胞/kg的速率。

Central laboratory assessments were used for the efficacy results. Local laboratory results were used for clinical treatment decisions.  .

中央实验室评估用于疗效结果。当地实验室结果用于临床治疗决策。。

About APHEXDA® APHEXDA (motixafortide) is a CXCR4 antagonist with long receptor occupancy (greater than 72 hours) that, in combination with filgrastim (G-CSF), enables mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous stem cell transplantation in patients with multiple myeloma.6.

关于APHEXDA®APHEXDA（motixafortide）是一种CXCR4拮抗剂，具有较长的受体占有率（大于72小时），与非格司亭（G-CSF）联合使用，可以将造血干细胞动员到外周血中进行采集和随后的自体干细胞移植。多发性骨髓瘤患者。

INDICATION AND IMPORTANT SAFETY INFORMATION

指示和重要安全信息

INDICATIONAPHEXDA is indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.

适应症PEXDA与非格司亭（G-CSF）联合使用，将造血干细胞动员到外周血中，用于多发性骨髓瘤患者的采集和随后的自体移植。

IMPORTANT SAFETY INFORMATION

重要安全信息

CONTRAINDICATIONSAPHEXDA is contraindicated in patients with a history of serious hypersensitivity reactions to motixafortide.

禁忌症saphexda禁用于对莫西沙星有严重超敏反应史的患者。

WARNINGS AND PRECAUTIONS

警告和注意事项

Anaphylactic Shock and Hypersensitivity Reactions: Anaphylactic shock and hypersensitivity reactions have occurred. Premedicate all patients with a triple drug premedication regimen that includes an H1-antihistamine, an H2 blocker, and a leukotriene inhibitor approximately 30-60 minutes prior to each dose of APHEXDA.

过敏性休克和超敏反应：发生过敏性休克和超敏反应。在每次服用APHEXDA前约30-60分钟，对所有患者进行三药预用药方案，包括H1抗组胺药，H2阻滞剂和白三烯抑制剂。

Administer APHEXDA in a setting where personnel and therapies are immediately available for treatment of anaphylaxis and other systemic reactions. Monitor patients for 1 hour following APHEXDA administration and manage reactions promptly. Patients receiving negative chronotropic drugs (e.g., beta-blockers) may be more at risk for hypotension in the event of a hypersensitivity reaction and these drugs, when appropriate, should be replaced with non-chronotropic drugs..

在人员和疗法可立即用于治疗过敏反应和其他全身反应的环境中服用阿非克斯达。服用阿非昔达后监测患者1小时，并及时处理反应。在发生超敏反应的情况下，接受负变时性药物（例如β受体阻滞剂）的患者可能更容易发生低血压，在适当的情况下，这些药物应被非变时性药物替代。。

Injection Site Reactions: Injection site reactions (73%) including pain (53%), erythema (27%), and pruritus (24%) have occurred. Severe reactions occurred in 9% of patients. Premedicate with an analgesic premedication (e.g., acetaminophen) prior to each APHEXDA dose. Use analgesic medication and local treatments post-dose, as needed..

注射部位反应：发生了注射部位反应（73%），包括疼痛（53%），红斑（27%）和瘙痒（24%）。9%的患者发生严重反应。在每次服用APHEXDA之前，先服用止痛药（例如对乙酰氨基酚）。根据需要，在给药后使用止痛药和局部治疗。。

Tumor Cell Mobilization in Patients with Leukemia: For the purpose of hematopoietic stem cell (HSC) mobilization, APHEXDA may cause mobilization of leukemic cells and subsequent contamination of the apheresis product. Therefore, APHEXDA is not intended for HSC mobilization and harvest in patients with leukemia..

白血病患者的肿瘤细胞动员：为了造血干细胞（HSC）动员的目的，APHEXDA可能导致白血病细胞的动员和随后的单采产品污染。因此，APHEXDA不适用于白血病患者的HSC动员和收获。。

Leukocytosis: Administering APHEXDA in conjunction with filgrastim increases circulating leukocytes as well as HSC populations. Monitor white blood cell counts during APHEXDA use.

白细胞增多症：与非格司亭联合使用阿非克斯达可增加循环白细胞以及HSC人群。在使用APHEXDA期间监测白细胞计数。

Potential for Tumor Cell Mobilization: When APHEXDA is used in combination with filgrastim for HSC mobilization, tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. The effect of potential reinfusion of tumor cells has not been well-studied.

肿瘤细胞动员的潜力：当APHEXDA与非格司亭联合用于HSC动员时，肿瘤细胞可能从骨髓中释放出来，随后收集在白细胞分离产品中。肿瘤细胞潜在再融合的效果尚未得到很好的研究。

Embryo-fetal Toxicity: Based on its mechanism of action, APHEXDA can cause fetal harm. Advise pregnant women of the potential risk to the fetus. Verify pregnancy status in females of reproductive potential prior to initiating treatment with APHEXDA and advise use of effective contraception during treatment and for 8 days after the final dose..

胚胎-胎儿毒性：根据其作用机制，APHEXDA可引起胎儿伤害。告知孕妇对胎儿的潜在风险。在开始使用APHEXDA治疗之前，验证具有生殖潜力的女性的妊娠状况，并建议在治疗期间和最终剂量后8天内使用有效的避孕措施。。

ADVERSE REACTIONSThe most common adverse reactions (incidence >20%) in patients treated with APHEXDA were injection site reactions [73%, including pain (53%), erythema (27%), pruritus (24%)]; pruritus (38%); flushing (33%); back pain (21%).

不良反应用APHEXDA治疗的患者最常见的不良反应（发生率>20%）是注射部位反应[73%，包括疼痛（53%），红斑（27%），瘙痒（24%）]；瘙痒（38%）；冲洗（33%）；背痛（21%）。

USE IN SPECIFIC POPULATIONS

在特定人群中使用

Pregnancy: Please see the important information in Warnings and Precautions under Embryo-fetal Toxicity.

怀孕：请参阅胚胎胎儿毒性警告和注意事项中的重要信息。

Lactation: There are no data on the presence of motixafortide in human milk, the effects on the breastfed child, or the effects on milk production. Advise females that breastfeeding is not recommended during treatment with APHEXDA and for 8 days after the final dose.

哺乳期：没有关于母乳中存在莫西沙福肽，对母乳喂养的孩子的影响或对产奶量的影响的数据。建议女性在服用阿非克斯达期间和服用最终剂量后8天内不建议母乳喂养。

Pediatric Use: The safety and effectiveness of APHEXDA have not been established in pediatric patients.

儿科使用：APHEXDA的安全性和有效性尚未在儿科患者中确定。

Please see the accompanying full Prescribing Information.

请参阅随附的完整处方信息。

About BioLineRxBioLineRx Ltd. (NASDAQ/TASE: BLRX) is a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The company's first approved product is APHEXDA® (motixafortide) with an indication in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma. BioLineRx is advancing a pipeline of investigational medicines for patients with sickle cell disease, pancreatic cancer, and other solid tumors. Headquartered in Israel, and with operations in the U.S., the company is driving innovative therapeutics with end-to-end expertise in development and commercialization, ensuring life-changing discoveries move beyond the bench to the bedside..

关于BioLineRxBioLineRx Ltd.（纳斯达克/塔斯社：BLRX）是一家商业阶段的生物制药公司，致力于在肿瘤学和罕见疾病中寻求改变生命的疗法。该公司的首款获批产品是APHEXDA®（motixafortide），在美国用于干细胞动员以用于多发性骨髓瘤的自体移植。BioLineRx正在推进镰状细胞病、胰腺癌和其他实体瘤患者的研究药物管道。该公司总部位于以色列，在美国开展业务，在开发和商业化方面拥有端到端的专业知识，正在推动创新疗法的发展，确保改变生命的发现从板凳走向床边。。

Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on Twitter and LinkedIn.

了解更多关于我们是谁、我们做什么以及我们如何在 www.biolinerx.com，或 推特 和 LinkedIn。

Forward Looking StatementVarious statements in this release concerning BioLineRx's future expectations constitute 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as 'anticipates,' 'believes,' 'could,' 'estimates,' 'expects,' 'intends,' 'may,' 'plans,' 'potential,' 'predicts,' 'projects,' 'should,' 'will,' and 'would,' and describe opinions about future events.

前瞻性声明本新闻稿中有关BioLineRx未来预期的各种声明构成了1995年《私人证券诉讼改革法案》所指的“前瞻性声明”。这些陈述包括“预期”、“相信”、“可能”、“估计”、“预期”、“打算”、“可能”、“计划”、“潜力”、“预测”、“项目”、“应该”、“将会”等词，并描述了对未来事件的看法。

These include statements regarding management's expectations, beliefs and intentions regarding, among other things, the potential benefits of APHEXDA, the execution of the launch of APHEXDA and the plans and objectives of management for future operations and expectations and commercial potential of motixafortide, as well as its potential investigational uses.

其中包括关于管理层的期望、信念和意图的声明，其中包括关于阿非克斯达的潜在益处、阿非克斯达启动的执行情况、管理层对未来运营的计划和目标、莫西沙福肽的期望和商业潜力，以及其潜在的研究用途。

These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.

这些前瞻性陈述涉及已知和未知的风险、不确定性和其他因素，这些因素可能导致BioLineRx的实际结果、绩效或成就与此类前瞻性陈述所表达或暗示的任何未来结果、绩效或成就存在重大差异。

Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials, and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; whether BioLineRx's collaboration partners will be able to execute on collaboration goals in a timely manner; whether the clinical trial results for APHEXDA will be predictive of real-world result.

可能导致BioLineRx的实际结果与此类前瞻性声明中表达或暗示的结果存在重大差异的因素包括但不限于：BioLineRx的临床前研究，临床试验和其他治疗候选开发工作的开始，时间，进展和结果；BioLineRx将其治疗候选人推进临床试验或成功完成其临床前研究或临床试验的能力；BioLineRx的合作伙伴是否能够及时执行合作目标；APHEXDA的临床试验结果是否可以预测现实世界的结果。

Kumar SK, et al. Blood. 2008;111(5):2516-2520.

Kumar SK等人，Blood。2008;111(5):2516-2520.

Dhakal B, Zhang M, Burns L, et al. Haematologica. 2023;106(8):2257-2260.

Dhakal B，Zhang M，Burns L等。血液学。2023年；106（8）：2257-2260。

Ahmed N, Li L, Rojas P, et al. Bone Marrow Transplant. 2021;56(6):1458-1461.

Ahmed N，Li L，Rojas P，等。骨髓移植。2021;56(6):1458-1461.

Data on file.

文件中的数据。

American Cancer Society. Key Statistics About Multiple Myeloma. Atlanta, Ga: American Cancer Society; 2024.

美国癌症协会。关于多发性骨髓瘤的关键统计数据。佐治亚州亚特兰大：美国癌症协会；2024

APHEXDA. Prescribing Information. BioLineRx Ltd; 2023.

阿菲克斯达。处方信息。BioLineRx有限公司；2023

©BioLineRx USA, Inc. 2024. All Rights Reserved.APHEXDA® is a registered trademark of BioLineRx Ltd.All names and trademarks are property of their respective owners.

©BioLineRx USA，Inc.2024年。保留所有权利。APHEXDA®是BioLineRx Ltd.的注册商标。所有名称和商标均为其各自所有者的财产。

SOURCE BioLineRx

源BioLineRx