- 6 of 11 Patients in the Pilot Phase Experienced a Partial Response, with 4 Confirmed; One Patient Experienced Resolution of the Hepatic Metastatic Lesion -

-试验阶段的11名患者中有6名经历了部分反应，其中4名得到证实；一个病人经历了肝转移病灶的解决-

- Data Presented at AACR Special Conference on Pancreatic Cancer -

-AACR胰腺癌特别会议上提供的数据-

- Multi-Center, Randomized Phase 2 Study Currently Enrolling -

-多中心，随机2期研究目前正在招募-

TEL AVIV, Israel, Sept. 28, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced encouraging data from the single-arm pilot phase of the investigator-initiated CheMo4METPANC Phase 2 combination clinical trial evaluating the company's CXCR4 inhibitor motixafortide, the PD-1 inhibitor cemiplimab, and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancer (PDAC)..

以色列特拉维夫，2023年9月28日/PRNewswire/-BioLineRx Ltd.（纳斯达克股票代码：BLRX）（TASE:BLRX），一家商业阶段的生物制药公司，致力于肿瘤学和罕见疾病的改变生命的疗法，今天宣布了研究者发起的CheMo4METPANC 2期联合临床试验的单臂试验阶段的令人鼓舞的数据，该试验评估了该公司的CXCR4抑制剂motixafortide，PD-1抑制剂cemiplimab，以及标准化疗吉西他滨和nab-紫杉醇，与吉西他滨和nab-紫杉醇单独用于一线胰腺癌（PDAC）。。

The data were published in an online abstract as part of the American Association of Cancer Research (AACR) Special Conference on Pancreatic Cancer taking place in Boston, Massachusetts from September 27-30, 2023.  An oral presentation of the data will take place later today, September 28, 2023.

这些数据以在线摘要的形式发布，作为美国癌症研究协会（AACR）胰腺癌特别会议的一部分，于2023年9月27日至30日在马萨诸塞州波士顿举行。数据的口头介绍将在稍后进行今天，2023年9月28日。

The pilot phase of the Phase 2 study enrolled 11 patients with metastatic pancreatic cancer.  As of May 2023, 6 patients (55%) experienced a partial response (PR) of which 4 (36%) were confirmed PRs with one patient experiencing resolution of the hepatic (liver) metastatic lesion. Three patients (27%) experienced stable disease, resulting in a disease control rate of 82%.  These findings compare favorably to historic partial response and disease control rates of 23% and 48%, respectively, reported with the current standard of care, the chemotherapy combination gemcitabine and nab-paclitaxel..

2期研究的试验阶段招募了11名转移性胰腺癌患者。截至2023年5月，6名患者（55%）出现部分缓解（PR），其中4名（36%）确诊为PR，1名患者肝（肝）转移病灶消退。3名患者（27%）病情稳定，疾病控制率为82%。这些发现与当前的护理标准，吉西他滨和纳他紫杉醇联合化疗报告的历史部分缓解率和疾病控制率分别为23%和48%相比具有优势。。

'These initial data from the pilot phase of this ongoing Phase 2 study give us hope that motixafortide could potentially serve as the backbone of a new treatment regimen for PDAC, which is among the most difficult cancers to treat,' said Philip Serlin, Chief Executive Officer of BioLineRx Ltd.  'We are deeply committed to this important collaboration with Columbia University investigators and eagerly look forward to the data from the randomized phase of the trial.'.

Philip Serlin说：“这项正在进行的第二阶段研究的试验阶段的这些初步数据使我们希望motixafortide有可能成为PDAC新治疗方案的骨干，PDAC是最难治疗的癌症之一，BioLineRx有限公司首席执行官：“我们深深地致力于与哥伦比亚大学调查人员的这一重要合作，并热切期待试验随机阶段的数据。”。

Based on these pilot data, earlier this year, the CheMo4METPANC Phase 2 trial was amended to become a randomized study, with planned enrollment increasing from 30 to 102 patients.  The trial, sponsored by Columbia University, is the first large, multi-center, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line PDAC chemotherapies.  A poster of the amended clinical trial design was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 2-6 in Chicago, Illinois (see abstract)..

根据这些试点数据，今年早些时候，CheMo4METPANC 2期临床试验被修改为随机研究，计划入组人数从30人增加到102人。该试验由哥伦比亚大学赞助，是第一项用PD-1抑制剂和一线PDAC化疗评估motixafortide的大型多中心随机研究。经修订的临床试验设计海报于6月2日至6日在伊利诺伊州芝加哥举行的2023年美国临床肿瘤学会（ASCO）年会上发表（见摘要）。。

Pancreatic ductal adenocarcinoma (PDAC) is the most common type of pancreatic cancer and is expected to be the second leading cause of cancer-related death in the U.S. by 2023.  Because it is typically diagnosed at later stages, greater than 80 percent of pancreatic cancer is inoperable. Most pancreatic cancer is incurable and unfortunately newer immunotherapy approaches, while beneficial against other solid tumor types, have had limited efficacy in pancreatic cancer due to immunosuppressive pathways..

胰腺导管腺癌（PDAC）是最常见的胰腺癌类型，预计到2023年将成为美国癌症相关死亡的第二大原因。由于胰腺癌通常在晚期诊断，超过80%的胰腺癌无法手术。大多数胰腺癌是无法治愈的，不幸的是，较新的免疫治疗方法虽然对其他实体瘤类型有益，但由于免疫抑制途径对胰腺癌的疗效有限。。

An earlier single-arm, Phase 2a clinical trial (COMBAT/KEYNOTE-202) and pre-clinical studies evaluating motixafortide in combination with PD-1 immunotherapies and chemotherapies in PDAC have been promising, suggesting the ability of motixafortide to support an immune response.

早期的单臂2a期临床试验（COMBAT/KEYNOTE-202）和临床前研究评估了motixafortide与PDAC中PD-1免疫疗法和化学疗法的组合，这表明了motixafortide支持免疫反应的能力。

Presentation at AACR Special Conference in Cancer Research: Pancreatic Cancer

在AACR癌症研究特别会议上的演讲：胰腺癌

Westin Copley Place, Boston Massachusetts

威斯汀-科普利广场，波士顿马萨诸塞州

Plenary Session Details

全体会议详情

Title:             CheMo4METPANC: Combination Chemotherapy (gemcitabine and nab-paclitaxel), chemokine (C-X-C) Motif receptor 4 inhibitor (motixafortide), and immune checkpoint blockade (cemiplimab) in METastatic treatment-naïve PANCreatic adenocarcinoma

题目：CheMo4METPANC：联合化疗（吉西他滨和纳他紫杉醇），趋化因子（C-X-C）基序受体4抑制剂（motixafortide）和免疫检查点阻断（cemiplimab）治疗转移性治疗初治胰腺癌

Presenter:    Gulam A. Manji, MD, PhD, Columbia University Irving Medical Center/New York Presbyterian, New York, N.Y.

主持人：Gulam A.Manji，哥伦比亚大学欧文医学中心医学博士，纽约长老会，纽约，纽约。

Session:        Plenary Session 3: Clinical Updates

会议：全体会议3：临床更新

Date:            Thursday, September 28, 2023

日期：2023年9月28日星期四

Time:            2:30-4:40 pm EDT

时间：2:30-4:40 pm EDT

About CheMo4METPANC Phase 2 Clinical Trial

关于CheMo4METPANC 2期临床试验

The multi-center CheMo4METPANC Phase 2 clinical trial is a randomized, investigator-initiated clinical trial in first line metastatic pancreatic cancer.  Sponsored by Columbia University, the study is evaluating the combination of CXCR4 inhibitor motixafortide, PD-1 inhibitor cemiplimab, and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel, alone in 102 patients.  The trial's primary endpoint is progression free survival (PFS).

多中心CheMo4METPANC 2期临床试验是一项随机，研究者发起的一线转移性胰腺癌临床试验。该研究由哥伦比亚大学赞助，目前正在评估102例患者中CXCR4抑制剂motixafortide，PD-1抑制剂cemiplimab和标准化疗吉西他滨和nab-紫杉醇与吉西他滨和nab-紫杉醇的联合应用。试验的主要终点是无进展生存期（PFS）。

Secondary objectives include safety, response rate, disease control rate, duration of clinical benefit and overall survival..

次要目标包括安全性，有效率，疾病控制率，临床获益持续时间和总生存期。。

About Pancreatic Cancer

关于胰腺癌

Pancreatic cancer has a low rate of early diagnosis and a poor prognosis.  In the United States in 2023, an estimated 64,000 adults will be diagnosed with the disease, which accounts for approximately 3% of all cancers in the U.S. and about 7% of all cancer deaths.  Worldwide, an estimated 496,000 people were diagnosed with the disease in 2020.  In the U.S., if the cancer is detected at an early stage when surgical removal of the tumor is possible, the 5-year relative survival rate is 44%.

胰腺癌早期诊断率低，预后差。在2023年的美国，估计将有64000名成年人被诊断患有这种疾病，约占美国所有癌症的3%，约占所有癌症死亡人数的7%。在世界范围内，2020年估计有496000人被诊断患有这种疾病。在美国，如果在手术切除肿瘤的早期阶段发现癌症，5年相对生存率为44%。

About 12% of people are initially diagnosed at this stage. If the cancer has spread to surrounding tissues or organs, the 5-year relative survival rate is 15%.  For the 52% of patients who are initially diagnosed with metastatic cancer, the 5-year relative survival rate is 3%.[i]  In particular, hepatic (liver) metastases are a critical risk factor driving poor prognoses for patients with metastatic PDAC.

大约12%的人在此阶段最初被诊断出来。如果癌症扩散到周围组织或器官，5年相对存活率为15%。对于最初诊断为转移性癌症的52%的患者，5年相对生存率为3%。[i] 特别是，肝（肝）转移是导致转移性PDAC患者预后不良的关键风险因素。

These data highlight the need for the development of new therapeutic options..

这些数据突出了开发新的治疗选择的必要性。。

About Motixafortide in Cancer Immunotherapy

关于Motixafortide在癌症免疫治疗中的应用

Motixafortide inhibits CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including pancreatic ductal adenocarcinoma (PDAC). Motixafortide leverages the expression of the CXCR4 receptor on different immune cells and potentiates the immune system against the tumor.  Among CXCR4-expressing immune cells, some exhibit anti-tumoral activity, such as effector T cells and some exhibit pro-tumoral activity and support tumor growth.

Motixafortide抑制CXCR4，一种趋化因子受体和一种经过充分验证的治疗靶点，在许多人类癌症中过表达，包括胰腺导管腺癌（PDAC）。Motixafortide利用CXCR4受体在不同免疫细胞上的表达，增强免疫系统对抗肿瘤。在表达CXCR4的免疫细胞中，一些表现出抗肿瘤活性，例如效应T细胞，一些表现出促肿瘤活性并支持肿瘤生长。

By blocking the CXCR4 receptor, motixafortide was shown in a Phase 2 study in pancreatic cancer patients to enhance anti-tumoral activity and to ameliorate the pro-tumoral activities by modulating the effector/suppressor cell ratio towards a proinflammatory profile..

通过阻断CXCR4受体，motixafortide在胰腺癌患者的2期研究中显示，通过调节效应/抑制细胞比例朝向促炎特征来增强抗肿瘤活性并改善促肿瘤活性。。

About BioLineRx

关于BioLineRx

BioLineRx 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. .

BioLineRx Ltd.（纳斯达克/塔斯：BLRX）是一家商业级生物制药公司，致力于肿瘤和罕见疾病的生命改变疗法。该公司的第一批批准产品是APHEXDA™ （motixafortide），在美国有迹象表明干细胞动员 自体移植治疗多发性骨髓瘤。BioLineRx正在为镰状细胞病，胰腺癌和其他实体瘤患者推进一系列研究药物。该公司总部设在以色列，在美国运营，正在推动创新疗法的开发和商业化方面的端到端专业知识，确保改变生活的发现超越实验室到床边。 .

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做 www.biolinerx.com或上 Twitter 和 LinkedIn。

Forward Looking Statement

前瞻性声明

Various 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.

本版本中有关BioLineRx未来期望的各种陈述构成了1995年“私人证券诉讼改革法”含义内的“前瞻性陈述”。这些陈述包括诸如“预期”，“相信”，“可以”，“估计”，“期望”，“打算”，“可以”，“计划”，“潜力”，“预测”，“项目”，“应该”，“将会”和“将会”，并描述对未来事件的看法。

These include statements regarding.

这些包括关于。

management's expectations, beliefs and intentions regarding, among other things, the potential benefits of APHEXDA, the timing and 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.

管理层的期望，信念和意图除其他外，还涉及APHEXDA的潜在益处，APHEXDA推出的时间和执行以及管理层对未来运营的计划和目标以及motixafortide的期望和商业潜力，以及潜在的调查用途。

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，不确定性和其他可能导致BioLineRx的实际结果，表现或成就与此类前瞻性陈述所表达或暗示的任何未来结果，表现或成就大不相同的因素。

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 the clinical trial results for APHEXDA will be predictive of real-world results; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates, including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; whether access to APHEXDA is achieved in a commercially viable manner and whether APHEXDA receives adequate reimbursement from third-party payors; BioLineRx's ability to establish a.

可能导致BioLineRx实际结果与此类前瞻性陈述中表达或暗示的结果大不相同的因素包括但不限于：BioLineRx临床前研究，临床试验和其他治疗候选药物开发的开始，时间，进展和结果努力；BioLineRx能够将其治疗候选药物推进临床试验或成功完成其临床前研究或临床试验；APHEXDA的临床试验结果是否可以预测现实世界的结果；BioLineRx收到其治疗候选人的监管批准，以及其他监管文件和批准的时间；BioLineRx治疗候选药物的临床开发，商业化和市场接受程度，包括APHEXDA在多发性骨髓瘤患者自体移植中动员造血干细胞的市场吸收程度和速度；是否以商业上可行的方式获得APHEXDA以及APHEXDA是否从第三方付款人处获得足够的报销；BioLineRx建立a的能力。

Contacts:

联络：

United StatesJohn LaceyBioLineRx[email protected]

美国John LaceyBioLineRx[电子邮件保护]

IsraelMoran MeirLifeSci Advisors, LLC[email protected]

IsraelMoran MeirLifeSci Advisors，LLC[电子邮件保护]

[i] ASCO Cancer.Net.  Cancer.Net Editorial Board Approval March 2023.

[i] ASCO-Cancer.Net.Cancer.Net编辑委员会批准2023年3月。

SOURCE BioLineRx Ltd

SOURCE BioLineRx Ltd