New data suggests that baseline serum myeloperoxidase (MPO) levels below the threshold may predict overall survival (OS) improvement when comparing the CM24+nivolumab+Nal-IRI/5FU/LV vs. Nal-IRI/5FU/LV arms

新数据表明，当比较CM24+nivolumab+Nal-IRI/5FU/LV与Nal-IRI/5FU/LV臂时，基线血清髓过氧化物酶（MPO）水平低于阈值可以预测总生存率（OS）的改善

Data reported at the 2024 ASCO annual meeting demonstrated reduced risk of death and cancer progression, prolongation of OS and progression free survival (PFS) as well as higher objective response rate (ORR) and disease control rate (DCR) and decreasing CA19-9 levels in the CM24+Nivolumab+Nal-IRI/5FU/LV arm  .

2024年ASCO年会报告的数据显示，死亡和癌症进展的风险降低，OS和无进展生存期（PFS）延长，客观缓解率（ORR）和疾病控制率（DCR）提高，CA19-9水平降低CM24+Nivolumab+Nal IRI/5FU/LV组。

Further data and top line results are expected in the second half of 2024

预计2024年下半年将有进一步的数据和顶线结果

Company to host virtual key opinion leader (KOL) event to discuss results on July 11, 2024

公司将于2024年7月11日举办虚拟关键意见领袖（KOL）活动，讨论结果

REHOVOT, Israel, June 27, 2024 (GLOBE NEWSWIRE) --  Purple Biotech Ltd. (“Purple Biotech” or “the Company”) (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class oncology therapies that overcome tumor immune evasion and drug resistance, today reported additional positive interim data from its randomized, controlled, open label, multicenter Phase 2 study (NCT 04731467) of CM24, in combination with Bristol Myers Squibb’s immune checkpoint inhibitor nivolumab and standard of care (SoC) chemotherapy, in second-line metastatic pancreatic ductal adenocarcinoma (PDAC).

以色列雷霍沃特，2024年6月27日（环球通讯社）--紫色生物技术有限公司（“紫色生物技术”或“该公司”）（纳斯达克/塔斯社：PPBT），一家临床阶段公司，开发了克服肿瘤免疫逃避和耐药性的一流肿瘤学疗法，今天报道了其CM24随机，对照，开放标签，多中心2期研究（NCT 04731467）与百时美施贵宝的免疫检查点抑制剂nivolumab和标准治疗（SoC）化疗联合用于二线转移性胰腺导管腺癌（PDAC）的额外阳性中期数据。

These results suggest that serum MPO may be a predictive biomarker for survival in the CM24+Nivolumab + Nal-IRI/5FU/LV arm. The company also announced that it will host a virtual KOL event on Thursday, July 11, 2024 at 10:30 AM ET to discuss the results in detail. To register for the event, click here..

这些结果表明，血清MPO可能是CM24+Nivolumab+Nal IRI/5FU/LV组存活的预测生物标志物。。要注册活动，请单击此处。。

Interim results that were presented on June 1, 2024 during a late-breaking abstract poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrated a 26% reduction in risk of death (HR=0.74) and a 28% risk reduction in progression or death (HR=0.72) in previously-treated patients treated with CM24+nivolumab+Nal-IRI/5FU/LV vs.

2024年6月1日在2024年美国临床肿瘤学会（ASCO）年会上发表的一份最新摘要海报展示中显示，在先前接受CM24+nivolumab+Nal IRI/5FU/LV治疗的患者中，死亡风险降低了26%（HR=0.74），进展或死亡风险降低了28%（HR=0.72）。

Nal-IRI/5FU/LV chemotherapy alone (i.e., SoC). Median OS was prolonged by 2.1 months and median PFS was extended by 1.9 months in the CM24+nivolumab+Nal-IRI/5FU/LV regimen vs. SoC. The prolongation of both OS and PFS by the CM-24-nivolumab therapy is further supported by a higher ORR (25% vs 7%), DCR (63% vs 40%), and decrease in CA19-9 level (61% decrease vs.

单独使用Nal IRI/5FU/LV化疗（即SoC）。CM24+nivolumab+Nal IRI/5FU/LV方案与SoC相比，中位OS延长了2.1个月，中位PFS延长了1.9个月。CM-24-nivolumab治疗OS和PFS的延长进一步得到了更高ORR（25%比7%），DCR（63%比40%）和CA19-9水平降低（61%比40%）的支持。

34% increase)..

34%的增长）。。

“The concordant and consistent improvement in primary and all secondary endpoints including OS, PFS, ORR, DCR and CA19-9 are compelling, and the addition of a potential predictive biomarker provides further support for the potential of CM24 in combination with nivolumab plus the SoC chemotherapy regimen Nal-IRI/5FU/LV to improve clinical outcomes for those with advanced metastatic PDAC.” stated Gil Efron, Chief Executive Officer of Purple Biotech.

“包括OS，PFS，ORR，DCR和CA19-9在内的主要和所有次要终点的一致和一致的改善是令人信服的，并且添加潜在的预测性生物标志物为CM24联合nivolumab加SoC化疗方案Nal-IRI/5FU/LV的潜力提供了进一步的支持，以改善晚期转移性PDAC患者的临床结果。”Purple Biotech首席执行官Gil Efron表示。

“We plan to report further clinical study data in the second half of 2024.”.

“我们计划在2024年下半年报告进一步的临床研究数据。”。

New Interim Exploratory Biomarker Data:

新的中期探索性生物标志物数据：

This interim biomarker analysis comparing the experimental and control arms suggests measured baseline serum MPO as a potential clinical outcome biomarker for CM24-nivolumab therapy.

这种比较实验组和对照组的临时生物标志物分析表明，测量的基线血清MPO是CM24 nivolumab治疗的潜在临床结果生物标志物。

Enhanced MPO levels were measured in >90% of the patients with mean MPO over 6-fold higher than healthy donors. The mean MPO is used as a threshold for evaluating MPO as a potential biomarker.

在平均MPO比健康供体高6倍以上的患者中，>90%的患者MPO水平升高。平均MPO被用作评估MPO作为潜在生物标志物的阈值。

The effect of the CM24-nivolumab therapy in combination with Nal-IRI/5FU/LV is most pronounced among patients with serum MPO levels below the mean MPO and is associated with OS improvement of 3.6 months in median OS of 8.1 months vs. 4.5 months (HR 0.34 (95% CI: 0.099-1.149)).

CM24 nivolumab联合Nal IRI/5FU/LV治疗的效果在血清MPO水平低于平均MPO的患者中最为明显，并且与中位OS为8.1个月比4.5个月的OS改善3.6个月相关（HR 0.34（95%CI:0.099-1.149））。

While in a small sample size, these findings suggest that serum MPO may be a predictive biomarker for the treatment effect of CM24+Nivo+ Nal-IRI/5FU/LV on OS.

虽然样本量较小，但这些发现表明血清MPO可能是CM24+Nivo+Nal IRI/5FU/LV对OS治疗效果的预测生物标志物。

Presentation of the biomarker data is planned at an upcoming medical conference.

计划在即将举行的医学会议上介绍生物标志物数据。

The experimental arms of the randomized Phase 2 study administered patients with CM24 plus nivolumab and a choice of one of two SoC chemotherapies used in second-line PDAC, and dependent on prior first line therapy regimen; either gemcitabine/nab-paclitaxel or liposomal irinotecan (Nal-IRI)/5-fluorouracil (5-FU) and leucovorin (LV) (Nal-IRI/5FU/LV), while the control arms administered either respective SoC chemotherapy alone.

随机2期研究的实验组给予CM24加nivolumab患者，并选择二线PDAC中使用的两种SoC化学疗法之一，并依赖于先前的一线治疗方案；。

Interim results are provided for the Nal-IRI/5FU/LV sub study. An analysis of the gemcitabine/nab-paclitaxel sub study will be performed later when the data sufficiently matured..

为最终IRI/5FU/LV子研究提供了中期结果。当数据足够成熟时，将在稍后进行吉西他滨/nab-紫杉醇亚研究的分析。。

CM24 is a humanized monoclonal antibody that blocks CEACAM1, an immune checkpoint protein responsible for tumor immune evasion and poor tumor response and/or resistance to immune checkpoint inhibitors. Neutrophil extracellular traps (NETs) which are involved in immune evasion and metastasis known to affect disease progression and patient survival.

CM24是一种人源化单克隆抗体，可阻断CEACAM1，CEACAM1是一种免疫检查点蛋白，负责肿瘤免疫逃逸，肿瘤反应差和/或对免疫检查点抑制剂的耐药性。中性粒细胞胞外陷阱（NETs）参与免疫逃避和转移，已知会影响疾病进展和患者生存。

CM24, a CEACAM1 antibody, was reported1 to also bind to NET structures and significantly suppresses the NET-induced migration of various cancer cells, as an additional Mechanism of Action. In an earlier part of this study, CM24+nivolumab treatment significantly reduced the level of the NET marker, as represented by measurable MPO in patient serum..

据报道，CEACAM1抗体CM24也与NET结构结合，并显着抑制NET诱导的各种癌细胞迁移，作为另一种作用机制。在本研究的早期部分，CM24+nivolumab治疗显着降低了NET标记物的水平，如患者血清中可测量的MPO所示。。

The poster presentation at ASCO 2024 may be viewed on Purple Biotech’s website HERE and the abstract may be accessed on ASCO’s website HERE.

ASCO 2024的海报展示可以在紫色生物技术公司的网站上查看，摘要可以在ASCO的网站上访问。

1.        Poster presentation at AACR Special Conference: Pancreatic cancer 2023: Phase 1 Study of CM24 in Combination with Nivolumab in Patients with Advanced Pancreatic Cancer - Survival, Exploratory Biomarkers and Effect on Neutrophil Extracellular Traps (NETs)

1.AACR特别会议海报介绍：2023年胰腺癌：CM24联合Nivolumab治疗晚期胰腺癌患者的第一阶段研究-生存率，探索性生物标志物以及对中性粒细胞胞外陷阱（NETs）的影响

About Purple Biotech

关于紫色生物技术

Purple Biotech Ltd. (NASDAQ/TASE: PPBT) is a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance. The Company’s oncology pipeline includes NT219, CM24 and IM1240. NT219 is a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3.

Purple Biotech Ltd.（纳斯达克/塔斯社：PPBT）是一家临床阶段公司，开发一流的疗法，旨在克服肿瘤免疫逃避和耐药性。该公司的肿瘤学管道包括NT219，CM24和IM1240。NT219是一种双重抑制剂，新型小分子，可同时靶向IRS1/2和STAT3。

A Phase 1 dose escalation study is being concluded and a Phase 2 study of NT219 at its recommended Phase 2 level in combination with cetuximab in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck cancer (SCCHN) is planned. CM24 is a humanized monoclonal antibody that blocks CEACAM1, an immune checkpoint protein that supports tumor immune evasion and survival through multiple pathways.

一项1期剂量递增研究正在结束，计划对复发和/或转移性头颈部鳞状细胞癌（SCCHN）患者进行NT219推荐的2期水平联合西妥昔单抗的2期研究。CM24是一种人源化单克隆抗体，可阻断CEACAM1，CEACAM1是一种免疫检查点蛋白，可通过多种途径支持肿瘤免疫逃避和存活。

The Company is advancing CM24 as a combination therapy with anti-PD-1 checkpoint inhibitors in a Phase 2 study for the treatment of pancreatic ductal adenocarcinoma (PDAC). The Company has entered into a clinical collaboration agreement with Bristol Myers Squibb for the Phase 2 clinical trials to evaluate the combination of CM24 with the PD-1 inhibitor nivolumab in addition to chemotherapy.

该公司正在推进CM24作为抗PD-1检查点抑制剂的联合疗法，用于治疗胰腺导管腺癌（PDAC）的2期研究。该公司已与百时美施贵宝（Bristol-Myers Squibb）签订了2期临床试验的临床合作协议，以评估CM24与PD-1抑制剂nivolumab的联合化疗。

The Company is also advancing a preclinical platform of conditionally-activated tri-specific antibodies that engage both T cells and NK cells to induce a strong, localized immune response within the tumor microenvironment. The cleavable capping technology confines the compound’s therapeutic activity to the local tumor microenvironment, and thereby potentially increases the anticipated therapeutic window in patients.

该公司还正在推进一个有条件激活的三特异性抗体的临床前平台，该抗体可与T细胞和NK细胞结合，在肿瘤微环境中诱导强烈的局部免疫反应。可切割的封端技术将化合物的治疗活性限制在局部肿瘤微环境中，从而可能增加患者的预期治疗窗口。

The third arm of the antibody specifically targets the Tumor Associated Antigen (TAA). The technology presents a novel mechanism of action by unleashing both innate and adaptive immune systems to induce an optimal anti-tumor immune re.

抗体的第三臂特异性靶向肿瘤相关抗原（TAA）。该技术通过释放先天性和适应性免疫系统来诱导最佳的抗肿瘤免疫反应，提出了一种新的作用机制。

Forward-Looking Statements and Safe Harbor Statement

前瞻性声明和安全港声明

Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements that are not statements of historical fact, and may be identified by words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters.

本新闻稿中的某些前瞻性声明而非历史事实声明是1995年《私人证券诉讼改革法》安全港条款所指的前瞻性声明。此类前瞻性陈述包括但不限于不属于历史事实陈述的陈述，可以通过“相信”、“期望”、“打算”、“计划”、“可能”、“应该”、“可能”、“可能”、“寻求”、“目标”、“将”、“项目”、“预测”、“继续”或“预期”等词语或其他类似词语的否定或变化，或者通过这些陈述不严格涉及历史事项的事实来识别。

You should not place undue reliance on these forward-looking statements, which are not guarantees of future performance. Forward-looking statements reflect our current views, expectations, beliefs or intentions with respect to future events, and are subject to a number of assumptions, involve known and unknown risks, many of which are beyond our control, as well as uncertainties and other factors that may cause our actual results, performance or achievements to be significantly different from any future results, performance or achievements expressed or implied by the forward-looking statements.

您不应过度依赖这些前瞻性声明，因为这些声明并不能保证未来的业绩。。

Important factors that could cause or contribute to such differences include, among others, risks relating to: the plans, strategies and objectives of management for future operations; product development for NT219, CM24 and IM1240; the process by which such early stage therapeutic candidates could potentially lead to an approved drug product is long and subject to highly significant risks, particularly with respect to a joint development collaboration; the fact that drug development an.

可能导致或促成这种差异的重要因素包括与以下相关的风险：未来运营的管理计划、战略和目标；NT219、CM24和IM1240的产品开发；；药物开发的事实。

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Lior Fhima

Lior Fhima

Chief Financial Officer

首席财务官

IR@purple-biotech.com

IR@purple-biotech.com