Breast cancer patient who improved from a progressive disease diagnosis to an over nine-month sustained stable disease diagnosis has now successfully transitioned to a higher dose level, accessing the potential for greater clinical benefit in the ALG.APV-527 clinical trial

乳腺癌患者从进行性疾病诊断改善为9个月以上持续稳定的疾病诊断，现已成功过渡到更高的剂量水平，从而在ALG中获得更大的临床益处。APV-527临床试验

Cohort 5 dosing imminent, trial more than 50% enrolled

队列5即将给药，试验登记率超过50%

APVO436 Phase 1b/2 dose optimization trial initiation expected 1H 2024

APVO436 1b/2期剂量优化试验预计于2024年1月开始

Premier CRO, Prometrika, engaged as partner for dose optimization trial to evaluate APVO436 in frontline AML in combination with venetoclax + azacitidine in venetoclax naïve patients

Prometrika Premier CRO作为剂量优化试验的合作伙伴，评估APVO436在一线AML联合venetoclax+阿扎胞苷治疗venetoclax初治患者中的作用

APVO711 demonstrates its ability to induce tumor killing properties in preclinical studies

APVO711在临床前研究中证明了其诱导肿瘤杀伤特性的能力

APVO711 dual mechanism checkpoint inhibitor with unique precision targeting capabilities progressing towards IND

APVO711双机制检查点抑制剂具有独特的精确靶向能力，正在向IND发展

SEATTLE, WA / ACCESSWIRE / April 10, 2024 /Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies, today announced advancements in both clinical programs and one preclinical program..

华盛顿州西雅图/ACCESSWIRE/2024年4月10日/Aptevo Therapeutics Inc。（纳斯达克：APVO），一家临床阶段生物技术公司，专注于开发基于其专有ADAPTIR™和ADAPTIR-FLEX™平台技术的新型免疫肿瘤学疗法，今天宣布了临床项目和一个临床前项目的进展。。

A heavily pretreated breast cancer patient, enrolled in the ALG.APV-527 Phase 1 open-label, multi-center, multi-cohort trial for the treatment of multiple solid tumor types, entered the trial and improved from progressive disease to long-lasting stable disease (SD) while on therapy. The patient has remained on study for more than nine months and been successfully transitioned to a higher dose level, which may allow for increased clinical benefit.

一名经过严重预处理的乳腺癌患者，参加了ALG。用于治疗多种实体瘤类型的APV-527 1期开放标签，多中心，多队列试验进入试验，并在治疗期间从进行性疾病改善为持久稳定疾病（SD）。该患者已进行了九个多月的研究，并已成功过渡到更高的剂量水平，这可能会增加临床获益。

The trial is more than 50% enrolled and dosing in cohort five (of six) is imminent..

该试验的登记率超过50%，第五组（六组）的剂量即将到来。。

'I'm encouraged by the promise that ALG.APV-527 brings to the treatment of solid tumor patients. Witnessing a patient maintaining a stable disease, especially for more than nine months, and then moving to a higher dose level within a Phase 1 trial is uncommon, but we believe it can be therapeutically beneficial for this patient and is a testament to the drug's clinical potential,' stated Dirk Huebner, MD, Chief Medical Officer at Aptevo..

“ALG的承诺让我深受鼓舞。APV-527带来了实体瘤患者的治疗。Aptevo首席医疗官Dirk Huebner医学博士表示：“目睹患者病情稳定，尤其是9个月以上，然后在1期试验中达到更高的剂量水平是不常见的，但我们相信它对该患者的治疗有益，并且证明了该药物的临床潜力。”。。

The Company is on track to initiate part 1 of its upcoming two-part Phase 1b/2 trial in 1H 2024. The study will further evaluate APVO436 for the treatment of acute myeloid leukemia (AML). Aptevo has partnered with premier CRO, Prometrika, for the upcoming study. The first part is a dose optimization trial evaluating standard of care venetoclax + azacitidine along with APVO436 as a frontline treatment for AML patients.

该公司有望在2024年上半年启动其即将进行的两部分1b/2期试验的第一部分。该研究将进一步评估APVO436治疗急性髓细胞白血病（AML）的疗效。Aptevo已与首席首席风险官Prometrika合作进行即将进行的研究。第一部分是剂量优化试验，评估标准护理venetoclax+阿扎胞苷以及APVO436作为AML患者的一线治疗。

It is planned as an open-label, multi-center, multi-cohort study. The trial will evaluate safety/tolerability and efficacy of the triplet combination at multiple dose levels..

它计划作为一项开放标签，多中心，多队列研究。该试验将评估三联疗法在多剂量水平下的安全性/耐受性和有效性。。

The therapeutic combination of venetoclax + azacitidine + APVO436 was selected based on outcomes from the Company's dose expansion trial that showed promising outcomes across all categories of evaluation including safety, efficacy, and duration of remission.

venetoclax+阿扎胞苷+APVO436的治疗组合是根据该公司剂量扩展试验的结果选择的，该试验在包括安全性，有效性和缓解持续时间在内的所有评估类别中均显示出有希望的结果。

'We are eager to initiate the next phase of development in support of lead candidate APVO436 as a therapeutic option in combination therapy for the treatment of AML,' said Marvin White, President and CEO of Aptevo. 'APVO436 results have been positive across the board. For example, we demonstrate an exemplary safety profile, noting that patients experienced cytokine release syndrome at rates that are about one-third the benchmarks demonstrated in literature.

Aptevo总裁兼首席执行官马文·怀特（MarvinWhite）说：“我们渴望启动下一阶段的开发，支持主要候选药物APVO436作为联合治疗AML的治疗选择。”APVO436的结果总体上是积极的。例如，我们展示了一个示范性的安全性概况，注意到患者经历细胞因子释放综合征的比率约为文献中证明的基准的三分之一。

Similarly, efficacy results demonstrate clinical responses that are almost double the benchmarks in literature. We anticipate that our dose optimization results will reinforce our growing body of data and demonstrate the clinical potential of APVO436 in patients with frontline AML.'.

同样，疗效结果表明临床反应几乎是文献中基准的两倍。我们预计，我们的剂量优化结果将加强我们不断增长的数据，并证明APVO436在一线AML患者中的临床潜力。”。

APVO711 is currently progressing through preclinical evaluation intended to target a broad range of solid tumors. The Company continues to move this anticancer checkpoint inhibitor with added dual mechanism of action functionality toward the clinic. Key learnings to date include:

APVO711目前正在通过旨在针对广泛实体瘤的临床前评估取得进展。该公司继续将这种具有双重作用机制功能的抗癌检查点抑制剂推向临床。迄今为止的主要经验包括：

APVO711 imparts beneficial attributes to both antigen presenting cells and T cells that boost the immune response targeted at controlling tumor cells

APVO711赋予抗原呈递细胞和T细胞有益的属性，从而增强针对控制肿瘤细胞的免疫应答

Experiments in cultured cells have confirmed that APVO711 enhances tumor cell killing by T cells

在培养细胞中的实验证实，APVO711增强了T细胞对肿瘤细胞的杀伤作用

In vivo studies have confirmed that APVO711 reduces the size of PD-L1-expressing tumors

体内研究证实，APVO711可以减少表达PD-L1的肿瘤的大小

'We are pleased with the progress we have made to date in preclinical studies for our dual mechanism checkpoint inhibitor APVO711. This PD-L1 x CD40 molecule, represents an anticancer approach that combines a checkpoint inhibitor with a potent immune mediator. This innovative therapeutic strategy holds promise for unleashing the full potential of the immune system to combat cancer, offering new hope for patients in need of more effective treatments,' said Michelle H.

“我们对迄今为止在双机制检查点抑制剂APVO711的临床前研究中取得的进展感到高兴。这种PD-L1 x CD40分子代表了一种抗癌方法，它将检查点抑制剂与有效的免疫介质相结合。MichelleH。

Nelson, Ph.D., Director of Immunobiology at Aptevo Therapeutics..

Nelson博士，Aptevo Therapeutics免疫生物学主任。。

More About the Programs

有关计划的更多信息

ALG.APV-527

ALG。APV-527

ALG.APV-527 is a conditional 4-1BB agonist bispecific that is designed for activation only upon simultaneous binding to 4-1BB and 5T4. It is designed to target cancer cells by activating both T cells and natural killer cells and is intended to bind to tumor-specific antigens while sparing healthy cells and maximizing immune response.

阿尔格。APV-527是一种有条件的4-1BB激动剂双特异性，仅在同时结合4-1BB和5T4时才被激活。它旨在通过激活T细胞和自然杀伤细胞来靶向癌细胞，并旨在与肿瘤特异性抗原结合，同时保留健康细胞并最大程度地提高免疫反应。

This has the potential to be clinically important because 4-1BB can stimulate the immune cells (antitumor-specific T cells and NK cells) involved in tumor control, making 4-1BB a particularly compelling target for cancer immunotherapy. The compound is currently being evaluated for multiple solid tumor types in a multi-center, dose escalation trial that is more than 50% enrolled..

这可能具有临床重要性，因为4-1BB可以刺激参与肿瘤控制的免疫细胞（抗肿瘤特异性T细胞和NK细胞），使4-1BB成为癌症免疫治疗的特别引人注目的靶标。该化合物目前正在一项多中心剂量递增试验中评估多种实体瘤类型，该试验的登记率超过50%。。

Additional promising preliminary data includes:

其他有希望的初步数据包括：

In addition to the patient described above, a second heavily pretreated breast cancer patient who was progressing prior to enrolling in the trial has sustained long lasting stable disease and remained on study drug for seven months. Analysis demonstrated measurable level of drug in circulation (pharmacokinetic) and reproducible elevation of serum pharmacodynamic markers with dosing, suggesting the drug is biologically active.

除了上述患者外，第二名在参加试验之前正在进展的经过严重预处理的乳腺癌患者持续了长期稳定的疾病，并在研究药物上持续了七个月。分析表明，循环中药物的可测量水平（药代动力学）和血清药效学标志物随剂量的可重复升高，表明该药物具有生物活性。

Treatment to date has been overall well-tolerated, and a maximum tolerated dose has not yet been determined, dose-escalation in higher-dose cohorts is ongoing as the Company moves into cohort five (of six)

迄今为止，治疗总体耐受性良好，最大耐受剂量尚未确定，随着公司进入第五组（共六组），高剂量组的剂量递增正在进行中

ALG.APV-527 has been measurable in all patients with plasma concentration of ALG.APV-527 consistent with the administered dose

阿尔格。APV-527在所有血浆ALG浓度的患者中都是可测量的。APV-527与给药剂量一致

Biomarker analyses indicate the expression of the targets (4-1BB and 5T4) in tumor biopsies and confirm biological activity of ALG.APV-527

生物标志物分析表明靶标（4-1BB和5T4）在肿瘤活检中的表达，并证实了ALG的生物活性。APV-527

'We are excited by the emerging data from the ALG.APV-527 clinical trial, indicating biological activity and generating stable disease even at the lowest dose levels tested in heavily pretreated patients. This molecule is engineered to target cancer cells while preserving healthy tissues, all the while amplifying a specific immune response.

“我们对ALG的新数据感到兴奋。APV-527临床试验，表明生物活性，即使在经过严重预处理的患者中测试的最低剂量水平下也能产生稳定的疾病。这种分子被设计成靶向癌细胞，同时保留健康组织，同时放大特定的免疫反应。

We eagerly anticipate sharing forthcoming data and continuing to unveil the immense potential of this bispecific candidate in the solid tumor space,' expressed Dirk Huebner, MD, Chief Medical Officer at Aptevo..

我们热切期待分享即将到来的数据，并继续揭示这种双特异性候选人在实体瘤领域的巨大潜力，”Aptevo首席医疗官Dirk Huebner医学博士表示。。

APVO436

APVO436

Aptevo's wholly owned lead proprietary drug candidate, APVO436 is targeting AML and is differentiated by design to redirect the immune system of the patient to destroy leukemic cells and leukemic stem cells expressing the target antigen CD123, which is a compelling target for AML due to its overexpression on leukemic stem cells and AML blasts .

Aptevo全资拥有的主要专有候选药物APVO436针对AML，并通过设计进行区分，以重定向患者的免疫系统，以破坏表达靶抗原CD123的白血病细胞和白血病干细胞，由于其在白血病干细胞和AML母细胞上的过表达，CD123是AML的引人注目的靶标。

This antibody-like recombinant protein therapeutic is designed to engage both leukemic cells and T cells of the immune system and bring them closely together to trigger the destruction of leukemic cells. APVO436 is purposefully designed to reduce the likelihood and severity of CRS by use of a unique CD3 derived from CRIS-7 vs.

这种抗体样重组蛋白治疗剂旨在与免疫系统的白血病细胞和T细胞结合，并将它们紧密结合在一起，引发白血病细胞的破坏。APVO436旨在通过使用源自CRIS-7 vs的独特CD3来降低CRS的可能性和严重程度。

the CD3 used by other competitors. APVO436 has received orphan drug designation ('orphan status') for AML according to the Orphan Drug Act..

其他竞争对手使用的CD3。根据《孤儿药法案》，APVO436已获得反洗钱孤儿药指定（“孤儿身份”）。。

The Phase 1b Dose escalation trial results showed a 91% clinical benefit rate in combination with venetoclax + azacitidine in venetoclax naïve patients, a 27% incidence of CRS across all trial cohorts (the majority were grades 1 & 2) and meaningful duration of remission, including three patients who transitioned to transplant after receiving therapy, the best possible outcome for AML patients..

1b期剂量递增试验结果显示，与venetoclax+阿扎胞苷联合治疗venetoclax初治患者的临床获益率为91%，所有试验队列（大多数为1级和2级）的CRS发生率为27%，缓解期有意义，包括三名接受治疗后转为移植的患者，这是AML患者可能获得的最佳结果。。

The Company is planning to commence the first part of the Phase 1b/2 dose optimization program in the first half of 2024.

该公司计划在2024年上半年开始1b/2期剂量优化计划的第一部分。

APVO711

APVO711

APVO711, a bispecific checkpoint inhibitor with added functionality, targets PD-L1 and CD40, and is designed to function to synergistically induce a biological response. This is achieved by simultaneously engaging in two clinically validated T cell activating mechanisms: 1) blocking of PD-L1/PD-1 inhibitory pathway and 2) CD40 signaling augments APC maturation resulting in enhanced T cell stimulation.

APVO711是一种具有附加功能的双特异性检查点抑制剂，靶向PD-L1和CD40，旨在协同诱导生物反应。这是通过同时参与两种临床验证的T细胞活化机制来实现的：1）阻断PD-L1/PD-1抑制途径和2）CD40信号传导增强APC成熟，导致增强的T细胞刺激。

APVO711 is designed to activate CD40 only in the presence of PD-L1 binding for an improved safety profile. The Company believes APVO711 has the potential to positively impact the treatment paradigm of multiple solid tumor types for which there is currently significant unmet medical need..

APVO711旨在仅在PD-L1结合的情况下激活CD40，以改善安全性。该公司认为，APVO711有可能对多种实体瘤类型的治疗模式产生积极影响，目前这些实体瘤类型的医疗需求尚未得到满足。。

About Aptevo Therapeutics Inc.

关于Aptevo Therapeutics Inc。

Aptevo Therapeutics Inc. is a clinical-stage biotechnology company focused on developing novel immuno-oncology therapies for the treatment of cancer. Aptevo is seeking to improve treatment outcomes for cancer patients. For more information, please visit www.aptevotherapeutics.com.

Aptevo Therapeutics Inc.是一家临床阶段生物技术公司，专注于开发用于治疗癌症的新型免疫肿瘤学疗法。Aptevo正在寻求改善癌症患者的治疗效果。有关更多信息，请访问www.aptevotherapeutics.com。

Safe Harbor Statement

安全港声明

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, Aptevo's expectations about the activity, efficacy, safety, tolerability and durability of its therapeutic candidates and potential use of any such candidates, including in combination with other drugs, as therapeutics for treatment of disease, its expectations regarding the effectiveness of its ADAPTIR and ADAPTIR-FLEX platforms, statements related to the progress of Aptevo's clinical programs, including statements related to anticipated clinical and regulatory milestones such as Phase 1b/2 trial initiation for APVO436 in frontline, venetoclax naïve AML patients, whether further study of APVO436 in a Phase 1b dose optimization trial focusing on multiple doses of APVO436 in combination with venetoclax + azacitidine on a targeted patient population will continue to show clinical benefit, whether Aptevo's final trial results will vary from its earlier assessment, whether biomarker analyses will continue to confirm biological activity of ALG.APV-527, whether higher dose ranges will result in increased signs of clinical activity, whether further study of ALG.APV-527 across a cross section of multiple tumor types will continue to show clinical benefit, the possibility and timing of interim data readouts for ALG.APV-527, whether Aptevo's final trial results will vary from its preliminary or interim assessments, the possibility and timing of preliminary or interim data readouts for ALG.APV-527, statements related to the progress of and enthusiasm for Aptevo's clinical programs, whether pre-clinical studies of APVO711 will show the desired anti-tumor efficacy, m.

本新闻稿包括1995年《私人证券诉讼改革法案》所指的前瞻性声明。除历史事实陈述外的所有陈述，包括但不限于Aptevo对其候选治疗药物的活性、疗效、安全性、耐受性和耐久性的期望，以及任何此类候选治疗药物（包括与其他药物联合使用）作为疾病治疗剂的潜在用途，Aptevo对其ADAPTIR和ADAPTIR-FLEX平台有效性的期望，与Aptevo临床计划进展相关的陈述，包括与预期的临床和监管里程碑相关的陈述，例如在一线、venetoclax初治AML患者中启动APVO436的1b/2期试验，是否在1b期剂量优化试验中进一步研究APVO436，重点是多剂量的APVO436 VO436联合venetoclax+阿扎胞苷对目标患者人群将继续显示临床益处，无论Aptevo的最终试验结果是否与早期评估有所不同，生物标志物分析是否将继续证实ALG的生物活性。APV-527，较高的剂量范围是否会导致临床活动迹象增加，是否进一步研究ALG。跨越多种肿瘤类型的横截面的APV-527将继续显示临床益处，ALG临时数据读数的可能性和时间。APV-527，Aptevo的最终试验结果是否会与其初步或中期评估不同，ALG的初步或中期数据读数的可能性和时间。APV-527，与Aptevo临床计划的进展和热情有关的声明，APVO711的临床前研究是否会显示出所需的抗肿瘤功效，m。

There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; further assessment of preliminary or interim data or different results from later clinical trials; adverse events and unanticipated problems, adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; and changes in regulatory, social, macroeconomic and political conditions.

有几个重要因素可能导致Aptevo的实际结果与此类前瞻性声明所示的结果存在重大差异，包括Aptevo业务或前景的恶化；进一步评估初步或中期数据或后期临床试验的不同结果；不良事件和意外问题，临床开发中的不良发展，包括临床试验期间观察到的意外安全问题；以及监管、社会、宏观经济和政治条件的变化。

For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary or interim data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and the completion of clinical trials, the availability and timing of data from ongoing clinical trials, the trial design includes combination therapies that may make it difficult to accurately ascertain the benefits of APVO436, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners or raise funds on acceptable terms or at all and other matters that could affect the availability or commercial potential of Aptevo's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the coronavirus (referred to as COVID-19), geopolitical risks, including the current war between Russia and Ukraine and the rising conflict in the Mid.

例如，由于各种重要因素，实际结果可能与此类前瞻性陈述所表明的结果存在重大差异，包括初步或中期数据结果固有的不确定性，以及预测后期临床试验结果的临床前研究，患者的启动，入组和维护，以及临床试验的完成，正在进行的临床试验数据的可用性和时间安排，试验设计包括可能难以准确确定APVO436益处的联合疗法，对监管审查过程中所需时间和步骤的期望，对监管批准的期望，竞争产品的影响，我们与战略合作伙伴达成协议或以可接受的条款筹集资金的能力，以及可能影响的其他事项Aptevo候选产品的可用性或商业潜力，灾难或其他事件导致的商业或经济中断，包括自然灾害或公共卫生危机，如冠状病毒（简称COVID-19），地缘政治风险，包括当前俄罗斯和乌克兰之间的战争以及中期不断上升的冲突。

CONTACT:

联系人：

Miriam Weber Miller

米里亚姆·韦伯·米勒

Head, Investor Relations & Corporate Communications

投资者关系与企业传播主管

Aptevo Therapeutics

Aptevo治疗学

Email: IR@apvo.com or Millerm@apvo.com

电子邮件IR@apvo.com或Millerm@apvo.com

Phone: 206-859-6628

电话：206-859-6628

SOURCE: Aptevo Therapeutics

来源：Aptevo Therapeutics

View the original press release on accesswire.com

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