Efficacy and safety of AFM24 in combination with atezolizumab, a checkpoint inhibitor, is being evaluated in non-small cell lung cancer patients with EGFR wild-type and EGFR mutant advanced/metastatic cancers in the ongoing AFM24-102 phase 1/2a study

正在进行的AFM24-102 1/2a期研究正在评估AFM24联合检查点抑制剂atezolizumab治疗EGFR野生型和EGFR突变型晚期/转移性非小细胞肺癌患者的疗效和安全性

The FDA’s Fast Track designation was granted after its review of the initial efficacy data of the EGFR wild-type cohort from the AFM24-102 study

FDA在审查了AFM24-102研究中EGFR野生型队列的初始疗效数据后，获得了快速通道指定

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need

快速通道是一个旨在促进药物开发和加速药物审查的过程，以治疗严重疾病并满足未满足的医疗需求

Company to host a conference call / webcast on June 1, 2024 at 7:00 p.m. EDT to discuss the updated data from the AFM24-102 trial

公司将于2024年6月1日美国东部夏令时下午7:00举行电话会议/网络广播，讨论AFM24-102试验的最新数据

MANNHEIM, Germany, May 29, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that the FDA has granted Fast Track designation to the combination of its innate cell engager (ICE®) AFM24 with atezolizumab for the treatment of patients with advanced and/or metastatic non-small cell lung cancer (NSCLC) not harboring any activating EGFR mutations (EGFR wild-type) after progression on PD-(L)1 targeted therapy and platinum-based chemotherapy.

曼海姆，德国，2024年5月29日（环球通讯社）--Affimed N.V.（纳斯达克：AFMD），一家致力于让患者恢复其天生的抗癌能力的临床阶段免疫肿瘤学公司，今天宣布，FDA已批准其先天细胞接合器（ICE®）AFM24与atezolizumab联合用于治疗PD-（L）1靶向治疗和铂类化疗进展后未携带任何活化EGFR突变（EGFR野生型）的晚期和/或转移性非小细胞肺癌（NSCLC）患者。

Data from the AFM24-102 study in this patient population will be presented at the upcoming annual meeting of the American Society of Clinical Oncology on June 1, 2024..

来自AFM24-102研究的数据将在2024年6月1日即将举行的美国临床肿瘤学会年会上公布。。

“The clinical data of AFM24 in combination with the checkpoint inhibitor atezolizumab is compelling. We're observing meaningful responses in patients resistant to prior checkpoint inhibitor treatment,” said Dr. Wolfgang Fischer, Chief Operating Officer at Affimed. “The Fast Track designation emphasizes the belief in the potential of this combination therapy to address currently unmet needs of patients with this devastating, life threatening disease who have exhausted all standard of care options, including chemotherapy and checkpoint inhibitors.”.

Affimed首席运营官Wolfgang Fischer博士说：“AFM24联合检查点抑制剂atezolizumab的临床数据令人信服。我们正在观察对先前检查点抑制剂治疗耐药的患者的有意义的反应。”。“快速通道指定强调了这种联合治疗的潜力，以解决目前尚未满足的患有这种毁灭性，威胁生命的疾病的患者的需求，这些患者已经用尽了所有标准的护理选择，包括化疗和检查点抑制剂。”。

Fast Track is a process designed to facilitate the development and expedite the review of new drugs that are intended to treat or prevent serious conditions and have the potential to address an unmet medical need. The FDA’s decision is based on initial activity observed in the first evaluable patients of the phase 2 part of the AFM24-102 study of AFM24 in combination with atezolizumab in heavily pretreated patients with NSCLC EGFRwt.

快速通道是一个旨在促进开发和加速审查旨在治疗或预防严重疾病并有可能解决未满足医疗需求的新药的过程。FDA的决定是基于AFM24-102研究AFM24与atezolizumab联合治疗严重预处理的NSCLC EGFRwt患者的AFM24-102研究第二阶段第一批可评估患者的初始活动。

With the Fast Track designation, the therapeutic development of the combination can benefit from more frequent engagement with the FDA, which will support the collection of appropriate data needed to accelerate its development..

通过快速通道指定，该组合的治疗发展可以受益于与FDA的更频繁接触，这将支持收集加速其发展所需的适当数据。。

About FDA Fast Track Designation

关于FDA快速通道指定

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Its purpose is to get important new drugs to patients earlier. Fast Track addresses a broad range of serious conditions. With Fast Track designation, a new therapy is eligible for some or all of the following:.

快速通道是一个旨在促进药物开发和加速审查的过程，以治疗严重疾病并满足未满足的医疗需求。其目的是尽早向患者提供重要的新药。快速通道可解决各种严重情况。通过快速通道指定，新疗法符合以下部分或全部条件：。

More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval

更频繁地与FDA会面，讨论药物的开发计划，并确保收集支持药物批准所需的适当数据

More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers

FDA更频繁地就拟议临床试验的设计和生物标志物的使用等事项进行书面沟通

Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met

如果符合相关标准，则有资格加速批准和优先审查

Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA..

滚动审查，这意味着制药公司可以提交其生物许可证申请（BLA）或新药申请（NDA）的完整部分供FDA审查，而不是等到NDA的每个部分都完成后才能对整个申请进行审查。BLA或NDA审查通常要等到制药公司向FDA提交了整个申请后才能开始。。

Please refer to Fast Track | FDA for further information.

有关更多信息，请参阅Fast Track | FDA。

Conference Call and Webcast Information

电话会议和网络广播信息

Affimed will host a conference call and webcast for the financial community on June 1, 2024, at 6:00 p.m. CDT / 7:00 p.m. EDT. The conference call will be available via phone and webcast. The live audio webcast of the call will be available in the “Webcasts” section on the “Investors” page of the Affimed website at https://www.affimed.com/investors/webcasts-and-corporate-presentation/.

Affimed将于2024年6月1日下午6:00 CDT/7:00 EDT为金融界主持电话会议和网络广播。电话会议将通过电话和网络广播进行。电话的实时音频网络广播将在Affimed网站“投资者”页面的“网络广播”部分提供https://www.affimed.com/investors/webcasts-and-corporate-presentation/.

To access the call by phone, please use link:.

要通过电话访问呼叫，请使用链接：。

https://register.vevent.com/register/BIff607338e5d247f99b548240be2ad413, and you will be provided with dial-in details and a pin number.

https://register.vevent.com/register/BIff607338e5d247f99b548240be2ad413，您将获得拨入详细信息和pin码。

About AFM24

关于AFM24

AFM24 is a tetravalent, bispecific ICE® that activates the innate immune system by binding to CD16A on innate immune cells and epidermal growth factor receptors (EGFR), a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK® platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis..

AFM24是一种四价双特异性ICE®，通过与先天免疫细胞上的CD16A和表皮生长因子受体（EGFR）（一种在实体瘤上广泛表达的蛋白质）结合来激活先天免疫系统，从而杀死癌细胞。AFM24由Affimed的fit for purpose ROCK®平台产生，它代表了一种独特的作用机制，它使用EGFR作为对接位点，通过抗体依赖性细胞毒性和抗体依赖性细胞吞噬作用与先天免疫细胞结合，杀死肿瘤细胞。。

About Affimed N.V.

关于Affined N.V。

Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The Company’s innate cell engagers (ICE®) enable a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors.

Affimed（纳斯达克：AFMD）是一家临床阶段免疫肿瘤学公司，致力于通过实现先天免疫系统未开发的潜力，使患者恢复其先天的抗癌能力。该公司的先天细胞参与者（ICE®）能够以肿瘤为靶点的方法识别和杀死一系列血液和实体瘤。

ICE® are generated on the Company’s proprietary ROCK® platform which predictably generates customized molecules that leverage the power of innate immune cells to destroy tumor cells. A number of ICE® molecules are in clinical development, being studied as mono- or combination therapy. Headquartered in Mannheim, Germany, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by the bold vision to stop cancer from ever derailing patients’ lives.

ICE®是在该公司专有的ROCK®平台上生成的，该平台可预测地生成定制分子，利用先天免疫细胞的力量破坏肿瘤细胞。许多ICE®分子正在临床开发中，正在作为单一或联合疗法进行研究。Affimed总部位于德国曼海姆，由经验丰富的生物技术和制药领导者团队领导，通过大胆的愿景团结起来，阻止癌症不断扰乱患者的生活。

For more about the Company’s people, pipeline and partners, please visit: www.affimed.com..

有关公司人员、管道和合作伙伴的更多信息，请访问：www.affimed.com。。

Forward-Looking Statement

前瞻性声明

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions.

本新闻稿包含前瞻性声明。除历史事实陈述外，所有陈述都是前瞻性陈述，通常用“预期”、“相信”、“可能”、“估计”、“预期”、“目标”、“打算”、“期待”、“可能”、“计划”、“潜力”、“预测”、“项目”、“应该”、“将会”、“将会”等术语以及类似的表达方式表示。

Forward-looking statements appear in a number of places throughout this release and include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of acimtamig (AFM13), AFM24, AFM28 and the Company’s other product candidates, the value of its ROCK® platform, its ongoing and planned preclinical development and clinical trials, its corporate restructuring, the associated headcount reduction and the impact this may have on Company’s anticipated savings and total costs and expenses, its collaborations and development of its products in combination with other therapies, the timing of and its ability to make regulatory filings and obtain and maintain regulatory approvals for its product candidates, its intellectual property position, its collaboration activities, its ability to develop commercial functions, clinical trial data, its results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which it operates, the macroeconomic trends that may affect the industry or the Company, such as the instability in the banking sector experienced in the first quarter of 2023, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation, the impact on its business by political events, war, terrorism, business inte.

前瞻性声明出现在本版本的多个地方，包括关于公司的意图、信念、预测、前景、分析和当前期望的声明，其中包括关于acimtamig（AFM13）、AFM24、AFM28和公司其他候选产品的潜力、其ROCK®平台的价值、其正在进行和计划的临床前开发和临床试验、其公司重组、相关人员减少以及这可能对公司预期节约和总成本和费用的影响、其与其他疗法相结合的产品的合作和开发、其进行监管备案以及获得和维护候选产品监管批准的时间和能力，以及其知识产权地位、合作活动、开发商业功能的能力、临床试验数据、经营成果、现金需求、财务状况、流动性、，前景、未来交易、增长和战略、经营所在行业、可能影响行业或公司的宏观经济趋势，如2023年第一季度银行业的不稳定、新型冠状病毒疫情的影响、孤儿药指定的好处、政治事件、战争、恐怖主义、商业情报对其业务的影响。

Investor Relations Contact

投资者关系联系人

Alexander Fudukidis

Alexander Fudukidis

Director, Investor Relations

投资者关系总监

E-Mail: a.fudukidis@affimed.com

电子邮件：a.fudukidis@affimed.com

Tel.: +1 (917) 436-8102

电话：+1（917）436-8102

Media Contact

媒体联系人

Mary Beth Sandin

玛丽·贝丝·桑丁

Vice President, Marketing and Communications

营销与传播副总裁

E-Mail: m.sandin@affimed.com

电子邮件：m.sandin@affimed.com