Pathway leverages immunobridging approach via serum virus neutralizing antibody (sVNA) titers enabled by prior successful COVID-19 treatment clinical trial “STAMP” conducted with prototype antibody adintrevimab

该途径通过血清病毒中和抗体（sVNA）滴度利用免疫桥接方法，该滴度是由先前成功的COVID-19治疗临床试验“STAMP”与原型抗体adintrevimab进行的

Company anticipates submitting a COVID-19 treatment EUA application for PEMGARDA™ (pemivibart) imminently

该公司预计将立即提交针对PEMGARDA™（pemivibart）的新型冠状病毒肺炎治疗EUA申请

COVID-19 treatment EUA pathway offers a novel, rapid pathway to potential second EUA for pemivibart

COVID-19治疗EUA途径为pemivibart潜在的第二EUA提供了一种新的快速途径

Invivyd leaves 2024 net product revenue and year-end cash guidance unchanged although potential near-term COVID-19 treatment EUA and associated commercial dynamics were not considered

Invivyd保持2024年产品净收入和年终现金指导不变，尽管未考虑潜在的近期新型冠状病毒肺炎治疗EUA和相关的商业动态

Further details on upcoming 1Q 2024 results call on May 9, 2024

有关2024年第一季度业绩的更多详情，请于2024年5月9日致电

WALTHAM, Mass., May 07, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced its intention to submit an emergency use authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for pemivibart for the treatment of mild to moderate symptomatic COVID-19 in certain immunocompromised people utilizing a rapid immunobridging pathway.

马萨诸塞州沃尔瑟姆，2024年5月7日（环球通讯社）--Invivyd，Inc.（纳斯达克：IVVD），一家致力于提供严重病毒性传染病保护的生物制药公司，今天宣布其打算向美国食品和药物管理局（FDA）提交紧急使用授权（EUA）申请，用于使用快速免疫桥接途径治疗某些免疫功能低下人群的轻度至中度症状性COVID-19。

This immunobridging pathway leverages a similar approach Invivyd used to achieve its current EUA for PEMGARDA™ (pemivibart) for pre-exposure prophylaxis (PrEP) of COVID-19 in certain immunocompromised people and was aligned in principle with the FDA. The immunobridging pathway for COVID-19 treatment is enabled by data from the Phase 2/3 clinical trial (STAMP) of adintrevimab, the prototype monoclonal antibody (mAb), for the treatment of COVID-191 and data from the ongoing CANOPY Phase 3 clinical trial of pemivibart for PrEP of COVID-19.

该免疫桥接途径利用Invivyd的类似方法，用于实现目前针对PEMGARDA™（pemivibart）的EUA，用于某些免疫功能低下人群的新型冠状病毒暴露前预防（PrEP），原则上与FDA保持一致。用于治疗COVID-19的免疫桥接途径是由用于治疗COVID-191的原型单克隆抗体（mAb）adintrevimab的2/3期临床试验（STAMP）的数据和正在进行的冠层3期临床试验的数据实现的。pemivibart用于制备COVID-19。

The potential COVID-19 treatment EUA request would focus on the critical treatment needs of people in the U.S. who have moderate-to-severe immune compromise and for whom alternative COVID-19 treatment options are not clinically appropriate or accessible. Subsequent to the anticipated submission of an EUA request, Invivyd plans to initiate a compact clinical trial focused on confirmatory safety, pharmacokinetics (PK), and clinical virology..

潜在的COVID-19治疗EUA请求将重点关注美国中度至重度免疫功能低下以及替代COVID-19治疗方案在临床上不合适或不可获得的人群的关键治疗需求。在预期提交EUA请求后，Invivyd计划启动一项紧凑的临床试验，重点是确认安全性，药代动力学（PK）和临床病毒学。。

“We are glad to once again align with the FDA on a rapid pathway towards addressing a critical unmet medical need among immunocompromised people who may benefit from alternative approaches to treating their symptomatic COVID-19. In the past, immunoglobulin G (IgG) mAbs targeting the receptor binding domain (RBD) of the SARS-CoV-2 spike protein have been highly effective therapeutic options for symptomatic COVID-19, and we are happy to leverage our prior success and proprietary technology with the aim to serve both prevention and now treatment of symptomatic disease for immunocompromised people as soon as possible,” commented Marc Elia, Chairman of the Invivyd Board of Directors.

“我们很高兴再次与FDA合作，快速解决免疫功能低下人群的严重未满足医疗需求，这些人群可能会从治疗症状性新型冠状病毒肺炎的替代方法中受益。过去，针对SARS-CoV-2尖峰蛋白受体结合域（RBD）的免疫球蛋白G（IgG）单克隆抗体一直是症状性COVID-19的高效治疗选择，我们很高兴利用我们先前的成功和专有技术，旨在尽快为免疫功能低下的人预防和治疗症状性疾病，”Invivyd董事会主席马克·埃利亚评论道。

“Our current manufacturing plan contemplates approximately one hundred thousand doses available through the second half of 2024 and anticipated seasonal uptick in circulating virus to serve both PrEP and potential treatment uses. We are currently considering options to expand and accelerate product availability.”.

“我们目前的生产计划预计到2024年下半年将有大约10万剂可用，预计流行病毒的季节性上升将同时用于PrEP和潜在的治疗用途。我们目前正在考虑扩大和加速产品可用性的选择。”。

“Treatment of active COVID-19 infection, which presents a substantial risk to immunocompromised patients, is a medical context well suited for an infused antibody therapy, as prior COVID-19 treatment mAbs were generally provided via intravenous (IV) infusion to enhance the speed at which antiviral titers are delivered to patients in need,” said Mark Wingertzahn, SVP of Clinical Development and Medical Affairs.

临床开发和医疗事务高级副总裁Mark Wingertzahn说：“治疗活动性COVID-19感染，对免疫功能低下的患者来说是一个非常适合输注抗体治疗的医学背景，因为以前的COVID-19治疗单克隆抗体通常是通过静脉（IV）输注提供的，以提高抗病毒滴度输送给有需要的患者的速度。”。

“We are moving with considerable urgency as we believe that immunobridging provides us with a more rapid and efficient pathway to deliver an important COVID-19 treatment option, complementing our efforts with PrEP.”.

“我们非常迫切地采取行动，因为我们相信免疫桥接为我们提供了一种更快速有效的途径来提供重要的新型冠状病毒肺炎治疗选择，补充了我们的PrEP努力。”。

Observational studies have demonstrated that people who are immunocompromised continue to be disproportionally impacted by COVID-19-related hospitalizations and death.2-3 In addition to small molecule treatment options, where appropriate a monoclonal antibody may be a highly attractive option to alter the course of established infection..

观察性研究表明，免疫功能低下的人继续受到COVID-19相关住院和死亡的不成比例的影响。2-3除了小分子治疗选择之外，在适当的情况下，单克隆抗体可能是改变既定感染过程的极具吸引力的选择。。

“It’s important to remember that SARS-CoV-2 still poses a major threat to many people, such as those who are significantly immunocompromised and at higher risk for severe outcomes if they develop a COVID-19 infection,” said Brian Koffman, MDCM (retired), MS Ed, Co-Founder, Executive Vice President and Chief Medical Officer of the CLL (Chronic Lymphocytic Leukemia) Society.

“重要的是要记住，SARS-CoV-2仍然对许多人构成重大威胁，例如那些免疫功能严重受损的人，如果他们感染了COVID-19，则有更高的严重后果风险，”CLL（慢性淋巴细胞白血病）协会联合创始人、执行副总裁兼首席医疗官、MDCM（退休）布莱恩·科夫曼女士说。

“For people who develop a COVID-19 infection, today’s treatment options are not always adequate or clinically appropriate, especially for those who are immunocompromised and may be taking other drugs that are contraindicated for use with certain antivirals. For this vulnerable population, it would be extremely helpful to have a new monoclonal antibody as an option for treatment, a therapeutic approach that was shown during the earlier days of the pandemic to be highly effective against previous variants.”.

“对于发展为新型冠状病毒感染的人来说，今天的治疗选择并不总是足够的或临床上合适的，特别是对于那些免疫功能低下并且可能正在服用其他禁忌用于某些抗病毒药物的药物的人。对于这一弱势群体，拥有一种新的单克隆抗体作为治疗选择将非常有帮助，这种治疗方法在大流行的早期被证明对以前的变异非常有效。”。

Invivyd is maintaining its existing guidance of $150-$200 million in anticipated 2024 PEMGARDA net product revenue and year end cash guidance of at least $75 million in cash and cash equivalents, although the previously issued guidance was based on PEMGARDA being authorized for PrEP of COVID-19 in certain immunocompromised people and did not contemplate any potential sales for COVID-19 treatment or inventory build that may be required to deliver medicine timely to patients in need..

Invivyd在预计2024年PEMGARDA净产品收入和年终现金指导（至少7500万美元现金和现金等价物）中维持其现有指导（1.5亿至2亿美元），尽管之前发布的指导是基于PEMGARDA被授权在某些免疫功能低下的人群中制备新型冠状病毒，并且没有考虑任何可能的新型冠状病毒治疗或库存建设销售，这些销售可能需要及时向有需要的患者提供药物。。

About PEMGARDA

彭加达

PEMGARDA™ (pemivibart) is a half-life extended investigational monoclonal antibody (mAb). PEMGARDA was engineered from adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and provided evidence of clinical efficacy in global Phase 2/3 clinical trials for both the prevention and treatment of COVID-19.

PEMGARDA™（pemivibart）是一种半衰期延长的研究性单克隆抗体（mAb）。PEMGARDA由Invivyd的研究性单克隆抗体adintrevimab设计而成，该单克隆抗体具有强大的安全性数据包，并在全球2/3期临床试验中为预防和治疗新型冠状病毒肺炎提供了临床疗效的证据。

PEMGARDA has demonstrated in vitro neutralizing activity in pseudotyped virus-like particle and authentic virus neutralization assays against major SARS-CoV-2 variants, including JN.1. PEMGARDA targets the SARS-CoV-2 spike protein receptor binding domain (RBD), thereby inhibiting virus attachment to the human ACE2 receptor on host cells..

PEMGARDA已经在针对主要SARS-CoV-2变体（包括JN.1）的假型病毒样颗粒和真实病毒中和测定中证明了体外中和活性。PEMGARDA靶向SARS-CoV-2刺突蛋白受体结合结构域（RBD），从而抑制病毒附着于宿主细胞上的人ACE2受体。。

PEMGARDA (pemivibart) injection (4500 mg), for intravenous use is an investigational mAb that has not been approved, but has been authorized for emergency use by the U.S. FDA under an EUA for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg) who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination.

静脉注射用PEMGARDA（pemivibart）注射液（4500 mg）是一种尚未获得批准的研究性单克隆抗体，但已被美国FDA根据EUA授权紧急使用，用于成人和青少年（12岁及以上体重至少40公斤）接触前预防（预防）新型冠状病毒肺炎，这些成年人和青少年由于某些医疗条件或接受某些免疫抑制药物或治疗而产生中度至重度免疫损害，并且不太可能对新型冠状病毒肺炎疫苗接种产生足够的免疫反应。

Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2. PEMGARDA is not authorized for use for treatment of COVID-19 or post-exposure prophylaxis of COVID-19. Anaphylaxis has been observed with PEMGARDA and the PEMGARDA Fact Sheet for Healthcare Providers includes a boxed warning for anaphylaxis.

接受者目前不应该感染SARS-CoV-2，也不应该最近接触过SARS-CoV-2感染者。PEMGARDA未被授权用于治疗COVID-19或暴露后预防COVID-19。PEMGARDA已经观察到过敏反应，PEMGARDA医疗保健提供者的情况说明书包括过敏反应的盒装警告。

The most common adverse events (all grades, incidence ≥2%) observed in participants who have moderate-to-severe immune compromise treated with PEMGARDA included systemic and local infusion-related or hypersensitivity reactions, upper respiratory tract infection, viral infection, influenza-like illness, fatigue, headache, and nausea.

在接受PEMGARDA治疗的中度至重度免疫功能低下的参与者中观察到的最常见的不良事件（所有等级，发生率≥2%）包括全身和局部输注相关或超敏反应，上呼吸道感染，病毒感染，流感样疾病，疲劳，头痛和恶心。

For additional information, please see the PEMGARDA full product Fact Sheet for Healthcare Providers, including important safety information and boxed warning..

有关更多信息，请参阅PEMGARDA针对医疗保健提供者的完整产品简介，包括重要的安全信息和盒装警告。。

To support the EUA for PEMGARDA, an immunobridging approach was used to determine if PEMGARDA may be effective for pre-exposure prophylaxis of COVID-19. Immunobridging is based on the serum virus neutralizing titer-efficacy relationships identified with other neutralizing human mAbs against SARS-CoV-2.

为了支持PEMGARDA的EUA，使用免疫桥接方法来确定PEMGARDA是否可以有效预防COVID-19的暴露前预防。免疫桥接基于与其他针对SARS-CoV-2的中和人mAb鉴定的血清病毒中和滴度-功效关系。

This includes adintrevimab, the parent mAb of pemivibart, and other mAbs that were previously authorized for EUA. There are limitations of the data supporting the benefits of PEMGARDA. Evidence of clinical efficacy for other neutralizing human mAbs against SARS-CoV-2 was based on different populations and SARS-CoV-2 variants that are no longer circulating.

这包括pemivibart的亲本单克隆抗体adintrevimab，以及先前授权用于EUA的其他单克隆抗体。支持PEMGARDA益处的数据存在局限性。其他针对SARS-CoV-2的中和人单克隆抗体的临床疗效证据是基于不再循环的不同人群和SARS-CoV-2变体。

Additionally, the variability associated with cell-based EC50 value determinations, along with limitations related to pharmacokinetic data and efficacy estimates for the mAbs in prior clinical trials, impact the ability to precisely estimate protective titer ranges..

此外，与基于细胞的EC50值测定相关的变异性，以及与先前临床试验中单克隆抗体的药代动力学数据和功效估计相关的局限性，影响了精确估计保护性滴度范围的能力。。

The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.

根据《联邦食品、药品和化妆品法》（21 U.S.C.）第564（b）（1）节的规定，紧急使用彭加尔达仅在声明存在证明在新型冠状病毒大流行期间紧急使用药物和生物制品合理的情况下被授权。

§ 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner..

§360bbb-3（b）（1），除非声明终止或授权提前撤销。。

About Invivyd

关于Invivyd

Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. The company’s proprietary INVYMAB™ platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering.

Invivyd，Inc.（纳斯达克：IVVD）是一家生物制药公司，致力于从SARS-CoV-2开始提供对严重病毒性传染病的保护。该公司专有的INVYMAB™平台方法将最先进的病毒监测和预测建模与先进的抗体工程相结合。

INVYMAB is designed to facilitate the rapid, serial generation of new monoclonal antibodies (mAbs) to keep pace with evolving viral threats. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for its first mAb in a planned series of innovative antibody candidates. Visit https://invivyd.com/ to learn more..

INVYMAB旨在促进快速，连续产生新的单克隆抗体（mAb），以跟上不断发展的病毒威胁。2024年3月，Invivyd获得了美国FDA的紧急使用授权（EUA），用于其计划的一系列创新抗体候选物中的第一个单克隆抗体。访问https://invivyd.com/了解更多。。

References

参考文献

Ison, Michael G et al. “Efficacy and Safety of Adintrevimab (ADG20) for the Treatment of High-Risk Ambulatory Patients With Mild or Moderate Coronavirus Disease 2019: Results From a Phase 2/3, Randomized, Placebo-Controlled Trial (STAMP) Conducted During Delta Predominance and Early Emergence of Omicron.” Open forum infectious diseases vol.

Ison，Michael G等人，“Adintrevimab（ADG20）治疗2019年轻度或中度冠状病毒病高危门诊患者的疗效和安全性：在Delta优势和Omicron早期出现期间进行的2/3期随机安慰剂对照试验（STAMP）的结果。”Open forum infectious diseases vol。

10,6 ofad279. 24 May. 2023, doi:10.1093/ofid/ofad279..

1979年的10.6。2023年5月24日，doi:10.1093/ofid/ofad279。

Evans, Rachael A et al. “Impact of COVID-19 on immunocompromised populations during the Omicron era: insights from the observational population-based INFORM study.” The Lancet regional health. Europe vol. 35 100747. 13 Oct. 2023.

Evans，Rachael A等人，《新型冠状病毒肺炎对Omicron时代免疫功能低下人群的影响：基于人群的观察性INFORM研究的见解》，《柳叶刀》地区卫生。欧洲卷35 100747。2023年10月13日。

Singson, Jason Robert C et al. “Factors Associated with Severe Outcomes Among Immunocompromised Adults Hospitalized for COVID-19 - COVID-NET, 10 States, March 2020-February 2022.” MMWR. Morbidity and mortality weekly report vol. 71,27 878-884. 8 Jul. 2022.

Singson，Jason Robert C等人，《因新型冠状病毒肺炎住院的免疫功能低下成年人的严重结局相关因素》，10个州，2020年3月至2022年2月。MMWR。发病率和死亡率周报第71,27 878-884卷。2022年7月8日。

Cautionary Note Regarding Forward Looking Statements

关于前瞻性声明的注意事项

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “could,” “expects,” “intends,” “potential,” “projects,” and “future” or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements.

本新闻稿包含1995年《私人证券诉讼改革法案》所指的前瞻性声明。诸如“预期”、“相信”、“可能”、“预期”、“打算”、“潜在”、“项目”和“未来”等词语或类似表达（以及其他涉及未来事件、条件或情况的词语或表达）旨在识别前瞻性陈述。

Forward-looking statements include statements concerning, among other things, the company’s plans to pursue a rapid immunobridging pathway to potential EUA for treatment of COVID-19 in moderately to severely immunocompromised people, including the company’s beliefs regarding the potential speed and efficiency of such pathway; the company’s anticipated submission of a COVID-19 treatment EUA request to the FDA for PEMGARDA (pemivibart), and the anticipated timing and focus of such potential EUA request; the company’s research and clinical development efforts, and the timing thereof, including the potential initiation of a compact clinical trial subsequent to the anticipated submission of a COVID-19 treatment EUA request; the company’s manufacturing plans and strategies, including its anticipated supply through the second half of 2024, and the potential to expand and accelerate product availability; the potential benefits of a new COVID-19 treatment mAb, if authorized or approved, to certain vulnerable populations; the company’s anticipated 2024 PEMGARDA net product revenue and the company’s projected 2024 year end cash and cash equivalents balance; the company’s EUA for PEMGARDA for PrEP of COVID-19 in certain immunocompromised people; the company’s devotion to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2; the design of the c.

前瞻性声明包括关于公司计划寻求快速免疫桥接途径以治疗中度至重度免疫功能低下人群中的新型冠状病毒肺炎的潜在EUA的声明，其中包括公司对这种途径的潜在速度和效率的信念；该公司预计将向FDA提交针对PEMGARDA（pemivibart）的新型冠状病毒治疗EUA请求，以及此类潜在EUA请求的预期时间和重点；该公司的研究和临床开发工作及其时间安排，包括在预期提交COVID-19治疗EUA请求后可能启动紧凑型临床试验；公司的制造计划和战略，包括2024年下半年的预期供应量，以及扩大和加速产品可用性的潜力；如果获得授权或批准，新的COVID-19治疗单克隆抗体对某些弱势人群的潜在益处；公司预计2024年彭加尔达净产品收入以及公司预计2024年末现金和现金等价物余额；该公司的PEMGARDA EUA用于在某些免疫功能低下的人群中制备COVID-19；该公司致力于从SARS-CoV-2开始提供对严重病毒性传染病的保护；c的设计。

This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release.

本新闻稿包含指向本新闻稿中不被视为引用的信息的超链接。

Contacts:

联系人：

Media Relations

媒体关系

(781) 208-1747

(781) 208-1747

media@invivyd.com

media@invivyd.com

Investor Relations

投资者关系

(781) 208-1747

(781) 208-1747

investors@invivyd.com

investors@invivyd.com