IgG levels and neutralizing antibodies against variants of concern persisted for at least 12 months, consistent with previous findings

IgG水平和针对关注变体的中和抗体持续至少12个月，与先前的发现一致

Antigen-specific T cell responses increased in the majority of participants studied, including those living with HIV, after administration of any of the samRNA constructs

在服用任何samRNA构建体后，大多数研究参与者（包括艾滋病毒感染者）的抗原特异性T细胞反应增加

Comprehensive data set demonstrates a consistent and strong immunogenicity profile across multiple patient populations in South Africa, including people living with HIV

综合数据集显示，南非多个患者人群（包括艾滋病毒感染者）具有一致且强大的免疫原性

EMERYVILLE, Calif., April 30, 2024 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today presented updated Phase 1 data from its CORAL-CEPI study, a Coalition for Epidemic Preparedness Innovations (CEPI)-funded study that is evaluating Gritstone’s self-amplifying mRNA (samRNA) vaccine against COVID-19 in HIV-negative and people living with HIV (PLWH) participants.

加利福尼亚州埃梅里维尔，2024年4月30日（环球通讯社）--Gritstone bio，Inc.（纳斯达克：GRTS），一家致力于开发世界上最有效疫苗的临床阶段生物技术公司，今天提供了来自其CORAL-CEPI研究的最新第一阶段数据，该研究是一项由防疫创新联盟（CEPI）资助的研究，正在评估Gritstone针对HIV阴性和HIV感染者（PLWH）参与者的新型冠状病毒（COVID-19）的自我扩增mRNA（samRNA）疫苗。

The presentation, at ESCMID Global 2024, reviewed the latest findings demonstrating the durability and potential broad utility of Gritstone’s samRNA vaccine against COVID-19. The new findings came from Group D, which evaluated immunogenicity of Gritstone’s samRNA vaccine candidate delivering the Spike BA.1 variant as compared to the Spike Beta variant evaluated in Groups A-C..

在2024年ESCMID全球大会上的演讲回顾了最新发现，这些发现证明了格瑞斯通针对新型冠状病毒的samRNA疫苗的耐久性和潜在的广泛用途。新发现来自D组，该组评估了与A-C组评估的尖峰β变体相比，递送尖峰BA.1变体的Gritstone samRNA候选疫苗的免疫原性。。

“The data presented at ESCMID Global, our most comprehensive Phase 1 dataset to date, highlights the potential of our samRNA vaccine to generate robust and durable immune responses across a diverse set of populations; naïve, convalescent and previously vaccinated,” said Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer of Gritstone bio.

Gritstone bio联合创始人、总裁兼首席执行官安德鲁·艾伦（AndrewAllen）医学博士说：“ESCMID Global是我们迄今为止最全面的第一阶段数据集，它提供的数据突显了我们的samRNA疫苗在不同人群中产生强大而持久的免疫反应的潜力，这些人群是幼稚、康复期和以前接种过疫苗的人群。”。

“Previously, we had shown our samRNA vaccine capable of driving potentially broad and durable protection through 12 months across three Phase 1 studies spanning multiple other populations and settings. The new findings announced today demonstrate the vaccine is capable of driving broad and durable B and T cell responses in previously unvaccinated or vaccinated individuals in South Africa, including in people living with HIV.

“之前，我们已经证明，我们的samRNA疫苗能够在跨越多个其他人群和环境的三项1期研究中，在12个月内提供潜在的广泛和持久的保护。今天宣布的新发现表明，该疫苗能够在南非以前未接种疫苗或接种疫苗的个体中，包括艾滋病毒感染者中，驱动广泛和持久的B细胞和T细胞反应。

These results add to the growing body of evidence suggesting this differentiated immune response extends beyond healthy individuals and potentially to the most vulnerable of patients.”.

这些结果增加了越来越多的证据表明，这种分化的免疫反应超出了健康个体的范围，并可能扩展到最脆弱的患者。”。

Karin Jooss, Ph.D., Executive Vice President and Head of R&D of Gritstone bio added, “As our Phase 1 data set grows, the potential advantages of the immune response induced by our samRNA vaccine candidates compared to currently approved COVID-19 vaccines is becoming increasingly clear. The ability of our candidates to generate T cell responses to Spike and non-Spike epitopes in people living with HIV, who are believed to have reduced T cell activity, highlights the potential power of our samRNA platform.

Gritstone bio执行副总裁兼研发负责人Karin Jooss博士补充道：“随着我们第一阶段数据集的增长，与目前批准的新型冠状病毒肺炎疫苗相比，我们的samRNA候选疫苗诱导的免疫反应的潜在优势越来越明显。我们的候选疫苗对HIV感染者的尖峰和非尖峰表位产生T细胞反应的能力，据信这些人的T细胞活性降低，突显了我们samRNA平台的潜在力量。

The fact that we continue to observe a consistently strong immunogenicity profile as we evaluate more new patient populations and constructs speaks to the potential global utility of self-amplifying mRNA.”.

随着我们评估更多新的患者群体和构建体，我们继续观察到持续强大的免疫原性特征，这一事实说明了自我扩增mRNA的潜在全球效用。”。

Highlights from CORAL-CEPI Poster at ECCMID 2024 Poster (Abstract 02893, Poster Presentation)

ECCMID 2024海报上CORAL-CEPI海报的亮点（摘要02893，海报展示）

Title: Durable Immune Response Induced by Self-amplifying mRNA (samRNA) SARS-CoV-2 Vaccine Candidates in HIV Negative and People Living with HIV (PLWH) Populations in South Africa

标题：南非HIV阴性和HIV感染者（PLWH）人群中自扩增mRNA（samRNA）SARS-CoV-2候选疫苗诱导的持久免疫反应

CORAL-CEPI (NCT05435027) is a Phase 1 study evaluating three samRNA-based SARS-CoV-2 vaccine candidates containing Spike plus other viral targets in HIV-negative (both SARS-CoV-2-naïve and convalescent) and people living with HIV (PLWH) in South Africa (N = 342).Results demonstrated:

CORAL-CEPI（NCT05435027）是一项1期研究，评估了三种基于samRNA的SARS-CoV-2候选疫苗，其中含有Spike和其他HIV阴性（SARS-CoV-2初治和康复期）和HIV感染者（PLWH）的病毒靶标。南非（N=342）。结果表明：

Favorable tolerability profile was consistent with previous findings, including in PLWH

良好的耐受性概况与先前的发现一致，包括PLWH

All doses of the three samRNA vaccine candidates were well tolerated in both HIV-negative participants and PLWH participants irrespective of age, SARS-CoV-2 serostatus, or prior SARS-CoV-2 vaccination status at baseline

无论年龄、SARS-CoV-2血清状态或之前的SARS-CoV-2疫苗接种状态如何，三种候选samRNA疫苗在HIV阴性参与者和PLWH参与者中均具有良好的耐受性

Across all vaccine candidates, IgG levels and nAb titers were high and sustained to multiple variants

在所有候选疫苗中，IgG水平和nAb滴度都很高，并持续到多种变异

All three samRNA vaccine candidates increased and maintained IgG levels and nAb titers against vaccines of concern for at least 12 months irrespective of prior SARS-CoV-2 vaccination status or serostatus

无论先前的SARS-CoV-2疫苗接种状态或血清状态如何，所有三种候选samRNA疫苗均能提高并维持针对所关注疫苗的IgG水平和nAb滴度至少12个月

After vaccination, T cell responses were induced and/or sustained in the vast majority of subjects, including PLWH

接种疫苗后，绝大多数受试者（包括PLWH）都会诱导和/或维持T细胞反应

Antigen-specific T cell responses were increased in the majority of participants tested to date after administration of any of the 3 samRNA vaccine candidates

迄今为止，在服用3种候选samRNA疫苗中的任何一种后，大多数受试者的抗原特异性T细胞反应均增加

Gritstone’s samRNA platform is well tolerated with consistent ability to drive robust and durable binding (IgG) and neutralizing antibodies (nAb) across SARS-CoV-2 variants in addition to broad T cell responses to both Spike and non-Spike epitopes

Gritstone的samRNA平台具有良好的耐受性，除了对尖峰和非尖峰表位的广泛T细胞反应外，还具有在SARS-CoV-2变体中驱动强大而持久的结合（IgG）和中和抗体（nAb）的一致能力

About the CORAL Program

关于珊瑚计划

Gritstone’s CORAL program is applying Gritstone’s infectious disease approach for the prevention of COVID-19. The program aims to drive both B cell and T cell immunity using self-amplifying mRNA (samRNA) and novel immunogens containing Spike plus additional viral targets. To date, the CORAL program has comprised three Phase 1 trials evaluating multiple samRNA vaccine candidates across various patient populations and settings: CORAL-BOOST (healthy volunteers following primary series of currently approved COVID-19 vaccines); CORAL-CEPI (vaccine-naïve healthy and HIV+ subjects in South Africa); and CORAL-NIH (run by the National Institute of Allergy and Infectious Disease [NIAID] in previously vaccinated healthy volunteers).

Gritstone的珊瑚计划正在应用Gritstone的传染病方法来预防COVID-19。该计划旨在使用自扩增mRNA（samRNA）和含有尖峰加额外病毒靶标的新型免疫原来驱动B细胞和T细胞免疫。迄今为止，CORAL计划包括三项第一阶段试验，评估了不同患者人群和环境中的多种samRNA疫苗候选物：CORAL-BOOST（健康志愿者遵循目前批准的COVID-19疫苗的主要系列）；CORAL-CEPI（南非未接种疫苗的健康和HIV+受试者）；和CORAL-NIH（由National Institute of Allergy and Infectious Disease[NIAID]在之前接种过疫苗的健康志愿者中运行）。

Results to date have demonstrated induction and persistence of high neutralizing antibody levels through at least 12 months as well as broad T cell responses. The CORAL program has been supported by Biomedical Advanced Research and Development Authority (BARDA), NIAID, the Coalition for Epidemic Preparedness Innovations (CEPI) and the Bill & Melinda Gates Foundation..

迄今为止的结果表明，在至少12个月的时间内，高中和抗体水平的诱导和持续存在以及广泛的T细胞反应。珊瑚计划得到了生物医学高级研究与发展局（BARDA）、NIAID、防疫创新联盟（CEPI）和比尔和梅琳达·盖茨基金会的支持。。

About Self-amplifying mRNA (samRNA)

关于自我扩增mRNA（samRNA）

Self-amplifying mRNA (samRNA) is rapidly emerging as a well-tolerated, scalable and widely-applicable platform technology which can be used to develop multiple vaccines simply by changing the sequence of the antigen (the target of the immune system) that is encoded in the vector RNA and delivered in a lipid nanoparticle.

自扩增mRNA（samRNA）作为一种耐受性良好，可扩展且广泛应用的平台技术正在迅速出现，它可以通过改变编码在载体中的抗原（免疫系统的靶标）的序列来开发多种疫苗RNA并以脂质纳米颗粒递送。

Like traditional mRNA vaccines, samRNA vaccines use the host cell’s translation system to convert mRNA to protein target antigens in order to stimulate immunity. Unlike traditional mRNA, samRNA creates multiple copies of the antigen RNA once in the cell, potentially leading to extended duration and magnitude of antigen expression.

与传统的mRNA疫苗一样，samRNA疫苗使用宿主细胞的翻译系统将mRNA转化为蛋白质靶抗原以刺激免疫力。与传统的mRNA不同，samRNA一次在细胞中产生多个拷贝的抗原RNA，可能导致抗原表达的持续时间和程度延长。

Gritstone designs novel immunogens, the vaccine regions encoding virus antigens, and includes both Spike antigen (similar to first-generation COVID-19 vaccines) and evolutionarily conserved, non-Spike antigens likely to drive T cell responses in its next-generation COVID-19 vaccines. Potential benefits of this samRNA “Spike plus” approach include (1) strong and durable induction of neutralizing antibodies to Spike, (2) broad and durable T cell immunity (CD4+ and CD8+) to multiple viral proteins, (3) potency at lower doses (dose sparing), and (4) refrigerator stability..

Gritstone设计了新型免疫原，即编码病毒抗原的疫苗区域，包括尖峰抗原（类似于第一代COVID-19疫苗）和进化上保守的非尖峰抗原，可能在其下一代COVID-19疫苗中驱动T细胞应答。这种samRNA“Spike plus”方法的潜在益处包括（1）强烈而持久地诱导针对Spike的中和抗体，（2）对多种病毒蛋白的广泛而持久的T细胞免疫（CD4+和CD8+），（3）较低剂量的效力（剂量保留），以及（4）冰箱稳定性。。

About Gritstone bio

关于砂砾生物

Gritstone bio, Inc. (Nasdaq: GRTS) is a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines. We leverage our innovative vectors and payloads to train multiple arms of the immune system to attack critical disease targets. Independently and with our collaborators, we are advancing a portfolio of product candidates to treat and prevent viral diseases and solid tumors in pursuit of improving patient outcomes and eliminating disease.

Grittone bio，Inc.（纳斯达克：GRTS）是一家临床阶段生物技术公司，旨在开发世界上最有效的疫苗。我们利用我们的创新载体和有效载荷来训练免疫系统的多个手臂来攻击关键的疾病目标。我们正在与合作者一起独立推进一系列候选产品，以治疗和预防病毒性疾病和实体瘤，从而改善患者预后并消除疾病。

www.gritstonebio.com.

www.gritstonebio.com。

Gritstone Contacts

砂石触点

Investors:

投资者：

George E. MacDougall

乔治·E·麦克道格尔

Gritstone bio, Inc.

砂砾石生物公司。

ir@gritstone.com

ir@gritstone.com

Media:

媒体：

Dan Budwick

还有布威克

1AB

1AB公司

(973) 271-6085

(973) 271-6085

dan@1abmedia.com

dan@1abmedia.com