CARLSBAD, Calif.--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that the results of imaging analyses demonstrating rapid improvement in outer retinal structure from patients enrolled in a Phase 1/2a clinical study of RG6501 (OpRegen) (ClinicalTrials.gov Identifier: NCT02286089), which were reviewed by multiple, independent reviewers, were presented at the 23rd EURETINA Congress.

加利福尼亚州卡尔斯巴德（BUSINESS WIRE）-Lineage Cell Therapeutics，Inc。（NYSE American and TASE:LCTX），一家临床阶段生物技术公司，为未满足的医疗需求开发同种异体细胞疗法，今天宣布，成像分析结果显示参加RG6501（OpRegen）（ClinicalTrials.gov Identifier:NCT02286089）1/2a期临床研究的患者的外部视网膜结构迅速改善，这些研究由多名独立评审员审查，在第23届EURETINA大会上发表。

The presentation, “Time to retinal structure improvements following OpRegen subretinal delivery in patients with geographic atrophy (GA),” was presented by Adiel Barak, M.D., Professor of Ophthalmology, Vitreoretinal Unit Director, Tel Aviv Medical Center, on behalf of Roche and Genentech, a member of the Roche Group..

特拉维夫医疗中心玻璃体视网膜单位主任眼科教授Adiel Barak，M.D.，代表罗氏和基因泰克，罗氏集团成员，介绍了地理萎缩（GA）患者视网膜下分娩后视网膜结构改善的时间。。

RG6501 (OpRegen) is a suspension of human allogeneic retinal pigmented epithelial (RPE) cells currently in development for the treatment of GA secondary to age-related macular degeneration (AMD). OpRegen subretinal delivery has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal cell health and improving retinal structure and function.

RG6501（OpRegen）是目前正在开发的用于治疗继发于年龄相关性黄斑变性（AMD）的GA的人类同种异体视网膜色素上皮（RPE）细胞的悬浮液。OpRegen视网膜下递送有可能通过支持视网膜细胞健康和改善视网膜结构和功能来抵消GA病变区域中的RPE细胞损失。

It is being developed under an exclusive worldwide collaboration between Lineage, Roche, and Genentech, a member of the Roche Group, and is currently being evaluated in a Phase 2a clinical study in patients with GA secondary to AMD (ClinicalTrials.gov Identifier: NCT05626114)..

它是在Lineage，Roche和罗氏集团成员Genentech之间的独家全球合作下开发的，目前正在AMD继发GA患者的2a期临床研究中进行评估（ClinicalTrials.gov标识符：NCT05626114）。。

“We are extremely pleased to see these additional observations of rapid improvements to outer retinal structure in the initial clinical study of OpRegen. These data suggest that OpRegen RPE cells may provide direct support to the patients’ remaining retinal cells within atrophic areas, and that the improvements to retinal structure can be detected within the first three months following a single administration.

“我们非常高兴在OpRegen的初步临床研究中看到这些关于外部视网膜结构快速改善的额外观察结果。这些数据表明OpRegen RPE细胞可能为患者在萎缩区域内剩余的视网膜细胞提供直接支持，并且可以在sin后的前三个月内检测到视网膜结构的改善gle管理。

We look forward to additional, future clinical data updates on the OpRegen program from our partners, Roche and Genentech,” stated Brian Culley, CEO of Lineage..

Lineage首席执行官Brian Culley说，我们期待来自合作伙伴Roche和Genentech的OpRegen计划的其他未来临床数据更新。。

23rd EURETINA Congress Highlights:

第23届EURETINA大会亮点：

- All 5 patients enrolled in cohort 4 who had extensive coverage of the GA lesion with the surgical bleb containing OpRegen in suspension, demonstrated evidence of improvement in outer retinal structure as assessed by optical coherence tomography (OCT) within the first 3 months after treatment.

-参加队列4的所有5名患者均广泛覆盖了GA病变，并悬浮了含有OpRegen的手术泡，在治疗后的前3个月内通过光学相干断层扫描（OCT）评估了外部视网膜结构改善的证据。

Retinal structural improvement in the patients described above were initially observed on day 1 (n=1), day 14 (n=1), month 1 (n=2), and month 3 (n=1).

最初在第1天（n=1），第14天（n=1），第1个月（n=2）和第3个月（n=1）观察到上述患者的视网膜结构改善。

Maintenance and/or greater improvements in retinal structure were observed over time.

随着时间的推移观察到视网膜结构的维持和/或更大的改善。

Structural improvement (as defined below) was only observed within GA lesions with extensive coverage with the surgical bleb suggesting that OpRegen RPE cells provide support to the remaining retinal cells within atrophic areas.

结构改善（定义如下）仅在GA病变内观察到，手术泡广泛覆盖，表明OpRegen RPE细胞为萎缩区域内的剩余视网膜细胞提供支持。

These 5 patients had an average of 4.4 letter BCVA gain by 3 months and 12.8 letter BCVA gain by 1 year compared to baseline.

与基线相比，这5名患者平均3个月获得4.4个字母的BCVA增益，1年获得12.8个字母的BCVA增益。

OCT images were reviewed by three independent graders from the day after surgery to the start of structural improvement and subsequent follow-up visits.

从手术后第二天到结构改善开始和随后的随访，OCT图像由三名独立的评分员进行评估。

Structural improvement on OCT was qualitatively defined as meeting all pre-specified criteria including: 1) reduction in outer plexiform layer (OPL) and/or inner nuclear layer (INL) subsidence; 2) reappearance of external limiting membrane (ELM); and 3) increased hyperreflectivity and/or thickness of RPE and/or Bruch’s membrane or reduction of hypertransmission on at least two non-adjacent B scans..

OCT的结构改进定性地定义为满足所有预先规定的标准，包括：1）减少外丛状层（OPL）和/或内核层（INL）沉降；2） 外部限制膜（ELM）的再现；3）在至少两次非相邻的B扫描中，RPE和/或Bruch膜的高反射率和/或厚度增加或超传输减少。。

The patient who demonstrated retinal structure improvement as early as day 1 following OpRegen subretinal delivery exhibited persistence of structural improvement as measured by OCT, with resolution of areas of complete RPE and outer retinal atrophy (cRORA) features at 24 months following treatment.

早在OpRegen视网膜下分娩后第1天就表现出视网膜结构改善的患者，通过OCT测量，其结构改善持续存在，并且在治疗后24个月时可分辨出完全RPE区域和外部视网膜萎缩（cRORA）特征。

Durability of retinal structure improvements beyond the 12-month primary endpoint is still being evaluated in other patients..

其他患者仍在评估超过12个月主要终点的视网膜结构改善的持久性。。

- A Phase 2a study evaluating the success of OpRegen delivery to target areas of GA is currently enrolling patients (ClinicalTrials.gov: NCT05626114).

-评估OpRegen向GA目标区域递送成功的2a期研究目前正在招募患者（ClinicalTrials.gov:NCT05626114）。

Dr. Barak’s presentation is now available on the Events and Presentations section of Lineage’s website.

现在可以在Lineage网站的“事件和演示”部分找到Barak博士的演示文稿。

About EURETINA

关于EURETINA

EURETINA started life as the European Retina, Macula and Vitreous Society in June 2000. Since then, the organization has grown to over 4,500 members and its annual Congress attracts thousands of delegates. Its goal is to enable access to the same cutting-edge retina science worldwide. Through membership, annual Congress, Winter Meeting and always-on digital resource, the organization and its members share robust scientific and educational resources relating to retina.

EURETINA于2000年6月开始成为欧洲视网膜，黄斑和玻璃体学会。从那时起，该组织已发展到4500多名成员，其年会吸引数千名代表。其目标是在全球范围内访问相同的尖端视网膜科学。通过会员资格，年会，冬季会议和始终在数字资源方面，该组织及其成员共享与视网膜有关的强大科学和教育资源。

For more information, please visit https://euretina.org or follow the association on Twitter @EURetina..

欲了解更多信息，请访问https://euretina.org或者在Twitter@EURetina上关注该协会。。

About the Phase 1/2a Study

关于1/2a期研究

The Phase 1/2a study is an open-label, single-arm, multi-center, dose-escalation trial evaluating a single administration of OpRegen delivered subretinally in patients with bilateral GA secondary to dry-form AMD. Twenty-four patients were enrolled into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with a best corrected visual acuity (BCVA) of 20/200 or worse.

1/2a期研究是一项开放标签，单臂，多中心，剂量递增试验，评估在继发于干性AMD的双侧GA患者中单次给予视网膜下递送的OpRegen。24名患者被纳入4个队列。前3个队列仅招募了最佳矫正视力（BCVA）为20/200或更差的合法盲患者。

The fourth cohort enrolled 12 patients with impaired vision (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new “thaw-and-inject” formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility.

第四组招募了12名视力受损患者（BCVA从20/65到20/250，GA平均面积较小）。队列4还包括使用OpRegen的新“解冻和注射”制剂治疗的患者，其可以直接运送到现场并在解冻后立即使用，消除了必须使用剂量制备设施的并发症和后勤问题。

The primary objective of the study was to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment-emergent adverse events. Secondary objectives are to evaluate the preliminary activity of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance..

该研究的主要目的是评估OpRegen的安全性和耐受性，通过治疗紧急不良事件的发生率和频率进行评估。次要目标是通过评估通过各种主要临床相关方法测得的眼科参数变化来评估OpRegen治疗的初步活性。。

About Geographic Atrophy

关于地理萎缩

Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD) characterized by severe loss of visual function. GA is a leading cause of adult blindness in the developed world, affecting at least 5 million people globally. There are two forms of advanced AMD: neovascular AMD and GA.

地理萎缩（GA）是年龄相关性黄斑变性（AMD）的高级形式，其特征在于视觉功能的严重丧失。GA是发达国家成人失明的主要原因，影响全球至少500万人。有两种形式的晚期AMD：新生血管AMD和GA。

GA and neovascular AMD can occur simultaneously in the same eye, and patients treated for neovascular AMD may still go on to develop GA. GA typically affects both eyes..

GA和新生血管性AMD可以同时发生在同一只眼睛中，接受新生血管性AMD治疗的患者仍可能继续发展GA。GA通常会影响两只眼睛。。

About Lineage Cell Therapeutics, Inc.

关于Lineage Cell Therapeutics，Inc。

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials.

Lineage Cell Therapeutics是一家临床阶段生物技术公司，为未满足的医疗需求开发新型细胞疗法。Lineage的计划基于其强大的专有基于细胞的治疗平台以及相关的内部开发和制造能力。利用该平台，谱系从其多能和祖细胞起始材料开发和制造专门的终末分化人细胞。

These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage.

开发这些分化的细胞以替代或支持由于退行性疾病或创伤性损伤而功能失调或缺失的细胞，或作为帮助身体对癌症产生有效免疫应答的手段施用。Lineage的临床和临床前项目在市场上有数十亿美元的机会，包括五种同种异体（“现成”）产品候选：（i）OpRegen，一种视网膜色素上皮细胞疗法，用于治疗继发于年龄相关性黄斑变性的地理萎缩，正在与罗氏集团成员罗氏和基因泰克的全球合作下开发；（ii）OPC1，1/2a期发育中的少突胶质细胞祖细胞疗法，用于治疗急性脊髓损伤；（iii）VAC2，一种由Lineage的免疫肿瘤学和传染病VAC技术平台生产的树突状细胞疗法，目前正处于治疗非小细胞肺癌的1期临床开发阶段；（iv）ANP1，一种听觉神经元祖细胞疗法，可潜在治疗听觉神经病；（v）PNC1，一种感光神经细胞疗法，可潜在治疗由于感光器功能障碍或损伤引起的视力丧失。

For more information, please visit www.lineagecell.com or follow the company on Twit.

欲了解更多信息，请访问www.lineagecell.com或关注Twit公司。

Forward-Looking Statements

前瞻性声明

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions.

沿袭提醒您，本新闻稿中包含的除历史事实陈述外的所有陈述均为前瞻性陈述。前瞻性陈述，在某些情况下，可以用“相信”，“目标”，“可能”，“将会”，“估计”，“继续”，“预期”，“设计”，“意图”，“期望”，“可以”，“可以”，“计划”，“潜力”，“预测”，“寻求”，“应该”，“会”，“沉思”，“项目”，“目标”倾向于”或这些单词和类似内容的否定版本表达。

Such statements include, but are not limited to, statements relating to: the potential therapeutic benefits OpRegen in patients with GA secondary to AMD; the significance of clinical data reported to date from the Phase 1/2a study of OpRegen, including the findings of retinal tissue restoration and visual function improvements; and the potential utilization of OCT imaging to measure efficacy in a pivotal clinical trial of OpRegen.

这些陈述包括但不限于以下陈述：继发于AMD的GA患者的潜在治疗益处；迄今为止，OpRegen 1/2a期研究报告的临床数据的意义，包括视网膜组织恢复和视功能改善的发现；以及OCT成像在OpRegen关键临床试验中测量疗效的潜在利用。

Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that competing alternative therapies may adversely impact the commercial potential of OpRegen; that Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular.

前瞻性陈述涉及已知和未知的风险，不确定性和其他可能导致沿袭实际结果，绩效或成就与本新闻稿前瞻性陈述表达或暗示的未来结果，绩效或成就有实质性差异的因素，包括但不限于，以下风险：产品候选人的早期临床和/或非临床研究中的阳性结果可能无法预测该候选人随后的临床和/或非临床研究的成功；竞争性替代疗法可能会对OpRegen的商业潜力产生不利影响；罗氏和基因泰克可能无法成功推进OpRegen或无法成功完成OpRegen的进一步临床试验和/或在任何特定情况下获得OpRegen的监管批准。