Scinai Immunotherapeutics Announces Positive Regulatory Feedback from the Paul Erlich Institute (the PEI) for its drug development program towards Phase 1/2a clinical trial of its anti-IL-17A/F nanoAb (SCN-1) in Plaque Psoriasis

Scinai Immunotherapeutics宣布Paul Erlich研究所（PEI）对其针对斑块状银屑病的抗IL-17A/F nanoAb（SCN-1）的1/2a期临床试验的药物开发计划提供了积极的监管反馈

Clarified preclinical toxicology and clinical program for Plaque Psoriasis First-in-human with intralesional injections for the treatment of patients with mild to moderate Plaque Psoriasis

首次阐明斑块状银屑病的临床前毒理学和临床计划，并通过病灶内注射治疗轻度至中度斑块状银屑病患者

The PEI had requested to see data of efficacy in blocking IL-17F; this data became available as per the Company's announcement last week describing the positive in vivo proof of concept results.

PEI要求查看阻断IL-17F的功效数据；该数据是根据该公司上周的公告提供的，该公告描述了积极的体内概念验证结果。

The PEI accepted the Company's position that toxicology studies can be conducted in pigs rather than in Non-Human Primates.

贝聿铭接受了该公司的立场，即毒理学研究可以在猪身上进行，而不是在非人类灵长类动物身上进行。

The PEI accepted the Company's position to compare the SCN-1 to placebo directly in patients with mild to moderate plaque psoriasis while skipping the need for testing in healthy volunteers, resulting in a phase 1/2a clinical trial, which will assess both safety and efficacy in the same trial.

PEI接受了该公司的立场，将SCN-1与安慰剂直接用于轻度至中度斑块状银屑病患者，同时不需要在健康志愿者中进行测试，从而进行了1/2a期临床试验，该试验将在同一试验中评估安全性和有效性。

The PEI agreed to compare SCN-1 to placebo on the same human subject, a strategy that could significantly reduce the number of patients required for the clinical trial

PEI同意在同一人类受试者上比较SCN-1和安慰剂，这一策略可以显着减少临床试验所需的患者数量

The PEI commented that the manufacturing process looks well developed and that controls and specifications presented are acceptable

PEI评论说，制造过程看起来很成熟，所提供的控制和规范是可以接受的

The Phase 1/2a study is expected to include approximately 24 plaque psoriasis patients and is expected to commence in the second half of 2025 with readout in 2026.

1/2a期研究预计将包括约24名斑块状银屑病患者，预计将于2025年下半年开始，2026年开始读数。

JERUSALEM, July 23, 2024 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) (the 'Company'), a biotechnology company focused on developing inflammation and immunology (I&I) biological products and on providing CDMO services through its Scinai Bioservices business unit, today announced the receipt of minutes of meeting from a recent Scientific Advice ('SA') with the Paul Erlich Institute, Federal Institute for Vaccines and Biomedicines (the 'PEI'), which is considered acceptable guidance for IMPD filing with the European Medicines Agency (EMA) and is also considered the European comparable to a pre-IND meeting with the FDA in the U.S.

耶路撒冷，2024年7月23日/PRNewswire/--Scinai Immunotherapeutics Ltd.（纳斯达克：SCNI）（“公司”）是一家生物技术公司，专注于开发炎症和免疫学（I＆I）生物产品，并通过其Scinai Bioservices业务部门提供CDMO服务，今天宣布收到了最近与联邦疫苗和生物医学研究所（PEI）保罗·埃利希研究所（PaulErlich Institute）的科学建议（“SA”）的会议记录，该会议被认为是向欧洲药品管理局（EMA）提交IMPD的可接受指南，也被认为是欧洲可与美国食品和药物管理局（FDA）举行的IND前会议相媲美的会议。

The Company believes that the minutes of meeting reflect positive regulatory feedback, which can be translated into significant time and cost savings in its IL-17 nanoAb drug development plans..

该公司认为，会议记录反映了积极的监管反馈，可以在其IL-17纳米抗体药物开发计划中节省大量时间和成本。。

On June 4, 2024, Scinai's scientific team met, over a video conference, with representatives of the PEI for a pre-scheduled, official, Scientific Advisory meeting during which Scinai presented its drug development plan of its novel anti-IL-17A/F nanoAb for the treatment of mild to moderate plaque psoriasis and asked the PEI for guidance and advice on various aspects..

2024年6月4日，Scinai的科学团队通过视频会议与PEI的代表举行了一次预定的正式科学咨询会议，其间Scinai介绍了其新型抗IL-17A/F纳米抗体的药物开发计划，用于治疗轻度至中度斑块状银屑病，并请PEI在各个方面提供指导和建议。。

The Meeting

会议

In the meeting, Scinai presented its Chemistry Manufacturing and Controls package, its results from non-clinical ex-vivo and in-vivo studies and its plans for toxicology and first-in-human clinical trial. In addition, Scinai presented the advantages in developing an anti-IL-17 nanoAb for local administration into the psoriatic lesions and the unmet medical need for the intended indication of patients with mild to moderate psoriasis.

在会议上，Scinai介绍了其化学制造和控制包，非临床离体和体内研究的结果以及毒理学计划和首次人体临床试验。此外，Scinai在开发抗IL-17纳米抗体用于局部给药银屑病病变方面具有优势，并且对于轻度至中度银屑病患者的预期适应症的医疗需求尚未得到满足。

Scinai indicated that localized treatments to date, including corticosteroid-based creams/ointments and phototherapy require far more intense treatment regimens. These treatments require either more frequent applications (corticosteroids twice a day and biologics once a month) or more frequent visits to the clinic (phototherapy).

Scinai指出，迄今为止的局部治疗，包括基于皮质类固醇的乳膏/软膏和光疗，需要更强烈的治疗方案。这些治疗需要更频繁的应用（每天两次皮质类固醇和每月一次生物制剂）或更频繁的诊所就诊（光疗）。

It is expected that the biological activity of Scinai's nanoAb will last well after the treatment which would potentially result in a far less demanding treatment regimen. Moreover, as a considerable proportion of patients with mild-moderate psoriasis do not respond well to treatments that are intended for mild to moderate psoriasis (corticosteroids, phototherapy) and are treated with biological (mAbs), the unmet need appears well established..

预计Scinai的nanoAb的生物活性在治疗后会持续很长时间，这可能会导致要求低得多的治疗方案。此外，由于相当大比例的轻中度牛皮癣患者对用于轻度至中度牛皮癣（皮质类固醇，光疗）并用生物（单克隆抗体）治疗的治疗反应不佳，因此未满足的需求似乎已经确立。。

Taken together, it was agreed by the PEI that the results of the non-clinical Proof of Concept (PoC) study (results which were announced on July 15th, 2024) and clinical explorations will shed further light on the suitability of intended localized treatment setting and regimen for Scinai's nanoAb.

综上所述，PEI同意非临床概念验证（PoC）研究（结果于2024年7月15日公布）和临床探索的结果将进一步阐明预期局部治疗环境和方案对Scinai nanoAb的适用性。

Overall, the PEI commented that the manufacturing process looks well developed, that the in-process controls and the Drug Substance (DS) and Drug Product (DP) specifications are all acceptable. The PEI accepted the Company's approach that for local treatment, conducting toxicology studies in pigs rather than in Non-Human Primates is acceptable.

总的来说，PEI评论说，制造过程看起来很发达，过程控制以及原料药（DS）和药品（DP）规格都是可以接受的。PEI接受了该公司的方法，即对于局部治疗，在猪而不是非人类灵长类动物中进行毒理学研究是可以接受的。

This would translate to a significant time and cost saving for the Company. Additionally, the PEI was in agreement with the proposed design for the clinical trial and its definition as phase 1/2a trial, as it will evaluate both safety and efficacy. They supported the recruitment of mild to moderate plaque psoriasis patients (skipping the evaluation of the NanoAb in healthy volunteers) and comparing the NanoAb to placebo.

。此外，PEI与临床试验的拟议设计及其作为1/2a期试验的定义一致，因为它将评估安全性和有效性。他们支持招募轻度至中度斑块状银屑病患者（跳过健康志愿者对NanoAb的评估），并将NanoAb与安慰剂进行比较。

Again, this will speed up the recruitment stage and lessen the cost. For correct intra-patient comparison, the PEI recommended ensuring a similar lesion size in the experimental and control groups..

同样，这将加快招聘阶段并降低成本。为了正确的患者内比较，PEI建议确保实验组和对照组的病变大小相似。。

Upon receiving the above guidance from the PEI, the Company expects to commence preparations for a pre-clinical toxicology study before commencing a first-in-human clinical trial of its anti-IL 17 NanoAbs for the treatment of plaque psoriasis in 2025.

在收到PEI的上述指导后，该公司预计将开始准备临床前毒理学研究，然后在2025年开始其抗IL 17纳米抗体治疗斑块状银屑病的首次人体临床试验。

The unmet market need

未满足的市场需求

Today, there are about 13 million patients diagnosed with plaque psoriasis in the 7 major markets (US, EU5 and Japan). 50% of all psoriasis patients suffer from mild disease and about 28% suffer from moderate psoriasis1. Patients diagnosed with mild to moderate plaque psoriasis often suffer from considerable and visible lesions which may be uncomfortable, painful, and have a negative impact on their social and mental well-being, especially when the lesions are located on the face, genitals, scalp, palms of hands, and bottom of feet.

今天，在7个主要市场（美国、欧盟5国和日本），约有1300万患者被诊断患有斑块状银屑病。所有牛皮癣患者中有50%患有轻度疾病，约28%患有中度牛皮癣1。被诊断为轻度至中度斑块状银屑病的患者通常会遭受相当大且可见的病变，这些病变可能会让人不舒服，痛苦，并对他们的社交和心理健康产生负面影响，尤其是当病变位于面部，生殖器，头皮，手掌和脚底时。

The therapeutics for mild to moderate plaque psoriasis include mostly corticosteroids, applied topically, and phototherapy. These treatments require very frequent use, have risks for local adverse effects such as skin atrophy and development of tolerance, and suffer from low patient adherence to treatment schedule.

轻度至中度斑块状银屑病的治疗方法主要包括皮质类固醇，局部应用和光疗。这些治疗方法需要非常频繁地使用，存在局部不良反应的风险，例如皮肤萎缩和耐受性的发展，并且患者对治疗时间表的依从性较低。

The current therapeutics for moderate to severe disease include mostly biologics and JAK inhibitors. While highly efficacious, these treatments are administered systemically, are highly expensive and require chronic use, which carries long term health risks and considerable economic burden to the patients and the health care system.

目前用于中重度疾病的治疗方法主要包括生物制剂和JAK抑制剂。虽然非常有效，但这些治疗方法是全身给药的，价格昂贵，需要长期使用，这给患者和医疗保健系统带来了长期的健康风险和相当大的经济负担。

Therefore, treatment of mild to moderate plaque psoriasis is suboptimal and can be improved..

因此，轻度至中度斑块状银屑病的治疗并不理想，可以改善。。

Scinai's product candidate is designed to address the major shortcomings of currently available treatments. It is a biologic, intended to be delivered locally, intradermally, into the psoriatic lesions using a very short and almost painless needle. Scinai's product is designed to allow patients with mild to moderate psoriasis to benefit from a low frequency treatment that comes with the high specificity and potency saved for biologics but with significantly reduced risk of local side effects associated with corticosteroids or systemic side effects associated with systemic administration of biologics..

Scinai的候选产品旨在解决目前可用治疗的主要缺点。它是一种生物制剂，旨在使用非常短且几乎无痛的针头局部皮内递送到银屑病病变中。Scinai的产品旨在使轻度至中度牛皮癣患者受益于低频治疗，该治疗具有生物制剂的高特异性和效力，但与皮质类固醇相关的局部副作用或与全身给药相关的全身副作用的风险显着降低生物制剂。。

Dr. Tamar Ben-Yedidia, Scinai's Chief Scientist, noted, 'It is encouraging to receive such a supportive regulatory summary for our plans. The PEI agreed with the unmet need of the patients with mild-to-moderate psoriasis for a better therapy and accepted our pre-clinical and clinical plans that will allow faster development of this product.'.

Scinai首席科学家塔玛·本·耶迪迪亚（TamarBenYedidia）博士指出，“我们的计划得到如此支持性的监管总结，令人鼓舞。PEI同意轻度至中度牛皮癣患者对更好治疗的未满足需求，并接受了我们的临床前和临床计划，这将加快该产品的开发。”。

'I'd like to thank the PEI for their collaboration and guidance,' continued Ben-Yedidia.

本·耶迪迪亚（BenYedidia）继续说道：“我要感谢贝聿铭（PEI）的合作和指导。”。

Scinai next intends to further fine tune dosing and drug half-life and conduct a longer duration follow on in-vivo animal study in late 2024, again, in collaboration with Prof. Gilhar of the Technion Israel Institute of Technology, complemented by a pre-clinical toxicology study before commencing a first-in-human clinical trial in late 2025. .

Scinai next打算在2024年末与以色列理工学院的Gilhar教授合作，进一步微调剂量和药物半衰期，并在2025年末开始第一次人体临床试验之前，进行更长时间的后续体内动物研究，并辅以临床前毒理学研究。

1 Global Data Plaque Psoriasis: Global Drug Forecast and Market Analysis to 2030, November 2021

1斑块状银屑病全球数据：2030年全球药物预测和市场分析，2021年11月

About Scinai Immunotherapeutics

关于Scinai Immunotherapeutics

Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) is a biopharmaceutical company with two complementary business units, one focused on in-house development of inflammation and immunology (I&I) biological therapeutic products beginning with an innovative, de-risked pipeline of nanosized VHH antibodies (NanoAbs) targeting diseases with large unmet medical needs, and the other a boutique CDMO providing biological drug development, analytical methods development, clinical cGMP manufacturing, and pre-clinical and clinical trial design and execution services to early stage biotech drug development programs..

Scinai Immunotherapeutics Ltd.（纳斯达克股票代码：SCNI）是一家生物制药公司，拥有两个互补的业务部门，一个专注于炎症和免疫学（I＆I）生物治疗产品的内部开发，首先是针对大量未满足医疗需求的疾病的纳米级VHH抗体（NanoAbs）的创新，去风险管道，另一个是精品CDMO，为早期生物技术药物开发计划提供生物药物开发，分析方法开发，临床cGMP制造以及临床前和临床试验设计和执行服务。。

Company Contacts

公司联系人

Investor Relations | +972 8 930 2529 | ir@scinai.com

投资者关系|+972 8 930 2529|ir@scinai.com

Business Development | +972 8 930 2529 | bd@scinai.com

业务发展|+972 8 930 2529 |bd@scinai.com

Website: www.scinai.com

网址：www.comune.de

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as 'expect,' 'believe,' 'intend,' 'plan,' 'continue,' 'may,' 'will,' 'anticipate,' and similar expressions are intended to identify forward-looking statements. All statements, other than statements of historical facts, are forward-looking statements.

本新闻稿包含1995年《私人诉讼改革法案》所指的前瞻性声明。诸如“期望”、“相信”、“打算”、“计划”、“继续”、“可能”、“意志”、“预期”等词以及类似的表达都是为了识别前瞻性陈述。除历史事实陈述外，所有陈述均为前瞻性陈述。

Examples of such statements include, but are not limited to, the timing of pre-clinical and clinical trials. These forward-looking statements reflect management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of Scinai Immunotherapeutics Ltd.

此类陈述的例子包括但不限于临床前和临床试验的时间安排。。

Risks and uncertainties include, but are not limited to, the risk that Scinai will not conduct a follow on in-vivo animal study in late 2024, complemented by a pre-clinical toxicology study, will not conduct an in-human clinical trial, or that such studies and trial will be delayed; that; the risk of delay in, Scinai's inability to conduct, or the unsuccessful results of, its research and development activities, including the contemplated in-vivo studies and a clinical trial; the risk that Scinai will not be successful in expanding its CDMO business or in-license other NanoAbs; the risk that Scinai may not be able to secure additional capital on attractive terms, if at all; the risk that the therapeutic and commercial potential of NanoAbs will not be met or that Scinai will not be successful in bringing the NanoAbs towards commercialization; the risk of a delay in the preclinical and clinical trials data for NanoAbs, if any; the risk that our business strategy may not be successful; the ri.

风险和不确定性包括但不限于Scinai不会在2024年末进行后续体内动物研究的风险，并辅以临床前毒理学研究，不会进行人体临床试验，或者此类研究和试验将被延迟；那；Scinai无法进行研究和开发活动（包括预期的体内研究和临床试验）的延迟风险或不成功的结果；Scinai无法成功扩展其CDMO业务或许可其他纳米抗体的风险；Scinai可能无法以有吸引力的条款获得额外资本（如果有的话）的风险；无法满足纳米抗体的治疗和商业潜力，或者Scinai无法成功将纳米抗体商业化的风险；纳米抗体的临床前和临床试验数据延迟的风险（如果有的话）；我们的业务战略可能不成功的风险；国际扶轮。

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