Collaboration leverages AAV manufacturing expertise to advance a preclinical-stage gene therapy program for a rare pediatric neurological disorder.

合作利用AAV制造专业知识，推进一种罕见的儿童神经系统疾病的临床前基因治疗项目。

SAN SEBASTIÁN, Spain and LONDON

西班牙圣塞巴斯蒂安和伦敦

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，

May 5, 2026

2026年5月5日

/PRNewswire/ -- Viralgen, a leading contract development and manufacturing organization (CDMO) specializing in recombinant adeno-associated virus (rAAV) gene therapies, announced today a partnership with Elaaj Bio, a biotechnology company focused on development of transformative treatments for CDKL5 Deficiency Disorder (CDD).

/PRNewswire/ -- Viralgen，一家专注于重组腺相关病毒（rAAV）基因疗法的领先合同开发和制造组织（CDMO），今天宣布与专注于开发治疗CDKL5缺陷障碍（CDD）变革性疗法的生物技术公司Elaaj Bio达成合作伙伴关系。

Elaaj Bio is a wholly owned subsidiary of the Loulou Foundation, a private non-profit foundation dedicated to the development and research of therapeutics for CDD. The collaboration, to advance an investigational CDKL5 gene therapy, brings together complementary expertise across development and manufacturing services for adeno-associated virus (AAV) vectors to support advancement of the program toward clinical development..

Elaaj Bio是Loulou基金会的全资子公司，该基金会是一家致力于CDD治疗药物研发的私人非营利基金会。此次合作旨在推进一项CDKL5基因疗法的研究，汇集了在腺相关病毒（AAV）载体的开发和生产服务方面的互补专长，以支持该项目向临床开发迈进。

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Viralgen scientist

病毒源科学家

As part of the collaboration, Viralgen will leverage its expertise in AAV vector manufacturing to support key development activities, including process development and optimization, manufacturing across multiple scales, and analytical characterization and quality control. Initial development work has been successfully completed, demonstrating technical feasibility of the manufacturing approach, and ongoing activities are focused on process scale-up, including the preparation of larger-scale batches..

作为合作的一部分，Viralgen将利用其在AAV载体生产方面的专业知识，支持关键的开发活动，包括工艺开发与优化、多规模生产以及分析表征和质量控制。初期开发工作已成功完成，证明了该生产工艺的技术可行性，当前的工作重点是工艺放大，包括制备更大规模的批次。

'Collaborations like this are essential to advancing complex gene therapy programs, particularly in rare pediatric diseases where the need for new therapies and innovations remains high,' said Jimmy Vanhove, Chief Executive Officer at Viralgen. 'By working with Elaaj Bio and the Loulou Foundation, we're uniting complementary strengths in development and manufacturing to help accelerate ELJ-101 toward clinical development.'.

“像这样的合作对于推进复杂的基因治疗项目至关重要，特别是在罕见的儿科疾病领域，对新疗法和创新的需求仍然很高，”Viralgen首席执行官Jimmy Vanhove表示。“通过与Elaaj Bio和Loulou基金会合作，我们正在结合开发和制造方面的互补优势，以帮助加速ELJ-101进入临床开发。”

CDKL5 Deficiency Disorder (CDD) is a rare and severe developmental and epileptic encephalopathy caused by alterations in the CDKL5 gene. The condition is characterized by early-onset seizures and significant neurodevelopmental impairment, with a profound impact on affected individuals and their families.

CDKL5缺乏症（CDD）是一种由CDKL5基因变异引起的罕见且严重的发育性和癫痫性脑病。该病的特征是早期发作的癫痫和显著的神经发育障碍，对受影响的个体及其家庭产生深远的影响。

The.

那个。

investigational gene therapy program is being developed to target the underlying genetic cause of the disease.

正在开发一种研究性基因疗法项目，旨在针对该疾病的潜在遗传原因。

'Elaaj Bio and the Loulou Foundation are mission-driven: everything we do is focused on finding treatments for CDD,' said Russ Addis, Chief of Pipeline Strategy and Head of Genetic Medicine at the Loulou Foundation. 'The Viralgen team have embraced that mission; we have great hopes that this collaboration will result in an effective gene therapy that treats the underlying cause of CDKL5 Deficiency.'.

“Elaaj Bio和Loulou基金会是使命驱动的：我们所做的一切都专注于寻找CDD的治疗方法，” Loulou基金会的管线战略主管兼基因医学负责人Russ Addis说道。“Viralgen团队已经接受了这一使命；我们充满希望，相信这次合作将带来一种有效的基因疗法，能够治疗CDKL5缺乏症的根本原因。”

The teams plan to initiate the first clinical trial for this program, ELJ-101, in early 2027. Current efforts are focused on scaling manufacturing processes to support future clinical development.

团队计划于 2027 年初启动该计划的首个临床试验 ELJ-101。当前的工作重点是扩大生产工艺规模，以支持未来的临床开发。

About Viralgen:

关于Viralgen：

Viralgen is a leading Contract Development and Manufacturing Organization (CDMO) specializing exclusively in adeno-associated virus (AAV)-based gene therapies. Founded in 2017 as a subsidiary of AskBio, Inc. within the Bayer AG group, Viralgen delivers end-to-end support from early development to large-scale commercial manufacturing.

Viralgen 是一家领先的合同开发和制造组织 (CDMO)，专注于基于腺相关病毒 (AAV) 的基因疗法。该公司成立于 2017 年，是拜耳集团旗下的 AskBio, Inc. 的子公司，Viralgen 提供从早期开发到大规模商业生产的端到端支持。

Leveraging their proprietary Pro10™ suspension cell line and Aava™ manufacturing platform, Viralgen achieves industry-leading, high-yield, scalable manufacturing across all AAV serotypes. Located in San Sebastian, Spain, its state-of-the-art facility features three cGMP suites with 2,000-liter capacities each, certified by the AEMPS/EMA, and integrates services including plasmid production, process optimization, fill-finish, and in-house QC testing.

利用其专有的Pro10™悬浮细胞系和Aava™生产平台，Viralgen实现了在所有AAV血清型中行业领先的高产量、可扩展的生产。公司位于西班牙圣塞巴斯蒂安，其最先进的设施包括三个经过AEMPS/EMA认证的cGMP套间，每个套间容量为2,000升，并整合了质粒生产、工艺优化、灌装完成以及内部QC测试等服务。

With over 1,500 AAV batches produced, Viralgen provides reliable, efficient solutions bringing life-changing gene therapies to patients with greater speed and consistency. Learn more at .

Viralgen已生产超过1500批AAV，提供可靠、高效的解决方案，以更快的速度和更高的一致性将改变生命的基因疗法带给患者。了解更多信息，请访问。

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About Elaaj Bio and the Loulou Foundation:

关于Elaaj Bio和Loulou基金会：

Elaaj Bio is a wholly owned subsidiary of the Loulou Foundation, a private non-profit UK foundation dedicated to advancing research into the understanding and development of therapeutics for CDKL5 deficiency disorder. The Foundation funds research projects at leading universities and institutes in the US and Europe, with a.

Elaaj Bio 是 Loulou 基金会的全资子公司，该基金会是一家位于英国的私人非营利组织，致力于推动对CDKL5缺陷障碍的理解及治疗开发的研究。基金会资助美国和欧洲多所顶尖大学和研究机构的研究项目。

total of 31 separate projects in 41 labs at 30 different institutions so far, enabling the

迄今为止，共有31个独立项目在30个不同机构的41个实验室中进行，使得

focused research of over 120 scientists.

超过120名科学家的集中研究。

The Loulou Foundation also hosts the CDKL5 Forum, the annual conference which has become the flagship meeting for CDKL5 deficiency disorder basic and clinical science. Learn more at

路路基金会还举办了CDKL5论坛，这一年度会议已成为CDKL5缺陷障碍基础与临床科学的旗舰会议。欲了解更多信息，请访问

http://www.louloufoundation.org

http://www.louloufoundation.org

and

和

http://www.elaajbio.com

http://www.elaajbio.com

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。

This press release contains forward-looking statements regarding the development of an investigational gene therapy program. These statements are subject to risks and uncertainties, including those related to research and development, manufacturing, and regulatory processes. The investigational therapy described herein has not been approved by the U.S.

本新闻稿包含有关开发一种研究性基因治疗计划的前瞻性声明。这些声明受到风险和不确定性的约束，包括与研发、生产以及监管流程相关的风险。本文所述的研究性疗法尚未获得美国批准。

Food and Drug Administration or any other regulatory authority..

食品和药物管理局或任何其他监管机构。

SOURCE Viralgen

来源：Viralgen

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