Preclinical data from the next generation eyedrop platform to be unveiled for the first time at ARVO 2024

下一代滴眼液平台的临床前数据将在ARVO 2024首次公布

DAEJEON, South Korea, April 22, 2024 /PRNewswire/ -- PharmAbcine, Inc. ('PharmAbcine' or the 'Company') (KOSDAQ: 208340), a clinical-stage public company developing next generation therapeutics to treat medical unmet needs, announced today that the Company's U.S. subsidiary, Wincal Biopharm, Inc. ('WincalBio'), will present preclinical findings on its innovative ocular drug delivery platform at the upcoming conference, Association for Research in Vision and Ophthalmology (ARVO), the world's largest ophthalmology conference which will be held from May 5th to 9th, 2024 in Seattle, WA, United States..

韩国大田，2024年4月22日/PRNewswire/--PharmAbcine，Inc.（“PharmAbcine”或“公司”）（KOSDAQ:208340），一家临床阶段的上市公司，开发下一代治疗药物以治疗未满足的医疗需求，今天宣布，该公司的美国子公司Wincal Biopharm，Inc.（“WincalBio”）将在即将举行的会议上介绍其创新眼部药物输送平台的临床前研究结果，该会议将于2024年5月5日至9日在美国华盛顿州西雅图举行，是世界上最大的眼科会议。。

Based in South San Francisco, California, WincalBio is an emerging biotech dedicated to developing next-generation ocular drug delivery platforms and therapeutics for vascular diseases. Its proprietary Ocular Penetration Carrier (OPC) screening platform has shown high potential in treating various ocular diseases using eyedrop formulation of antibody therapeutics, thereby replacing the need for intravitreal injections.

WincalBio位于加利福尼亚州南旧金山，是一家新兴的生物技术公司，致力于开发下一代眼部药物输送平台和血管疾病治疗方法。其专有的眼穿透载体（OPC）筛选平台已显示出使用抗体治疗剂的滴眼液制剂治疗各种眼部疾病的巨大潜力，从而取代了玻璃体内注射的需要。

This novel OPC platform has a mechanism in facilitating the delivery of antibody therapeutics through the vitreous humor of the eye, reaching critical structures such as the aqueous chamber, vitreous, retina, and choroid..

这种新型OPC平台具有促进抗体治疗剂通过眼玻璃体液递送的机制，可到达关键结构，例如房水，玻璃体，视网膜和脉络膜。。

WincalBio stands as a pioneer in biotech industry with a leading program validated in mouse CNV models for anti-VEGF antibody therapies, a significant advancement in treating age-related macular degeneration (AMD) and diabetic macular edema (DME). These breakthroughs, along with preclinical data from various animal models, will be unveiled for the first time at ARVO 2024.

WincalBio是生物技术行业的先驱，其领先的抗VEGF抗体治疗小鼠CNV模型验证了该项目，这在治疗年龄相关性黄斑变性（AMD）和糖尿病性黄斑水肿（DME）方面取得了重大进展。这些突破以及来自各种动物模型的临床前数据将在ARVO 2024首次公布。

While anti-VEGF antibody therapies are the standard of care for AMD treatment, they are currently limited to intravitreal injections..

虽然抗VEGF抗体疗法是AMD治疗的标准治疗方法，但目前仅限于玻璃体内注射。。

Dr. TaeWeon Lee, Chief Scientific Officer of WincalBio, underscored the importance of presenting these groundbreaking findings at ARVO, noting, 'The OPC platform, developed internally over the past few years, has never been publicly disclosed. Presenting the preclinical data for the first time at ARVO holds tremendous significance.' Additionally, Dr.

WincalBio首席科学官TaeWeon Lee博士强调了在ARVO上展示这些突破性发现的重要性，并指出，“过去几年内部开发的OPC平台从未公开披露。在ARVO首次提供临床前数据具有巨大意义。”此外，博士。

Venice Chiueh, Director at WincalBio and the oral presenter, expressed gratitude for the keen interest of ARVO meeting organizers. 'We appreciate the opportunity provided by ARVO reviewers to present advancements in eyedrop development. We are committed to ensuring the success of clinical studies aimed at transitioning existing patients from intravitreal injections to eyedrop applications.'.

WincalBio董事兼口头主持人VeniceChiueh对ARVO会议组织者的浓厚兴趣表示感谢我们感谢ARVO审稿人提供的展示滴眼液开发进展的机会。我们致力于确保旨在将现有患者从玻璃体内注射转变为滴眼液应用的临床研究取得成功。”。

Eyedrop applications of therapeutics offer significant advantage of being non-invasive, as well as enhancing patient convenience with minimum side effects. While effectively delivering sufficient quantities of the therapeutics to the back of the eye remains the primary challenge for topical applications, WincalBio's OPC platform aims to overcome this challenge..

治疗剂的滴眼液应用提供了非侵入性的显着优势，并且以最小的副作用增强了患者的便利性。虽然有效地将足量的治疗药物输送到眼后仍然是局部应用的主要挑战，但WincalBio的OPC平台旨在克服这一挑战。。

ARVO, founded in 1928, is the world's largest ophthalmology conference with over 10,000 members from over 75 countries.

ARVO成立于1928年，是世界上最大的眼科会议，有来自75多个国家的10000多名成员。

The schedule of the presentation is as follows:

演讲时间表如下：

Presentation Number: 2159 Presentation Title: Development of eyedrops for anti-VEGF therapeutic antibodies as a substitute for IVT injection for posterior ocular disease indications Session Number: 240 Session Title: Advancements in age-related macular degeneration: Novel drugs, delivery systems, and mechanistic insights Session Date/Start Time: May 6, 2024 from 3:00 PM to 3:15 PM Room: Yakima 1 (Seattle Convention Center - Arch Building).

报告编号：2159报告标题：开发抗VEGF治疗性抗体滴眼液替代IVT注射治疗后眼病适应症会议编号：240会议标题：年龄相关性黄斑变性的进展：新药，输送系统和机械见解会议日期/开始时间：2024年5月6日下午3:00至下午3:15会议室：Yakima 1（西雅图会议中心-Arch Building）。

About Wincal Biopharm, Inc.

关于Wincal Biopharm，Inc。

Wincal Biopharm (WincalBio) is focused on developing vascular therapeutics. Our current focus is on developing eyedrop formulations for therapeutic antibodies using proprietary Ocular Penetration Carrier (OPC) screening platform to identify a matching antibody:carrier pair that allows therapeutic antibodies reach intraocular space including aqueous chamber, vitreous, retina and choroid, which is difficult without injection.

Wincal Biopharm（WincalBio）专注于开发血管疗法。我们目前的重点是使用专有的眼穿透载体（OPC）筛选平台开发用于治疗性抗体的滴眼剂制剂，以鉴定匹配的抗体：载体对，其允许治疗性抗体到达眼内空间，包括房水，玻璃体，视网膜和脉络膜，这是困难的没有注射。

This non-invasive eyedrop delivery of therapeutic antibodies without intravitreal injections opens up broader treatment opportunities for multiple intraocular diseases including wet AMD, DME, diabetic retinopathy, uveitis, geographic atrophy, thyroid eye disease and uveal melanoma to lower the treatment burden for both patients and clinicians.

这种无需玻璃体内注射的治疗性抗体的非侵入性滴眼液为多种眼内疾病（包括湿性AMD，DME，糖尿病视网膜病变，葡萄膜炎，地理萎缩，甲状腺眼病和葡萄膜黑色素瘤）提供了更广泛的治疗机会，以降低患者和临床医生的治疗负担。

It can be used as a monotherapy with already FDA approved anti-VEGF antibodies as well as combination with other novel target antibodies including cytokine targets such as ILs (IL-1, IL-4, IL-6, IL-10, IL-17, IL-18, IL-23), TNFa, TGFb, FGF, PDGF, FasL, EGFR as well as ocular cancer targets (PD-1, PD-L1, CTLA4).

它可以用作已经FDA批准的抗VEGF抗体的单一疗法，以及与其他新型靶向抗体的组合，包括细胞因子靶标，如IL（IL-1，IL-4，IL-6，IL-10，IL-17，IL-18，IL-23），TNFα，TGFb，FGF，PDGF，FasL，EGFR以及眼癌靶标（PD-1，PD-L1，CTLA4）。

Currently, anti-VEGF antibody is a lead program with preclinical efficacy demonstration in mouse CNV model, and planning to do clinical studies in 2026 followed by other novel target antibody programs and combination programs. At WincalBio, our commitment to in vivo science with a needle free drug delivery underpins to improve patient's quality of life and compliance..

目前，抗VEGF抗体是在小鼠CNV模型中具有临床前疗效证明的领先项目，并计划在2026年进行临床研究，然后是其他新型靶向抗体项目和组合项目。在WincalBio，我们致力于无针给药的体内科学，以提高患者的生活质量和依从性。。

About OPC Platform

关于OPC平台

Ocular Penetration Carrier (OPC) platform is an in vivo ocular penetration screening to quickly identify a matching cargo protein to carrier formulation from our proprietary carrier library. Delivered target protein localization from cornea, anterior chamber, vitreous, retina, choroid and optic nerve can be monitored with a labeled fluorescent signal.

眼部穿透载体（OPC）平台是一种体内眼部穿透筛选，可从我们专有的载体文库中快速识别匹配的货物蛋白与载体制剂。可以用标记的荧光信号监测角膜，前房，玻璃体，视网膜，脉络膜和视神经的靶蛋白定位。

A wide variety of large molecule therapeutic candidates including Fab, scFv, IgGs, Fc fusion proteins, recombinant proteins and growth factors can be delivered to the back of eye. Our proprietary carriers were designed to facilitate large molecules to intraocular target area..

可以将多种大分子治疗候选物（包括Fab，scFv，IgG，Fc融合蛋白，重组蛋白和生长因子）递送至眼后。我们的专有载体旨在促进大分子进入眼内靶区。。

About Aflibercept-ED (WBP-101)

关于Aflibercept ED（WBP-101）

Aflibercept-ED (WBP-101) is an aflibercept/OPC eyedrop formulation to target retinal area without using needles. Aflibercept has been clinically well proven anti-VEGF therapeutics with the delivery route of intravitreal injections. WBP-101 eyedrop application can significantly improve ease of use and avoid injection related issues including pain, bleeding, infection or inflammation and may improve patient adherence rate by lowering treatment related burdens.

Aflibercept ED（WBP-101）是一种Aflibercept/OPC滴眼液制剂，无需使用针头即可靶向视网膜区域。Aflibercept已被临床证明具有玻璃体内注射的递送途径的抗VEGF治疗剂。WBP-101滴眼液的应用可以显着提高易用性，避免注射相关问题，包括疼痛，出血，感染或炎症，并可以通过降低治疗相关负担来提高患者的依从性。

Patients can easily apply eyedrops at home, which can replace IVT injection procedures for ocular disease treatment. WBP-101 can be a primary monotherapy or can be used as a maintenance therapy after an initial IVT injection. Combination therapy is also possible by delivering different pathway blocking antibodies in a single formulation.

患者可以在家中轻松使用滴眼液，可以替代IVT注射程序治疗眼部疾病。WBP-101可以是主要的单一疗法，也可以在初次IVT注射后用作维持疗法。通过在单一制剂中递送不同的途径阻断抗体，也可以进行联合治疗。

Preclinical PoC in mouse CNV model demonstrated a comparable efficacy profile to the IVT injected..

小鼠CNV模型中的临床前PoC表现出与IVT注射相当的疗效。。

For additional information about Wincal Biopharm, Inc., visit https://www.wincalbio.com.

For additional information about Wincal Biopharm, Inc., visit https://www.wincalbio.com.

SOURCE PharmAbcine

来源PharmAbcine