SHANGHAI, China, July 3, 2023 – Skyline Therapeutics, an innovation-driven gene therapy company committed to developing unique and novel solutions for rare and severe diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for Phase I/IIa clinical trial of SKG0106, a one-time intravitreally delivered AAV gene therapy for the treatment of neovascular age-related macular degeneration (nAMD). Global Phase I clinical trial will be initiated soon.
SKG0106 is a distinctively designed recombinant adeno-associated virus (rAAV)-mediated gene therapy for ocular disease. It encompasses a proprietary novel AAV capsid and a uniquely configured transgene genome encoding anti-VEGF protein. In comprehensive preclinical studies, SKG0106 has demonstrated potent efficacy of inhibition of intraocular neovascularization, a favorable safety profile, and long-lasting durability following a single intravitreal administration.
In support of the IND application, SKG0106 GMP-grade material was produced utilizing Skyline Therapeutics' proprietary manufacturing platform that integrates cell line development, plasmid and viral vector process development, analytical development and GMP production, ensuring unwavering support for the Company’s preclinical and clinical programs in its pipeline.
About SKG0106
Investigational SKG0106 is a proprietary novel recombinant adeno-associated viral vector containing a uniquely configured transgene with potent inhibition effect on intraocular neovascularization, an innovative one-time intravitreally delivered AAV gene therapy that is being developed for the treatment of serious ophthalmic conditions including nAMD. Robust preclinical proof-of-concept studies validated SKG0106 as a safe and effective anti-angiogenic treatment with durable suppression of neovascular lesions at a low-dose single intravitreal injection, which results in the prevention of choroidal or retinal neovascularization and relief of retinal edema and vascular leakage.
About Skyline Therapeutics
Skyline Therapeutics is an innovation-driven clinical-stage gene therapy company dedicated to developing unique and novel solutions to address unmet needs in rare and severe diseases. Our cutting-edge adeno-associated virus (AAV) platform comprises multiple proprietary technologies for capsid discovery, transgene design and vector engineering. Combining our AAV expertise with robust in-house process and analytical development, and GMP manufacturing for clinical-grade plasmid and viral vector production, we are advancing a diverse pipeline of gene therapies for ocular, neurological, cardiovascular and metabolic disorders. Our lead programs, with significant therapeutic potential as validated by rigorous preclinical studies, are now in first-in-human clinical trials, bringing us closer to providing life-changing therapies to patients in need. Skyline Therapeutics has established global presence for research, development, regulatory, and manufacturing in Shanghai and Hangzhou, China, and Boston, MA, USA. www.skytx.com
Copyright © 2023 Skyline Therapeutics. All rights reserved. | 沪公网安备 31011502019226号 | 沪ICP备2020027216号-4
Terms and Conditions | Privacy Policy
This website www.skytx.com (“Website”) is developed and operated by Skyline Therapeutics (Shanghai) Co., Ltd. (“Skyline”). Any entity or individual is advised to read this Terms and Conditions carefully before access, browse or use this website. Do not access this Website if you do not consent to the terms herein. By your continued accessing, browsing, or using this Website, you will be deemed to have understood and fully agreed to be subject to this Terms and Conditions and abide by the laws and regulations applicable to this Terms and Conditions.
You understand and agree that we may change this Terms and Conditions at any time without prior notice. Please review this Terms and Conditions periodically to make sure that you are aware of contents in the most up-to-date version. If you do not accept any revision to this Terms and Conditions, please stop visiting, browsing, and otherwise using the Website.
Your access to and use of this Website is also governed by the Privacy Policy of Skyline, which is hereby incorporated by reference.
ProhibitionsWhen using this Website, you shall (a) not infringe lawful interests of Skyline or other third parties, (b) not interfere with or attempt to interfere with, by any means whatsoever, normal operation of this Website, (c) not to attempt to decrypt, decompile, disassemble or reverse engineer any software contained on or constitutes this Website, (d) not to delete or change any published material by Skyline or any other person or entity on this Website, or (e) not to include or link to any material or information provided on this Website within the web framework.
Content and Intellectual PropertyAll contents on this Website and their copyrights, including but not limited to data, texts, logos, graphics, audios, animations, records, or videos, belong to Skyline, unless otherwise indicated or be made known expressly that they belong to a third party. This website and all relevant contents are protected under the laws and regulations of China and applicable international laws and regulations on copyrights.
All trademarks, service marks, trade names, logos, and icons used and displayed on this Website are proprietary to Skyline and its affiliates. Other company, product, and service names on this Website may be trademarks or service marks owned by third parties ("third-party trademarks", together with trademarks owned by Skyline collectively referred to as "Trademark"). Nothing in this Website or this Terms and Conditions shall be construed as granting, by implication, estoppel or otherwise, any license or right to use any Trademarks displayed on this Website without the prior written consent of Skyline or other relevant trademark owners. Trademarks may not be used to undermine the image, product, or service of Skyline or any third party, or to damage the goodwill represented by the Trademark in any way (as judged by reasonable business rules).
DisclaimersTO THE FULL EXTENT PERMISSIBLE BY LAW, OFFICIALS, DIRECTORS, EMPLOYEES, AGENTS, SUPPLIERS OR LICENSORS OF EACH OF SKYLINE AND ITS AFFILIATES (COLLECTIVELLY REFERRED TO AS “SKYLINE PARTIES”) MAKE NO WARRANTIES, STATEMENTS OR REPRESENTATIONS, EXPRESS OR IMPLIED, ON ANY CONTENT ON THIS WEBSITE (INCLUDING BUT NOT LIMITED TO, PROMPTNESS, GENERALITY, PRECISION, RELIABILITY, COMPLETENESS OF SUCH CONTENT FOR A PARTICULAR PURPOSE, OR ACCURATENESS OR CREDIBILITY OF ANY INFORMATION GAINED FROM THIS WEBSITE). SKYLINE MAKES NO COMMITMENT TO UPDATE ALL OR PART OF THE CONTENTS ON THIS WEBSITE IN A TIMELY MANNER. SKYLINE RESERVES THE RIGHT TO CORRECT, MODIFY OR CEASE TO PUBLISH ALL OR ANY PART OF THE CONTENTS ON THIS WEBSITE WITHOUT NOTICE TO ANY PARTY AND SHALL NOT UNDERTAKE ANY LIABILITIES THEREOF. YOU ASSUME TOTAL RESPONSIBILITY FOR ALL THE RISKS ARISING FROM YOUR ACCEPTANCE OF ANY SUGGESTION, VIEW, STATEMENT, OR INFORMATION ON THIS WEBSITE, IN WHICH CASE SKYLINE DISCLAIMS ANY AND ALL LIABILITY.
FOR THE USE OF THIS WEBSITE OR ANY INFORMATION OBTAINED OR DOWNLOADED FROM THIS WEBSITE, YOU SHALL AGREE THAT YOU WILL, AT YOUR OWN RISK, DECIDE WHETHER TO USE THEM. SKYLINE, ITS LICENSOR, SUPPLIER OR ANY THIRD PARTY MENTIONED ON THIS WEBSITE SHALL NOT UNDERTAKE ANY LIABILITY FOR ANY LOSS RESULTING FROM THE USE OR UNAVAILABILITY OF THIS WEBSITE, OR ANY MALFUNCTION, COMPUTER VIRUS OR LOSS OF DATA OCCURRED IN OPERATION OR TRANSITION.
IndemnificationYou agree to hold, indemnify, and prevent Skyline and Skyline Parties from being liable for any claims, damages, costs, liability, or expense resulting from or allegedly resulting from your breach of this Terms and Conditions, including but not limited to reasonable attorney fees and accounting fees. In the event of such claims, damages, costs, liability, or expense, Skyline will notify you. Skyline has the right to exclusive defense and control of any matter for indemnification under this section. In this case, you agree to provide Skyline with assistance as Skyline may reasonably request in defending such matters.
Termination of useSkyline reserves the right, in its sole discretion, to limit, suspend, or terminate this Terms and Conditions and your rights to use all or any part of this Website or Content at any time and for any reason, without notice or liability. Skyline reserves the right to change, suspend or terminate all or any part of this Website or Content at any time without notice or liability.
Medical InformationNothing on this Website shall be construed as providing any kind of medical advice or recommendation and shall not be relied on for any decision or action. Specific medical advice shall always be sought from a qualified medical practitioner.
Third Party WebsitesThis Website contains links to third party websites. Skyline shall not be deemed to have agreed to any of its contents by providing such links. Neither does Skyline accept any responsibility for the availability or the contents of such websites or any liability or damage resulting from the use of such contents. Links to such websites are provided to users of this website merely for the sake of convenience. Users access such websites at their own risks.
Governing lawAny dispute in connection with this Website or this Terms and Conditions shall be governed by laws of the People’s Republic of China, excluding the Hong Kong, Macau, and Taiwan.
Dispute ResolutionIn the event of any dispute, controversy or claim arising out of or relating to these Terms of Use or your use of the Website, Content or Services, you shall attempt in the first instance to resolve such dispute through friendly consultations.
In the event such dispute is not resolved through consultations within thirty (30) days after the date such consultations were first requested in writing, then you or we may submit the dispute for arbitration in Shanghai before the Shanghai International Economic and Trade Arbitration Commission(“SHIAC”) in accordance with SHIAC Arbitration Rules then in force.
The latest version of this Terms and Conditions is made and effective on November 26, 2021.
Skyline Therapeutics (Shanghai) Co., Ltd. (hereinafter referred to as “Skyline”, or “we”) respects the privacy of visitors (“You” or “Users) to our website www.skytx.com (“Website”), and therefore we establish this Privacy Policy (this “Policy”) pursuant to the applicable laws and regulations of China on the protection of personal information. This Policy applies to this Website and the services you may use on this Website. Please read carefully and make sure that you fully understand this Policy. If you do not agree to this Policy, please do not use this Website.
Information CollectionWhen you interact with us through this Website, we may collect your personal information to perform and respond to your requests to us. Under this Policy, “Personal Information” means any information by which you can be identified, such as your name, birthday, e-mail address, postal address, telephone number, or education background and professional experience (such as to submit resume online).
It is entirely your choice to provide us your Personal Information, and Skyline only collects the information you provide to us. According to this Policy, you will be deemed to have agreed to our use of your Personal Information when you visit this Website and provide us with your Personal Information.
Use of CookiesThis Website may use "Cookies" and other similar technologies. We store small data files called Cookies on your computer or mobile device for the normal operation of the Website. We will not use Cookies for any purpose other than those described in this policy. You may configurate Cookies under the help feature of the tool bar of most browsers. You may configurate most of the browsers to notify you when you receive a new cookie or choose to have your browser disable cookies altogether. Because Cookies allow you to take advantage of some of this Website’s essential features, we recommend that you leave them turned on.
Information UseWe will use such Personal Information solely for the purposes of maintaining this website, assisting you to register to acquire relevant services you may need, and responding to your questions and requests for information.
When we want to use Personal Information for other purposes not specified in this policy, we will seek your consent in advance. When we want to use the Personal Information collected for a specific purpose for other purposes, we will ask for your consent in advance.
Information Disclosures and SharingExcept as provided below, we will not share your Personal Information with third parties unless you have consented to the disclosure.
Sometimes we will ask some other companies or persons for service such as system technical support. To provide this kind of service, they may have access to your Personal Information but will not use the Personal Information for any other purpose.
We may share Personal Information to respond to duly authorized subpoenas or other lawful information requests of governmental authorities, including to meet national security or law enforcement requirements, to provide Internet security, or where required by law.
Security MeasuresIn accordance with relevant national standards, we implement security precaution measures that satisfies industrial standards to protect your Personal Information. Nevertheless, you shall remain responsible to make sure that your computer is sufficiently secured and protected from leaking your Personal Information.
Third Party LinksThis Policy applies only to this Website. This Website may contain links to other Websites ("Third-Party Websites") that are not operated or controlled by Skyline. The policies and procedures described herein do not apply to Third-Party Websites. Links to this Website do not imply that we endorse or have reviewed Third-Party Websites. We encourage you to contact these sites directly to obtain their privacy policy.
Minor’s PrivacyOur service does not address anyone under the age of fourteen (14). We do not knowingly collect personally identifiable information from minors under fourteen (14). In the case we discover that a minor under fourteen (14) has provided us with personal information, we immediately delete this from our servers. If you are a parent or guardian and you are aware that your child has provided us with personal information, please contact us so that we will be able to take necessary steps.
MiscellaneousThis Policy is made and effective on November 26, 2021, which is the latest version.
Skyline reserves the right to modify this Policy at any time by notifying Users, via the Website, of a new or updated Policy, and you can review the most up-to-date version on this Website.
Contact UsIf you have any questions about this Policy, please contact us at info@skytx.com.
