Kodiak Sciences Announces Upcoming Presentation of First Time Results of KSI-501ABC Phase 1 Study at the Angiogenesis, Exudation, and Degeneration 2024 Virtual Meeting
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"We look forward to sharing for the first time the results of our Phase 1 study of KSI-501ABC, our anti-IL-6 antibody and VEGF-trap bispecific therapeutic candidate in its antibody biopolymer conjugate form. The data being presented will outline the safety and bioactivity of KSI-501ABC in patients with diabetic macular edema (DME), a disease known to have high levels of cytokine-mediated microvascular inflammation in addition to VEGF-mediated fluid and leakage. We believe these early results support further clinical development of the KSI-501 program," said Dr. J. Pablo Velazquez-Martin, MD., Senior Vice President of Clinical Research and Development.
Details on the presentation are as follows:
Title: KSI-501 Bispecific Anti-VEGF Anti-IL-6 Antibody Biopolymer Conjugate: First Time Results of the Multiple Ascending Dose Phase 1 Study
Presenter: Mark R. Barakat, M.D., Managing Partner and Director of Clinical Research, Retina Macula Institute of
Date and time: Saturday, February 3, 2024, at 3:30 PM ET
Kodiak plans to post the presentation slides on the "Events and Presentations" section of Kodiak's website at http://ir.kodiak.com/ at the beginning of the presentation.
About the KSI-501 Clinical Program
KSI-501 is our first-in-class bispecific investigational medicine designed to inhibit both IL-6 mediated inflammation and VEGF-mediated angiogenesis and vascular permeability. IL-6 is known to play an important role in the pathophysiology of multiple retinal diseases and, in conditions for which anti-VEGF therapy is used, elevated levels of ocular IL-6 have been associated with poor anti-VEGF treatment response.
The KSI-501 program will be developed in parallel as a free protein and as a bioconjugate, addressing two very different unmet needs.
We intend to develop KSI-501 both as (1) KSI-501ABC bioconjugate, for the treatment of high prevalence retinal vascular diseases, where addressing multiple biologies is still a significant unmet need; (2) KSI-501P, its unconjugated bispecific protein, for the treatment of macular edema secondary to inflammation, as currently there are no available intravitreal biologic therapies addressing the spectrum of inflammatory diseases of the retina.
The Phase 1 study of KSI-501ABC is a multiple ascending dose study in patients with diabetic macular edema (DME). The study enrolled treatment naïve and previously treated DME patients with an 8-week washout period. Each subject received 3 monthly doses and was followed for 24 weeks.
The KSI-501 program may represent a new category of retinal medicine with the potential to provide additional clinical benefits beyond anti-VEGF monotherapies across both high prevalence retinal vascular disease and inflammatory disease of the retina.
About Kodiak Sciences, Inc.
Kodiak (Nasdaq: KOD) is a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high-prevalence retinal diseases. We are focused on bringing new science to the design and manufacture of next generation retinal medicines to prevent and treat the leading causes of blindness globally. Our antibody biopolymer conjugate platform, or ABC Platform™, is at the core of Kodiak's discovery engine. Kodiak's first investigational medicine, tarcocimab tedromer, is a novel anti-VEGF antibody biopolymer conjugate explored for the treatment of retinal vascular diseases. Kodiak's second clinical program, KSI-501, built from a first-in-class bispecific protein targeting both IL-6 (anti-IL-6 antibody) and VEGF (VEGF-trap), is intended to treat both retinal inflammatory and high prevalence retinal vascular diseases. Kodiak is based in Palo Alto, CA. For more information, please visit www.kodiak.com.
Forward-Looking Statements
This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding: The KSI-501 program may represent a new category of retinal medicine with the potential to provide additional clinical benefits beyond anti-VEGF monotherapies; the objectives and potential benefits of KSI-501, including its potential to be a first-in-class bispecific ABC inhibiting VEGF and IL-6; and the potential for KSI-501 to represent a new category of medicine in retina. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "could," "expect," "plan," "believe," "intend," "pursue," and other similar expressions among others. Any forward-looking statements are based on management's current expectations of future events and are subject to a risks and uncertainties that could cause actual results to differ materially and adversely from those in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: cessation or delay of any clinical studies and/or development of KSI-501 may occur; the risk that KSI-501 may not inhibit VEGF and IL-6, provide extended durability or have an impact on the treatment of patients as expected; adverse economic conditions may significantly impact our business and operations, including our clinical trial sites, and those of our manufacturers, contract research organizations or others with whom we conduct business; as well as the other risks identified in our filings with the Securities and Exchange Commission (SEC). For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in our most recent Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof and Kodiak undertakes no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.
Kodiak®, Kodiak Sciences®, ABC™, ABC Platform™ and the Kodiak logo are registered trademarks or trademarks of Kodiak Sciences Inc. in various global jurisdictions.
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