Kodiak Sciences Announces Upcoming Presentation of KSI-301 (tarcocimab tedromer) Clinical Data and Antibody Biopolymer Conjugate Development Programs at the Angiogenesis, Exudation and Degeneration 2023 Virtual Meeting

Rhea-AI Summary

Kodiak Sciences Inc. (Nasdaq: KOD) announced a presentation scheduled for February 11, 2023, at the Angiogenesis, Exudation and Degeneration 2023 Virtual Meeting, focusing on clinical data for its investigational therapy KSI-301 (tarcocimab tedromer) and updates on its Antibody Biopolymer Conjugate (ABC) development programs. CEO Victor Perlroth highlighted the progress with KSI-301, anticipating four Phase 3 clinical study readouts in Q3 2023. Additionally, the company has successfully opened an Investigational New Drug (IND) application for KSI-501, a bispecific therapy aimed at retinal diseases, with a Phase 1 study set to begin shortly.

Positive

• Anticipation of four Phase 3 clinical study readouts for KSI-301 in Q3 2023.
• Successful opening of IND for KSI-501, initiating a Phase 1 study soon.
• KSI-301 shows potential for improved treatment intervals in retinal diseases.

Negative

• Risks associated with potential delays or cessation of clinical studies.
• Uncertainty regarding the ongoing efficacy and durability of KSI-301 and KSI-501.

PALO ALTO, Calif., Feb. 9, 2023 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases, announced today that a presentation will be made at the upcoming Angiogenesis, Exudation and Degeneration 2023 Virtual Meeting including clinical data from Kodiak's investigational therapy KSI-301 (tarcocimab tedromer) and an update on Kodiak's pipeline of Antibody Biopolymer Conjugate (ABC) development programs.

Details of the presentation are as follows:

Title: Update on KSI-301 (tarcocimab tedromer) and Antibody Biopolymer Conjugate Development Programs

Presenter: Diana V. Do, M.D., Professor of Ophthalmology, Vice Chair of Clinical Affairs, Byers Eye Institute, Stanford University School of Medicine, Stanford, CA

Presentation date and time: February 11, 2023; 1:10 PM ET

"We continue to make strong progress executing multiple trials across the tarcocimab (KSI-301) clinical program. We anticipate four Phase 3 clinical study readouts later this year, in approximately 3Q2023. Building on the unique durability shown in BEACON, our positive Phase 3 study in retinal vein occlusion where we doubled the treatment interval for all patients, we look forward to the results across the broader Phase 3 program in which we explore 5- and 6- month durability in patients with diabetic eye disease," said Victor Perlroth, M.D., Chief Executive Officer of Kodiak Sciences.

"We are also pleased to have successfully opened the IND for KSI-501, our second product candidate built from the ABC platform. KSI-501 is a potential first-in-class bispecific ABC that is designed to inhibit two powerful pathophysiologic mechanisms in retinal disease, VEGF and IL-6. With the IND cleared by the US FDA, we plan to initiate the Phase 1 study shortly. We look forward to engaging with the retina community as we actively develop this new agent which has the potential to bring additional benefits to patients with a number of retinal diseases including diabetic eye disease, neovascular macular degeneration and uveitic macular edema."

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 tarcocimab tedromer (KSI-301)

Tarcocimab tedromer is an investigational anti-VEGF therapy built on Kodiak's Antibody Biopolymer Conjugate (ABC) Platform and is designed to maintain potent and effective drug levels in ocular tissues for longer than existing available agents. Kodiak's objective with tarcocimab tedromer is to develop a new first-line agent to improve outcomes for patients with retinal vascular diseases and to enable earlier treatment and prevention of vision loss for patients with diabetic eye disease. The tarcocimab tedromer clinical program is designed to assess the product's durability, efficacy and safety in several major retinal vascular diseases in parallel, through the DAYLIGHT study in wet AMD, the GLEAM and GLIMMER studies in DME, the BEACON study in RVO and the GLOW study in non-proliferative DR (without DME). The global tarcocimab tedromer clinical program is being conducted at 150+ study sites in more than 10 countries. Kodiak is developing and owns global rights to tarcocimab tedromer.

About KSI-501

Also built on Kodiak's Antibody Biopolymer Conjugate (ABC) Platform, KSI-501 is an investigational, potential first-in-class bispecific ABC that is designed to inhibit two mechanisms implicated in retinal diseases: vascular endothelial growth factor (VEGF) and interleukin-6 (IL-6). The trap-antibody fusion component of KSI-501 acts as (i) a soluble decoy receptor inhibiting the binding of VEGF-A and PLGF to their cognate receptors and (ii) an antibody that binds soluble interleukin-6, inhibiting its binding to both soluble and membrane-bound IL-6 receptors. IL-6 is a pro-inflammatory cytokine implicated in the pathophysiology of multiple retinal diseases and, in conditions for which anti-VEGF treatment is used, elevated levels of ocular IL-6 have been associated with poor anti-VEGF treatment response. KSI-501 is designed to provide potent inhibition of both VEGF-mediated angiogenesis and IL-6 mediated inflammation and has the potential to become a new category of retinal medicines with greater therapeutic efficacy than existing therapies. The IND for KSI-501 has been cleared, and a Phase 1 dose escalation study in diabetic macular edema (DME) patients is planned to commence shortly.

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. Founded in 2009, 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 ABC Platform™ uses molecular engineering to merge the fields of antibody-based and chemistry-based therapies and is at the core of Kodiak's discovery engine. Kodiak's lead product candidate, tarcocimab tedromer, is a novel anti-VEGF antibody biopolymer conjugate being developed for the treatment of retinal vascular diseases including wet age-related macular degeneration, the leading cause of blindness in elderly patients in the developed world, and diabetic eye diseases, the leading cause of blindness in working-age patients in the developed world. Kodiak has leveraged its ABC Platform to build a pipeline of product candidates in various stages of development. KSI-501 is our dual inhibitor antibody biopolymer conjugate targeting both VEGF (VEGF-trap) and IL-6 (anti-IL-6 antibody) for the treatment of retinal diseases. We are expanding our early research pipeline to include ABC Platform based triplet inhibitors for multifactorial retinal diseases such as dry AMD and glaucoma. Kodiak is based in Palo Alto, CA. For more information, please visit www.kodiak.com.

Kodiak®, Kodiak Sciences®, ABC™, ABC Platform™ and the Kodiak logo are registered trademarks or trademarks of Kodiak Sciences Inc. in various global jurisdictions.

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 expected timing of clinical study readouts; the potential benefits of KSI-501, including its potential to be a first-in-class bispecific ABC inhibiting VEGF and IL-6; the anticipated commencement of a Phase 1 study of KSI-501; the objectives and anticipated benefits of our KSI-301 clinical program; and expansion of our research pipeline. 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 tarcocimab and/or KSI-501 may occur; the risk that preliminary safety, efficacy and durability data for our tarcocimab tedromer product candidate may not continue or persist; the risk that tarcocimab tedromer may not have the anti-VEGF effect or impact on the treatment of patients as expected; the risk that KSI-501 may not inhibit VEGF and IL-6 or have an impact on the treatment of patients as expected; future regulatory milestones of tarcocimab and/or KSI-501, including related to current and planned clinical studies, may be insufficient to support regulatory submissions or approval; 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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SOURCE Kodiak Sciences Inc.

FAQ

What is the presentation by Kodiak Sciences on February 11, 2023, about?

The presentation will focus on KSI-301 (tarcocimab tedromer) clinical data and updates on the Antibody Biopolymer Conjugate development programs.

What trials is Kodiak Sciences anticipating results from?

Kodiak expects four Phase 3 clinical study readouts for KSI-301 in Q3 2023.

What is KSI-501 and when will its Phase 1 study commence?

KSI-501 is a bispecific therapy targeting retinal diseases, and its Phase 1 study is set to start shortly.

What are the potential benefits of KSI-301?

KSI-301 is designed to improve treatment intervals for patients with retinal diseases, potentially enhancing patient outcomes.