Kodiak Sciences Announces Upcoming Presentations on its Product and Research Pipeline at ARVO 2023 Annual Meeting

News provided by

Apr 21, 2023, 07:30 ET

PALO ALTO, Calif., April 21, 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 multiple scientific presentations on its clinical and research pipeline programs will be made at the Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting, being held from April 23 – 27 in New Orleans, United States.

"We look forward to sharing data across our pipeline of investigational medicines at this year's ARVO Annual Meeting," said Victor Perlroth, M.D., Chief Executive Officer of Kodiak Sciences. "Our efforts encompass Phase 3 clinical studies with our lead tarcocimab tedromer, a Phase 1 clinical study with our new bispecific KSI-501, and earlier discovery efforts. We believe the data being presented will demonstrate the robust retina-focused research and development engine at Kodiak. We remain committed to our mission of bringing new science to the prevention and treatment of high prevalence retinal diseases."

The following data will be presented at the meeting:

Presentation on tarcocimab tedromer (KSI-301):

Abstract Title: Nonclinical Pharmacokinetics, Distribution and Excretion of ¹²⁵I-KSI-301 after Intravenous Administration in Rats
Session Title: Retina / RPE: New drugs, mechanisms of action and toxicity
Session Date and Time: April 25, 2023; 8:45 – 10:45 AM CT
Presentation Type: Poster Session
Poster Number: 2606 - B0319

Presentations on KSI-501:

Abstract Title: KSI-501 is a novel anti-VEGF and anti-IL-6 bispecific biopolymer conjugate to simultaneously address neovascularization and inflammation in retinal diseases
Session Title: AMD New drugs, delivery systems and mechanisms of action 2
Session Date and Time: April 23, 2023; 3:45 – 5:45 PM CT
Presentation Type: Poster Session
Poster Number: 1153 - C0308

Abstract Title: Biological benefits of KSI-501: Novel bispecific anti-inflammatory and anti-angiogenic therapy for the treatment of both retinal vascular and inflammatory diseases
Session Title: AMD anti-VEGF
Session Date and Time: April 24, 2023; 3:15 – 5:00 PM CT
Presentation Type: Poster Session
Poster Number: 2215 - C0168

Presentations on research pipeline:

Abstract Title: Development and characterization of an anti-HTRA1 antibody for dry AMD treatment
Session Title: AMD New drugs, delivery systems and mechanisms of action 2
Presentation Date and Time: April 23, 2023; 3:45 – 5:45 PM CT
Presentation Type: Poster Session
Poster Number: 1151 - C0306

Abstract Title: Development of a modular IL-1 trap and anti-HTRA1 bispecific for the treatment of dry AMD
Session Title: AMD New drugs, delivery systems and mechanisms of action 2
Presentation Date and Time: April 23, 2023; 3:45 – 5:45 PM CT
Presentation Type: Poster Session
Poster Number: 1152 - C0307

About tarcocimab tedromer (tarcocimab, KSI-301)

Tarcocimab 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 is to enable earlier treatment and prevention of vision loss for patients with diabetic eye diseases and to develop a new first-line agent to improve outcomes for patients with retinal vascular diseases as a whole. The tarcocimab clinical program is designed to explore 6-month durability in the majority of patients with diabetic eye disease through the GLEAM and GLIMMER Phase 3 studies in diabetic macular edema ("DME") and the GLOW Phase 3 study in non-proliferative diabetic retinopathy ("NPDR") without DME. The tarcocimab clinical program is also exploring the product's durability, efficacy and safety in retinal vein occlusion ("RVO") via the BEACON Phase 3 study and in wet age-related macular degeneration ("wet AMD") via the on-going DAYLIGHT Phase 3 study. The BEACON study met its primary endpoint in 2022, and four Phase 3 clinical studies are expected to announce topline data in 3Q2023. If successful, Kodiak plans to file a single Biologics Licensing Applications ("BLA") for tarcocimab in the four major retinal vascular disease indications. The global tarcocimab clinical program is being conducted at 150+ study sites in more than 10 countries. Kodiak is developing and owns global rights to tarcocimab.

About KSI-501

Also built on Kodiak's ABC Platform, KSI-501 is an investigational, 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). IL-6 is a pro-inflammatory cytokine and growth factor 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 a trap-antibody fusion biopolymer conjugate designed to provide potent inhibition of (i) VEGF-mediated angiogenesis and vascular permeability through a soluble decoy receptor inhibiting the binding of VEGF-A and PLGF to their cognate receptors and (ii) IL-6 mediated inflammation through an antibody that binds soluble interleukin-6, inhibiting its binding to both soluble and membrane-bound IL-6 receptors. In cell-based assays, KSI-501 inhibits angiogenesis and also normalizes inner and outer blood retinal barriers; dual inhibition of VEGF and IL-6 by KSI-501 confers superior normalization of cell morphology and junctional biology compared to either anti-VEGF or anti-IL-6 monotherapy. We believe KSI-501 has the potential to become a new category of retinal medicines with greater therapeutic efficacy than existing therapies while also benefiting from the promising long-interval durability of Kodiak's ABC Platform. A Phase 1 study of KSI-501 is currently dosing patients in the United States to evaluate the safety, tolerability and bioactivity of KSI-501 in DME patients.

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™, 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 investigational medicine, tarcocimab tedromer, is a novel anti-VEGF antibody biopolymer conjugate being developed for the treatment of retinal vascular diseases including diabetic eye diseases, the leading cause of blindness in working-age patients in the developed world, and wet age-related macular degeneration, the leading cause of blindness in elderly patients in the developed world. The tarcocimab clinical program is designed to assess the product candidate's durability, efficacy and safety in major retinal vascular diseases in parallel, through the GLEAM and GLIMMER studies in diabetic macular edema, the BEACON study in retinal vein occlusion, the GLOW study in non-proliferative diabetic retinopathy and the DAYLIGHT study in wet age-related macular degeneration. Phase 3 data across the tarcocimab clinical program are expected in 3Q2023. 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) and is being investigated in a Phase 1 clinical study initially in patients with diabetic macular edema. We are expanding our early research pipeline to include ABC Platform based triplet inhibitors for multifactorial retinal diseases. 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 and presentation of clinical study readouts; our robust retina-focused research and development engine; the potential of the ABC Platform to maintain potent and effective drug levels in ocular tissues for longer than existing available agents; the potential for KSI-501 to achieve a greater therapeutic benefit for certain patients and to provide potent inhibition of both VEGF-mediated vascular permeability and IL-6 mediated inflammation; future development plans; the objectives and potential benefits of our tarcocimab clinical program, including its potential to enable earlier treatment and prevention of vision loss for patients with diabetic eye diseases; 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 its potential to provide extended durability; and the potential for a single BLA submission in four major retinal vascular disease indications. 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 KSI-501 may not inhibit VEGF and IL-6, provide extended durability or have an impact on the treatment of patients as expected; the risk that tarcocimab may not enable earlier treatment and prevention of vision loss for patients with diabetic eye diseases as expected; future potential regulatory milestones of tarcocimab/KSI-501, including those 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.