Kodiak Sciences Announces Upcoming Presentations of Tarcocimab Tedromer (KSI-301) Phase 3 BEACON Study Results in Retinal Vein Occlusion (RVO)

2022-08-19

合作抗体

PALO ALTO, Calif., Aug. 18, 2022 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases, today announced that results from the Phase 3 BEACON study in Retinal Vein Occlusion (RVO) of its investigational therapy tarcocimab tedromer (KSI-301) will be presented at two upcoming ophthalmology conferences: the 22nd EURETINA Congress in Hamburg, Germany, and the 2022 American Academy of Ophthalmology Meeting in Chicago, Illinois.

Details of the presentations are as follows:

22nd EURETINA Congress, Euretina Session 8: Late Breakings (Hamburg, Germany)

Title: KSI-301 Anti-VEGF Antibody Biopolymer Conjugate for Retinal Vein Occlusion: Primary 24-Week Efficacy and Safety Outcomes of the BEACON Phase 3 Pivotal Study

Presenter: Arshad Khanani, M.D., M.A., FASRS, Director of Clinical Research, Sierra Eye Associates, Reno, NV

Presentation date and time: September 2, 2022; 16:45 CEST

2022 American Academy of Ophthalmology Meeting, Retina Subspecialty Day (Chicago, Illinois)

Title: KSI-301 Anti-VEGF Antibody Biopolymer Conjugate for Retinal Vein Occlusion: Primary and Secondary 24- Week Efficacy and Safety Outcomes of the BEACON Phase 3 Pivotal Study

Presenter: Michael A Singer, M.D., Clinical Professor of Ophthalmology, University of Texas Health Science Center, and Director of Clinical Research, Medical Center Ophthalmology Associates, San Antonio, TX

Presentation date and time: September 30, 2022; 4:39 PM CST

Kodiak plans to post the slides from these presentations on the "Events and Presentations" section of Kodiak's website at http://ir.kodiak.com/ following each 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 wet AMD, DME, RVO and non-proliferative DR (without DME) through clinical studies run in parallel. The Company's GLEAM and GLIMMER studies in patients with diabetic macular edema, the BEACON study in patients with retinal vein occlusion, the DAYLIGHT study in patients with wet AMD and the GLOW study in patients with NPDR are anticipated to form the basis of the Company's BLA to support potential approval and commercialization in multiple indications. 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 the BEACON Study

The Phase 3 BEACON study is a global, multi-center, randomized study designed to evaluate the durability, efficacy and safety of tarcocimab tedromer in 568 patients with treatment-naïve macular edema due to retinal vein occlusion, including both branch and central subtypes. Patients are randomized 1:1 to receive tarcocimab 5 mg or aflibercept 2 mg. In the first six months, patients receiving tarcocimab are treated with a proactive, fixed regimen which includes two monthly loading doses followed by treatment every 8 weeks, and patients receiving aflibercept are treated monthly as per its label. In the second six months, patients in both groups will receive treatment on an individualized basis per protocol-specified criteria. Patients can then continue to receive tarcocimab tedromer for an additional six months on an individualized basis. In the BEACON study, tarcocimab tedromer dosed every two months met the primary endpoint of non-inferior visual acuity gains compared to aflibercept dosed every month. Tarcocimab is the first anti-VEGF therapy to achieve non-inferiority in visual acuity gains while doubling the treatment interval in patients with RVO. In the study, tarcocimab was well tolerated with a low rate of intraocular inflammation and no new or unexpected safety signals. Results from the BEACON study are intended to serve as the basis for the potential approval of tarcocimab in RVO. Additional information about the BEACON study (also called Study KS301P103) can be found on www.clinicaltrials.gov under Trial Identifier NCT04592419 (https://clinicaltrials.gov/show/NCT04592419).

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.

机构