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.
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 our regulatory strategy,
including the expected bases on which regulatory approval may be
sought; 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 may occur; future
regulatory milestones of tarcocimab, 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.