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.