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.
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SOURCE Kodiak Sciences Inc.