PALO
ALTO, Calif., Jan. 30,
2024 /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 first time
results of the KSI-501ABC Phase 1 Study will be presented at the
Angiogenesis, Exudation, and Degeneration 2024 virtual meeting.
KSI-501ABC is the second product candidate built on Kodiak's
Antibody Biopolymer Conjugate (ABC) Platform.
"We look forward to sharing for the first time the results of
our Phase 1 study of KSI-501ABC, our anti-IL-6 antibody and
VEGF-trap bispecific therapeutic candidate in its antibody
biopolymer conjugate form. The data being presented will outline
the safety and bioactivity of KSI-501ABC in patients with diabetic
macular edema (DME), a disease known to have high levels of
cytokine-mediated microvascular inflammation in addition to
VEGF-mediated fluid and leakage. We believe these early results
support further clinical development of the KSI-501 program," said
Dr. J. Pablo Velazquez-Martin, MD.,
Senior Vice President of Clinical Research and Development.
Details on the presentation are as follows:
Title: KSI-501 Bispecific Anti-VEGF Anti-IL-6 Antibody
Biopolymer Conjugate: First Time Results of the Multiple Ascending
Dose Phase 1 Study
Presenter: Mark R.
Barakat, M.D., Managing Partner and Director of Clinical
Research, Retina Macula Institute of Arizona, Clinical Assistant Professor of
Ophthalmology, University of Arizona
College of Medicine, Phoenix,
AZ
Date and time: Saturday, February
3, 2024, at 3:30 PM ET
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 the KSI-501 Clinical Program
KSI-501 is our first-in-class bispecific investigational
medicine designed to inhibit both IL-6 mediated inflammation and
VEGF-mediated angiogenesis and vascular permeability. IL-6 is known
to play an important role in the pathophysiology of multiple
retinal diseases and, in conditions for which anti-VEGF therapy is
used, elevated levels of ocular IL-6 have been associated with poor
anti-VEGF treatment response.
The KSI-501 program will be developed in parallel as a free
protein and as a bioconjugate, addressing two very different unmet
needs.
We intend to develop KSI-501 both as (1) KSI-501ABC
bioconjugate, for the treatment of high prevalence retinal vascular
diseases, where addressing multiple biologies is still a
significant unmet need; (2) KSI-501P, its unconjugated bispecific
protein, for the treatment of macular edema secondary to
inflammation, as currently there are no available intravitreal
biologic therapies addressing the spectrum of inflammatory diseases
of the retina.
The Phase 1 study of KSI-501ABC is a multiple ascending dose
study in patients with diabetic macular edema (DME). The study
enrolled treatment naïve and previously treated DME patients with
an 8-week washout period. Each subject received 3 monthly doses and
was followed for 24 weeks.
The KSI-501 program may represent a new category of retinal
medicine with the potential to provide additional clinical benefits
beyond anti-VEGF monotherapies across both high prevalence retinal
vascular disease and inflammatory disease of the retina.
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™, is at the core of Kodiak's
discovery engine. Kodiak's first investigational medicine,
tarcocimab tedromer, is a novel anti-VEGF antibody biopolymer
conjugate explored for the treatment of retinal vascular diseases.
Kodiak's second clinical program, KSI-501, built from a
first-in-class bispecific protein targeting both IL-6 (anti-IL-6
antibody) and VEGF (VEGF-trap), is intended to treat both retinal
inflammatory and high prevalence retinal vascular diseases. 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: The
KSI-501 program may represent a new category of retinal medicine
with the potential to provide additional clinical benefits beyond
anti-VEGF monotherapies; 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 the
potential for KSI-501 to represent a new category of medicine in
retina. 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 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; 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.