PALO
ALTO, Calif., April 3,
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 the first
patient has been treated in the Phase 1 study of KSI-501, an
investigational bispecific antibody biopolymer conjugate targeting
both VEGF and IL-6. KSI-501 is the second product candidate built
on Kodiak's Antibody Biopolymer Conjugate (ABC) Platform to enter
the clinic.
The Phase 1 study of KSI-501 is being conducted in the
USA as an open-label, multiple
ascending dose study and initially is enrolling patients with
diabetic macular edema (DME). The primary objectives of the Phase 1
study are to evaluate ocular and systemic safety and to establish a
maximum tolerated dose.
"We are proud to continue to be a key early participant in
Kodiak's Phase 1 clinical studies," said Mark R. Barakat, M.D., an investigator in the
study and Director of the Retinal Research Institute at Retinal
Consultants of Arizona,
Phoenix, AZ. "From our
experience with tarcocimab tedromer, Kodiak's first ABC product
candidate, we know that the ABC Platform has great potential for
potent, durable responses in patients with retinal diseases.
KSI-501 is unique in its dual mechanisms of action and inhibits
both vascular endothelial growth factor (VEGF) and interleukin-6
(IL-6). I am enthusiastic about the potential for KSI-501 with its
anti-IL-6 activity to achieve a greater therapeutic benefit for
patients whose retinal disease has an inflammatory component. We
look forward to learning more about KSI-501's safety and
bioactivity from the ongoing Phase 1 study."
"We are very pleased to have initiated dosing in the Phase 1
study of KSI-501," said Jason
Ehrlich, M.D., Ph.D., Chief Medical Officer and Chief
Development Officer of Kodiak Sciences. "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. We believe
KSI-501 represents a new category of retinal medicine, uniquely
designed to provide potent inhibition of both VEGF-mediated
vascular permeability and IL-6 mediated inflammation in a single
bispecific molecule and also with the benefits of extended
durability enabled by our ABC Platform. Our Phase 1 study of
KSI-501 will initially focus on establishing safety in patients
with DME, a disease known for its high levels of microvascular
inflammation, and we anticipate broadening the spectrum of diseases
under study once dose escalation is complete. For example, KSI-501
may be an important new treatment option for diseases that
currently lack targeted therapies such as uveitic macular
edema."
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 primary cell 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 enrolling 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 product
candidate, tarcocimab, 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
potential of the ABC Platform for potent, durable responses in
patients with retinal diseases; the potential for KSI-501 to
achieve a greater therapeutic benefit for patients whose retinal
disease has an inflammatory component and to provide potent
inhibition of both VEGF-mediated vascular permeability and IL-6
mediated inflammation; future development plans and the expected
timing of clinical study readouts; 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 objectives of the our
tarcocimab clinical program. 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.