- Tarcocimab clinical and non-clinical data highlight strong
6-month efficacy profile in diabetic retinopathy patients and
continued favorable safety profile.
- KSI-501 clinical and non-clinical data highlight multiple
ascending dose safety, bioactivity and durability in
treatment-naïve and treatment-experienced patients and next steps
of Phase 3 development for KSI-501 and Phase 1b development for KSI-101.
- Novel small molecules and protein therapeutics highlight
potential for targeted, high drug-antibody-ratio (DAR) conjugates
built on Kodiak's ABC Platform.
PALO ALTO, Calif., May 2, 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 nine scientific presentations on its clinical and
research pipeline programs will be made at the Association for
Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting,
being held from May 5 – 9 in
Seattle, Washington.
"We present clinical and non-clinical data on our ABC Platform
medicines tarcocimab and KSI-501. We also begin to disclose the
progress and potential for our duet and triplet drug platform.
Conjugates of different active pharmaceutical intermediates (API)
such as proteins, peptides, macrocycles, oligonucleotides, and
small molecules, all with high drug antibody ratio (DAR) and
tailored release, can be designed and manufactured. We wrap these
within the 15 years of science and development experience with our
ABC Platform and its thousands of patient years of clinical safety
data and our commercial scale manufacturing facility Ursus," said
Dr. Victor Perlroth, Chief Executive
Officer of Kodiak Sciences. "With many companies focused on
engineering a better biologic or a better small molecule, we are
instead extending our ABC Platform to make copolymer conjugates
that power a next generation of targeted, high-DAR, multi-specific
and multi-modality therapeutic candidates with relevance for
retinal and systemic diseases."
Presentations on tarcocimab tedromer (KSI-301):
Title: Tarcocimab tedromer (KSI-301) 5mg:
outcomes of the Phase 3 GLOW1 Study in patients with
non-proliferative diabetic retinopathy.
Session Title:
Diabetic retinopathy I
Session Date and Time: May 6, 2024;
8:30 – 10:15 AM PT
Presentation Type: Poster Session
Poster Number: 221 – B0116
Approximately eight million people in the U.S. live with
diabetic retinopathy (DR), which is the leading cause of vision
loss in the working-age population. The adoption of approved
anti-VEGF therapies for DR patients is constrained by their high
treatment burden. Kodiak's GLOW1 study with tarcocimab showed for
the first time that a therapeutic agent dosed in all patients on an
every 6-month interval can successfully treat and prevent disease
worsening in DR patients. Tarcocimab offers the hope of an
achievable prevention and treatment strategy in real-world clinical
practice for DR patients at risk of vision loss. Currently, the
Phase 3 GLOW2 study is enrolling patients with DR, with the goal to
enable tarcocimab's marketing authorization application.
Title: Metabolic control in patients with
non-proliferative diabetic retinopathy (NPDR) treated with
anti-VEGF active injections or sham injections. Prespecified
results from the Phase 3 GLOW Study in patients treated with
tarcocimab tedromer.
Session Title: Diabetic retinopathy
II
Session Date and Time: May 7, 2024;
8:30 – 10:15 AM PT
Presentation Type: Poster Session
Poster Number: 323 – B0508
The prespecified analysis of the GLOW1 study demonstrated that
both the tarcocimab treatment arm and sham arm had negligible
change in systemic metabolic control as measured by HbA1c levels,
and both arms showed similar distribution of change in HbA1c from
baseline to primary endpoint at Week 48. These results suggest that
subjects in the tarcocimab arm achieved superiority in ≥2-step
improvement in DRSS over sham injections irrespective of baseline
and systemic metabolic control, as evidenced by HbA1c levels, and
any potential presumed knowledge by the patient about treatment
assignment due to the use of sham as a comparator did not
systematically influence their glycemic control.
Title: An embryo-fetal development study of
tarcocimab after intravenous injection in rabbits
Session
Title: Retina/RPE: New drugs, mechanisms of action, and
toxicity
Session Date and Time: May 8, 2024;
2:15 – 4:00 PM PT
Presentation Type: Poster Session
Poster Number: 5100 – A0357
The non-clinical study demonstrated that maternal administration
of tarcocimab to New Zealand White female rabbits by intravenous
injection at the highest tested dose of 5 mg/kg during the
organogenesis period of pregnancy was well tolerated. There were no
tarcocimab related mortality or abortions for any dosage regimen,
and no effects on embryo-fetal viability or fetal body weights, as
well as no malformations or variations at external, visceral, or
skeletal examination. These results continue to highlight the
favorable safety profile of tarcocimab and of Kodiak's ABC platform
and compare favorably to published results with marketed anti-VEGF
agents which have demonstrated embryo-fetal development effects in
animal studies.
Presentations on KSI-501:
Title: Ocular and systemic toxicity study of
KSI-501 demonstrates tolerability after intravitreal and
intravenous administration in cynomolgus
monkeys
Session Title: Retina/RPE: New drugs,
mechanisms of action, and toxicity
Session Date and Time: May 8, 2024;
2:15 – 4:00 PM PT
Presentation Type: Poster Session
Poster Number: 5094 – A0351
The non-clinical study demonstrated that repeated monthly
bilateral intravitreal administration of up to 5.25 mg/eye/dose
(maximum feasible dose) or intravenous dosing of up to 5 mg/kg/dose
(maximum tested dose) of KSI-501 in cynomolgus monkeys was safe and
well tolerated. Due to the mild severity of findings and the lack
of impact on the health and well‑being of animals administered 5
mg/kg IV or 5.25 mg/eye IVT, these doses were considered the
No Observed Adverse Effect Levels (NOAELs) for systemic and ocular
administration, respectively. These results provide a clear
margin of safety for repeat dosing and information for adequate
safety monitoring to support further clinical investigations with
KSI-501 (bioconjugate) and KSI-101 (bispecific protein) which are
ongoing. These results are also consistent with non-clinical data
generated with tarcocimab, another ABC Platform derived therapeutic
candidate, and suggest the continued safety profile of the ABC
Platform.
Title: KSI-501: a bispecific fusion protein
antibody inhibiting both interleukin-6 and vascular endothelial
growth factor. First-in-human trial results of multiple ascending
doses in patients with diabetic macular edema
Session Title:
Diabetic macular edema
Session Date and Time: May 9, 2024;
11:45 AM – 1:30 PM PT
Presentation Type: Poster Session
Poster Number: 530 – B0162
This first-in-human study was Part 1 of a Phase 1 multiple
ascending dose study of KSI-501 in both treatment naïve and
treatment experienced patients with DME. Part 1 demonstrated that
repeated monthly dosing of KSI-501 was safe and well tolerated and
achieved meaningful and sustained improvement in BCVA and OCT CST.
These results support further clinical development of both (1)
KSI-501, a bispecific antibody biopolymer conjugate, for high
prevalence retinal diseases to address the leading unmet needs of
durability and targeting multiple disease biologies; and (2)
KSI-101, a bispecific protein with high potency and high
formulation strength for inflammatory diseases of the eye.
Presentations on Research Pipeline:
Title: Identification and characterization of
novel NLRP3 inflammasome Inhibitors for the potential treatment of
retinal disease
Session Title: Treatment strategies
for inherited retinal disease
Presentation Date and Time: May 6,
2024; 3:00 – 4:45 PM PT
Presentation Type: Poster Session
Poster Number: 2208 – A0062
We disclose for the first time the discovery and
characterization of novel NLRP3 pathway inhibitors that are potent
and act on all levels of the NLRP3 pathway without non-specific
anti-inflammatory action. This work highlights Kodiak's small
molecule discovery capabilities, which play an important part in
our development of duet and triplet therapeutic candidates designed
to provide targeted high drug-antibody-ratio (DAR) and sustained
therapeutic benefit for both ophthalmic and systemic diseases.
Title: Development of anti-inflammatory bispecific
trap-antibodies
Session Title: Diabetic retinopathy,
anti-inflammatory agents, antibiotics and antivirals
Session Date and Time: May 8, 2024;
10:30 AM - 12:15 PM PT
Presentation Type: Poster Session
Poster Number: 4599 – A0328
We present a portfolio of novel bispecific anti-inflammatory
biologics targeting proinflammatory cytokines. This work highlights
the expansion of our modular trap-antibody platform and presents a
group of promising therapeutic candidates with the potential to
mitigate the complex effects of ocular inflammation in a
controlled, multi-specific manner.
Title: Internalization of antibody biopolymer conjugate via
receptor-mediated mechanism
Session Title: AMD New drugs,
delivery systems and mechanisms of action II
Session Date/Times: May 9, 2024;
8:00 - 9:45 AM PT
Presentation Type: Poster Session
Poster Number: 6120 – B1019
We demonstrate that antibody biopolymer conjugates built on our
ABC platform can be internalized upon binding to cell-surface
receptors, a key step enabling the use of our ABC platform for
cell-specific drug deliveries. The ABC platform, combined with
diverse drug modalities such as oligonucleotides, small molecules
and peptides including macrocycles, can overcome current limits on
drug-antibody-ratio (DAR) and provide a broad range of options for
multi-specific bioactive loading and targeted delivery.
Title: Development of enhanced complement regulators for the
treatment of geographic atrophy
Session Title: AMD New
drugs, delivery systems and mechanisms of action II
Session Date/Times: May 9, 2024; 8:00
– 9:45 AM PT
Presentation Type: Poster Session
Posterboard Number: 6119 – B1018
Geographic atrophy (GA), the advanced form of dry age-related
macular degeneration, affects approximately one million patients in
the U.S. and is characterized by atrophic lesions in the retina
that progressively expand to the central macular and fovea, leading
to irreversible vision loss. Currently there are two approved
therapies for GA, both are anti-complement therapies that offer
modest therapeutic benefit and require monthly or every other month
intravitreal injections. Here we present a promising therapeutic
strategy to treat GA and potentially wet AMD by combining
complement regulators with an anti-VEGF Fab to achieve potent,
concurrent inhibition of complement pathway activation and VEGF
pathway signaling.
About Kodiak Sciences Inc.
Kodiak Sciences (Nasdaq: KOD) is a biopharmaceutical company
committed to researching, developing, and commercializing
transformative therapeutics to treat a broad spectrum of 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 ABC Platform™
uses molecular engineering to merge the fields of protein-based and
chemistry-based therapies and has been at the core of Kodiak's
discovery engine. We are developing a portfolio of three clinical
programs, two of which are late-stage today and derived from our
ABC Platform and one which is platform-independent and which we
believe can progress rapidly into pivotal studies.
Kodiak's lead investigational medicine, tarcocimab, is a novel
anti-VEGF antibody biopolymer conjugate under development for the
treatment of high prevalence retinal vascular diseases including
diabetic retinopathy, 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.
KSI-501 is our second investigational medicine, a first-in-class
anti-IL-6, VEGF-trap bispecific antibody biopolymer conjugate
designed to inhibit both IL-6 mediated inflammation and
VEGF-mediated angiogenesis and vascular permeability. KSI-501 is
being developed for the treatment of high prevalence retinal
vascular diseases to address the unmet needs of targeting multiple
biologies and extended durability.
Additionally, Kodiak is developing a third product candidate,
KSI-101, a novel anti-IL-6, VEGF-trap bispecific protein, the
unconjugated protein portion of KSI-501. Kodiak intends to develop
KSI-101 for the treatment of retinal inflammatory diseases, as
currently there are no available intravitreal biologic therapies
addressing the spectrum of inflammatory conditions of the
retina.
Kodiak has expanded its early research pipeline of duet and
triplet inhibitors that embed small molecules and other bioactive
molecules in the biopolymer backbone to provide a high
drug-antibody ratio ("DAR"). The diverse active pharmaceutical
intermediates (API) are designed to be released over time to
achieve sustained modulation of targeted biological pathways. The
unique combination of high DAR and tailored therapeutic benefit
offers potential for broad application to multifactorial ophthalmic
and systemic diseases.
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
continued favorable safety profile of tarcocimab; next steps of
Phase 3 development for KSI-501 and Phase 1b development for KSI-101; the potential for
targeted, high drug-antibody-ratio conjugates built on Kodiak's ABC
Platform; the potential for the duet and triplet drug platform;
promising therapeutic candidates with the potential to mitigate the
complex effects of ocular inflammation; and a promising therapeutic
strategy to treat GA and potentially wet AMD by combining
complement regulators with an anti-VEGF Fab to achieve potent,
concurrent inhibition of complement pathway activation and VEGF
pathway signaling. 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.
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SOURCE Kodiak Sciences Inc.