- Purpose-built bioconjugation facility in Lonza's
Ibex® Dedicate Biopark in Visp, Switzerland to support the potential
commercial launch of Kodiak's lead product candidate KSI-301 for
high-prevalence retinal diseases
- The opening ceremony took place on May
17, 2022 following mechanical completion of the facility in
March 2022
BASEL,
Switzerland and PALO ALTO,
Calif., May 19, 2022 /PRNewswire/ -- Kodiak
Sciences Inc. (Nasdaq: KOD), a biopharmaceutical company committed
to researching, developing and commercializing transformative
therapeutics to treat high prevalence retinal diseases, and Lonza
announced today the opening of a new, custom-built, bioconjugation
facility within Lonza's Ibex® Dedicate manufacturing
complex in Visp (CH).
The facility will play a key role in the scaled manufacturing of
Kodiak's lead therapeutic candidate KSI-301 to support a potential
global commercial launch. Once fully operational and if KSI-301 is
approved for commercial use, the facility is expected to have the
capacity to supply over 10 million dose equivalents of KSI-301
annually. The strong relationship between Kodiak and Lonza has led
to a multi-year commercial collaboration that has created 12
full-time positions at Kodiak Sciences in Visp and 70 positions at
Lonza.
Kodiak Sciences leverages its core technology, the Antibody
Biopolymer Conjugate (ABC) PlatformTM, to develop
next-generation, long-durability ophthalmic therapies. KSI-301 is
the lead product candidate based on the ABC Platform, consisting of
a custom-built antibody inhibiting Vascular Endothelial Growth
Factor (VEGF), a potent cytokine known to contribute to the
pathology of retinal vascular diseases, conjugated with a
phosphorylcholine biopolymer. Existing clinical data has
demonstrated the potential for extended dosing of up to six months
in certain patients treated with KSI-301. KSI-301 is currently
being studied in parallel Phase 3 trials for wet age-related
macular degeneration ("wet AMD"), diabetic macular edema ("DME"),
retina vein occlusion ("RVO"), and non-proliferative diabetic
retinopathy ("NPDR"). If successful, Kodiak Sciences intends to
include data from these trials in a Biologics License Application
(BLA) with the U.S. FDA and potentially other global regulatory
agencies. Lonza will support Kodiak in scaling up and securing
supply chain as Kodiak progresses towards BLA readiness and
potential commercial launch to meet growing market demand.
Victor Perlroth, MD, Chief
Executive Officer, Kodiak Sciences Inc., commented: "The grand
opening of Ursus, our dedicated bioconjugate facility, is an
important milestone in our journey to develop medicines for
patients in need worldwide. We are thankful to have our trusted
partner Lonza, a global leader with the needed expertise, systems
and production capacity, navigate the challenges of manufacturing
and supplying KSI-301, our lead product candidate. We are also very
appreciative of the long-standing support from the local community
of Visp and the canton of Valais."
Pierre-Alain Ruffieux, Chief
Executive Officer, Lonza, added: "It is a privilege to work
alongside Kodiak to develop this world-class suite for ophthalmic
technologies through our innovative Ibex® Dedicate
offering. Our relationship with Kodiak has evolved over the last
seven years, from the development of the antibody, to incorporating
conjugation and now opening this dedicated suite. This journey
reflects how our two businesses are able to work as one team
towards a single purpose."
Christophe Darbellay,
Conseiller d'Etat, Chef du Département de l'Economie et de la
Formation du Canton du Valais, added: "The grand opening of
Kodiak Sciences' manufacturing facility confirms and reinforces the
position of Valais in life sciences. I would like to thank Kodiak
Sciences for having chosen and trusted our canton and its
capacities."
Lonza's leadership in bioconjugation, together with its
experience in managing the complex supply chains under one quality
system, will help Kodiak meet the precision standards required for
ophthalmic intravitreal injected therapies. The new dedicated
bioconjugation facility will allow for rapid product launch and
provide flexible commercial manufacturing capacity that can scale
to meet market needs. Lonza will also utilize its global network of
facilities, including Nansha (CN) and Visp (CH) to produce Kodiak's
biopolymer, and Portsmouth (U.S.) to produce Kodiak's monoclonal
antibody.
About Lonza
Lonza is a preferred global partner to the pharmaceutical,
biotech and nutrition markets. We work to enable a healthier world
by supporting our customers to deliver new and innovative medicines
that help treat a wide range of diseases. We achieve this by
combining technological insight with world-class manufacturing,
scientific expertise and process excellence. Our unparalleled
breadth of offerings enables our customers to commercialize their
discoveries and innovations in the healthcare industry.
Founded in 1897 in the Swiss Alps, today, Lonza operates across
five continents. With approximately 16,000 full-time employees, we
comprise high-performing teams and individual talent that make a
meaningful difference to our own business, as well as to the
communities in which we operate. The company generated
sales of CHF 5.4 billion with a
CORE EBITDA of CHF 1.7 billion
in Full-Year 2021. Find out more at www.lonza.com.
Follow @Lonza on LinkedIn
Follow @LonzaGroup on Twitter
About Kodiak Sciences
Kodiak (Nasdaq: KOD) is a biopharmaceutical company committed to
researching, developing and commercializing transformative
therapeutics to treat high prevalence retinal diseases. Founded in
2009, Kodiak is 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. Kodiak's 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,
KSI-301, 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 a dual inhibitor antibody
biopolymer conjugate targeting both VEGF (VEGF-trap) and IL-6
(anti-IL-6 antibody) for the treatment of retinal diseases. Kodiak
is expanding its early research pipeline to include ABC Platform
based triplet inhibitors for multifactorial retinal diseases such
as dry AMD and glaucoma. For more information, please
visit www.kodiak.com.
Kodiak Sciences Inc. is headquartered in Palo Alto, California, USA, and is listed on
the NASDAQ Stock Exchange. Kodiak has additional facilities in Zug,
Switzerland and Valais,
Switzerland.
About KSI-301
KSI-301 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 KSI-301 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 KSI-301 clinical program is designed
to assess KSI-301's durability, efficacy and safety in
wet AMD, DME, RVO and non-proliferative DR (without DME)
through clinical studies run in parallel. If successful, Kodiak's
GLEAM and GLIMMER pivotal studies in patients with diabetic macular
edema, the BEACON pivotal study in patients with retinal vein
occlusion and the DAYLIGHT pivotal study in patients with
wet AMD are anticipated to form the basis of Kodiak's
initial BLA to support potential approval and commercialization in
multiple indications. An additional Phase 3 pivotal study, GLOW, in
patients with non-proliferative diabetic retinopathy is also
underway. The global KSI-301 clinical program is being conducted at
over150 study sites in more than 10 countries. Kodiak is developing
KSI-301 and owns global rights to KSI-301.
Additional Information and Disclaimer
Lonza Group Ltd has its headquarters in Basel, Switzerland, and is listed on the SIX
Swiss Exchange. It has a secondary listing on the Singapore
Exchange Securities Trading Limited ("SGX-ST"). Lonza Group Ltd is
not subject to the SGX-ST's continuing listing requirements but
remains subject to Rules 217 and 751 of the SGX-ST Listing
Manual.
Certain matters discussed in this news release may constitute
forward-looking statements. These statements are based on current
expectations and estimates of Lonza Group Ltd, although Lonza Group
Ltd can give no assurance that these expectations and estimates
will be achieved. Investors are cautioned that all forward-looking
statements involve risks and uncertainty and are qualified in their
entirety. The actual results may differ materially in the future
from the forward-looking statements included in this news release
due to various factors. Furthermore, except as otherwise required
by law, Lonza Group Ltd disclaims any intention or obligation to
update the statements contained in this news release.
Forward-Looking Statements for Kodiak Sciences
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. Any forward-looking statements are
not based on historical fact and are based on management's current
expectations of future events and are subject to a number of risks
and uncertainties that could cause actual results to differ
materially and adversely from those set forth in or implied by such
forward-looking statements. 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. Forward-looking statements include statements regarding the
anticipated fully operational status of the Ursus facility,
potential manufacture and supply of KSI-301, approval of KSI-301
for commercial use, the supply capacity of the facility once
operational, the ability of Lonza to help Kodiak meet standards,
the ability of the facility to allow for rapid launch and provide
for sufficient manufacturing capacity, and the potential use of
facilities in various locations to produce Kodiak's monoclonal
antibody. For a discussion of 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-Q,
as well as discussions of potential risks, uncertainties, and other
important factors in Kodiak's subsequent filings with the
Securities and Exchange Commission. 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.