Combangio, Inc., a Wholly Owned Subsidiary of Kala Pharmaceuticals, Awarded $15 Million by California Institute for Regenerative Medicine to Support Ongoing KPI-012 Program for the Treatment of PCED
28 Avril 2023 - 2:00PM
Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a clinical-stage
biopharmaceutical company dedicated to the research, development
and commercialization of innovative therapies for rare and severe
diseases of the eye, today announced that the California Institute
for Regenerative Medicine (CIRM) has awarded Combangio, Inc., a
wholly owned subsidiary of Kala, a $15 million grant to support its
ongoing KPI-012 program for the treatment of persistent corneal
epithelial defect (PCED). The grant includes funding for the CHASE
(
Corneal
Healing
After
SEcretome therapy) Phase 2b
clinical trial as well as product and process characterization and
analytical development for the program.
“Consistent with CIRM’s mission to accelerate the development of
potentially transformative medicines to improve the care of
patients globally, we are excited to support the KPI-012 program
for the treatment of PCED,” said Maria T. Millan, M.D., President
and CEO of CIRM. “KPI-012’s differentiated product profile has the
potential to deliver rapid and sustained wound healing with
broad-based application across all underlying PCED etiologies. We
look forward to partnering with the company to bring this
regenerative therapy to the thousands of patients in need.”
KPI-012 is a human mesenchymal stem cell secretome (MSC-S),
being developed for the treatment of PCED. Based on its
multifactorial mechanism of action and preclinical and clinical
data generated to-date, Kala believes KPI-012 may represent a
significant advancement in the treatment of PCED and could become
the first approved treatment for PCED across all its various
etiologies.
The CHASE Phase 2b clinical trial includes two patient cohorts.
In March 2023, the company reported positive safety data from the
first patient cohort, evaluating the safety of the high dose of
KPI-012 (3 U/mL) dosed topically four times per day (QID). The
second patient cohort is currently enrolling in a multicenter,
randomized, double-masked, vehicle-controlled, parallel-group study
to evaluate the safety and efficacy of two doses of KPI-012
ophthalmic solution (3 U/mL and 1 U/mL) versus vehicle dosed
topically QID for 56 days in approximately 90 patients. The primary
endpoint of the trial is the complete healing of the PCED as
measured by corneal fluorescein staining. Topline safety and
efficacy data is targeted in the first quarter of 2024. If the
results are positive, and subject to discussion with regulatory
authorities, the company believes this trial could serve as the
first of two pivotal trials required to support the submission of a
Biologics License Application (BLA) to the U.S. Food and Drug
Administration (FDA).
“We are honored that CIRM has recognized KPI-012’s potential to
correct impaired corneal healing,” said Mark Iwicki, Chief
Executive Officer and Chairman of Kala Pharmaceuticals. “We believe
this grant not only serves as further validation for KPI-012 and
our MSC-S platform, but will provide us with important funding to
advance our ongoing Phase 2b trial, which could serve as the first
of two pivotal trials needed to support the submission of a BLA to
the FDA.”
About KPI-012 for Persistent Corneal Epithelial Defect
(PCED)
Persistent corneal epithelial defect, which is defined as a
persistent non-healing corneal defect or wound that is refractory
to conventional treatments, is a rare disease with an estimated
incidence in the United States of 100,000 cases per year and
238,000 cases per year in the United States, European Union and
Japan combined. PCED can have various etiologies, including
neurotrophic keratitis, surgical epithelial debridement,
microbial/viral keratitis, corneal transplant, limbal stem cell
deficiency and mechanical and chemical trauma and, if left
untreated, can lead to infection, corneal ulceration or
perforation, scarring, opacification and significant vision
loss.
Based on a multifactorial mechanism of action and preclinical
and clinical data generated to-date, Kala believes KPI-012 may
represent a significant advancement in the treatment of PCED and
could become the first approved treatment for PCED across all its
various etiologies.
About Kala Pharmaceuticals
Kala is a clinical-stage biopharmaceutical company dedicated to
the research, development and commercialization of innovative
therapies for rare and severe diseases of the eye. Kala’s
biologics-based investigational therapies utilize Kala’s
proprietary mesenchymal stem cell secretome (MSC-S) platform.
Kala’s lead product candidate, KPI-012, is a human MSC-S, which
contains numerous human-derived biofactors, such as growth factors,
protease inhibitors, matrix proteins and neurotrophic factors that
can potentially correct the impaired corneal healing that is an
underlying etiology of multiple severe ocular diseases. KPI-012 is
currently in clinical development for the treatment of persistent
corneal epithelial defect (PCED), a rare disease of impaired
corneal healing, for which it has received Orphan Drug and Fast
Track designations from the U.S. Food and Drug Administration. Kala
is also targeting the potential development of KPI-012 for the
treatment of Limbal Stem Cell Deficiency and ocular manifestations
of moderate-to-severe Sjögren’s and has initiated preclinical
studies to evaluate the potential utility of its MSC-S platform for
retinal degenerative diseases, such as Retinitis Pigmentosa and
Stargardt Disease. For more information on Kala, please
visit www.kalarx.com.
About The California Institute for Regenerative Medicine
(CIRM)
CIRM was created by the people of California to accelerate
regenerative medicine to patients with unmet medical needs, and act
with a sense of urgency to succeed in that mission. To meet this
challenge, CIRM’s team of highly trained and experienced
professionals actively partner with both academia and industry in a
hands-on, entrepreneurial environment to fast track the development
of today’s most promising regenerative medicine technologies. With
$5.5 billion in funding and more than 150 active stem cell programs
in its portfolio, CIRM is the world’s largest institution dedicated
to helping people by bringing the future of cellular medicine
closer to reality. For more information on CIRM, please visit
www.cirm.ca.gov.
Forward Looking Statements:
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that involve substantial risks and uncertainties. Any statements in
this press release about Kala’s future expectations, plans and
prospects, including but not limited to statements about the
potential benefits and future operation of the CIRM award; Kala’s
expectations with respect to potential advantages of KPI-012 and
its MSC-S platform; the clinical utility of KPI-012 for PCED;
anticipated timelines to report topline data for the CHASE Phase 2b
clinical trial of KPI-012; Kala’s belief that the Chase Phase 2b
trial could serve as the first of two pivotal trials required to
support the submission of a BLA to the FDA; Kala’s plans to pursue
research and development of KPI-012 and its MSC-S platform for
other indications; and other statements containing the words
“anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,”
“plan,” “predict,” “project,” “target,” “potential,” “likely,”
“will,” “would,” “could,” “should,” “continue,” and similar
expressions constitute forward-looking statements. Actual results
may differ materially from those indicated by such forward-looking
statements as a result of various important factors, including:
Kala’s ability to comply with the requirements under the CIRM
award; uncertainties inherent in the initiation and conduct of
preclinical studies and clinical trials; uncertainties regarding
availability and timing of data from clinical trials; whether
results of early clinical trials or trials in different disease
indications will be indicative of the results of ongoing or future
trials; whether results of the Phase 1b clinical trial of KPI-012
will be indicative of results for any future clinical trials and
studies of KPI-012, including the CHASE Phase 2b clinical trial;
whether interim data from a clinical trial will be predictive of
the results of the trial; uncertainties associated with regulatory
review of clinical trials and applications for marketing approvals;
Kala’s ability to retain and hire key personnel; the impact of
extraordinary external events, such as the current pandemic health
event resulting from the coronavirus (COVID-19), and their
collateral consequences; the sufficiency of cash resources and need
for additional financing and other important factors, any of which
could cause Kala’s actual results to differ from those contained in
the forward-looking statements, discussed in the “Risk Factors”
section of Kala’s Annual Report on Form 10-K and other filings Kala
makes with the Securities and Exchange Commission. These
forward-looking statements represent Kala’s views as of the date of
this press release and should not be relied upon as representing
Kala’s views as of any date subsequent to the date hereof. Kala
does not assume any obligation to update any forward-looking
statements, whether as a result of new information, future events
or otherwise, except as required by law.
Investor Contact:
Hannah Deresiewiczhannah.deresiewicz@sternir.com
212-362-1200
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