FibroBiologics Plans to Collaborate with Charles River to Manufacture Fibroblast-based Spheroids
25 Abril 2024 - 7:00AM
FibroBiologics, Inc., (Nasdaq: FBLG) ("FibroBiologics") and Charles
River Laboratories (“Charles River”), a highly respected, global
provider of drug discovery, development, and manufacturing
solutions, today announced the signing of a letter of intent
allowing for the transfer, testing and validation of
FibroBiologics’ technology. This agreement comes ahead of entering
into an anticipated master services agreement for the development
and manufacture of FibroBiologics’ master cell bank, working cell
bank, and fibroblast-based spheroids to be utilized in clinical
trials.
FibroBiologics, a clinical-stage biotechnology company with
150+ patents issued and pending for the development of therapeutics
and potential cures for chronic diseases using fibroblasts and
fibroblast-derived materials, is investigating the potential
treatment of chronic diseases using the immunomodulatory and
regenerative capabilities of fibroblasts and fibroblast-derived
materials. Indications being studied include degenerative disc
disease, multiple sclerosis, wound healing, psoriasis, thymic
involution reversal, and cancer.
To help advance FibroBiologics’ fibroblast-based therapies into
the clinic, Charles River will conduct feasibility studies on
FibroBiologics' cell manufacturing processes within its facility.
Additionally, contingent upon entering into a master services
agreement, Charles River would serve as the contract development
and manufacturing organization (CDMO) responsible for producing
drug products for certain FibroBiologics’ clinical trials.
In recent years, Charles River has significantly broadened its
cell and gene therapy portfolio to simplify complex supply chains
and meet growing demand for plasmid DNA, viral vector, and cell
therapy services. Combined with its legacy testing capabilities,
Charles River offers a premier “concept-to-cure” advanced therapies
solution.
Pete O’Heeron, Founder and Chief Executive Officer of
FibroBiologics commented, "We are proud to discuss opportunities to
work with Charles River, a global leader in cell and gene therapy
development and manufacturing, as we look to advance our unique
fibroblast-based spheroids into the clinic. We are both committed
to bringing innovative and potentially curative therapies to
patients suffering from chronic diseases."
Cautionary Statement Regarding Forward-Looking
Statements
This communication contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995.
Forward-looking statements include information concerning
potentially entering into a master services agreement with Charles
River for development and manufacturing services, expected research
targets and indications of interest, and plans for, and the timing
of, clinical trials. These forward-looking statements are not
guarantees of future performance, conditions or results, and
involve a number of known and unknown risks, uncertainties,
assumptions and other important factors, many of which are outside
FibroBiologics' management's control, that could cause actual
results to differ materially from the results discussed in the
forward-looking statements, including those set forth under the
caption "Risk Factors" and elsewhere in FibroBiologics' annual,
quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form
8-K) as filed or furnished with the SEC and any subsequent public
filings. Copies are available on the SEC's website, www.sec.gov.
These risks, uncertainties, assumptions and other important factors
include, but are not limited to: (a) our ability to successfully
enter into a master services agreement with Charles River; (b)
risks related to FibroBiologics' liquidity and its ability to
maintain capital resources sufficient to conduct its business; (c)
expectations regarding the initiation, progress and expected
results of our R&D efforts and preclinical studies; and (d) the
unpredictable relationship between R&D and preclinical results
and clinical study results. Forward-looking statements speak only
as of the date they are made. Readers are cautioned not to put
undue reliance on forward-looking statements, and FibroBiologics
assumes no obligation and, except as required by law, does not
intend to update or revise these forward-looking statements,
whether as a result of new information, future events, or
otherwise. FibroBiologics gives no assurance that it will achieve
its expectations.
About FibroBiologicsBased in Houston,
FibroBiologics is a cell therapy and regenerative medicine company
developing a pipeline of treatments and seeking potential cures for
chronic diseases using fibroblast cells and fibroblast-derived
materials. FibroBiologics holds 150+ US and internationally issued
patents/patents pending across various clinical pathways, including
disc degeneration, orthopedics, multiple sclerosis, wound healing,
reversing organ involution, and cancer. FibroBiologics represents
the next generation of medical advancement in cell therapy. For
more information, visit www.FibroBiologics.com.
FibroBiologics Investor Relations:Nic
JohnsonRusso Partners(212) 845-4242fibrobiologicsIR@russopr.com
FibroBiologics Media Contact:Liz PhillipsRusso
Partners(347) 956-7697Elizabeth.phillips@russopartnersllc.com
FibroBiologics General
Inquiries:info@fibrobiologics.com
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