iBio Enters into Agreement with Safi Biosolutions to Develop Growth Factors and Cytokines Using the FastPharming® System
October 02 2020 - 7:00AM
iBio, Inc. (NYSE AMERICAN:IBIO) (“iBio” or the “Company”), a
biotech innovator and biologics contract manufacturing
organization, today announced that it has entered into a Master
Services Agreement (“MSA”) with Boston-based Safi Biosolutions,
Inc. (“Safi”) to evaluate iBio’s
FastPharming® System for the
expression of key proteins to be used in the bioprocessing of Safi
blood cell therapy products.
Safi is an early stage biotech company working
as the cell therapy commercialization partner for a five-year
government program aiming to produce blood on-demand, a national
priority. Initial development efforts for manufactured blood cell
therapies include red blood cells for trauma, tailored red blood
cells for specific transfusion indications and a neutrophil
progenitor cell therapy for the treatment of chemotherapy-induced
neutropenia. To achieve the quality and cost-of-goods objectives
for the program, Safi turned to iBio’s plant-based protein
expression system.
iBio’s process development, biochemistry and
pharmaceutical development teams plan to engage with Safi to
evaluate options to use iBio’s FastPharming System
to generate cGMP growth factors and cytokines.
“iBio is pleased to partner with Safi as we
leverage our capabilities and know-how for this innovative cell
therapy program,” said Tom Isett, Chairman & CEO of iBio. “This
opportunity is a natural fit for our new portfolio of Research
& Bioprocess products, in which we are developing animal-free
solutions for cell culture and 3D-bioprinting applications, amongst
others.”
Pursuant to the MSA, iBio will manufacture ten
proteins to be evaluated in the production of Safi’s cell therapies
as part of the first Statement of Work. Safi will have the option
to designate certain proteins as proprietary to their bioprocess,
but iBio will have the right to commercialize all other
products.
Doug McConnell, co-founder and CEO of Safi
Biosolutions, commented, “Safi Biosolutions believes iBio’s
plant-based expression system has the potential to provide both
quality improvement and cost reduction for many of the important
cytokines and media used in our cell culture and growth process,
and we are excited to initiate this strategic partnership.”
Additionally, iBio has agreed to invest $1.5
million in Safi in the form of a convertible promissory note (the
"Note"). The Note will bear interest at a rate of 5% per annum and
will be fully convertible into common shares of Safi, at the option
of iBio under certain circumstances. The Note will have a maturity
date of three years from the date of issuance and is due in full if
not converted at or before the three-year term.
About Safi
Biosolutions, Inc.
Safi Biosolutions is developing blood cell
products and therapeutics through novel and proprietary cell
manufacturing and source expansion techniques. The co-founders and
leadership team at Safi Biosolutions bring experience in ex vivo
human blood cell development, biologic and pharmaceutical
manufacturing, pre-clinical and clinical development, and
regulatory submissions.
About iBio, Inc.
iBio is a global leader in plant-based biologics
manufacturing. Its FastPharming®
System combines vertical farming, automated hydroponics, and glycan
engineering technologies to rapidly deliver high-quality monoclonal
antibodies, vaccines, bioinks and other proteins. The Company’s
subsidiary, iBio CDMO LLC, provides FastPharming
Contract Development and Manufacturing Services. iBio’s
Glycaneering Development Service™ includes an
array of new glycosylation technologies for engineering
high-performance recombinant proteins. Additionally, iBio is
developing proprietary products, which include IBIO-100 for the
treatment of fibrotic diseases, and vaccines for COVID-19 disease.
For more information, visit www.ibioinc.com.
FORWARD-LOOKING
STATEMENTSCertain statements in this press release
constitute "forward-looking statements" within the meaning of the
federal securities laws. Words such as "may," "might," "will,"
"should," "believe," "expect," "anticipate," "estimate,"
"continue," "predict," "forecast," "project," "plan," "intend" or
similar expressions, or statements regarding intent, belief, or
current expectations, are forward-looking statements. These
forward-looking statements are based upon current estimates and
assumptions and include statements regarding iBio’s cell culture,
biochemistry and pharmaceutical development teams plans to engage
with Safi Bio to accelerate the program and iBio’s plant-based
expression system having the potential to provide both quality
improvement and cost reduction for many of the important cytokines
and other media used in cell culture and growth processing. While
the Company believes these forward-looking statements are
reasonable, undue reliance should not be placed on any such
forward-looking statements, which are based on information
available to us on the date of this release. These forward-looking
statements are subject to various risks and uncertainties, many of
which are difficult to predict that could cause actual results to
differ materially from current expectations and assumptions from
those set forth or implied by any forward-looking statements.
Important factors that could cause actual results to differ
materially from current expectations include, among others, the
ability of iBio’s plant-based expression system to provide both
quality improvement and cost reduction for many of the important
cytokines and other media used in cell culture and growth
processing, the Company’s ability to obtain regulatory approvals
for commercialization of its product candidates, including its
COVID-19 vaccines, or to comply with ongoing regulatory
requirements, regulatory limitations relating to its ability to
promote or commercialize its product candidates for specific
indications, acceptance of its product candidates in the
marketplace and the successful development, marketing or sale of
products, its ability to maintain its license agreements, the
continued maintenance and growth of its patent estate, its ability
to establish and maintain collaborations, its ability to obtain or
maintain the capital or grants necessary to fund its research and
development activities, competition, its ability to retain its key
employees or maintain its NYSE American listing, and the other
factors discussed in the Company’s Annual Report on Form 10-K for
the year ended June 30, 2019 and the Company’s subsequent filings
with the SEC, including subsequent periodic reports on Forms 10-Q
and 8-K. The information in this release is provided only as of the
date of this release, and we undertake no obligation to update any
forward-looking statements contained in this release on account of
new information, future events, or otherwise, except as required by
law.
Contacts:
Stephen KilmeriBio, Inc.Investor Relations(646)
274-3580 skilmer@ibioinc.com
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