SAN FRANCISCO, May 20, 2020 /PRNewswire/ -- Kindred Biosciences,
Inc. (NASDAQ: KIN), a biopharmaceutical company developing novel
biologics, today announced it has entered into an agreement
with Vaxart, Inc. (Nasdaq: VXRT) for the manufacture of Vaxart's
oral vaccine candidate for COVID-19.
"We are proud to be contributing toward the effort to develop a
COVID-19 vaccine. We look forward to working with Vaxart to bring
this innovative technology to patients as quickly as possible,"
said KindredBio's Chief Executive Officer, Richard Chin, M.D. "This marks an important step
in the development of our contract manufacturing business, which
has the potential to help fund our promising pipeline."
Under the terms of the agreement, KindredBio will
provide manufacturing services from
its state-of-the-art biological development and cGMP
manufacturing facility in Burlingame,
CA. There, KindredBio will produce the candidate vaccine
bulk drug substance under Good Manufacturing Practices, and provide
it to Vaxart to be formulated into a vaccine tablet to be
taken by mouth instead of by needle injection. KindredBio
will manufacture the vaccine for clinical trials beginning in the
second half of 2020.
"We are pleased to be partnering with Kindred Biosciences in the
development of our oral COVID-19 vaccine candidate," said Vaxart's
Chief Executive Officer, Wouter
Latour, M.D. "We believe our novel approach utilizing a room
temperature-stable tablet offers important logistical advantages in
widespread oral vaccination, and that KindredBio with its
state-of-the-art manufacturing plants is an ideal partner to
realize our vision."
KindredBio's core expertise includes protein engineering, cell
line development, master cell banking, process development, assay
development, stability testing, and cGMP clinical and commercial
manufacturing from 50 litres to 2,000 litres. The biologics team
comprises experts in product development, manufacturing, quality
control and quality assurance personnel, and is supported by a
strong project management organization.
KindredBio's contract development and manufacturing (CDMO)
activities are managed by a wholly owned subsidiary, Centaur
Biopharmaceutical Services.
About Kindred Biosciences
Kindred Biosciences is a biopharmaceutical company developing
innovative biologics focused on saving and improving the lives of
pets. Its mission is to bring to pets the same kinds of safe and
effective medicines that human family members enjoy. The company's
strategy is to identify targets that have already demonstrated
safety and efficacy in humans and to develop therapeutics based on
these validated targets for dogs and cats. KindredBio has a deep
pipeline of novel biologics in development across many therapeutic
classes, alongside state-of-the-art biologics manufacturing
capabilities and a broad intellectual property portfolio.
For more information, please visit: www.kindredbio.com
About Vaxart
Vaxart is a clinical-stage biotechnology company and its oral
recombinant vaccine candidate is based on its proprietary VAAST™
platform. Vaxart's vaccines are administered using a convenient
room temperature-stable tablet, rather than by injection.
For more information, please visit www.vaxart.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995. All statements contained in this press release that do not
relate to matters of historical fact should be considered
forward-looking statements, including, but not limited to,
statements regarding our expectations about the trials, regulatory
approval, manufacturing, distribution and commercialization of our
current and future product candidates, and statements regarding our
anticipated revenues, expenses, margins, profits and use of
cash.
These forward-looking statements are based on our current
expectations. These statements are not promises or guarantees, but
involve known and unknown risks, uncertainties and other important
factors that may cause our actual results to be materially
different from any future results expressed or implied by the
forward-looking statements. These risks include, but are not
limited to, the following: our limited operating history and
expectations of losses for the foreseeable future; the absence of
significant revenue from our products and our product candidates
for the foreseeable future; the likelihood that our revenue will
vary from quarter to quarter; our potential inability to obtain any
necessary additional financing; our substantial dependence on the
success of our products and our lead product candidates which may
not be successfully commercialized even if they are approved for
marketing; the effect of competition; our potential inability to
obtain regulatory approval for our existing or future product
candidates; our dependence on third parties to conduct some of our
development activities; our dependence upon third-party
manufacturers for supplies of our products and our product
candidates and the potential inability of these manufacturers to
deliver a sufficient amount of supplies on a timely basis;
the uncertain effect of the COVID-19 pandemic on our business,
results of operations and financial condition; uncertainties
regarding the outcomes of trials regarding our product candidates;
our potential failure to attract and retain senior management and
key scientific personnel; uncertainty about our ability to enter
into satisfactory agreements with third-party licensees of our
biologic products or to develop a satisfactory sales organization
for our equine small molecule products; our significant costs of
operating as a public company; potential cyber-attacks on our
information technology systems or on our third-party providers'
information technology systems, which could disrupt our operations;
our potential inability to repay the secured indebtedness that we
have incurred from third-party lenders, and the restrictions on our
business activities that are contained in our loan agreement with
these lenders; the risk that our 2020 strategic realignment plan
will result in unanticipated costs or revenue shortfalls;
uncertainty about the amount of royalties that we will receive from
the sale of Mirataz® to Dechra Pharmaceuticals PLC; our potential
inability to obtain and maintain patent protection and other
intellectual property protection for our products and our product
candidates; potential claims by third parties alleging our
infringement of their patents and other intellectual property
rights; our potential failure to comply with regulatory
requirements, which are subject to change on an ongoing basis; the
potential volatility of our stock price; and the significant
control over our business by our principal stockholders and
management.
For a further description of these risks and other risks that we
face, please see the risk factors described in our filings with
the U.S. Securities and Exchange
Commission (the SEC), including the risk factors
discussed under the caption "Risk Factors" in our Annual Report on
Form 10-K and any subsequent updates that may be contained in our
Quarterly Reports on Form 10-Q filed with the SEC. As a result
of the risks described above and in our filings with the SEC,
actual results may differ materially from those indicated by the
forward-looking statements made in this press release.
Forward-looking statements contained in this press release speak
only as of the date of this press release and we undertake no
obligation to update or revise these statements, except as may be
required by law.
The results stated in this press release have not been reviewed
by the Food and Drug Administration or the United States Department
of Agriculture Center for Veterinary Biologics, as applicable.
Contacts
For investor inquiries:
Katja Buhrer
Katja.buhrer@kindredbio.com
(917) 969-3438
For CDMO services:
Jeremy Vrchota
jeremy.vrchota@kindredbio.com
(605) 370-2258
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SOURCE Kindred Biosciences, Inc.