JERUSALEM, Oct. 19, 2021 /PRNewswire/ -- BiondVax
Pharmaceuticals Ltd. (Nasdaq: BVXV), which focuses on
developing, manufacturing and commercializing innovative products
for the prevention and treatment of infectious diseases and other
illnesses, today announced the signing of a term sheet that
includes binding financial terms of contemplated definitive
agreements with the Max Planck Society and the University
Medical Center Göttingen in Germany. The parties intend to enter into a
5-year strategic research collaboration including an option for
BiondVax to license innovative VHH antibodies. Frequently referred
to as nanobodies*, VHH antibodies have the potential to
serve as therapeutics and diagnostics for many diseases. The
transaction is subject to execution of definitive agreements.
![BiondVax Pharmaceuticals Logo BiondVax Pharmaceuticals Logo](https://mma.prnewswire.com/media/615570/BiondVax_Pharmaceuticals_Logo.jpg)
VHH antibodies developed by Professor Dirk
Görlich, Director at the Max Planck Institute for Biophysical
Chemistry and Professor Matthias
Dobbelstein, Professor of Molecular Oncology at the
University Medical Center Göttingen, exhibit key advantages over
current industry standard human monoclonal antibodies (mAbs). These
include: the ability to bind to smaller target sites; significantly
higher affinity to the target; higher stability which supports
novel routes of administration such as inhalation; ease and lower
cost of manufacturing; and potential for improved patient
safety.
Upon execution of definitive agreements based on the term sheet
signed today, the collaboration will begin with BiondVax's
exclusive worldwide licensing of novel COVID-19 VHH
antibody candidates shown in Görlich and Dobbelstein's labs to
neutralize all known major COVID-19 variants of concern at around
100-times lower drug concentrations than current COVID-19 mAbs and
all other reported COVID-19 VHH antibodies. BiondVax anticipates
completing preclinical proof-of-concept inhalation studies in 2022
and initiating human clinical trials in 2023.
Görlich and Dobbelstein will also conduct research on
additional molecular targets for which the parties believe VHH
antibodies have clear advantages over existing drugs used against
various diseases. These targets are the basis for validated and
currently marketed mAbs including for autoimmune conditions such
as psoriasis, asthma, macular degeneration, and psoriatic
arthritis. BiondVax will have an exclusive option for an exclusive
worldwide license to advance these additional VHH antibodies
through preclinical and clinical development, manufacturing, and
commercialization. Notably, these VHH antibodies can be
mass-produced through recombinant protein manufacturing in sites
such as BiondVax's state-of-the-art facility in Jerusalem.
Mr. Amir Reichman,
BiondVax's CEO, commented, "We are thrilled to embark on
this new direction for BiondVax. The VHH antibody platform will
serve as a basis for a new pipeline of commercially attractive
products. We see enormous potential for the COVID-19 VHH
antibodies and we're ready to hit the ground running to
bring them into the clinic. In addition, this collaboration aims to
address unmet therapeutic needs of many common diseases such as
psoriasis, psoriatic arthritis, asthma and macular degeneration.
The technology is a great fit to our manufacturing site in
Jerusalem and our experience and
expertise in drug development. I wish to thank Professors Görlich
and Dobbelstein for their enthusiasm for this project, and Max
Planck Innovation's technology transfer team including Dr.
Dieter Link for their assistance in
developing this innovative collaboration."
Professor Dirk Görlich, Director at the Max
Planck Institute for Biophysical Chemistry, commented, "We
believe that the innovative platform developed at the Max Planck
Institute for Biophysical Chemistry has great potential. In this
respect, we are looking forward to a final agreement with BiondVax
that will leverage their CMC, manufacturing, regulatory and
clinical development expertise to advance this technology into
clinical applications."
Mr. Mark Germain,
Chairman of BiondVax, stated, "This collaboration is
the start of an exciting new era for BiondVax, with multiple
opportunities to create significant shareholder
value. Professors Görlich and Dobbelstein are world class
scientists with a unique talent to develop highly differentiated
VHH antibodies, and it's been a pleasure working with them and
their colleagues at Max Planck and the University Medical Center
Göttingen. Since coming on board in March 2021, Amir has worked tirelessly to help
identify the right opportunity around which to relaunch BiondVax
and to negotiate the transaction being announced today. He and
the BiondVax team have done an outstanding job researching the
value proposition represented by the collaboration and the
development path forward. On behalf of the entire Board of
Directors, kudos and appreciation to all involved in making this
happen."
Binding terms of the term sheet, which would be included in the
definitive agreements, include upfront, milestone and royalty-based
cash and stock payments by BiondVax to MPG and UMG. The parties aim
to complete definitive agreements within 90 days, although there is
no guarantee if and when the parties will execute the definitive
agreements.
The collaboration has been facilitated by kENUP, a civic society
organization promoting innovative industries in Europe.
* Nanobody is a trademark registered by ABLYNX
N.V., a wholly owned subsidiary of Sanofi. BiondVax has no
affiliation with and is not endorsed by Sanofi.
Analyst event information: BiondVax will host a Zoom
webinar this Thursday, October
21st at 9am Eastern
Time (ET) to discuss the VHH antibody MPG-UMG-BiondVax
collaboration and provide a forum to answer investor and analyst
questions. Investors and analysts are invited to submit questions
by tomorrow, Wednesday 5pm ET,
to investor relations at ir@biondvax.com. To attend the webinar,
please register your attendance from either a link at BiondVax's
investor relations website or via the following Zoom link:
https://us06web.zoom.us/webinar/register/9516341082202/WN_Xg-NP1f4TKudDPD9DzQDdQ
About BiondVax
BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a
biopharmaceutical company focused on developing, manufacturing and
commercializing innovative products for the prevention and
treatment of infectious diseases and other illnesses. Since its
inception, the company has executed eight clinical trials including
a seven country, 12,400 participant Phase 3 trial of its vaccine
candidate and has built a state-of-the-art manufacturing facility
for biopharmaceutical products. With highly experienced
pharmaceutical industry leadership, BiondVax is aiming to
develop a pipeline of diversified and commercially viable products
and platforms. www.biondvax.com.
Contact Details
Company: Joshua E. Phillipson |
+972 8 930 2529 | j.phillipson@biondvax.com
Investor Relations: Kenny Green |
+1 212 378 8040 | kgreen@edisongroup.com
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Litigation Reform Act of 1995. Words
such as "expect," "believe," "intend," "plan," "continue," "may,"
"will," "anticipate," and similar expressions are intended to
identify forward-looking statements. All statements, other than
statements of historical facts, included in this press release
regarding strategy, future operations, future financial position,
future revenue, projected expenses, prospects, plans and objectives
of management are forward-looking statements. Examples of such
statements include, but are not limited to, statements regarding
execution of a definitive agreement with the Max Planck Society and
the University Medical Center Göttingen; the therapeutic and
commercial potential of VHH antibodies; and the timing of
proof-of-concept studies and clinical trials in VHH antibodies.
These forward-looking statements reflect management's current views
with respect to certain current and future events and are subject
to various risks, uncertainties and assumptions that could cause
the results to differ materially from those expected by the
management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties
include, but are not limited to, the risk that BiondVax will not
execute a definitive agreement with the Max Planck Society and the
University Medical Center Göttingen; the risk that the therapeutic
and commercial potential of VHH antibodies will not be met; the
risk that proof-of-concept studies and clinical trials in VHH
antibodies will not occur, will be delayed or not be successful;
the risk that BiondVax may not be able to secure additional capital
on attractive terms, if at all; the risk that the European
Investment Bank may accelerate the loans under its finance contract
with BiondVax; the risk that BiondVax may not execute a strategic
alternative to M-001 or implement a strategy that will diversify
BiondVax's risk, and, if executed, may not be successful; risks
relating to the COVID-19 (coronavirus) pandemic; BiondVax's ability
to acquire rights to additional product opportunities; BiondVax's
ability to enter into collaborations on terms acceptable to
BiondVax or at all; timing of receipt of regulatory approval of
BiondVax's manufacturing facility in Jerusalem, if at all or when required; the
risk that the manufacturing facility will not be able to be used
for a wide variety of applications and other vaccine and treatment
technologies, and the risk that drug development involves a lengthy
and expensive process with uncertain outcomes. More detailed
information about the risks and uncertainties affecting the Company
is contained under the heading "Risk Factors" in the Company's
Annual Report on Form 20-F filed with the Securities and Exchange
Commission on May 13, 2021. BiondVax
undertakes no obligation to revise or update any forward-looking
statement for any reason.
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SOURCE BiondVax Pharmaceuticals Ltd.