JERUSALEM, Dec. 22, 2021 /PRNewswire/ -- BiondVax
Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company
focused on developing, manufacturing and commercializing innovative
products for the prevention and treatment of infectious diseases
and other illnesses, today announced the signing of definitive
agreements with the Max Planck Society (MPG), the parent
organization of the Max Planck Institute of Biophysical
Chemistry, and the University Medical Center Göttingen (UMG), both
in Germany, to enter into a
strategic collaboration for the development and commercialization
of innovative COVID-19 nanosized antibodies (NanoAbs*). These
agreements are part of a broader collaboration, expected to be
signed in January 2022, covering
development and commercialization of NanoAbs for several other
disease indications with large market sizes that leverage their
unique binding affinity, stability at high temperatures, and
potential for more effective and convenient routes of
administration.
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The lead NanoAb candidates for the COVID-19 program, developed
by Professor Dirk Görlich, Director at the Max Planck
Institute of Biophysical Chemistry, and Professor
Matthias Dobbelstein,
Professor of Molecular Oncology at the UMG, exhibit a strong
competitive edge over existing COVID-19 therapies. For example, the
NanoAbs exhibit superior affinity to the target, neutralizing the
SARS-COV-2 virus, in-vitro, at drug concentrations about 100-times
lower than those required by currently commercially available
monoclonal antibodies. This may lead to increased efficacy, reduced
side effects, and allow production at a lower cost. In addition,
the NanoAbs' small size and hyper-thermostability at
95°C (200°F) potentially enables
administration through inhalation and longer shelf life, and
potentially avoids the need for enhanced cold chain storage and
transport. Together, these attributes are designed to create
significant competitive advantages.
The NanoAbs have demonstrated strong neutralization at very low
concentrations of major Variants of Concern (VoCs) including Alpha,
Beta, Gamma and Delta in in-vitro studies in Görlich's and
Dobbelstein's laboratories and based on in-silico studies, are
expected to neutralize Omicron. Given the potential of additional
emerging VoCs, the BiondVax-MPG-UMG collaboration covers
development of new NanoAbs as needed during the evolution of
COVID-19. The methodologies employed by the Görlich and Dobbelstein
labs enable generation of new NanoAb candidates within weeks of
acquiring the sequence for any emerging variant, and thereby
positions BiondVax to stay at the forefront of COVID-19
preparedness.
In addition to the COVID-19 NanoAb collaboration and as
previously announced, BiondVax, MPG and UMG have signed a
term-sheet for development of NanoAbs towards other indications
with major opportunities in key therapeutic areas of psoriasis,
asthma, macular degeneration, and psoriatic arthritis. These are
all diseases with known and validated antibody drug targets
(thereby shortening development timelines and lowering risk), and
where the NanoAb advantages have the potential to capture
significant market share. BiondVax anticipates finalizing the
collaboration agreements for these additional NanoAbs in
January 2022.
BiondVax is planning a rapid development path that leverages the
company's expertise and capabilities in biological drug development
and manufacturing. In particular, NanoAbs can be mass-produced
through recombinant protein manufacturing in sites such as
BiondVax's GMP biologics manufacturing facility in
Jerusalem. BiondVax anticipates conducting COVID-19 NanoAb
preclinical studies in 2022 with initial human clinical trials
results in 2023.
Mr. Amir Reichman,
BiondVax's CEO, commented, "As Omicron's recent and rapid
emergence makes clear, improved therapeutics are needed to
bring COVID-19 under control. The innovative COVID-19 NanoAb
candidates offer the potential for a superior therapeutic platform.
Overall, the NanoAb platform is an incredible opportunity for
BiondVax. It will serve as a basis for an exciting new pipeline of
commercially attractive products to address unmet therapeutic needs
of 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 biological 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. BiondVax is in the process of a transformative
turnaround, and I am highly confident that these NanoAb therapies
present compelling commercial potential and will address important
healthcare needs."
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 and the
University Medical Center of Göttingen has great potential to
provide patients with superior therapies. We are particularly
pleased to team with BiondVax to use their drug development and
manufacturing capabilities and expertise to advance the COVID-19
nanosized antibodies through additional development towards
marketing approvals."
The collaboration has been facilitated by kENUP, a civic society
organization promoting innovative industries in Europe.
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, beginning with an innovative nanosized
antibody pipeline. For more information, please visit
www.biondvax.com.
* About NanoAbs: NanoAbs are novel nanosized antibodies
also known as VHH-antibodies or nanobodies. 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. The
NanoAbs created by Professors Görlich and Dobbelstein exhibit
potential to serve as highly attractive therapies for COVID-19, as
described in their paper titled "Neutralization of SARS-CoV-2 by
highly potent, hyperthermostable, and mutation-tolerant
nanobodies" published in The EMBO Journal and available at
https://doi.org/10.15252/embj.2021107985. Subsequent to publication
of the paper earlier this year, Professors Görlich and Dobbelstein
have generated a newer generation of nanoAbs that have been
specifically selected for potent neutralization of Alpha, Beta,
Gamma, and Delta variants. Based on in-silico studies, they
are also expected to neutralize Omicron. These NanoAbs are also
included in the collaboration and exclusive licensing agreement
with BiondVax.
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 an additional agreement with the Max Planck Society
and the University Medical Center Göttingen; the therapeutic and
commercial potential of NanoAb antibodies, the company's NanoAb
program, the potential for NanoAbs to safely and effectively target
COVID-19, the timing of preclinical and clinical data for NanoAbs
and the timing of future clinical trial data. 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 additional
agreements with the Max Planck Society and the University Medical
Center Göttingen or that it will be delayed; the risk that the
therapeutic and commercial potential of NanoAb
antibodies will not be met; the risk of a delay in the
preclinical and clinical data for NanoAbs, if any; the risk that
BiondVax and EIB will not reach agreement with respect to the
restructuring of the loan from EIB; 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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