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2021-11-23 06:47:00
o Multi-target agreement covers five programs focused on off-the-shelf vaccines
for cancer and infectious disease
o Nykode Therapeutics (formerly Vaccibody*)) to receive an upfront payment of
USD 30 million and an equity investment of USD 20 million at a premium of 20% of
Nykode Therapeutics' share price
o Nykode Therapeutics will potentially be eligible to receive more than USD 875
million in additional payments based on potential future development and
commercial achievements, plus royalties
o Regeneron to cover all research, development and commercialization costs
(Please also refer to the separate announcements by Nykode Therapeutics issued
today regarding the Company's name change*), and the calling for an
extraordinary general meeting.)
Oslo, Norway, November 23, 2021 - Nykode Therapeutics (formerly Vaccibody*))
(Euronext Growth (Oslo): VACC), a clinical-stage biopharmaceutical company
dedicated to the discovery and development of vaccines and novel
immunotherapies, announced today that it has entered into a license and
collaboration agreement with Regeneron for the discovery, development and
commercialization of potential new vaccines for cancer and infectious diseases.
The agreement includes five distinct programs, three within cancer and two
within infectious diseases. Each of these may include several vaccine
candidates, all of which being eligible for milestone and royalty payments. The
vaccines will combine Regeneron's unique antigen selection expertise and
innovative VelociSuite® in vivo models with Nykode Therapeutics' modular vaccine
platform and expertise in vaccine design. Nykode Therapeutics will be
responsible for vaccine generation and characterization, as well as product
supply through the end of Phase 1 trials. Regeneron will be responsible for
antigen identification, preclinical and clinical development, manufacturing
(from the end of Phase 1 trials) and commercialization.
Under the terms of the agreement, Nykode Therapeutics will receive a USD 30
million upfront payment and a USD 20 million equity investment at a premium of
20% on a 30-day volume weighted average price of the Nykode Therapeutics share
for the last 30 trading days before the effective date of the agreement.
Additionally, Nykode Therapeutics will potentially be eligible to receive more
than USD 875 million in milestone payments, plus high single-digit to low
double-digit tiered royalties on sales of commercialized products arising from
the collaboration, bringing the total potential value of the agreement to more
than USD 925 million, plus royalties. Regeneron will cover costs for research,
as well as potential clinical, regulatory, manufacturing and commercialization
activities.
Michael Engsig, CEO of Nykode Therapeutics, said: "We are very pleased to have
entered into this groundbreaking agreement with Regeneron that may accelerate
the expansion of our pipeline and fully leverage our unique and modular vaccine
technology platform within multiple, large and commercially significant disease
areas, in line with our corporate strategy. The agreement further validates
Nykode Therapeutics' position as a leading next-generation immunotherapy
platform company. We are thrilled about the choice of programs and their
therapeutic potential within cancer, and prophylactic and therapeutic potential
within infectious diseases."
Agnete B. Fredriksen, Chief Innovation & Strategy Officer of Nykode
Therapeutics, continued: "Regeneron has generated unique know how in selecting
and validating immunogenic antigens from extensive analysis of patient material.
These can now be incorporated into our vaccine platform to deliver the antigens
directly to antigen presenting cells and optimize the likelihood of inducing
strong and broad clinically relevant immune responses. Regeneron has also
developed a unique suite of proprietary VelociSuite® technologies and in vivo
models that can accelerate and improve the traditional drug development process,
and they will use their deep clinical expertise to guide development of these
novel vaccines. Therefore, Regeneron will be a tremendous partner as we work to
bring multiple additional vaccines based on our technology platform to patients
in the fastest and broadest manner and complement the expansion and acceleration
of internal programs."
Mikkel W. Pedersen, Chief Scientific Officer of Nykode Therapeutics, added: "We
are excited about the opportunity to work with the Regeneron team. The extensive
disease biology expertise of Regeneron coupled with Nykode Therapeutics' modular
and targeted vaccine platform will enable us to design and potentially bring
into the clinic new unique therapeutic vaccine concepts within both oncology and
infectious diseases."
Gavin Thurston, Ph.D., Senior Vice President, Oncology Research, at Regeneron
said: "Collaborating with Nykode Therapeutics will bring another dimension to
Regeneron's already robust research and development programs for oncology and
infectious disease and, in particular, provides new opportunities to help people
with challenging tumor types or infectious diseases with high unmet need. Nykode
Therapeutics' platform efficiently delivers vaccine payloads to antigen
presenting cells and allows for vaccine candidates that can be easily
manufactured. It has already shown robust CD8+ antigen-specific T cell responses
in animal models and in patients with cancer. Combining their platform with our
industry-leading VelociSuite® technologies and expertise may help to accelerate
this emerging and promising therapeutic approach."
Webcast
CEO Michael Engsig and other members of management will host a webcast on
November 23, 2021 at 4 p.m. CET / 10 a.m. EST to present the license and
collaboration agreement with Regeneron. The slides will be made available before
the webcast. The webcast may be viewed here:
https://channel.royalcast.com/landingpage/hegnarmedia/20211118_4/
*) Vaccibody AS, which is changing its company name to Nykode Therapeutics AS,
has called for an EGM on November 30, 2021, to vote for the approval of the
change of its company name from Vaccibody AS to Nykode Therapeutics AS.
About Nykode Therapeutics
Nykode Therapeutics, is a clinical-stage biopharmaceutical company, dedicated to
the discovery and development of vaccines and novel immunotherapies for the
treatment of cancer and infectious diseases. Nykode Therapeutics' modular
vaccine technology specifically targets antigens to Antigen Presenting Cells,
which are essential for inducing rapid, strong and long-lasting antigen specific
immune responses and elicit efficacious clinical responses.
Its lead product candidates are VB10.16, a therapeutic vaccine for the treatment
of human papilloma virus 16 induced malignancies which is in Phase 2 for the
treatment of cervical cancer