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VACC: Vaccibody to initiate a phase 1/2 trial to evaluate two second-generation SARS CoV-2 virus DNA vaccine candidates to address emerging variants of concern
o Vaccibody to initiate phase 1/2 trial to evaluate second-generation SARS CoV-2
virus DNA vaccine candidates to address emerging variants of concern
o 2-armed strategy with one RBD- and one T cell candidate
o CTA to be submitted in Q3 and first subject expected to be dosed in early Q4
o The clinical trial will be conducted in Norway at Oslo University hospital and
Haukeland University hospital, Bergen
o Frequent regulatory and scientific advice consultations with the Norwegian
Oslo, Norway, June 29, 2021 - Vaccibody AS (Euronext Growth (Oslo): VACC), a
clinical-stage biopharmaceutical company dedicated to the discovery and
development of vaccines and novel immunotherapies, announced today that it is
initiating a phase 1/2, open label, dose escalation trial in healthy adult
volunteers to determine safety and immunogenicity of two SARS CoV-2 virus DNA
vaccine candidates: an RBD candidate and a T-cell candidate.
Vaccibody's development strategy is to develop second-generation SARS CoV-2
vaccines that may respond to the emerging threats of evolving variants with
reduced sensitivity to first generation vaccines that were developed using the
2020 prototype spike protein. The trial is a continuation of the promising
pre-clinical work published by Vaccibody in December 2020 showing that
pre-clinical vaccine candidates induced rapid, strong and long-lasting
neutralizing antibodies, as well as multifunctional, dominant CD8+ T cell and
Th1 CD4+ T cell responses in mice, after a single dose.
Michael Engsig, CEO of Vaccibody comments: "The two SARS CoV-2 vaccine
candidates are the first results of our vaccine strategy within infectious
diseases. It is an important milestone, and we are proud to demonstrate the
rapid development and fast turn-around time for our Vaccibody technology
platform with these second-generation CoV-2 vaccine candidates. In addition,
Vaccibody continues to work on other pathogens as part of the Company's
infectious disease strategy."
The 2-armed trial takes its outset in two development candidates designed around
the modular Vaccibody technology platform, targeting antigens to antigen
presenting cells. The dose escalation trial will enroll both pre-treated and
treatment naïve subjects.
The first new drug candidate is an RBD candidate encoding the receptor binding
domain (RBD) derived from the SARS-CoV-2 virus. The RBD domain is responsible
for binding to the ACE2 receptor and is a relevant target for neutralizing
antibodies. It is expected to elicit protection against disease by inducing
neutralizing antibodies alongside a balanced CD8+ and Th1 biased CD4+ response.
The second candidate builds on emerging evidence showing that T cell responses
are likely to play an essential role in SARS-CoV-2 immunity and viral clearance,
and that T cell-epitopes are less prone to immune evasion than the
surface-exposed spike epitopes including current and future variants of concern.
The candidate encodes multiple immunogenic and conserved T cell epitopes
spanning multiple antigens across the SARS-CoV-2 genome.
Anne Margarita Dyrhol Riise, Professor, MD, PhD, Department Head Infectious
disease, Oslo University hospital and the principal investigator for the trial
says: "The SARS-CoV-2 pandemic has demonstrated the need for efficient and safe
vaccine programs that address the paramount public health burden of COVID-19.
The new emerging variants of concern demonstrate that there is still a large
unmet patient need and we are very pleased to participate in this important
Chief Medical Officer of Vaccibody, Siri Torhaug, continues: "We are very
excited about this upcoming trial. We are in close and frequent dialogue with
regulatory and scientific advice consultations with the Norwegian Medicines
Agency (NoMA). Vaccibody consults their experts in a rolling review of key
documents to be included in the application for the trial. The primary objective
of this flexible process is to proactively align expectations for the approval
of the trial to allow for a rapid initiation of the clinical activities".
The trial is currently in the planning phase and with the CTA (Clinical Trial
Application) expected to be submitted in Q32021 and the first patient expected
to be dosed in early Q42021. The trial plans to enroll approximately 100-200
Vaccibody AS, is a clinical-stage biopharmaceutical company, dedicated to the
discovery and development of vaccines and novel immunotherapies. The Company
develops vaccines for the treatment of cancer and infectious diseases.
Vaccibody's 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 include VB10.NEO, a cancer neoantigen
vaccine, which is exclusively outlicensed to Genentech and is in phase I/IIa
clinical trial for the treatment of melanoma, lung-, head and neck, renal-, and