Nykode Therapeutics Announces Clinical Collaboration with MSD to Evaluate VB10.16 in Combination with KEYTRUDA® (pembrolizumab) in Patients with HPV16-Positive High-Risk Locally Advanced Cervical Cancer
May 14 2024 - 1:15AM
Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage
biopharmaceutical company dedicated to the discovery and
development of novel immunotherapies, today announced that it has
expanded its collaboration with MSD (Merck & Co., Inc., Rahway,
NJ, USA) to include a clinical trial collaboration and supply
agreement for a phase 2 trial evaluating Nykode’s wholly-owned lead
candidate, VB10.16, in combination with MSD’s anti-PD-1 therapy,
KEYTRUDA® (pembrolizumab). This study will enroll HPV16-positive
high-risk patients with locally advanced cervical cancer undergoing
chemoradiotherapy.
VB10.16 is a potentially first-in-class
off-the-shelf therapeutic cancer vaccine specifically designed to
treat HPV16-induced malignancies. The cancer vaccine is built on
Nykode’s technology platform of targeting antigens to antigen
presenting cells. Nykode has reported promising data from the phase
2 VB C-02 trial (NCT04405349) in heavily pre-treated cervical
cancer patients receiving VB10.16 in combination with atezolizumab
with a median overall survival not yet reached (estimated to 25
months at the time of analysis). These data support Nykode’s
ongoing efforts with the phase 2 VB-C-04 trial (NCT06099418) in
second-line recurrent/metastatic cervical cancer. Furthermore, the
VB10.16 clinical development program is expanding into new
indications, including head and neck cancer, for which Nykode has
an existing clinical trial collaboration and supply agreement with
MSD for the ongoing VB-C-03 trial (NCT06016920) evaluating VB10.16
in combination with KEYTRUDA in patients with HPV16-positive,
PD-L1-positive, recurrent or metastatic head and neck squamous cell
carcinoma.
Agnete Fredriksen, EVP, Chief Scientific Officer
and Business Development, commented, "We are excited to expand our
clinical development to include earlier stages of cervical cancer
where there is a significant unmet medical need, and we see a huge
potential for cancer vaccines. We are thrilled to continue building
on our already established, highly valued collaboration with the
experienced and talented team at MSD, a global leader in
immuno-oncology."
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About Nykode TherapeuticsNykode
Therapeutics is a clinical-stage biopharmaceutical company
dedicated to the discovery and development of novel immunotherapies
with a focus on the treatment of cancer and autoimmune diseases.
Nykode’s modular vaccine technology specifically targets antigens
to antigen presenting cells (APC), which have been shown to induce
a broad, strong and long-lasting antigen specific immune response
in cancer, which correlates with clinical responses.
Nykode’s lead product candidates are VB10.16, a
therapeutic vaccine for the treatment of HPV16 induced malignancies
which demonstrated favorable safety and efficacy results from its
Phase 2 trial for the treatment of cervical cancer. VB10.16 is
being expanded into multiple trials for treatment of head and neck
cancer and cervical cancer. VB10.NEO, an individualized cancer
neoantigen vaccine, is exclusively out-licensed to Genentech, a
member of the Roche Group.
The Company’s partnerships include Genentech
within oncology and a multi-target collaboration with Regeneron in
oncology and infectious diseases.
Nykode is also utilizing its APC-targeted
technology to create an inverse vaccine platform for the potential
use in autoimmune disorders, organ transplant rejections, anti-drug
antibody reactions and allergy.
Nykode Therapeutics’ shares are traded on the
Oslo Stock Exchange (OSE: NYKD). Further information about Nykode
Therapeutics can be found at http://www.nykode.com.
Forward-looking statements for Nykode
Therapeutics
This announcement and any materials distributed
in connection with this announcement may contain certain
forward-looking statements. By their nature, forward-looking
statements involve risk and uncertainty because they reflect the
company's current expectations and assumptions as to future events
and circumstances that may not prove accurate. A number of material
factors could cause actual results and developments to differ
materially from those expressed or implied by these forward-looking
statements.
Contact for Nykode Therapeutics
ASA:
EVP, Chief Scientific Officer and Business Development, Agnete
FredriksenNykode Therapeutics ASA IR@nykode.com
Nykode Therapeutics ASA
Oslo Science ParkGaustadalléen 21N-0349 Oslo, Norway