Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage
biopharmaceutical company dedicated to the discovery and
development of novel immunotherapies, today announced the
initiation of the Phase 2 clinical trial VB-C-04. The trial
evaluates VB10.16, the company’s off-the-shelf therapeutic cancer
vaccine candidate for HPV16-positive cancers, alone or in
combination with Roche’s checkpoint inhibitor atezolizumab
(Tecentriq®1) in patients with HPV16-positive, PD-L1-positive,
recurrent, or metastatic cervical cancer.
Step 1 of VB-C-04 is a two-arm Phase 2 trial
evaluating the efficacy and safety of VB10.16 alone or in
combination with atezolizumab in patients with recurrent or
metastatic cervical cancer refractory to first-line treatment with
pembrolizumab plus chemotherapy +/- bevacizumab.
The Phase 2 trial (GOG-3091) will be conducted
in the United States (U.S.) in collaboration with The GOG
Foundation, Inc. (GOG Foundation), a U.S. based not-for-profit
organization with the purpose of promoting excellence in the
quality and integrity in clinical trials in gynecologic
malignancies. The GOG Foundation is the only clinical trialist
group in the United States that focuses its research on patients
with pelvic malignancies, such as cancer of the ovary (including
surface peritoneal malignancies), uterus (including endometrium,
soft tissue sarcoma, and gestational trophoblastic neoplasia),
cervix, and vulva.
Dr. Bradley Monk, Director of GOG, said, "Today
marks an important step forward in our efforts to advance cancer
treatment with the initiation of the Phase 2 trial of VB10.16 in
second line HPV16-positive cervical cancer. This is a collaborative
effort between GOG and Nykode, introducing a novel and promising
approach to address a significant unmet medical need. As we embark
on this Phase 2 trial, we are optimistic about the potential impact
on reshaping the landscape of cancer care and look forward to
contributing to advancements that can make a meaningful difference
in patients' lives."
“Initiating the VB10.16 trial for HPV16-positive
cervical cancer addressing a high unmet medical need, is a
significant step in our clinical development strategy," said Klaus
Edvardsen, Chief Development Officer of Nykode Therapeutics. "The
encouraging clinical profile and favorable tolerability exhibited
by VB10.16 in combination with atezolizumab among patients with
advanced HPV16 positive cervical cancer observed in VB-C-02
supports our dedication to advancing VB10.16 as an innovative
immunotherapy for HPV16 positive cancers.”
Atezolizumab is supplied by Roche. Nykode
retains all commercial rights to VB10.16 worldwide.
About VB10.16
VB10.16 is a potentially first-in-class
off-the-shelf therapeutic DNA-based cancer vaccine candidate in
development for the treatment of human papillomavirus type 16
(HPV16)-positive cancers. The cancer vaccine is designed based on
Nykode’s Vaccibody™ technology platform of targeting antigens to
antigen presenting cells. VB10.16 has reported promising data from
a Phase 2 trial in advanced PD-L1 positive cervical cancer patients
(NCT04405349) in combination with atezolizumab with mOS not
reached, but at least 24 months at the time of analysis. The
vaccine-induced significant HPV16-specific T cell responses that
were correlated with clinical responses. The candidate has also
demonstrated favorable clinical data in a Phase 1/2a study in
pre-cancerous HPV16-induced high grade cervical intraepithelial
neoplasia (HSIL; CIN 2/3) demonstrating a statistically significant
correlation of immune responses and clinical responses. Nykode is
currently investigating VB10.16 in VB-C-03, an open-label,
dose-finding Phase 1/2a trial evaluating VB10.16 in combination
with MSD’s PD-1 inhibitor KEYTRUDA® (pembrolizumab) in patients
with HPV16-positive, PD-L1-positive, recurrent, or metastatic head
and neck squamous cell carcinoma (HNSCC) in addition to the VB-C-04
trial initiated today.
About the Phase 2 Trial
The Phase 2 VB-C-04 trial (NCT06099418) is
designed to evaluate the efficacy and safety of VB10.16. Step 1 is
randomized and will evaluate VB10.16 as a monotherapy, and in
combination with Roche’s checkpoint inhibitor atezolizumab as a
second line treatment in patients with recurrent or metastatic
cervical cancer. Step 1 of the trial is expected to enroll 60
patients with disease progression after combination treatment with
pembrolizumab, chemotherapy +/- bevacizumab into the trial. Step 2
is intended to enroll additional patients in one cohort after
reviewing the data from Step 1.
About Cervical Cancer
Cervical cancer is the fourth leading cause of
cancer death in women worldwide and is most frequently diagnosed
between the ages of 35 and 44. Each year around 600,000 women are
diagnosed with cervical cancer worldwide. Almost all cases are
caused by human papillomavirus (HPV) infection and HPV16 accounts
for more than half of all cervical cancer cases. Approximately 80%
of patients with cervical cancer have squamous cell carcinoma and
most other patients have adenocarcinomas. Cervical cancer is often
curable when detected early and effectively managed, but treatment
options are more limited in advanced disease stages or when the
cancer has spread.
About Nykode Therapeutics
Nykode 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.
About The GOG Foundation, Inc.
(www.gog.org)
The GOG Foundation, Inc. is a not-for-profit
organization with the purpose of promoting excellence in the
quality and integrity of clinical and translational scientific
research in the field of gynecologic malignancies. The GOG
Foundation is committed to maintaining the highest standards in
clinical trials development, execution, analysis, and distribution
of results. The GOG Foundation is the only clinical trialist group
in the United States that focuses its research on patients with
pelvic malignancies, such as cancer of the ovary (including surface
peritoneal malignancies), uterus (including endometrium, soft
tissue sarcoma, and gestational trophoblastic neoplasia), cervix,
and vulva. The GOG Foundation is multi-disciplinary in its approach
to clinical trials, and includes gynecologic oncologists, medical
oncologists, pathologists, radiation oncologists, oncology nurses,
biostatisticians (including those with expertise in
bioinformatics), basic scientists, quality of life experts, data
managers, and administrative personnel.
About GOG Partners
Supported by industry, GOG Partners is
structured to work directly with pharmaceutical organizations and
operate clinical trials outside the National Cancer Institute (NCI)
framework. The GOG Partners shares the same mission of the GOG
Foundation dedicated to transforming the care in Gynecologic
Oncology. By providing an alternative venue for patient accrual and
site infrastructure support, GOG Partners has helped provide
additional trials and opportunities for patients outside the
national gynecologic clinical trials network.
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:
Alexandra Deschner, Head of IRNykode Therapeutics ASA
IR@nykode.com
Nykode Therapeutics ASA
Oslo Science ParkGaustadalléen 21N-0349 Oslo, Norway
1 Tecentriq® is a registered trademark of the Roche Group.