Nykode Therapeutics Announces Collaboration with The GOG Foundation, Inc. to Conduct the VB-C-04 Trial in Advanced Cervical Cancer

10 Feb 2023 06:45 CET

• Potentially registrational VB-C-04 trial in the U.S. expected to initiate 4Q
2023

• The GOG Foundation, Inc. (GOG) is a U.S. based not-for-profit organization
with the purpose of promoting excellence in the quality and integrity in
clinical trials; GOG’s mission is to transform the standard of care in
gynecologic cancers


Oslo, Norway, February 10, 2023 – Nykode Therapeutics ASA (OSE: NYKD), a
clinical-stage biopharmaceutical company dedicated to the discovery and
development of novel immunotherapies, today announced a collaboration with the
GOG Foundation, Inc. to conduct a clinical trial of VB10.16 in combination with
an immune checkpoint inhibitor for the treatment of advanced cervical cancer in
the U.S. The VB-C-04 trial will evaluate the combination therapies in patients
with cervical cancer that have progressed following first line treatment. Nykode
has previously reported positive interim data from the Phase 2 VB-C-02 trial in
Europe in patients with heavily pre-treated advanced cervical cancer. VB10.16,
wholly owned by Nykode, is a potentially first-in-class off-the-shelf
therapeutic cancer vaccine candidate in development for the treatment of
HPV16-positive cancers.

“Based on the positive interim data and in line with our potential
registrational trial strategy, we look forward to starting the VB-C-04 trial in
the U.S. The trial is aimed at providing a fast path to making VB10.16 available
to patients,” said Klaus Edvardsen, Chief Development Officer of Nykode
Therapeutics.

“We are excited to collaborate with the GOG Foundation, a leading organization
with unparalleled expertise in bringing best-in-class new treatments to
patients,” said Michael Engsig, Chief Executive Officer of Nykode Therapeutics.
“The GOG Foundation has a long history of successfully working with innovative
companies, gynecologic oncology clinical sites and U.S. regulators. The advice
and support from the GOG Foundation will increase the quality and facilitate the
execution for bringing VB10.16 forward towards the patients in need. We look
forward to engaging with the GOG Foundation on execution of the potential
registrational trial, VB-C-04.”

Since 1970, the GOG Foundation has conducted more than 350 clinical trials in
the U.S. with 400 participating sites and 115,000 patients. The results of the
GOG Foundation’s clinical trials have influenced the standard of care for
numerous malignant gynecologic neoplasms.

“We are thrilled to partner with Nykode Therapeutics to conduct VB-C-04, a
ground-breaking study to investigate Nykode’s therapeutic cancer vaccine
candidate for the treatment of patients with advanced cervical cancer. VB10.16,
which utilizes Nykode’s unique immunotherapy platform, has the potential to
meaningfully improve standard of care for patients with HPV16-positive cervical
cancer whose cancer has progressed after initial immunotherapy. This clinical
situation has quickly become an area of high unmet medical need, and while we
have made progress with other novel therapies, we remain dedicated to maximizing
our patients’ treatment options and choices. We look forward to working with
Nykode on VB-C-04 to advance our shared mission of delivering transformative
therapies to patients with cervical cancer and other gynecologic malignancies to
help our patients live as long as possible and feel as good as possible,” said
Leslie Randall, MD, MAS, Cervical Cancer Advisor for the GOG Partners in the GOG
Foundation.

“Despite recent advances in cervical cancer care, we still have gaps in
treatment strategies, particularly those who have received prior checkpoint
therapy. As we continue to explore opportunities to capitalize on recent
improvements in cervical cancer outcomes, innovative approaches and novel
therapies are required. The VB-C-04 study in patients with recurrent cervical
cancer with prior checkpoint inhibitor experience delivers this and offers an
opportunity to continue to change the landscape and survival impact for our
patients,” notes principal investigator of the study, Ritu Salani, MD, MBA,
Director, Division of Gynecologic Oncology, David Geffen School of Medicine at
UCLA.


About The GOG Foundation, Inc.
The GOG Foundation is a not-for-profit organization with the purpose of
promoting excellence in the quality and integrity of clinical and basic
scientific research in the field of gynecologic malignancies. For nearly 50
years, the GOG Foundation has been a trusted resource in the field of
gynecologic oncology research. 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, vagina, 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 VB10.16
VB10.16 is a potentially first-in-class off-the-shelf therapeutic 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 positive interim data from a Phase 2 trial in
heavily pre-treated cervical cancer patients (NCT04405349). The analysis
demonstrated a favorable safety profile, with responses observed in both PD-L1
positive and negative patients (ORR 27% and 17%, respectively). The
vaccine-induced significant HPV16-specific T cell responses were associated 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.


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 (arising from cells lining the bottom of the
cervix) and most other patients have adenocarcinomas (arising from glandular
cells in the upper cervix). 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 for the treatment of
cancer and infectious diseases. Nykode’s 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 eliciting
efficacious clinical responses.

Nykode’s lead product candidates are VB10.16, a therapeutic vaccine for the
treatment of human papilloma virus (HPV)-16 induced malignancies which
demonstrated positive interim efficacy and safety results from its Phase 2 trial
for the treatment of cervical cancer; and VB10.NEO, an individualized cancer
neoantigen vaccine, which is exclusively out-licensed to Genentech, a member of
the Roche Group. Additionally, Nykode is conducting a Phase 1/2 trial with
next-generation COVID-19 vaccine candidates.

The Company’s partnerships include Genentech within oncology, a multi-target
collaboration with Regeneron within oncology and infectious diseases and a
collaboration with Adaptive Biotechnologies for COVID-19 T cell vaccine
development.

Nykode Therapeutics’ shares are traded on the Oslo Stock Exchange (OSE: NYKD).
Further information about Nykode Therapeutics may 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:
Chief Business Officer, Agnete Fredriksen
Nykode Therapeutics ASA
IR@nykode.com

Nykode Therapeutics ASA
Oslo Science Park
Gaustadalléen 21
N-0349 Oslo, Norway

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