Nykode Therapeutics Announces Publication of Phase 2 VB-C-02 Data Confirming Prolonged Benefit and Definitive Vaccination Effects

08 Jan 2025 10:50 CET

• Final data from the Phase 2 VB-C-02 trial were published in the peer-reviewed
BMJ Journal for ImmunoTherapy of Cancer.

• VB10.16 in combination with atezolizumab (Tecentriq®) demonstrated a favorable
safety profile across 52 enrolled patients.

• The data affirm the prolonged benefit and definitive vaccination effect
observed in the interim analysis (efficacy population includes 47 patients), as
previously announced.

• Anti-tumor activity was observed with an overall response rate (ORR) of 19.1%,
increasing to 29.2% for PD-L1-positive patients and 40.0% for PD-L1-positive
patients with one prior line of systemic anti-cancer treatment (SACT).

• Durable efficacy was demonstrated with a median progression-free survival
(mPFS) of 4.1 months and a median overall survival (mOS) of 21.3 months in the
total efficacy population.

• Among PD-L1-positive patients, mPFS was 6.3 months, extending to 15.8 months
for those with one prior line of SACT, while mOS reached 24.7 months and was not
reached for PD-L1-positive patients with one prior line of SACT.


Oslo, Norway, January 8, 2025 – Nykode Therapeutics ASA (OSE: NYKD), a
clinical-stage biopharmaceutical company dedicated to the discovery and
development of novel immunotherapies, today announced the publication of a
manuscript entitled “Safety and efficacy of the therapeutic DNA-based vaccine
VB10.16 in combination with atezolizumab in persistent, recurrent or metastatic
HPV16-positive cervical cancer: a multicenter, single-arm phase 2a study” in the
peer-reviewed BMJ “Journal for ImmunoTherapy of Cancer” (JITC). The trial
investigated the use of Nykode’s wholly owned off-the-shelf therapeutic cancer
vaccine candidate VB10.16 in combination with Roche’s checkpoint inhibitor
atezolizumab in patients with persistent and recurrent or metastatic
HPV16-positive cervical cancer.

As previously communicated, the published results confirm prolonged clinical
benefits and indicate a potential synergistic treatment effect of VB10.16 in
combination with atezolizumab compared to what has previously been reported for
checkpoint inhibitor monotherapy. In this analysis the remaining patients were
followed for up to 24 months, compared to at least 12 months in the previously
reported data cut-off.

The trial demonstrated an ORR of 19.1% in the efficacy population. With the
extended 12-month follow-up period to the end of the trial, both mPFS and mOS
increased compared to what has previously been reported, reaching 4.3 months and
21.3 months, respectively.

In the subpopulation of PD-L1-positive patients (n=24) the ORR increased to
29.2% resulting in further improved mPFS and mOS of 6.3 months and 24.7 months,
respectively.

Among PD-L1-positive patients with one prior line of SATC (n=15), the ORR
increased to 40.0%, and mPFS and mOS further improved to 15.8 months and not
reached, respectively.

“Compared to historical data on checkpoint inhibitor monotherapy in highly
similar patient populations, the final VB10.16 C-02 data strongly indicate an
extended survival benefit and sustained efficacy of the combination of VB10.16
and atezolizumab. We are thrilled to see the data published in full for the
first time, enabling in-depth discussions with the medical community on the best
path forward for VB10.16,” said Michael Engsig, CEO of Nykode.

“As many cancer vaccines increasingly target earlier lines of treatment,
including adjuvant setting, we are proud to demonstrate strong and durable
efficacy in advanced-stage cervical cancer. Furthermore, the increased efficacy
observed in patients receiving second-line therapy compared to later lines
underscores the strong potential of this combination therapy and highlights a
promising area for further exploration with our cancer vaccines across various
lines of therapy.”

The manuscript is available here:
https://jitc.bmj.com/content/jitc/13/1/e010827.full.pdf


About the VB-C-02 trial
VB-C-02 is a multi-center, single arm, open-label Phase 2 trial to assess the
efficacy, immunogenicity and safety of VB10.16 in combination with the PD-L1
inhibitor atezolizumab in patients with advanced or recurrent, non-resectable
human papillomavirus type 16 (HPV16)-positive cervical cancer. Patients received
treatment with VB10.16 in combination with atezolizumab for up to one year. The
trial enrolled 52 patients at sites in Europe. Additional information about the
VB-C-02 trial is available at clinicaltrials.gov (NCT04405349).

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 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 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-L1 inhibitor KEYTRUDA® (pembrolizumab) in patients with HPV16-positive,
PD-L1-positive, recurrent, or metastatic head and neck squamous cell carcinoma
(HNSCC).

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 HPV16-Driven Cancers
One of the emerging challenges within oncology is the virus-induced cancer
types, with Human Papillomavirus (HPV) being one of the most prominent. There
are several types of high-risk HPV causing cancers, HPV16 being one of the most
common, with more than 130,000 new cases in the U.S. and EU per year. Using a
therapeutic cancer vaccine targeted specifically towards the HPV16 infected
cells in the tumors, such as Nykode’s cancer vaccine VB10.16, represents a novel
immunotherapeutic treatment option. By combining a therapeutic cancer vaccine
with the checkpoint inhibitors and/or other general immune therapies, the tumors
can be attacked by the cancer-specific T cells from several angles with the aim
of improving patient outcomes.

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.NEO, an individualized cancer neoantigen vaccine, is being investigated in
a trial with more than 10 different indications.

The Company’s partnerships include 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:
Alexandra Deschner, Head of IR
Nykode Therapeutics ASA
IR@nykode.com

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

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636106_250108_C-02 publication - FINAL.pdf