Oslo, Norway, April 19, 2024 - 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®) 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 VaccibodyTM 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