Potentially registrational trial with Nykode's lead candidate VB10.16 and
Roche's atezolizumab (Tecentriq®) in the U.S. is expected to be initiated 4Q
2023
Oslo, Norway, June 1, 2023 - 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 the
clinical collaboration and supply agreement with Roche to cover evaluation of
VB10.16, Nykode's wholly owned off-the-shelf therapeutic cancer vaccine
candidate, in combination with Roche's cancer immunotherapy atezolizumab in
patients with advanced cervical cancer who have progressed on pembrolizumab plus
chemotherapy +/- bevacizumab as first line treatment. The VB-C-04 trial is
expected to be initiated in the U.S. in the fourth quarter of 2023 with
registrational intent, which provides a potential fast-to-market path.
Under the terms of the agreement, Nykode will sponsor and fund the planned
clinical trial, and Roche will provide atezolizumab. Nykode retains all
commercial rights to VB10.16 worldwide.
Nykode has recently reported positive safety and efficacy results from the Phase
2 VB-C-02 trial in Europe in advanced cervical cancer patients with VB10.16 in
combination with atezolizumab. The results showed an overall response rate (ORR)
of 29%, median overall survival (mOS) not reached but greater than 25 months at
the time of analysis, and 6.3 months median progression free survival (mPFS) in
PD-L1+ patients. In the patient population most relevant for the upcoming
VB-C-04 trial, PD-L1+ patients with one prior line of systemic treatment, ORR
was 40% and disease control rate was 80% with mPFS of 16.9 months and mOS not
reached but greater than 25 months at the time of analysis.
"We look forward to expanding our collaboration with Roche to bring the
combination of VB10.16 and atezolizumab to cervical cancer patients with limited
treatment options. Cervical cancer has a poor prognosis, and the recent positive
clinical data from VB-C-02 has strengthened our commitment to contribute with a
well-tolerated treatment that can potentially prolong the life of these women.
The trial provides a potential fast path to market for VB10.16." said Michael
Engsig, CEO of Nykode Therapeutics. "Overall, the collaboration speaks to our
shared confidence in the unique potential of VB10.16, the platform, and the
synergy between our vaccine candidates and atezolizumab. In addition to the
existing VB-C-02 and the new VB-C-04 collaboration, Roche continues to be a
valuable partner under our collaboration agreement covering development of
individualized vaccines for a broad range of cancers."
The VB-C-04 trial will be conducted together with GOG Foundation, a U.S.-based
not-for-profit organization with expertise in bringing best-in-class new
treatments to patients.
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
VaccibodyTM technology platform of targeting antigens to antigen presenting
cells. VB10.16 has reported positive data from a Phase 2 trial in advanced
cervical cancer patients (NCT04405349) in combination with atezolizumab with mOS
not reached but greater than 25 months at the time of analysis in PD-L1+
patients. The vaccine-induced significant HPV16-specific T cell responses 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