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Land | Norge |
---|---|
Lista | OB Match |
Sektor | Hälsovård |
Industri | Bioteknik |
2024-08-21 06:30:00
o Strategic repositioning of VB10.16 development activities focused on locally
advanced cervical cancer and recurrent metastatic head and neck cancer, building
on positive feedback from key opinion leaders and potential future partners.
o Prioritization of these indications is driven by their significant unmet
medical needs, clear regulatory paths to approval, and high commercial
potential.
o Recent changes in standard-of-care have extended the timelines for the C-04
trial, making it less attractive as a fast-to-market strategy.
o Nykode has therefore decided to discontinue the C-04 trial to ensure financial
and human resources are concentrated on these promising indications.
o The decision is expected to reduce VB10.16 development costs by over $25
million, which combined with our planned partnering strategy, will substantially
extend the company's cash runway.
Oslo, Norway, August 21, 2024 - Nykode Therapeutics ASA (OSE: NYKD), a
clinical-stage biopharmaceutical company dedicated to the discovery and
development of novel immunotherapies, today announced a strategic repositioning
for VB10.16, 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.
As part of the strategic repositioning, the company has decided to focus the
development of VB10.16 on locally advanced cervical cancer and recurrent
metastatic head and neck cancer. This decision follows a comprehensive strategic
review, which considered the timing of development activities, the need to
optimize financial and human resources, and positive feedback from key opinion
leaders, alongside input from potential future partners.
Recent changes in standard-of-care has extended the timelines for the C-04
trial, diminishing its viability as a fast-to-market strategy. In light of this,
Nykode has decided to discontinue the C-04 trial to concentrate the company's
financial and human resources on more promising indications. The decision is
expected to reduce the VB10.16 development costs by over $25 million, which
combined with our planned partnering strategy, will substantially extend the
company's cash runway.
Michael Engsig, Chief Executive Officer of Nykode Therapeutics, stated: "The
decision to focus on locally advanced cervical cancer and recurrent metastatic
head and neck, and discontinue the C-04 trial in 2L cervical cancer, is part of
our strategic repositioning to concentrate resources on the most commercially
promising areas where we create significant benefits for patients in need, while
generating value for shareholders. We remain highly enthusiastic about the broad
potential of VB10.16 to make a meaningful difference in the lives of patients
with HPV-driven cancers. While we regret the impact of excluding 2L cervical
cancer from our immediate pipeline, we are eager to advance VB10.16 where we see
the highest likelihood of clinical efficacy and the greatest market potential.
Klaus Edvardsen, Chief Research & Development Officer of Nykode Therapeutics,
added: "Our commitment to developing VB10.16 as a treatment option for patients
with HPV-driven cancers remains strong. To focus our efforts on indications with
the clearest path to registration, we have decided to discontinue our work on
recurrent/metastatic cervical cancer to concentrate on locally advanced cervical
cancer, which is supported by the C-02 data demonstrating the vaccine's
capability of deepening responses and maintaining clinical benefit for a
prolonged period. We extend our gratitude to the partners involved in developing
the C-04 trial and look forward to continuing our work on VB10.16."
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