abipapogene suvaplasmid (VB10.16) / Nykode Therap - LARVOL DELTA

Nykode Announces Updated Strategy to Increase Value for Patients and Shareholders, Prioritizing VB10.16 as the Lead Value Driver (Nykode Therapeutics Press Release) - "At the core of the updated strategy is abi-suva, Nykode’s lead asset and highest priority for new investment....The trial will enroll up to 100 patients and is powered to deliver robust efficacy data in combination with pembrolizumab, the current standard-of-care for PD-L1-positive 1L r/m HNSCC patients. Interim analyses for efficacy are planned throughout the trial, with the first expected during 2027."

P2a data • Squamous Cell Carcinoma of Head and Neck

Integrative analysis of VB10.16 and atezolizumab in advanced HPV16-positive cervical cancer: Linking biomarker insights to clinical outcomes. (ASCO 2025) - P2 | "VB10.16 combined with atezolizumab induces durable responses, mitigates local and systemic immunosuppression, and demonstrates synergy between biomarkers and clinical outcomes. High CR/PR rates with favorable immune and TME characteristics highlight the promise of this combination therapy, warranting further exploration. 1Hillemanns P et al, 2025 doi:10.1136/jitc-2024-010827."

Biomarker • Clinical • Clinical data • IO biomarker • Metastases • Cervical Cancer • Oncology • Solid Tumor • IFNG

Nykode Therapeutics Highlights New Data in Two Poster Presentations at the 2025 ASCO Annual Meeting (TradingView) - "Nykode Therapeutics ASA...announced the presentation of newdata from two clinical trials evaluating its cancer immunotherapy candidates--VB10.16 and VB10.NEO, both in combination with atezolizumab (Tecentriq), --atthe 2025 American Society of Clinical Oncology (ASCO) Annual Meeting inChicago,Illinois."

Clinical data • Cervical Cancer • Solid Tumor

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 (J Immunother Cancer) - P2a | N=52 | NCT04405349 | Sponsor: Nykode Therapeutics ASA | "Between June 16, 2020, and January 25, 2022, 52 patients received at least one administration of study treatment. Of these, 47 patients had a minimum of one post-baseline tumor assessment. The median follow-up time for survival was 11.7 months. AEs related to VB10.16 were non-serious and mainly mild injection site reactions (9 of 52 patients). There were no signs of new toxicities other than what was already described with atezolizumab. ORR was 19.1% (95% CI 9.1% to 33.3%). Median duration of response was not reached (n.r.) (95% CI 2.2 to n.r.), median progression-free survival was 4.1 months (95% CI 2.1 to 6.2), and median overall survival was 21.3 months (95% CI 8.5 to n.r.)."

P2a data • Cervical Cancer

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. (PubMed, J Immunother Cancer) - P2 | "The therapeutic DNA-based vaccine VB10.16 combined with atezolizumab was safe and well tolerated showing a promising clinically meaningful efficacy with durable responses in patients with persistent, r/m HPV16-positive cervical cancer, especially if PD-L1-positive."

Journal • P2a data • Cervical Cancer • Oncology • Solid Tumor • PD-L1

VB-C-04: Efficacy and Safety of VB10.16 Alone or in Combination With Atezolizumab in Patients With Advanced Cervical Cancer. (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Nykode Therapeutics ASA | N=130 ➔ 0 | Recruiting ➔ Withdrawn

Combination therapy • Enrollment change • Metastases • PD(L)-1 companion diagnostic • Trial withdrawal • Cervical Cancer • Oncology • Solid Tumor • PD-L1

A phase I/IIa, open-label, dose-finding trial to evaluate safety, immunogenicity, and anti-tumour activity of VB10.16 in combination with pembrolizumab in patients with unresectable recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma (R/M HNSCC) (ESMO 2024) - P1/2 | "In a Phase II trial in R/M cervical cancer, VB10.16 combined with atezolizumab showed a favourable safety profile and promising efficacy. After 48 weeks of combination treatment, patients can either continue pembrolizumab with 200 mg Q3W administration or change to 400 mg Q6W at the discretion of the investigator and after consultation with the Sponsor corresponding to approximately 2 years of treatment. Pembrolizumab is supplied by Merck(MSD)."

Clinical • Combination therapy • Metastases • P1/2 data • Cervical Cancer • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CCL3

Nykode Therapeutics Announces Strategic Repositioning of VB10.16 to Focus on Locally Advanced Cervical Cancer and Recurrent Metastatic Head and Neck Cancer (Nykode Therapeutics Press Release) - "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....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 VB10.16 development costs by over $25 million, which combined with our planned partnering strategy, will substantially extend the company’s cash runway."

Commercial • Trial termination • Cervical Cancer • Head and Neck Cancer

Nykode Therapeutics Announces Clinical Collaboration with MSD to Evaluate VB10.16 in Combination with KEYTRUDA (pembrolizumab) in Patients with HPV16-Positive High-Risk Locally Advanced Cervical Cancer (GlobeNewswire) - "Nykode Therapeutics ASA...today announced that it has expanded its collaboration with MSD...to include a clinical trial collaboration and supply agreement for a phase 2 trial evaluating Nykode’s wholly-owned lead candidate, VB10.16, in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab). This study will enroll HPV16-positive high-risk patients with locally advanced cervical cancer undergoing chemoradiotherapy."

Licensing / partnership • Cervical Cancer

Efficacy and Safety of VB10.16 Alone or in Combination With Atezolizumab in Patients With Advanced Cervical Cancer. (clinicaltrials.gov) - P2 | N=130 | Recruiting | Sponsor: Nykode Therapeutics ASA | Not yet recruiting ➔ Recruiting | Initiation date: Dec 2023 ➔ Apr 2024

Combination therapy • Enrollment open • Metastases • PD(L)-1 companion diagnostic • Trial initiation date • Cervical Cancer • Oncology • Solid Tumor • PD-L1

Development of VB10.16, an APC-Targeting Therapeutic Cancer Vaccine for HPV-16 Induced Tumours (IO-SUMMIT EUROPE 2024) - "Progress on the development and clinical results with VB10.16, an off-the-shelf antigen-presenting cell-targeting therapeutic cancer vaccine for HPV-16 induced tumours will be presented. The use of HPV ctDNA as a biomarker in HPV-induced tumours will also be discussed."

Oncology

Nykode Therapeutics Initiates Phase 2 Trial of VB10.16 in Second Line HPV16-Positive Cervical Cancer (GlobeNewswire) - "Nykode Therapeutics ASA...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)..."

Trial status • Cervical Cancer

Development of VB10.16, an APC-Targeting Therapeutic Cancer Vaccine for HPV-16 Induced Tumours (IO-SUMMIT EUROPE 2024) - "Progress on the development and clinical results with VB10.16, an off-the-shelf antigen-presenting cell-targeting therapeutic cancer vaccine for HPV-16 induced tumours will be presented. The use of HPV ctDNA as a biomarker in HPV-induced tumours will also be discussed."

Oncology

KEYNOTE-E72: Safety and Efficacy of VB10.16 and Pembrolizumab in Patients With Head-Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P1/2 | N=51 | Recruiting | Sponsor: Nykode Therapeutics ASA | Initiation date: Sep 2023 ➔ Dec 2023

Metastases • Trial initiation date • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • IFNG • PD-L1

Investigating the Combination of VB10.16 and Atezolizumab in Patients With HPV 16-positive Cervical Cancer (clinicaltrials.gov) - P2 | N=52 | Completed | Sponsor: Nykode Therapeutics ASA | Active, not recruiting ➔ Completed | Phase classification: P2a ➔ P2 | Trial completion date: Mar 2024 ➔ Nov 2023 | Trial primary completion date: Aug 2023 ➔ Nov 2023

IO biomarker • Metastases • Phase classification • Trial completion • Trial completion date • Trial primary completion date • Cervical Cancer • Oncology • Solid Tumor • PD-L1

Efficacy and safety of the therapeutic DNA vaccine VB10.16 in combination with atezolizumab in advanced HPV16-positive cervical cancer: Updated analysis from the VB-C-02 trial (ESMO-IO 2023) - No abstract available

Clinical • Combination therapy • Metastases • Cervical Cancer • Oncology • Solid Tumor

Predictive value of circulating tumor DNA in patients with advanced HPV16-positive cervical cancer treated with VB10.16 in combination with atezolizumab (SITC 2023) - P2a | "Conclusions The data suggest that molecular response and early changes in HPV16 ctDNA are promising predictive biomarkers in patients with HPV16-positive recurrent or metastatic cervical cancer treated with VB10. 16 in combination with atezolizumab."

Circulating tumor DNA • Clinical • Combination therapy • IO biomarker • Metastases • Cervical Cancer • Oncology • Solid Tumor • PD-L1

Efficacy and Safety of VB10.16 Alone or in Combination With Atezolizumab in Patients With Advanced Cervical Cancer. (clinicaltrials.gov) - P2 | N=130 | Not yet recruiting | Sponsor: Nykode Therapeutics ASA

Combination therapy • Metastases • New P2 trial • PD(L)-1 companion diagnostic • Cervical Cancer • Oncology • Solid Tumor • PD-L1

Nykode Therapeutics Initiates Phase 1/2a Trial of VB10.16 in First Line HPV16-Positive Head and Neck Cancer (Nykode Therapeutics Press Release) - "Nykode Therapeutics ASA...announced the initiation of the Phase 1/2a clinical trial. The trial evaluates VB10.16, the Company’s wholly owned off-the-shelf therapeutic cancer vaccine candidate for HPV16-positive cancers, in combination with MSD’s (Merck & Co., Rahway, NJ, USA) PD-1 inhibitor KEYTRUDA® (pembrolizumab) in first line (1L) setting in patients with HPV16-positive, PD-L1-positive, recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)....The trial will take place in Europe."

Trial status • Squamous Cell Carcinoma of Head and Neck

Safety and Efficacy of VB10.16 and Pembrolizumab in Patients With Head-Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P1/2 | N=51 | Recruiting | Sponsor: Nykode Therapeutics ASA | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Nykode Therapeutics Announces FDA Approval of IND for VB-C-04, a Trial of VB10.16 in HPV16-Positive Cervical Cancer (GlobeNewswire) - "Nykode Therapeutics ASA...announced FDA approval of its investigational new drug (IND) application for the Phase 2 clinical trial. The trial is designed to evaluate VB10.16, the Company’s wholly owned off-the-shelf therapeutic cancer vaccine candidate for HPV16-positive cancers, in combination with Roche’s PD-L1 inhibitor atezolizumab (Tecentriq®) in patients with HPV16-positive, PD-L1-positive, recurrent or metastatic cervical cancer. Nykode is on track to initiate the trial in the fourth quarter of 2023."

IND • New P2 trial • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor

Nykode Therapeutics Announces Advances in Clinical Pipeline and Research (GlobeNewswire) - "VB-C-03 trial design: Phase 1/2a trial. Combination treatment of VB10.16+pembrolizumab in 1st line HPV16+ R/M HNSCC. On track to be initiated in Q3 2023....VB10.NEO: pioneering neoantigen research; Vaccine-specific T cells remain functional and immunogenic up to 1-year after last vaccination. Multiple vaccinations boost the breadth and magnitude of functional T cell responses....All five programs initiated and advancing, with multiple preclinical vaccine candidates designed for each program."

New P1/2 trial • Preclinical • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Safety and Efficacy of VB10.16 and Pembrolizumab in Patients With Head-Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P1/2 | N=51 | Not yet recruiting | Sponsor: Nykode Therapeutics ASA

Metastases • New P1/2 trial • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Investigating the Combination of VB10.16 and Atezolizumab in Patients With HPV 16-positive Cervical Cancer (clinicaltrials.gov) - P2a | N=50 | Active, not recruiting | Sponsor: Nykode Therapeutics ASA | Trial primary completion date: Mar 2023 ➔ Aug 2023

Metastases • Trial primary completion date • Cervical Cancer • Oncology • Solid Tumor • PD-L1

Nykode Therapeutics Announces Expansion of Clinical Collaboration with Roche to Evaluate VB10.16 in Combination with anti-PD-L1 in the next trial in Advanced Cervical Cancer (GlobeNewswire) - "Nykode Therapeutics ASA...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."

Licensing / partnership • New trial • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor