VB10.NEO / Nykode Therap - LARVOL DELTA

Integrative analyses of multiomics data and biomarker readout demonstrate clinical and immunological relevance of individualized vaccine design via the NeoSELECT™ platform (SITC 2025) - P1, P1/2 | "Data from 33 and 13 patients, respectively, was analyzed originating from mostly heavily pretreated patients with 12 different cancer diagnoses.Results NeoSELECT successfully identified neoantigens eliciting T-cell responses in patients treated with the individualized VB10.NEO vaccine. Atezolizumab was supplied by Roche for the N-02 trial.Trial Registration The clinical trials have the following ClinicalTrials.gov identifiers: NCT03548467 (N-01) and NCT05018273 (N-02).Ethics Approval The study protocols and their amendments were approved by local or national ethics committees for each participating site before study initiation. The studies were done in accordance with the ICH GCP guidelines, Declaration of Helsinki and all applicable laws, and all patients provided written informed consent."

Biomarker • Clinical • Oncology

Nykode Therapeutics ASA…announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 12,462,898, entitled, “Method For Selecting Neoepitopes” (Nykode Therapeutics Press Release) - "The newly issued patent relates to Nykode’s proprietary NeoSELECT platform which is used for the selection of neoantigens for the company’s fully individualized neoantigen-based therapy, VB10.NEO. The 20-year expiration date of this patent is September 27, 2039."

Patent • Oncology

Induction of neoantigen-specific immune responses by VB10.NEO in combination with atezolizumab in heavily pretreated patients with advanced solid tumors: Final analysis of the phase 1b VB N-02 trial. (ASCO 2025) - P1 | "VB10.NEO combined with atezolizumab demonstrated a favorable safety profile while eliciting robust, durable immune responses across all dose levels, even in heavily pretreated patients with advanced solid tumors. The potential correlation between immunogenicity and clinical benefit supports further exploration in earlier treatment settings."

Clinical • Combination therapy • IO biomarker • Metastases • P1 data • Tumor mutational burden • Tumor-specific neoantigens • Breast Cancer • Fatigue • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • PD-L1 • TMB

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

Study of VB10.NEO in Combination With Atezolizumab in Solid Tumors (clinicaltrials.gov) - P1 | N=26 | Completed | Sponsor: Nykode Therapeutics ASA | Active, not recruiting ➔ Completed | N=60 ➔ 26

Combination therapy • Enrollment change • Metastases • Trial completion • Anal Carcinoma • Breast Cancer • Cervical Cancer • Gastric Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • CRP

Nykode Therapeutics to Regain Control of VB10.NEO Program (Nykode Therapeutics Press Release) - "Nykode Therapeutics ASA...today announced that it has received notification from Genentech, a member of the Roche group, of its decision to terminate the collaboration and licensing agreement for Nykode’s VB10.NEO cancer vaccine program. With this notice, the existing collaboration and licensing agreement signed September 2020 will terminate effective January 6, 2025 and Nykode will regain control of VB10.NEO and its intellectual property portfolio along with rights to license the program."

Licensing / partnership • Oncology

Nykode Therapeutics Announces Issuance of Key Patent Covering Individualized Neoantigen Based Vaccines (GlobeNewswire) - "Nykode Therapeutics ASA...announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 12,059,459, entitled, 'Therapeutic Anticancer Neoepitope Vaccine'. The newly issued patent describes Nykode’s fully individualized neoantigen based vaccine, VB10.NEO, which is in development for the treatment of locally advanced or metastatic solid tumours. The 20 year expiration date of this patent is January 5, 2037."

Patent • Solid Tumor

Study of VB10.NEO in Combination With Atezolizumab in Solid Tumors (clinicaltrials.gov) - P1 | N=60 | Active, not recruiting | Sponsor: Nykode Therapeutics ASA | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Anal Carcinoma • Breast Cancer • Cervical Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • CRP

Study of VB10.NEO in Combination With Atezolizumab in Solid Tumors (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Nykode Therapeutics ASA | Phase classification: P1b ➔ P1

Combination therapy • Metastases • Phase classification • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • CRP

DIRECT-01: A Study to Evaluate Safety and Efficacy of Multiple Dosing With VB10.NEO and Bempegaldesleukin (NKTR-214) Immunotherapy in Patients With Locally Advanced or Metastatic Cancer (clinicaltrials.gov) - P1/2 | N=41 | Completed | Sponsor: Nykode Therapeutics ASA | Active, not recruiting ➔ Completed | N=65 ➔ 41 | Trial completion date: Mar 2024 ➔ Jan 2023 | Trial primary completion date: Mar 2024 ➔ Jan 2023

Checkpoint block • Checkpoint inhibition • Enrollment change • Metastases • Trial completion • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Head and Neck Cancer • Immune Modulation • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Individualized APC targeting VB10.NEO cancer vaccines induce broad neoepitope-specific CD8 T cell responses in patients with advanced or metastatic solid tumors: interim results from a phase 1/2a trial (AACR 2023) - "VB10.NEO was generally well tolerated in patients with various pre-treated and advanced cancers. Assessment of neoepitope-specific T cell reactivity demonstrated VB10.NEO-induced broad and long-lasting T cell responses, and the majority of tested neoepitopes activated polyfunctional CD8 T cells. Pre- and post-vaccination TCRseq analysis of blood and tumor samples demonstrated the presence of blood-expanded clones in the on-treatment tumor sample potentially indicating trafficking of VB10.NEO-expanded T cells to the tumor site."

Clinical • IO biomarker • Metastases • P1/2 data • Tumor mutational burden • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • CD8 • IFNG • TMB

Study of VB10.NEO in Combination With Atezolizumab in Solid Tumors (clinicaltrials.gov) - P1b | N=60 | Recruiting | Sponsor: Nykode Therapeutics ASA | N=40 ➔ 60

Combination therapy • Enrollment change • Metastases • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • CRP

Nykode Therapeutics Announces Presentation of Positive Immunogenicity Results from Phase 1/2a Study of VB10.NEO, an Individualized Therapeutic Cancer Vaccine, at the Neoantigen-Based Therapies Summit (GlobeNewswire) - P1/2 | N=65 | DIRECT-01 (NCT03548467) | Sponsor: Nykode Therapeutics ASA | "Nykode Therapeutics ASA...announced the presentation of positive preliminary safety and immunogenicity results from its Phase 1/2a study of VB10.NEO, a proprietary individualized therapeutic DNA cancer vaccine, in patients with locally advanced or metastatic solid tumors. The data will be presented today at the Neoantigen-Based Therapies Summit in Boston, Massachusetts....41 patients were dosed with VB10.NEO. The data show that VB10.NEO was generally safe and well-tolerated in patients with solid tumors when administered in combination with various anti-cancer treatments....22 patients were included in the interim analysis....A neoantigen-specific immune response was observed in all patients (ranging from 3-20 neoepitopes). A vaccine-induced T cell response was observed in 95% of patients, inducing expansion of both novel and pre-existing T cells."

P1/2 data • Oncology • Solid Tumor

Study of VB10.NEO in Combination With Atezolizumab in Solid Tumors (clinicaltrials.gov) - P1b; N=40; Recruiting; Sponsor: Vaccibody AS; Initiation date: Aug 2021 ➔ Dec 2021

Clinical • Combination therapy • Trial initiation date • Oncology • Solid Tumor • CRP

Study of VB10.NEO in Combination With Atezolizumab in Solid Tumors (clinicaltrials.gov) - P1b; N=40; Recruiting; Sponsor: Vaccibody AS

Clinical • Combination therapy • New P1 trial • Oncology • Solid Tumor • CRP

Finding neo: Vaccibody nets Roche in potential $715M cancer vaccine deal (Bioworld) - P1/2a, N=65; DIRECT-01 (NCT03548467); Sponsor: Vaccibody AS; "Underway is VB N-01, a phase I/IIa study testing VB10.NEO when combined with San Francisco-based Nektar Therapeutics Inc.’s bempegaldesleukin (bempeg, NKTR-214) immunotherapy in patients with locally advanced or metastatic melanoma, non-small-cell lung carcinoma (NSCLC), clear renal cell carcinoma (RCC) as well as urothelial cancer (UC) or squamous cell carcinoma of the head and neck (SCCHN). Positive first results have turned up, Vaccibody said, with VB10.NEO inducing strong tumor-specific immune responses. Interim data suggest a clear link between selection of high quality neoepitopes, generation of strong neoepitope-specific CD8+ T-cell responses, and clinical responses."

P1/2 data • Oncology • Solid Tumor

A Study to Evaluate Safety and Efficacy of Multiple Dosing With VB10.NEO and Bempegaldesleukin (NKTR-214) Immunotherapy in Patients With Locally Advanced or Metastatic Cancer (clinicaltrials.gov) - P1/2; N=65; Active, not recruiting; Sponsor: Vaccibody AS; Recruiting ➔ Active, not recruiting

Enrollment closed • Genito-urinary Cancer • Head and Neck Cancer • Immune Modulation • Inflammation • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Still Looking For A Cancer Vaccine Breakthrough, Roche Signs $200m Vaccibody Deal (Scripintelligence) - "Despite a recent disappointment in a similar partnership with BioNTech, Genentech is pushing ahead with its neoantigen-targeting strategy."

Licensing / partnership • Oncology

Vaccibody enters into worldwide license and collaboration agreement with Genentech, a member of the Roche Group, to develop individualized neoantigen cancer vaccines (PipelineReview) - “Multi-year agreement to develop DNA-based individualized neoantigen cancer vaccines based on VB10.NEO across multiple tumor types. Vaccibody to receive up to USD 715 million, including initial upfront and near-term payments of USD 200 million and with potential milestone payments of up to USD 515 million and in addition, tiered royalties on sales of commercialized products…Through this partnership, Genentech and Vaccibody will progress Vaccibody’s investigational product, VB10.NEO, into clinical trials in the U.S. and in Europe.”

Licensing / partnership • Oncology

Vaccibody AS and Nektar Therapeutics Announce First Patient Dosed in a Phase 1/2a Study Arm Evaluating VB10.NEO, a Personalized Neoantigen Cancer Vaccine, with Bempegaldesleukin (NKTR-214) in Patients with Squamous Cell Carcinoma of the Head and Neck (Nektar Therapeutics Press Release) - "At the 2019 Society for Immunotherapy of Cancer (SITC) Annual Meeting, Vaccibody presented interim data for VB10.NEO in a group of patients with various solid tumor types who had all received multiple lines of prior anti-cancer therapy and had been treated with at least one checkpoint inhibitor (CPI) (nivolumab or pembrolizumab) for a range of 5 to 32 months. The data presented showed that 50 percent (7/14) of patients treated with VB10.NEO achieved clinical responses, including four patients with SCCHN. Clinical response was defined as either >10% reduction in the target lesions (as identified at screening) or converting progressive lesions into stable lesions (<20% increase, up to 37 weeks follow-up)."

Clinical data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Vaccibody AS and Nektar Therapeutics Announce First Patient Dosed in a Phase 1/2a Study Arm Evaluating VB10.NEO, a Personalized Neoantigen Cancer Vaccine, with Bempegaldesleukin (NKTR-214) in Patients with Squamous Cell Carcinoma of the Head and Neck (Nektar Therapeutics Press Release) - "Vaccibody AS and Nektar Therapeutics…announced that the first patient has been dosed in the combination therapy of the Phase 1/2a study evaluating bempegaldesleukin (bempeg), Nektar's CD122-preferential IL-2 pathway agonist, with VB10.NEO, Vaccibody's personalized neoantigen cancer vaccine, in patients with advanced squamous cell carcinoma of the head and neck (SCCHN)."

Enrollment open • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck