공시 • May 23
Nykode Therapeutics ASA Highlights New Data in Two Poster Presentations At the 2025 Asco Annual Meeting Nykode Therapeutics ASA announced the presentation of new data from two clinical trials evaluating its cancer immunotherapy candidates -- VB10.16 and VB10.NEO, both in combination with atezolizumab (Tecentriq®?), at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. The two posters highlight the potential of Nykode's targeted immunotherapy platform in inducing robust immune responses in heavily pre-treated patient populations across multiple tumor types, with encouraging safety profiles. Integrative analysis of VB10.16 and atezolizumab in advanced HPV16-positive cervical cancer: Linking biomarker insights to clinical outcomes. Presenter: Kristina Lindemann, Department of Gynecological Oncology, Oslo University Hospital & Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Oslo, Norway. In patients with persistent, recurrent, or metastatic HPV16-positive cervical cancer, VB10.16 combined with ateolizumab induced durable clinical responses. The VB C-02 trial demonstrated that stronger HPV16-specific T cell responses were associated with reduced systemic immunosuppression during treatment. Tumor microenvironment (TME) characteristics are associated with higher response rates. These findings support the importance of identifying the right patient population as well as elucidating the treatment effect on the systemic immunosuppression and highlights the promise of VB10.16 in combination with atezolIZumab, warranting further exploration. Induction of neoantigen-specific immune responses by VB10.NEO in combination with atezolizeumab in heavily pretreated patients with advanced solid tumors: Final analysis of the phase 1b VB N-02 trial. Presenter: Seebastian Ochsenreither, Charite University of Medicine Berlin Comprehensive Cancer Center, Berlin, Germany. VB10.NEO Inc, VB10. NEO, Nykode's personalized cancer neoantigen vaccine, in combination with atezoluzumab, induced neoantigen-specific immune response. Neoantigen-specific immune responses were observed in 100% of the patients and de novo immune responses were observed in 85% of patients, as measured by in vitro stimulated IFNg ELISpot. Expansion of durable T cell clones was seen in 82% of patients, suggesting persistence of the immune response. The trial enrolled heavily pre-treated patients across more than 10 indications, a median of 5 prior therapy lines and predominantly low or negative PD-L1 expression resulting in a median PFS reached before 2 months, limiting the opportunity for thorough assessment of long-term immune responses and clinically meaningful responses. VB10.N NEO in combination with atezolizing a median PFS reached before2 months, limiting the opportunity for comprehensive assessment of long-term immune response and clinically meaningful responses. V B10.NEO in combination With atezolizumab demonstrated a favorable safety profile. These results support further development of VB10.NEO In additional solid tumor settings. 공시 • Apr 23
Nykode Therapeutics AS announces Annual dividend Nykode Therapeutics AS announced Annual dividend of NOK 1.0000 per share, ex-date on May 27, 2025 and record date on May 28, 2025. 공시 • Feb 28
Nykode Therapeutics ASA Announces Preclinical Data Highlighting its Immune Tolerance Platform's Ability to Modulate Multiple Key Immune Components in Autoimmune Disease Nykode Therapeutics ASA announced new preclinical findings reinforcing the unique mechanism of action and potential of its APC-targeted immune therapy platform in treating autoimmune diseases. Important new data show that Nykode's APC-targeted constructs increase antigen-specific regulatory T cells, which are known to downregulate an unwanted immune response, while simultaneously reducing antigen-specific effector T cells that drive inflammation. Furthermore, new data show that Nykodes's APC-targeted construct can reduce the generation of antigen-specific IgG autoantibodies, thereby shaping also the humoral component of the immune response, which is known to be involved in many autoimmune conditions. These changes suggest that the therapy works effectively through multiple arms of the antigen-specific immune system to promote its effectiveness and support its potential as a future therapy for autoimmune disorders, allergy and organ transplant rejection. Furthermore, new data show the data have been generated using MOG and PLP-1 antigens, which are applicable in chronic and relapsing-remitting EAE models. The Company remains committed to advancing its immune tolerance platform and further exploring the clinical potential of APC-targeted therapy for autoimmune diseases, allergies, and organ transplant rejection. 공시 • Jan 08
Nykode Therapeutics ASA Announces Publication of Phase 2 VB-C-02 Data Confirming Prolonged Benefit and Definitive Vaccination Effects Nykode Therapeutics ASA announced the publication of a manuscript entitled 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 in the peer-reviewed BMJ "Journal for ImmunoTherapy of Cancer" (JITC). The trial investigated the use of Nykode's wholly owned off-the- shelf therapeutic cancer vaccine candidate VB10.16 in combination with Roche's checkpoint inhibitor atezolizumab in patients with persistent and recurrent or metastatic HPV16-positive cervical cancer. As previously communicated, the published results confirm prolonged clinical benefits and indicate a potential synergistic treatment effect of VB10.16 in combination with atezolizumab compared to what has previously been reported for checkpoint inhibitor monotherapy. In this analysis the remaining patients were followed for up to 24 months, compared to at least 12 months in the previously reported data cut-off. The trial demonstrated an ORR of 19.1% in the efficacy population. With the extended 12-month follow- up period to the end of the trial, both mPFS and mOS increased compared to what has previously been reported, reaching 4.3 months and 21.3 months, respectively. In the subpopulation of PD-L1-positive patients (n=24) the ORR increased to 29.2% resulting in further improved mPFS and mOS of 6.3 months and 24.7 months, respectively. Among PD-L1-positive patients with one prior line of SATC (n=15), the ORR increased to 40.0%, and mPFS and mOS further improved to 15.8 months and not reached, respectively. VB-C-02 is a multi-center, single arm, open-label Phase 2 trial to assess the efficacy, immunogenicity and safety of VB10.16 in combination with the PD-L1 inhibitor atezolizumab in patients with advanced or recurrent, non-resectable human papillomavirus type 16 (HPV16)-positive cervical cancer. Patients received treatment with VB10.16 in combination with atezolizumab for up to one year. The trial enrolled 52 patients at sites in Europe. Additional information about the VB-C-02 trial is available at clinicaltrials.gov (NCT04405349). VB10.16 is a potentially first-in-class off-the-shelf therapeutic DNA-based cancer vaccine candidate in development for the treatment of 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 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; CIN 2/3) demonstrating a statistically significant correlation of immune responses and clinical responses. Nykode is currently investigating VB10.16 in VB-C-03, an open-label, dose-finding Phase 1/2a trial evaluating VB10.16 in combination with MSD's PD-L1 inhibitor KEYTRUDA® (pembrolizumab) in patients with HPV16-positive, PD-L1-positive, recurrent, or metastatic head and neck squamous cell carcinoma (HNSCC). Cervical cancer is the fourth leading cause of cancer death in women worldwide and is most frequently diagnosed between the ages of 35 and 44. Each year around 600,000 women are diagnosed with cervical cancer worldwide. Almost all cases are caused by human papillomavirus (HPV) infection and HPV16 accounts for more than half of all cervical cancer cases. Approximately 80% of patients with cervical cancer have squamous cell carcinoma and most other patients have adenocarcinomas. Cervical cancer is often curable when detected early and effectively managed, but treatment options are more limited in advanced disease stages or when the cancer has spread. One of the emerging challenges within oncology is the virus-induced cancer types, with Human Papillomavirus (HPV) being one of the most prominent. There are several types of high-risk HPV causing cancers, HPV16 being one of the most common, with more than 130,000 new cases in the U.S. and EU per year. Using a therapeutic cancer vaccine targeted specifically towards the HPV16 infected cells in the tumors, such as Nykode's cancer vaccine VB10.16, represents a novel immunotherapeutic treatment option. By combining a therapeutic cancer vaccine with the checkpoint inhibitors and/or other general immune therapies, the tumors can be attacked by the cancer-specific T cells from several angles with the aim of improving patient outcomes. 공시 • Jan 01
Nykode Therapeutics AS, Annual General Meeting, May 22, 2025 Nykode Therapeutics AS, Annual General Meeting, May 22, 2025. 공시 • Nov 07
Nykode Therapeutics ASA Announces Updates on its Inverse Vaccine Platform at Pegs Europe Nykode Therapeutics ASA announced new findings related to its APC-targeted inverse vaccine platform's efficacy in treating autoimmune disease at the annual PEGS Europe conference in Barcelona. The data presented emphasize the role of antigen-presenting cell (APC) targeting in achieving therapeutic effectiveness, particularly in Experimental Autoimmune Encephalomyelitis (EAE), a mouse model of human multiple sclerosis (MS). Findings from both therapeutic and preventive applications support the platform's potential in providing targeted, effective treatment for MS, an autoimmune disease that affects approximately 2.8 million people worldwide, with a high annual economic burden and a significant unmet medical need for new treatments. Nykode's latest data confirm that APC targeting by the inverse vaccine is essential for achieving effective therapeutic outcomes, demonstrating superior efficacy over a non-targeted vaccine or antigen alone. When applied therapeutically, a new version of Nykode's inverse vaccine provides robust disease protection in a relapsing-remitting EAE model which better reflect the relapsing-remitting disease in human MS. This result builds upon prior findings and includes efficacy of an alternative central nervous system autoantigen, broadening the inverse vaccine's potential applicability in MS treatment. Aligned with these outcomes, mice treated with the Nykode inverse vaccine exhibit a marked reduction in disease-associated inflammatory cytokine release following disease induction. This reduction aligns with mitigated disease severity and inflammation, highlighting the therapeutic potential of the Nykode inverse vaccine in immune disorders. 공시 • Jun 20
Nykode Therapeutics Announces Updates on its Inverse Vaccine Platform at FOCIS 2024 Meeting Nykode Therapeutics ASA announced advancements in its inverse vaccine platform at the annual Federation of Clinical Immunology Societies (FOCIS) meeting in San Francisco. Building on findings previously announced in March at the Antigen-Specific Immune Tolerance Summit in Boston, Nykode presented extended therapeutic data from the experimental autoimmune encephalomyelitis (EAE) model of Multiple Sclerosis (MS). The updates included demonstrating the disease-modifying effects of two distinct targeting units within its inverse vaccine platform in a therapeutic regimen, highlighting the versatility and effectiveness of antigen-presenting cell (APC)-targeting strategies. At the conference, Nykode presented data, demonstrating a dose-dependent and disease-modifying effect of its antigen-specific APC-targeting vaccine in a therapeutic regimen, compared to the delivery of antigen alone, emphasizing the platform’s potential for effective antigen-specific treatment for autoimmune disorders. There are approximately 100 different autoimmune diseases affecting about 4% of the world population, representing a significant unmet medical need for novel treatments. Nykode is focusing on developing antigen-specific treatments for autoimmune diseases by using its APC-targeting platform to deliver a tolerogenic response towards disease-associated antigens. 공시 • Apr 20
Nykode Therapeutics ASA Initiates Phase 2 Trial of VB10.16 in Second Line HPV16-Positive Cervical Cancer Nykode Therapeutics ASA 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®1) 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. Atezolizumab is supplied by Roche. Nykode retains all commercial rights to VB10.16 worldwide. 공시 • Mar 22
Nykode Therapeutics Announces Topline Conclusions Affirming Prolonged Clinical Benefits from Matured Survival Data in Phase 2 C-02 Trial in Advanced Cervical Cancer Nykode Therapeutics ASA announced key conclusions from the updated analysis from the Phase 2 VB-C-02 trial. The trial investigates the use of Nykode's wholly-owned off-the-shelf therapeutic cancer vaccine candidate VB10.16 in combination with Roche's checkpoint inhibitor atezolizumab in patients with recurrent or metastatic HPV16-positive cervical cancer. The updated results, which closely mirror the previously reported positive C-02 outcomes, affirm prolonged benefits and indicate a synergistic treatment effect of VB10.16 plus atezolizumab compared to the historical controls of monotherapy with checkpoint inhibitors. The updated analysis' observation time for the remaining patients was at least 24 months, compared to at least 12 months at the previously reported outcome. Nykode has a focused strategy to develop VB10.16, including a potentially US registrational trial C-04 in recurrent/metastatic cervical cancer and a C-03 trial in first-line head and neck cancer, two areas with a high unmet medical need. The company is also planning to move VB10.16 into early-stage cervical cancer. Nykode is committed to advancing the field of immunotherapy and sharing its research findings with the broader scientific community in line with their publication guidelines. To this end, the company will present the detailed data from the Phase 2 VB -C-02 trial in a future scientific publication and at a forthcoming medical conference. Nykode wishes to thank the patients, their families and the investigators for their participation and contribution to the VB-C-02 trials. VB-C-02 is a multi-center, single arm, open-label Phase 2 trial to assess the efficacy, immunogenicity and safety of VB10.16 in collaboration with the PD-L1 inhibitor atezolizum AB in patients with advanced or recurrent, non-resectable HPV16-positive cervical cancer; Patients received treatment with VB10.16 in combined with Roche's checkpoint inhibitor atezolizumab for up to one year. The cancer vaccine is designed based on Nykode's Vaccibody 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 greater than 25 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-cancerousHPV16-induced high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3) demonstrating a statistically significant correlation of immune responses and clinical responses. Nykode is currently investigating VB10.16 in VB-C-03, an open-label, dose-finding Phase 1/2a trial evaluating VB 10.16 in combination with MSD's PD-1 inhibitor KEYTRUDA®? (pembrolizumab) in patients with HPV16-positive, PD-L1-positive, recurrent, or metastatic head and neck squ squ squ squ squatatatatatat. 공시 • Mar 20
Nykode Therapeutics ASA Announces Advances in the Inverse Vaccine Platform with the Potential to Treat Autoimmune Diseases Nykode Therapeutics ASA announced key updates of the inverse vaccine platform with the potential to treat autoimmune diseases at the 7th Antigen-Specific Immune Tolerance Drug Development Summit in Boston. Nykode employs its unique technology platform to pioneer the field of inverse vaccines, with the potential to develop high-precision treatments for autoimmune diseases. At the conference, Nykode demonstrated for the first time a significant effect in a therapeutic setting in a preclinical model for Multiple Sclerosis (MS) with its inverse vaccine platform. The data also illustrate the strong contribution of the specific targeting unit and confirm that the disease protection is antigen-specific, underscoring the potential of Nykode’s technology in the field of autoimmune diseases. During its Capital Markets Day in New York in September last year, Nykode announced that its inverse vaccine platform had prevented serious disease in models of MS and type 1 diabetes in mice, showcasing the technology's broad disease-modifying potential in an antigen-specific manner. Notably, the efficacy was enhanced with the integration of Nykode's 4th Module technology, emphasizing its role in modulating the immune response to amplify therapeutic effects. 공시 • Dec 21
Nykode Therapeutics AS, Annual General Meeting, May 16, 2024 Nykode Therapeutics AS, Annual General Meeting, May 16, 2024. 공시 • Dec 14
Nykode Therapeutics Announces Expansion of Oncology Pipeline Aiming to Reduce the Burden of Colorectal Cancer Nykode Therapeutics ASA announced an expansion of the pipeline with a potential first-in-class preclinical oncology vaccine program aimed at preventing and treating colorectal cancer. Colorectal cancer begins as a premalignant polyp that grows on the mucosal surface of the colon or rectum and transforms into malignancy. The disease development and screening programs represent an opportunity to identify and treat high-risk patients at early stages in addition to treating patients with developed malignancies. Nykode's novel vaccines are based on a careful selection and combination of highly expressed tumor associated antigens involved in the development and progression of colonic polyps to colorectal cancer. The program will incorporate Nykode's 4th module proprietary second-generation technology to further optimize the immune responses tailored to diverse target populations. The program builds on Nykode's differentiating competence of creating broad and robust CD8 T cell responses with the potential to break tolerance against tumor-associated antigens, as illustrated by data presented at Nykode's recent Capital Market Day. Strong preclinical data generated in the discovery phase further supports the induction of potent CD8 T cell responses in both wild-type and HLA transgenic mice models. 공시 • Oct 01
Nykode Therapeutics ASA Initiates Phase 1/2a Trial of VB10.16 in First Line HPV16-Positive Head and Neck Cancer 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). VB-C-03 is a Phase 1/2a open-label, dose-finding trial investigating safety, tolerability, and efficacy. It consists of two consecutive phases, a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2a), testing VB10.16 in doses up to 9 mg, in combination with pembrolizumab in a 1L setting in patients with HPV16-positive, PD-L1-positive HNSCC. The trial will take place in Europe. Merck will supply KEYTRUDA, while Nykode retains all commercial rights to VB10.16 worldwide. 공시 • Sep 21
Nykode Therapeutics ASA Announces Advances in Clinical Pipeline and Research Nykode Therapeutics ASA announced significant advances in its clinical pipeline and research at the Capital Markets Day in New York. VB10.16: Therapeutic vaccine candidate for human papilloma virus (HPV) 16+ cancers with strong clinical data Additional VB-C-02 data supporting a differentiated long-lasting and clinically relevant immune response. VB-C-04 trial design: Potentially registrational phase 2 trial in recurrent/metastatic (R/M) cervical cancer progressing on 1st line standard of care (SOC) (pembrolizumab + chemotherapy +/- bevacizumab). IND approval received from FDA and on track to be initiated Fourth Quarter 2023. 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 Third Quarter 2023. VB10.16 is Nykode’s wholly owned candidate for treatment of HPV16-driven cancer types. Nykode is presenting additional data from the VB-C-02 trial which strongly supports the generation of durable clinically relevant T cell responses. The evidence includes the formation of multiple and enduring T cell clones post-vaccination and significant changes in blood cell composition. A robust correlation observed between HPV16 circulating tumor DNA and clinical outcomes. This correlation is discernible from the first measured post-vaccination timepoint which supports further exploration of HPV16 circulating tumor DNA as an early predictor of clinical outcome. Nykode has received FDA approval for its potentially registrational VB-C-04 trial, which is on track to initiate in the fourth quarter of the year. The trial builds on the positive data from the VB-C-02 trial indicating differentiated and durable anti-tumor responses. The VB-C-04 trial plans to enroll 130 patients with recurrent or metastatic cervical cancer, who have previously undergone first-line standard of care treatment (comprising pembrolizumab, chemotherapy, and optionally, bevacizumab). Part A of the trial will involve a randomized allocation of 30 patients each to receive either VB10.16 in combination with Atezolizumab or VB10.16 monotherapy. After an interim analysis, the superior treatment arm will be expanded to include an additional 70 patients. Nykode is expanding into first-line treatment for PD-L1-positive patients with head and neck cancer and has secured all the necessary regulatory approvals to initiate the VB-C-03 trial. 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. In-depth analysis of data stemming from Nykode’s fully personalized neoantigen trial, VB-N-01, has yielded encouraging results. Enduring immune responses to the vaccine neoantigens have been observed, persisting for at least one year following the administration of the last dose of VB10.NEO. This evidence reaffirms the ability to generate long-lasting T cell responses. VB10.NEO is exclusively outlicensed to Genentech, a member of the Roche Group. The VB-N-01 trial was conducted by Nykode prior to the outlicensing of VB.10.NEO to Genentech. Future cancer vaccines: De-risked through partnerships Regeneron partnership: All five programs initiated and advancing, with multiple preclinical vaccine candidates designed for each program. Nykode vaccine shows potential to induce potent T cell responses against self-antigens with various degrees of central tolerance. Next step involves selecting lead candidates for further development. Nykode’s partnership with Regeneron continues to make significant progress, with the process of lead selection moving forward. In addition to the development of preclinical candidates, Regeneron has explored Nykode’s vaccine platform's capacity to elicit T cell responses against germline-encoded tumor-associated antigens (self-antigens). The data demonstrates the possibility of the Nykode vaccine platform to overcome tolerance to various tumor-associated self-antigens that are characterized by low/no thymic expression, which may not be subject to central tolerance. These tumor-associated self-antigens include genes commonly overexpressed in tumor tissues and often prevalent among larger patient populations but with no expression in normal, healthy tissue. These promising findings exemplifies some of the many possibilities in Nykode’s future vaccine development endeavors beyond viral and individualized neoantigens. Advancements in Autoimmunity Nykode is leveraging its antigen presenting cells (APC)-targeted technology in a first-in-class approach to pursue treatments for autoimmune diseases. New data shows that Nykode vaccines targeting tolerogenic dendritic cells prevents serious disease in a Multiple Sclerosis (MS)-like mouse disease model. Disease-preventing effect demonstrated using different APC-targeting units. Additionally, Nykode vaccine targeting tolerogenic DCs shows efficacy in a spontaneous type 1 diabetes mouse model. Nykode’s 4th Module technology is found to further amplify the effect. its results demonstrate the technology's disease modifying potential in autoimmune disorders, as evidenced in models of both multiple sclerosis- and diabetes. This breakthrough presents a substantial additional potential commercial opportunity for Nykode, reinforcing its position as industry frontrunner. The data showed therapeutic effects with various APC-targeting units and both protein and plasmid DNA delivery methods. Interestingly, the addition of Nykode’s proprietary 4th module technology demonstrated potential to further improve the efficacy. Nykode has made a strategic commitment to intensify its efforts and has established a dedicated autoimmunity research group to drive optimal progress in this new and promising opportunity area. 공시 • Sep 06
Nykode Therapeutics ASA Announces FDA Approval of IND for VB-C-04, a Trial of VB-C-04 in HPV16-Positive Cervical Cancer 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®1) 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. Atezolizumab is supplied by Roche. Nykode retains all commercial rights to VB10.16 worldwide. 공시 • Jun 02
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 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. 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. 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. 공시 • May 12
Nykode Therapeutics AS Announces Management Changes Nykode Therapeutics AS at its Annual General Meeting held on May 11, 2023, approved Harald Arnet as a new board member to replace Jan Haudemann-Andersen, who has decided to step down from the board and approved Lars Lund-Roland as Chairperson of the Nomination Committee. The former Chair of the Nomination Committee, Harald Arnet, will resign from the Nomination Committee, as he has been elected as a board member of the Company. Following this, the Nomination Committee consists of: Lars Lund-Roland, Chair of the Committee; Lars Erik Larsson and Jan Fikkan.