Nykode Announces Updated Strategy to Increase Value for Patients and Shareholders, Prioritizing VB10.16 as the Lead Value Driver
o Nykode presents a highly focused strategy prioritizing core assetswith thegreatest potential to deliver significant clinical and commercial impact.
o VB10.16 prioritized as lead value driver, with a focus on initiating anewrandomized controlled trial in HPV16 driven 1st-line recurrent/metastatic headand neck cancer (1L r/m HNSCC) designed to demonstrate clinical efficacy andsupport continued advancement of the asset.
o VB10.NEO development streamlined, with targeted investments focused onstrengthening its position as the most attractive unencumbered individualizedneoantigen therapy, leveraging anticipated peer data readouts.
o Tolerance platform further advanced, aiming to leverage thedifferentiatedtechnology with best-in-class potential and pursuing partnerships toacceleratedevelopment.
o Disciplined execution and financial focus to reach key inflectionpointswithin the expected cash runway.
o Additional high-caliber Board members, including a new Chair, expectedto beelected at the Annual General Meeting in 2026, with the current Chairremainingon the Board.
Oslo, Norway, August 27, 2025 - Nykode Therapeutics ASA (OSE: NYKD), aclinical-stage biopharmaceutical company dedicated to the discovery anddevelopment of novel immunotherapies, today announced its updated corporatestrategy, in line with the commitment made at its first quarter results in May2025. The updated strategy includes prioritization of VB10.16 as the leadclinical asset and value driver, given the Company's increasing conviction inits potential to treat HPV16 positive cancers. As a natural step in thedevelopment of VB10.16, the WHO has accepted the International Non-proprietaryName (INN) abipapogene suvaplasmid (abi-suva).
Michael Engsig, Chief Executive Officer, commented: "Nykode's updated strategyis about focus, execution, and creating value for patients and the Company'sshareholders. Abi-suva (VB10.16) targets a highly attractive commercial marketand, with its potential to set a new standard of care, addresses a patientpopulation with few effective treatment options. Furthermore, we see VB10.NEOpositioned as the most attractive unpartnered individualized neoantigentherapy,ready to leverage peer readouts expected within the next 18 months. Inparallel,our tolerance platform has the potential to open the door to breakthroughtreatments in autoimmune diseases. With a focused pipeline and key inflectionpoints within our estimated cash runway, we are advancing our most promisingassets with disciplined capital allocation, ensuring that Nykode iswell-positioned to deliver meaningful results for patients and attractivereturns for shareholders."
Abi-suva (formerly VB10.16): Lead Value DriverAt the core of the updated strategy is abi-suva, Nykode's lead asset andhighestpriority for new investment. A randomized, open-label, multicenter Phase 2trial, referred to as Abili-T, will evaluate abi-suva in combination withMSD's(Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, pembrolizumab(KEYTRUDA®) versus pembrolizumab alone as first-line treatment for human papilloma virus(HPV)16-positive, PD-L1-positive recurrent or metastatic head and necksquamouscell carcinoma (1L r/m HNSCC).
The trial will enroll up to 100 patients and is powered to deliver robustefficacy data in combination with pembrolizumab, the current standard-of-carefor PD-L1-positive 1L r/m HNSCC patients. Interim analyses for efficacy areplanned throughout the trial, with the first expected during 2027.
Unmet need in 1L r/m HNSCC remains high. The selected trial populationrepresents a well-characterized subgroup of patients with limited durabletreatment options and rising incidence. Despite recent advances in 1L r/mHNSCC,HPV16-positive patients remain an underserved subgroup with limited durabletreatment options. Abi-suva may offer additional benefits without addedtoxicity, making it particularly relevant for this vulnerable patientpopulation.
Abi-suva is an off-the-shelf therapeutic cancer vaccine with a favorablesafetyprofile and demonstrated clinical activity in HPV16-positive, late-line r/mcervical cancer. In the VB-C-02 trial, abi-suva in combination withatezolizumab(Tecentriq®), achieved a median overall survival of 24.7 months inPD-L1-positive patients which is more than double what has been reported withimmune checkpoint inhibitor monotherapy. Importantly, strong and durableresponses generated in this study were correlated with the patient's immuneresponse. Furthermore, preliminary data from the ongoing VB-C-03 trialindicatesimilar level of added benefit of abi-suva on top of pembrolizumab in 1st linehead and neck cancer.
Agnete Fredriksen, Co-founder & Chief Scientific Officer, added: "Abi-suva hasbeen tested in three clinical trials, two complete and one ongoing. The trialsVB-C-02 and VB-C-01 provided strong and consistent efficacy signals. Thepreliminary data from the ongoing VB-C-03 trial indicate similar level ofaddedbenefit of abi-suva. This reinforces our confidence in abi-suva's potential todeliver meaningful benefit to patients and provides a strong rationale foradvancing abi-suva into a randomized setting."
VB10.NEO: Well-positioned as best unencumbered individualized therapyWith an established supply chain, an in-house AI-powered epitope selectionalgorithm and strong durable clinical immune responses, VB10.NEO iswell-positioned to attract potential partners following key peer data readoutsexpected within the next 18 months.
Nykode will make targeted, limited investments to further strengthenVB10.NEO'sstanding as the most attractive unencumbered INT asset.
Best-in-Class Antigen-Specific Immune Tolerance PlatformNykode will increase investments to accelerate the development of itsantigen-specific immune tolerance (ASIT) platform. Recent advancements supportbest-in-class potential specifically reducing unwanted, disease-causing immuneresponses. The addressable field of ASIT covers a broad range of autoimmunediseases, allergy and organ transplant rejections. Nykode will furthersubstantiate the platform's potential and explore partnerships to advancedevelopment and diversify indications.
Partnering StrategyNykode's updated strategy with focused advancement of the three prioritizedprograms aligns value-generating with optionality to enter strategicpartnerships in oncology and autoimmune indications.
Capital Allocation and Cash RunwayWith this disciplined and sharper strategic focus, the Company's current cashrunway is expected to extend into 2029. This guidance is predicated on apositive outcome of the pending tax case, while a ruling against Nykode wouldresult in a cash runway extending into 2028. As of June 30, 2025, Nykode had astrong cash position of USD 70.0 million, excluding a non-current receivableofUSD 32.2 million related to the pending tax case.
Future Board CompositionIn line with the Company's ambitions, and as previously stated, Nykode planstofurther strengthen its governance and expertise in selected strategic areas byexpanding the Board with additional high-caliber members, including a newChair,to help guide the next phase of the Company's evolution. These new members areexpected to be elected at the Company's Annual General Meeting in spring 2026.
About Abipapogene Suvaplasmid (formerly VB10.16)Abipapogene Suvaplasmid (abi-suva) is a potentially first-in-classoff-the-shelftherapeutic DNA-based cancer vaccine candidate in development for thetreatmentof HPV16-positive cancers. The cancer vaccine is designed based on Nykode'sVaccibodyTM technology platform of targeting antigens to antigen presentingcells. Abi-suva has reported promising data from a Phase 2 trial in late-linePD-L1 positive r/m cervical cancer patients (NCT04405349) in combination withatezolizumab. The candidate has also demonstrated favorable clinical data in aPhase 1/2a study in pre-cancerous HPV16-induced high grade cervicalintraepithelial neoplasia (HSIL; CIN 2/3) demonstrating a statisticallysignificant correlation of immune responses and clinical responses. Nykode iscurrently investigating abi-suva in VB-C-03, an open-label, dose-finding Phase1/2a trial evaluating abi-suva in combination with MSD's PD-L1 inhibitorpembrolizumab (KEYTRUDA®) in 1L patients with HPV16-positive, PD-L1-positive,recurrent, or metastatic head and neck squamous cell carcinoma (HNSCC).
About HPV16-Driven CancersOne of the emerging challenges within oncology is the virus-induced cancertypes, with Human Papillomavirus (HPV) being one of the most prominentoncogenicviruses. There are several types of cancer-causing high-risk HPV`s causingcancers, HPV16 being one of the most common, with more than 130,000 new cancercases in the U.S. and EU per year. Using a therapeutic cancer vaccine targetedspecifically towards the HPV16 infected cells in the tumors, such as Nykode'scancer vaccine abi-suva (VB10.16), represents a novel immunotherapeutictreatment option. By combining a therapeutic cancer vaccine with the immunecheckpoint inhibitors and/or other general immune therapies, the tumors can beattacked by the cancer-specific T cells from several angles with the aim ofimproving patient outcomes.
Cervical CancerGlobally, the greatest burden of HPV-related cancers is cervical cancer.Cervical cancer is often curable when detected early and effectively managed,but treatment options are more limited in advanced disease stages or when thecancer has spread.
Head and Neck CancerIn the United States and other high-income countries, head and neck cancer hasnow surpassed cervical cancer as the most common HPV related malignancy. Inheadand neck squamous cell carcinoma (HNSCC), there's a significant unmet need forimproved therapies, particularly for recurrent or metastatic cases. Whileimmunecheckpoint inhibition is now part of standard treatment for recurrent ormetastatic HNSCC in general, there are no established therapeutic treatmentsspecifically for HPV-related HNSCC.
About Nykode TherapeuticsNykode Therapeutics is a clinical-stage biopharmaceutical company dedicated tothe discovery and development of novel immunotherapies with a focus on thetreatment of cancer and autoimmune diseases. Nykode's modular immunotherapytechnology specifically targets antigens to antigen presenting cells (APC),which have been shown to induce a broad, strong and long-lasting antigenspecific immune response in cancer, which correlates with clinical responses.
Nykode's lead product candidates are abi-suva, a therapeutic immunotherapy forthe treatment of HPV16 induced malignancies which demonstrated favorablesafetyand efficacy results from its Phase 2 trial for the treatment of late-line r/mcervical cancer. Abi-suva is currently being further developed in head andneckcancer. VB10.NEO, an individualized cancer neoantigen immunotherapy, has beeninvestigated in two trials with more than 10 different indications.
Nykode is also utilizing its APC-targeted technology to create an immunetolerance platform for the potential use in autoimmune disorders, organtransplant rejections, anti-drug antibody reactions and allergy.
Nykode Therapeutics' shares are traded on the Oslo Stock Exchange (OSE: NYKD).Further information about Nykode Therapeutics can be found athttp://www.nykode.com.
Contact:Alexandra Deschner, Head of IRNykode Therapeutics ASAIR@nykode.com
Nykode Therapeutics ASAOslo Science ParkGaustadalléen 21N-0349 Oslo, Norway
Forward-looking statements for Nykode TherapeuticsThis announcement and any materials distributed in connection with thisannouncement may contain certain forward-looking statements. By their nature,forward-looking statements involve risk and uncertainty because they reflecttheCompany's current expectations and assumptions as to future events andcircumstances that may not prove accurate. A number of material factors couldcause actual results and developments to differ materially from thoseexpressedor implied by these forward-looking statements.
This information is considered to be inside information pursuant to the EUMarket Abuse Regulation and is subject to the disclosure requirements pursuantto Section 5-12 the Norwegian Securities Trading Act. This stock exchangeannouncement was published by Harald Gurvin, CFO at Nykode Therapeutics ASA,onAugust 27, 2025 at 7:01 CET.
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