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Results from first melanoma trial using LOAd703 tumor microenvironment gene engineering in combination with immune checkpoint inhibition is published in Nature Communications
UPPSALA, SWEDEN, February 17, 2026. Lokon Pharma AB, a Swedish Biotech company developing a cancer therapeutic targeting the tumor microenvironment through gene engineering announced today the publication of data from LOKON003, a clinical trial treating patients with metastatic malignant melanoma refractory to immune checkpoint inhibitor (ICI) therapy. LOAd703, drives the in vivo generation of tumor-reactive T and NK cells by stimulating the CD40 and 4-1BB pathways, leading to activation of antigen-presenting cells crucial to inducing T and NK cell responses and inducing signaling molecules such as cytokines and costimulatory molecules in the TME and draining lymph nodes.
“We are very excited to share the results from the LOKON003 trial” says Angelica Loskog, the CEO of Lokon Pharma and Professor of Immunotherapy at Uppsala University. By gene engineering with viral vectors, we reprogram the tumor microenvironment to generate tumor-reactive T cells directly in the patients.”
The LOKON003 (NCT04123470) trial was designed as a single-armed trial investigating LOAd703 plus the ICI atezolizumab provided by Hoffmann La-Roche in patients who had failed one or several lines of different prior ICI treatments. Local injection of LOAd703 served to systemically re-sensitize patients to continued ICI treatment.
Dr. Gustav Ullenhag, Professor of cancer immunotherapy and the principal investigator adds “Melanoma patients refractory to ICI have a poor prognosis, we have demonstrated the safety in ICI refractory patients with antitumor activity.1 We are encouraged by the median overall survival of 19.3 months (26.3 months in the lower dose cohort), which is higher than one would expect based on previously published in similar patients2 comparable to tumor-infiltrating lymphocytes (TIL) therapy.3 Almost half of the patients (46%) were still alive two years after enrollment..”
Omid Hamid MD, Director of the Phase 1 program at The Angeles Clinic and Research Institute, A Cedars Sinai Affiliate, noted that the therapy was well tolerated without major immune toxicities. “By changing the microenvironment we were able to elicit a durable response in patients without many options. It’s off the shelf nature allows us to treat patients immediately and can be related to multiple tumor types to increase efficacy of immune checkpoint inhibition”.
The study recruited patients at Uppsala Comprehensive Cancer Center, Uppsala University Hospital, Uppsala, Sweden, Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine in Houston, TX, and at The Angeles Clinic and Research Institute, a Cedars Sinai Affiliate, Medical Oncology, Los Angeles, CA.
Previously, LOAd703 was tested in combination with chemotherapy in patients with advanced pancreatic cancer. Results have been published Lancet Oncology.4 “A pivotal Phase 2/3 study is underway in pancreatic cancer in which LOAd703 was awarded a Fast Track Designation last year” says Angelica Loskog. “With the exciting results from LOKON003, Lokon Pharma is now planning for a randomized study for ICI refractory patients testing both LOAd703 monotherapy and an ICI combination.”
1Hamid O, Ekström-Rydén V, Mehmi I, Wang D, Patel M, Alsaqal S, Irenaeus S, Nordström C, Sandin LC, Grauers Wiktorin H, Lövgren T, Eriksson E, Leja Jarblad J, Loskog A, Ullenhag GJ. LOAd703-induced tumor microenvironment gene engineering in combination with atezolizumab in metastatic malignant melanoma – a phase I/II trial. Nature Communications, In Press 2026. EPub ahead of print February 16, 2026.
https://www.nature.com/article...
2Ryden V, Inan ElNaggar A, Koliadi A, Olsson Ladjevardi C, Digkas E, Valachis A, Ullenhag G. The role of dacarbazine and temozolomide therapy after treatment with immune checkpoint inhibitors in malignant melanoma patients: A case series and meta-analysis. Pigment Cell Melanoma Res. 2024. 37:352-362.
3Chesney J, Lewis KD, Kluger H, Hamid O, Whitman E, Thomas S, Wermke M, Cusnir M, Domingo-Musibay E, Phan GQ, Kirkwood MH, Hassel JC, Orloff M, Larkin J, Weber J, Furness AJS, Khushalani N, Medina T, Egger ME, Graf Finckenstein F, Jagasia M, Hari P, Sulur G, Shi W, Wu X, Sarnaik A. Efficacy and safety of lifileucel, a one-time autologous tumor-infiltrating lymphocyte (TIL) cell therapy, in patients with advanced melanoma after progression on immune checkpoint inhibitors and targeted therapies: pooled analysis of consecutive cohorts of the C-144-01 study. J Immunother Cancer. 2022. 10:
4Musher B, Rowinsky E, Smaglo B, Abidi W, Othman M, Patel K, Jawaid S, Jing J, Brisco A, Leen A, Wu M, Sandin LC, Wenthe J, Eriksson E, Ullenhag G, Grilley B, Leja-Jarblad J, Hilsenbeck SG, Brenner MK, Loskog ASI. LOAd703, an oncolytic virus-based immunostimulatory gene therapy, combined with chemotherapy for unresectable or metastatic pancreatic cancer (LOKON001): Results from arm 1 of a non-randomised single-centre, phase 1/2 study. Lancet Oncology. 2024, 25:488-500.
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About Lokon Pharma
Lokon Pharma AB is a leading Swedish biotech company in the rapidly expanding field of tumor microenvironment gene engineering based on replication-competent viruses and is focused on the clinical development of an immunostimulatory gene therapy for cancers with high unmet medical need. LOAd703 (delolimogene mupadenorepvec), the first clinical candidate from the LOAd platform, induces expression of TMZ-CD40L and 4-1BBL in the tumor microenvironment to cause stroma inflammation and subsequent antitumor immunity. CD40L and 4-1BBL are two potent stimulators of dendritic cells, T cells, and NK cells, which are crucial inducers of the immune response against cancer cells.
Further information can be found at: www.lokonpharma.com
