Dr Ana Arance, Medical Oncologist at Hospital Clinic de Barcelona, has presented safety and immune response data from the E011-MEL study at the ASCO (American Society of Clinical Oncology) Annual Meeting. The expert from Belgium-based eTheRNA immunotherapies NV conducted a study showing intranodal mRNA immunotherapy is clinically feasible and well tolerated.
Arance described the results during the poster session “Developmental Immunotherapy and Tumor Immunobiology” on 1 June. The study E011-MEL investigated the safety and immunogenicity of an mRNA-based immunotherapy ECI-006. ECI-006 is a combination of mRNAs encoding for the dendritic cell maturation triple mRNA TriMix together with mRNA coding for five tumour-associated antigens, which aims to elicit an immune response against the tumour.
Since the patients had been radically operated on, there was no expected, immediate clinical activity read-out.
The primary goal of the study was to study whether the injection of ECI-006 into inguinal or axillary lymph nodes was tolerable and clinically feasible. The intranodal injections were performed in the clinic under ultrasound guidance without anaesthesia. There were two treatment arms, each of 10 patients. One group received a dose of 600 µg and the other a dose of 1800 µg per injection.
The study was performed in centres in Belgium and Spain.
19 out of 20 patients completed the treatment. One patient discontinued the study after 4 doses due to disease relapse. Administration of ECI-006 was well tolerated in all patients with no serious side effects. ELISPOT and intracellular cytokine staining were performed on T cells pre-stimulated in vitro for 10-12 days. Vaccine-induced immune responses were detected in 4/10 and 3/10 patients treated with the low and high dose, respectively.
Arance said: “It is very encouraging that we see immune responses against most of the antigens used in the vaccine. Clinically this therapy was eminently well tolerated and feasible. Future studies should include patients with metastatic disease and test whether dosing with a concomitant check-point inhibitor can be additive.”
Dr Bertil Lindmark, CMO of eTheRNA Immunotherapies, said: “The study showed that intranodal therapy is clinically feasible and well tolerated. Specific immune responses in 35% of the patients in the adjuvant setting gives a good basis for coming studies in metastatic melanoma on top of a checkpoint inhibitor.”
