Early Data Shows mRNA-4359 May Be Effective in Patients with Advanced Solid Tumors

Interim data from Phase I dose-escalation study of mRNA cancer Immunotherapy (mRNA-4359) has shown promise in patients with advanced solid tumors.

The investigational mRNA cancer immunotherapy is aimed at lung cancer patients, Malignant melanoma and other solid tumors. Nineteen patients with advanced cancer received one to nine treatments with the immunotherapy. Scientists found that the therapy produced an immune response against the cancer and was well tolerated, although it did cause side effects, including fatigue, pain at the injection site, and fever.

Results from a Phase I trial, the first human study of the treatment, will be released on Saturday.^Number The findings were announced in September at the European Society for Medical Oncology conference in Barcelona by UK lead investigators from King's College London and Guy's and St Thomas' NHS Foundation Trust. The trial is sponsored by Moderna.

mRNA immunotherapy is just one of many cancer vaccines in clinical trials around the world. The therapy works by presenting common markers of tumors to a patient's immune system, training it to recognise and fight cancer cells that express them, while eliminating cells that might suppress the immune system.

The phase I trial was designed to test the safety and tolerability of immunotherapy, with secondary and tertiary objectives to evaluate radiological and immunological responses.

Of the 16 patients who could be assessed for response, eight were able to demonstrate that their tumors did not increase in size and no new tumors appeared.

The data also showed that mRNA immunotherapy was able to activate many patients' immune systems, generating immune cells in the blood that could recognize two proteins – PD-L1 and IDO1. The researchers were able to show that in some patients, immunotherapy increased levels of important immune cells that can kill cancer cells, while decreasing levels of other immune cells that may hinder the immune system from fighting cancer.

The study authors note that the results should be treated with caution because the sample size was small and the study's primary objective was to test safety and determine optimal dosing of the immunotherapy, but these promising early results support further research into mRNA-4359.

The trial continues to recruit patients with melanoma and lung cancer in combination with the immunotherapy drug pembrolizumab to provide further information on safety and efficacy. Efficacy Treatment.

“This study evaluating mRNA cancer immunotherapy will be an important first step towards developing new treatments for patients with advanced cancer,” said Dr Debasis Sarkar, the trial's UK lead investigator, Clinical Lead in Experimental Oncology at King's College London and Consultant in Medical Oncology at Guy's and St Thomas' NHS Foundation Trust.

“We have shown that this treatment is well tolerated, without serious side effects, and may help stimulate the body's immune system and make cancer treatment more efficient. However, the study only has a small number of patients so far, so it is too early to tell how effective it may be for people with advanced cancer.”

“The trial continues to recruit patients with melanoma and lung cancer and is a large international effort spanning the UK, US, Spain and Australia.”

We are encouraged by the results from the Phase 1 trial of mRNA-4359, which shows the potential to induce robust antigen-specific T cell responses while maintaining a manageable safety profile.

This novel approach may be a key component in shifting the tumor microenvironment toward a more immune-permissive state, potentially offering hope for patients with advanced solid tumors.”

Kyle Hollen, M.D., Senior Vice President and Head of Development, Therapeutics and Oncology, Moderna