The disease control rate of 90% mRNA cancer vaccine/Keytruda combination had positive early clinical results

Today, Moderna, which is working on mRNA vaccines and therapies, announced that its individualized cancer vaccine, mRNA-4157, has achieved positive results in early clinical trials.
mRNA-4157 was used in a phase 1 clinical trial to treat HPV-negative head and neck squamous cell carcinoma (HNSCC) patients with a total remission rate (ORR) of 50% (ORR) and a 9.8-month medium progressive survival (mPFS).
previously released Keytruda single-drug treatment had ORR of 14.6% and mPFS of 2.0 months.
results further demonstrate the potential of the mRNA vaccine to treat cancer in addition to preventing infectious diseases.
the development of an individualized cancer vaccine based on the body's immune response to cancer antigens.
cancer patients, because of a genetic mutation, expressed in the cells the absence of new antigens (neoantigen) in healthy tissue.
these new antigens stimulate the immune response of the body's immune system, such as activating T cells and promoting their proliferation.
activated T cells can migrate near tumors and attack them.
, however, the level of new antigens expressed in tumors is low enough to trigger a strong immune response.
strategy for the development of an individualized cancer vaccine is to identify new antigens in tumors and prepare them into vaccines to be injected into patients to stimulate a specific immune response to tumors.
development process for mRNA individualized vaccines The current individualized vaccine technology platform is divided into three main categories, peptide vaccines, RNA/DNA vaccines and degenerate cell vaccines.
development process for mRNA-individualized vaccines from Moderna starts with obtaining tissue samples from cancer patients.
Through next-generation sequencing (NGS) of cancer cells in patients' cancer tissue and blood samples, the researchers found genetic mutations unique to cancer cells and, through analysis of genetic mutations, selected new antigen sequences that best stimulate the body's immune response.
Moderna's mRNA cancer vaccine can hold up to 34 mRNA sequences encoded with new antigens.
the mRNA cancer vaccine is injected into the body, it can direct the body's cells to produce new antigens that stimulate the immune system to respond.
the production process of the mRNA individualized cancer vaccine (Photo: Moderna.com) In this Phase 1 clinical trial, HPV-negative patients with head and neck squamous cell carcinoma received a joint treatment of the individualized cancer vaccine mRNA-4157 and Keytruda.
The combination of these two therapies is expected to produce synergies and enhance anti-cancer effects, as individualized cancer vaccines stimulate the T-cell response of the immune system, and immuno-checkpoint inhibitors eliminate tumor-to-T-cell immunosuppression.
results from an early clinical trial of mRNA-4157, published today by Moderna, included 10 HPV-negative HNSCC patients and 17 patients with colorectal cancer (CRC) with microsatellitor stabilization (MSS).
in HNSCC patients, 2 patients received complete remission and 3 patients received partial remission, with a total remission rate of 50%.
same time, four patients were stable and had a disease control rate (DCR) of 90%.
the medium non-progression lifetime is 9.8 months, and the medium mitigation duration has not yet been reached.
but patients with MSS colorectal cancer did not respond. "The primary goal of Phase 1 clinical trials is safety, and we now know that this therapy is not only safe and toyed, but also that we should do further research on head and neck cancer," said Dr. Julie E. Bauman, a professor of medicine at the University of Arizona Cancer Center who is leading the phase 1 clinical trial at
mRNA-4157 (Photo source: Reference.
"Dr Bauman said the trial would expand the number of head and neck cancer patients recruited to 40.
addition to the new antigen vaccine, Moderna is working with Mercadon to develop a mRNA-based KRAS mutant vaccine.
BioNTech, which is working with Pfizer to develop the new crown vaccine, acquired Neon Therapeutics, the star company that developed the cancer vaccine earlier this year, and is currently developing several cancer vaccines in the pipeline.
the company, in partnership with Roche's Genentech, is exploring the effectiveness of individualized new antigen vaccines in combination with PD-1/PD-L1 inhibitors to treat patients with multiple solid tumors.
the company also reached an agreement with Regeneron in August to launch Phase 2 clinical trials to test the effectiveness of mRNA-based cancer vaccines in pairs with the PD-1 inhibitor Libtayo to treat melanoma patients.
: s1. Retrieved November 11, 2020, from [2] Moderna R&D Day. Retrieved November 11, 2020, from [3] A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone in Subjects With Resected Solid Tumors and in Combination With Pembrolizumab in Subjects With Unresectable Solid Tumors (Keynote-603). Retrieved November 11, 2020, from [4] Personalized cancer vaccine clinical trial to expand following promising early results. Retrieved November 11, 2020, from