mRNA cancer vaccine is a personalized tumor treatment method. Moderna official website Picture
On December 13, US time, mRNA vaccine giant Moderna (Moderna) and MSD (MSD) announced that the combined therapy of personalized cancer vaccines and immune checkpoint inhibitors jointly developed by the two companies can reduce the risk of death or recurrence in high-risk stage III and IV melanoma patients by 44%. However, the results have not been reviewed by independent scientists, and the complete clinical trial data will be released at the upcoming oncology medical conference. After the news was announced, Moderna's U.S. stock price rose by more than 20% on the same day.
"Today's results are very inspiring for the cancer treatment field. mRNA is transformative for COVID-19, and now, for the first time in history, we have demonstrated the potential of mRNA to have an impact on the results of randomized clinical trials for melanoma ." Stéphane Bancel, CEO of Modner , said that the two companies plan to discuss the results with regulators and launch a larger phase 3 clinical trial in 2023.
In an interview with the pharmaceutical industry media Endpoints News, Bensell said that the mRNA cancer vaccine uses the same technology as the new coronavirus vaccine it developed, so its safety has been verified to a certain extent. In the future, in addition to jointly promoting the combination therapy with Merck to other types of cancer treatments, Moderna plans to examine the effectiveness of the mRNA vaccine as a single agent for cancer treatment. The official report of
shows that this phase 2b clinical trial recruited 157 patients who had undergone melanoma resection and followed up for one year. The control group received the standard treatment for advanced melanoma, the key PD-1 inhibitor product of Merck, and the drug group also received nine doses of cancer vaccine code-named mRNA-4157/V940. The results showed that the combination therapy reduced the risk of recurrence or death by 44%, while in terms of safety, the adverse reaction rates in the drug and control groups were 14.4% and 10%, respectively.
This clinical trial is part of a six-year partnership between Merck and Moderna in the field of developing personalized cancer vaccines. In October this year, Merck agreed to pay Moderna $250 million to exercise the option to jointly develop and commercialize mRNA-4157/V940.
mRNA-4157/V940 consists of a single synthetic mRNA encoding up to 34 neoantigens. The vaccine is designed and produced based on the unique DNA sequence mutation characteristics of each patient's tumor. After injection into the body, the algorithm-derived and RNA-encoded new antigen sequence is translated endogenously into a protein and is presented through in vivo antigens, stimulating the production of T-cell antitumor responses. Therefore, mRNA cancer vaccine can make "cold tumors hot" and expand the drug response rate of PD-1 inhibitors.
Paul Burton, chief medical officer of Moderna, said in an interview that the mRNA cancer vaccine can be produced in about eight weeks, and the company ultimately hopes to cut production time by half. Public information from
shows that another mRNA vaccine giant and German pharmaceutical company BioNTech has also applied mRNA vaccine to melanoma treatment. BioNTech's BNT111 cancer vaccine is undergoing phase II clinical trials and has obtained the U.S. FDA fast-track qualification at the end of last year to treat stage III or stage IV melanoma of PD-1 inhibitors that are refractory/recurrent and unresectable. The BNT122 cancer vaccine jointly developed with Roche Pharmaceutical has also entered the second phase of clinical stage, and is also used in combination with Keytruda to treat advanced melanoma patients.
In March this year, Regeneron Pharmaceuticals and BioNTech expanded its strategic development cooperation to jointly promote the clinical trial of BioNTech's candidate cancer vaccine BNT116 and the PD-1 inhibitor Libtayo to treat advanced non-small cell lung cancer patients.
A scientist who leads the development of the world's first marketed PD-1 inhibitor once told the reporter of The Paper Technology that the first indication for pharmaceutical companies to develop tumor immune drugs must be melanoma, because from historical data, melanoma responds to tumor immune drugs with a high response, followed by lung cancer and kidney cancer .
Among domestic companies, the mRNA personalized cancer vaccine developed by Siwei (Shanghai) Biotechnology Co., Ltd. has conducted phase I clinical trials in Australia; two self-replicating mRNA cancer vaccine projects of Jiachen Xihai Biotechnology Co., Ltd. are conducting phase I/Phase II clinical trials in the United States and China respectively. Currently, domestic companies are still focusing on combined therapies for PD-1 immunosuppressants, combining radiotherapy, targeted drugs and other immunomodulators, and have not yet been jointly developed with mRNA cancer vaccines.
