It is a jump that the stock market rarely experiences: The shares of the American biotechnology company Moderna gained 177 percent in value on Wednesday, the price rose from 62.96 to 174.38 dollars. This was triggered by positive study data for a new therapeutic vaccine against skin cancer that Moderna is developing together with the American pharmaceutical company Merck & Co. Merck & Co. shares also benefited from the news, rising by 13 percent. The research success even had an impact on uninvolved companies: the share price of the German Moderna competitor Biontech rose by almost 22 percent. This has to do with the fact that Biontech, like Moderna, is working on cancer therapies based on so-called mRNA technology. This approach was used to create corona vaccines and is also used by Moderna and Biontech to develop cancer therapies.
The results from Moderna and Merck are considered a possible breakthrough for the use of mRNA technologies in cancer research. According to the companies, this is the first positive data from an mRNA-based cancer therapy from the third and final phase of a clinical study. The drug Intismeran, developed by Moderna and Merck, has helped prevent recurrence or metastasis of melanoma, the deadliest form of skin cancer. According to the American Cancer Society, melanoma accounts for only one percent of all skin cancer cases in the United States, but it accounts for the vast majority of all deaths. The organization expects that 112,000 cases of melanoma will be diagnosed in the United States this year and 8,510 people will die from this type of cancer.
The study involved more than 1,100 patients who had melanoma surgically removed. Intismeran was tested in conjunction with Keytruda, a cancer drug from Merck. According to the announcement, this combination therapy performed better than Keytruda alone in terms of melanoma recurrence and metastasis. The companies did not yet provide any specific study results and indicated that they would like to present further data at a medical conference in the near future. In second clinical phase studies, the combination therapy reduced the risk of melanoma recurrence by 49 percent and the risk of distant metastases fell by 59 percent.
Intismeran is also special because it is a personalized therapy that is tailored to each individual patient. The preparation is developed based on the genetic information of the respective tumor. After a sample is taken, it takes six weeks to produce the vaccine. In the meantime, patients receive Keytruda. Merck's cancer drug is one of the top-selling products in the entire pharmaceutical industry. It brought in almost $32 billion for the group last year, accounting for almost half of total sales.
Moderna CEO Stéphane Bancel called the study results a “decisive moment in cancer research.” The vision of developing mRNA therapies specifically for individual patients is becoming a reality. For Moderna, the research success could mark a turning point after a few difficult years. The company, founded in 2010, focuses entirely on mRNA preparations, and in the midst of the pandemic it became a high-flyer in the industry alongside Biontech with its corona vaccine introduced at the end of 2020. The stock peaked at more than $480 in 2021, and the company had sales of more than $19 billion in 2022. After the pandemic subsided, sales continued to decline; last year they were only $1.9 billion. Moderna now hopes to reverse this trend with cancer therapies. Bancel told The Wall Street Journal on Wednesday: “We are now a cancer company.” According to him, Intismeran could come onto the market next year. The drug is also being tested for use in other types of cancer.
Moderna and Merck's research success comes at a time when the American government is becoming more critical of mRNA technologies. Health Secretary Robert F. Kennedy Jr. is generally seen as a vaccine skeptic. Last year, his ministry discontinued 22 funding programs for mRNA projects worth almost $500 million, which also affected Moderna. Kennedy said at the time that mRNA vaccines were not effective protection against corona infections or the flu. A $590 million government program to help Moderna develop a bird flu vaccine was also canceled. In return, however, a new program was launched to promote vaccines against cancer, which also includes mRNA technologies.
In Germany, Biontech can look forward to the unexpected upswing in the stock market - especially since negative headlines have recently been in the foreground due to the departure of the founders and the planned job cuts. The share price looks better than it has in months. The last time the paper was above the 90 euro mark was in April. The fact that competitor Moderna is responsible for this is just a small downer. It may be a coincidence, but on Thursday morning Biontech rushed to announce that the company would also be presenting progress on late-clinical mRNA cancer agents, especially Pumitamig and Gotistobart, at the World Lung Cancer Congress (WCLC) in Seoul in September.
On the former, Biontech is working with the US pharmaceutical giant Bristol-Myers Squibb. The “super active ingredient” Pumitamig, with which more than 20 studies are underway, is intended to be used against various types of cancer. The results that the active ingredient has achieved in combination with chemotherapy in clinical studies with lung cancer and breast cancer patients are promising. For example, in May, Biontech presented data from the Phase 2/3 Rosetta study to an expert audience in the USA, which showed “encouraging anti-tumor activity” and a “high response rate” in patients with non-small cell lung cancer.
The lung cancer drug Gotistobart is also making important progress. In a first part of the phase 3 study, the risk of death in patients was reduced by 54 percent compared to standard chemotherapy. The second, approval-relevant part of the study is currently underway. Current data on overall survival will now follow at the congress in South Korea. There will also be so-called anti-drug conjugates developed by Biontech that specifically attack cancer cells. The candidate Elfetabart Drozuntecan is currently being tested in combination with Pumitamig.
And an individualized mRNA-based cancer vaccine is also in the pipeline. Biontech is developing this together with the Roche subsidiary Genentech; phase 2 studies are currently underway with patients who have previously had a tumor in the pancreas or intestine removed (adjuvant). The idea here too: to produce a vaccine that is tailored precisely to the protein structures that only occur on the cancer cells of the patient. “Due to these similarities, there is an expectation that the success of Moderna and Merck in the adjuvant treatment of melanoma could also allow positive conclusions to be drawn about Biontech’s programs,” explains analyst David Dai from UBS.
The race for drugs based on mRNA technology continues. Markus Manns, fund manager at Union Investment, emphasizes that it is now clear that the mRNA approach works. However, he restricts: "So far we only know that the approach is effective for skin cancer. Skin cancer is a comparatively 'simple' indication." According to Manns, skin cancer cells are particularly susceptible to tumor vaccines and thus attacks by the immune system.
This susceptibility varies depending on the tumor. Accordingly, lung cancer cells, which Biontech is focusing on, could react differently and possibly be more resistant to vaccines. The Moderna data therefore only allowed limited conclusions to be drawn about Biontech, especially since the Mainz company is testing its vaccine for other cancers. Both UBS expert Dai and Manns are critical of the fact that personalized mRNA therapies are difficult to produce and incur high costs. Dai therefore suspects that mRNA cancer vaccines could be produced “off the shelf” in advance and used directly.
