Merck and Moderna have collaborated on the research of cancer vaccines for the past six years, and the pharmaceutical giant has decided it wants to share equally in a vaccine in clinical development for melanoma. Merck is paying its partner $250 million to pick up its option on the cancer vaccine candidate, a move that comes in advance of a key clinical trial readout expected later this year.
By exercising its option on the Moderna cancer vaccine, mRNA-4157/V940, Merck is agreeing to share in the therapy’s development as well as its commercialization, if it’s approved. Going forward, the partners will split the costs and profits associated with the vaccine.
Cancer vaccines are therapies designed to prime the immune system to mount an anti-tumor response. Moderna’s mRNA-4157/V940 is personalized, meaning a batch is designed and manufactured for each patient. Moderna accomplishes this by sequencing samples of a patient’s tumor in order to identify the tumor-related antigens, also called neoantigens, that will prompt the immune response. The cancer vaccine consists of mRNA designed to express these neoantigens.
The Phase 2 study underway for mRNA-4157/V940 enrolled 157 patients whose melanoma has been surgically removed. However, these patients also face a high risk of cancer recurrence. The Moderna cancer vaccine is being tested in combination with Keytruda, a blockbuster cancer immunotherapy whose approvals include one in melanoma for use as an adjuvant, a therapy given after the primary treatment to reduce the risk of cancer’s return.
Participants in the clinical trial were randomly assigned to receive either the combination of the Moderna cancer vaccine and Keytruda every three weeks, or Keytruda alone. Patients continued to receive their assigned treatment for one year, or until the cancer comes back or toxicity becomes unacceptable. The study’s main goal is to measure recurrence-free survival, defined as the time from the first dose of Keytruda to the first sign of cancer or death, whichever comes first.
“We have been collaborating with Merck on [personalized cancer vaccines] since 2016, and together we have made significant progress in advancing mRNA-4157 as an investigational personalized cancer treatment used in combination with Keytruda,” Moderna President Stephen Hoge said in a prepared statement. “With data expected this quarter on [personalized cancer vaccines], we continue to be excited about the future and the impact mRNA can have as a new treatment paradigm in the management of cancer.”
When Merck inked the cancer vaccine partnership, Moderna was still unknown outside of biotech circles and its mRNA vaccine technology had yet to be proven. According to the terms of that deal, Merck paid Moderna $200 million up front. Moderna was responsible for designing the personalized cancer vaccines, making them, and then testing them in Phase 1 and Phase 2 clinical trials. Those studies would evaluate the vaccines as monotherapies and in combination with Keytruda.
The collaboration gave Merck the right to choose to share equally in the costs and profits of a vaccine following proof of concept studies. When the pact was initially announced, the companies did not disclose how much Merck would pay to exercise its option.
In 2018, the partners expanded the collaboration to include cancer vaccines Moderna designed to address cancers driven by KRAS mutations and other neoantigens that are shared, meaning they are not unique to individual patients. Last December, Merck decided to end this collaboration on shared neoantigens. Moderna has said in regulatory filings that it is evaluating next steps for mRNA-5671, a KRAS cancer vaccine covered under the shared neoantigens part of the agreement.
Public domain image by Julio C. Valencia via the National Cancer Institute
