Merck and Moderna have been collaborating on cancer vaccine research for the past six years, and the pharmaceutical giant has decided it wants to be equally involved in the clinical development of a melanoma vaccine. Merck will pay a partner $250 million to select a cancer vaccine candidate before key clinical trial results are expected this year.
By exercising its option on Moderna’s mRNA-4157/V90 cancer vaccine, Merck agrees to participate in the development and commercialization of the therapy if approved. In the future, the partners will share costs and benefits related to the vaccine.
Cancer vaccines are treatments designed to strengthen the immune system to produce an anti-tumor response. Moderna’s mRNA-4157/V190 is individualized, meaning that a batch is designed and manufactured for each patient.
Moderna accomplishes this by sequencing patient tumor samples to identify tumor-associated antigens, also known as neoantigens, that trigger an immune response. A cancer vaccine consists of mRNA engineered to express these neoantigens.
An ongoing phase 2 study of mRNA-4157/V190 includes 157 patients with surgically resected melanoma. However, these patients also have a high risk of cancer recurrence.
The clinical trial participants were randomly assigned to receive either a combination of Moderna’s cancer vaccine and Keytruda every three weeks, or Keytruda alone. Patients received the prescribed treatment for a year or until the cancer resolved or the toxicity became intractable. The primary goal of the study is to measure relapse survival, defined as the time from the first dose of Keytruda to the first sign of cancer or death, whichever occurs first.
“We have been working with Merck on [personalized cancer vaccines] since 2016, and together we have made significant progress with mRNA-
4157 as an investigational personalized cancer therapy to be used in combination with Keytruda,” Moderna president Stephen Hoge said in the report. opinion “With data expected this quarter on personalized cancer vaccines], we continue to be excited about the future and the impact that mRNA can have as a new cancer treatment paradigm.”
When Merck began the cancer vaccine partnership, Moderna was still unknown outside biotech circles and its mRNA vaccine technology was unproven. Under the terms of the deal, Merck paid Moderna $200 million up front. Moderna was responsible for designing, manufacturing, and testing personalized cancer vaccines in Phase 1 and 2 clinical trials. These studies evaluated the vaccines as monotherapy and in combination with Keytruda.
The collaboration gave Merck the right to decide, based on concept studies, to share the costs and benefits of the vaccine equally. When the deal was initially announced, the companies did not disclose how much Merck would pay to exercise its option.
In 2018, the partners expanded their collaboration with Moderna’s cancer vaccines designed to treat cancers caused by KRAS mutations and other common neoantigens, meaning they are not unique to individual patients. In December of last year, Merck decided to end the collaboration on this common neoantigen. Moderna said in regulatory filings that it is evaluating next steps for mRNA-5671, a KRAS cancer vaccine that is part of the conventional neoantigen portion of the deal.
