Merck and Moderna Move Forward with Personalized Cancer Vaccine (Updated)

Moderna_Maddie Meyer/Getty Images

Maddie Meyer/Getty Images

Merck and Moderna are moving forward with a personalized cancer vaccine as Merck exercised its option to develop and commercialize mRNA-4157/V940, the companies announced Wednesday.

The option is based on an existing Collaboration and License Agreement originally inked in 2016 and amended in 2018.

The two companies will develop and commercialize mRNA-4157/V940 together. It is currently being tested by Moderna in a Phase II trial in combination with Merck’s anti-PD-1 checkpoint inhibitor Keytruda (pembrolizumab) in the KEYNOTE-942 trial as adjuvant treatment for patients with high-risk melanoma. The trial has enrolled 157 patients.

After surgical resection, patients were randomized to receive 9 doses of the vaccine every three weeks and 200 mg of Keytruda or Keytruda alone every three weeks for about one year until disease recurrence or therapy-related toxicity forced them to stop.

Keytruda was chosen because it is the standard of care for this patient population. The primary endpoint is recurrence-free survival. Secondary endpoints include distant metastasis-free survival and overall survival. A data readout is expected before the end of the year.

PCVs are developed to stimulate the immune system so the patient’s own cells can create a specific antitumor response to their tumor mutation signature. mRNA-4157/V940 is engineered to stimulate an immune response by generating T-cell responses based on the patient’s “mutational signature.”

Mary Beth Woodin, senior director, R&D communications for Moderna told BioSpace the company is “hopeful for the future applications of mRNA cancer vaccines as a means of enhancing an individual’s immune response to cancer.

"We have already demonstrated that mRNA is a powerful clinical tool and we believe its application to cancer has the potential to transform cancer treatments with a uniquely personalized approach to address significant unmet medical needs in oncology," she said. 

Under the deal, Merck will pay Moderna $250 million for the option. Merck will expense the payment in the third quarter of this year and include it in its non-GAAP financial results. The two companies will split costs and any profits equally under the global deal.

“This long-term collaboration combining Merck’s expertise in immuno-oncology with Moderna’s pioneering mRNA technology has yielded a novel tailored vaccine approach,” stated Eliav Barr, M.D., SVP and head of global clinical development, CMO, Merck Research Laboratories.

Moderna vs. BioNTech

In April, John Haanen, M.D., Ph.D., of the Netherlands Cancer Institute (NCI) in Amsterdam, Netherlands, presented data from BioNTech’s ongoing first-in-human Phase I/II trial of its own mRNA-based cancer vaccine. BNT211, a CAR-T cell therapy, is being investigated in patients with advanced solid tumors.

BNT211 consists of two drug products: an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) and a CLDN6-encoding CAR-T cell amplifying RNA vaccine (CARVac). It uses BioNTech’s mRNA-lipoplex technology, which is used in the COVID-19 vaccines developed with Pfizer. Tumor indications include testicular cancer, ovarian cancer, endometrial cancer, fallopian tube cancer, sarcoma and gastric cancer.

The trial data presented demonstrated 6 of 14 evaluable patients had a partial response, and 5 had stable disease with their target lesions shrinking. In addition to demonstrating overall target efficacy, the results were proof-of-concept of mRNA technology outside infectious diseases.

In addition to mRNA-4157/V940, Moderna also has a KRAS vaccine (mRNA-5671) and a checkpoint vaccine (mRNA-4359) along with others in the cancer space.

BioNTech and Regeneron Pharmaceuticals are collaborating on an mRNA vaccine for advanced melanoma, BNT111, which is in Phase II. Late last year, the FDA granted the vaccine fast-track designation based on “available preclinical and clinical data showing the potential of BNT111 to overcome current limitations in the treatment of inoperable therapy-resistant advanced-stage melanoma.”

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