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Moderna, Merck Partner on Personal Cancer Vaccines

Human T-cell lymphocyte

Scanning electron micrograph of a human T-cell lymphocyte (National Institute of Allergy and Infectious Diseases, NIH)

29 June 2016. Biotechnology company Moderna Therapeutics and drug maker Merck are developing therapeutic vaccines using messenger RNA that address unique genetic patterns in patients’ tumors. The deal is expected to bring Moderna an immediate payment of $200 million, and the chance to earn further payments to develop cancer treatments combining Moderna’s technology with an approved targeted antibody therapy for cancer made by Merck.

Moderna Therapeutics in Cambridge, Massachusetts, develops medications that use genetic material to produce therapeutic proteins in the body, with a technology based on research licensed from Harvard University and MIT. That technology harnesses messenger RNA, a nucleic acid related to DNA used by cells to produce the amino acids in proteins for carrying out bodily functions. Moderna designs what it calls modified messenger RNA to produce proteins that act like drugs as treatments for diseases, creating antibodies able to cut the time and expense for therapeutic proteins over current genetic engineering methods.

Merck in Kenilworth, New Jersey developed pembrolizumab, a targeted antibody marketed under the brand name Keytruda that harnesses the immune system to fight tumors. Keytruda is in a class of drugs called checkpoint inhibitors that limit the actions of tumor cells to block the immune system. In this case, Keytruda stops receptor proteins on the surface of tumor cells from blocking the activation of T-cells in the immune system to attack tumors. Keytruda is already approved by Food and Drug Administration to treat melanoma, an advanced and metastatic form of skin cancer, and non–small cell lung cancer.

Under the agreement, the companies will develop therapeutic cancer vaccines using Moderna’s messenger RNA technology to target neoantigens, unique sets of mutations expressed in cancer patients’ tumors. The vaccines will be designed to induce immune responses specifically targeted to those mutations. The companies believe this personalized activation of immune responses will work well with Keytruda and other checkpoint inhibitors.

The deal calls for Merck to make an immediate payment of $200 million for Moderna to design and evaluate messenger RNA treatments with Keytruda. Moderna will be responsible for all initial research and development through proof-of-concept. The initial payment will also cover building a small-batch manufacturing facility on a Moderna site outside Boston meeting Good Manufacturing Practice, or GMP, standards for pharmaceuticals, designed to deliver personalized vaccines.

Following proof-of-concept tests, Moderna and Merck may move ahead on further development of personalized cancer vaccine therapies. The deal calls for the companies to share costs and profits equally in a worldwide collaboration, with Moderna having an option to co-promote products from the partnership in the U.S. Under the agreement, Merck will make another payment of an undisclosed amount to Moderna, if the companies go ahead with second stage.

Merck and Moderna are already collaborating on development of antiviral vaccines and passive immunity therapies, those induced with antibodies delivered from outside the body. That deal, begun in January 2015, runs for 3 years with an optional 1-year extension.

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