Moderna (MRNA) has regained all rights to respiratory syncytial virus vaccine (mRNA-1172) from Merck (MRK)

October 8, 2020 6:46 AM

Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that it has regained all rights to the respiratory syncytial virus (RSV) vaccine (mRNA-1172) from Merck, known as MSD outside the United States and Canada, including rights to develop RSV vaccines for adult populations. mRNA-1172, which uses a Merck lipid nanoparticle for delivery, entered Phase 1 development in 2019. Under the terms of the agreement, Merck will complete the Phase 1 study and transition the program to Moderna. Moderna has now consolidated all global commercial rights to all development candidates in its core prophylactic vaccines modality.

Among its RSV candidates, Merck decided to focus its efforts on RSV infections through its antibody program that is currently in Phase 2 development.

Separately, Moderna also announced the initiation of dosing in the Phase 1 study of its solely owned RSV vaccine candidate (mRNA-1345). This Phase 1 study includes initial dosing in adults, followed by age de-escalation into children. The company previously announced its intent to advance mRNA-1345 in children in combination with mRNA-1653, a vaccine against two other pediatric respiratory viruses (hMPV, PIV3) which is currently in its own age de-escalation study. With today’s announcement, Moderna will have the right to also advance RSV vaccines in adults, either alone or in combination with other respiratory virus vaccines.

Moderna’s mRNA-1345 vaccine uses the Company’s proprietary lipid nanoparticle delivery technology also used in the Company’s COVID-19 vaccine (mRNA-1273) and CMV vaccine (mRNA-1647).

Moderna and Merck will continue their ongoing collaboration in cancer vaccines. In 2016, Moderna and Merck entered into a collaboration for mRNA-4157, a personalized cancer vaccine candidate, which is currently being evaluated in a Phase 2 study. In 2018, the companies expanded the collaboration to include the development and commercialization of mRNA-5671 a mutant KRAS vaccine candidate currently in a Phase 1 study.

“We appreciate the collaboration with Merck to date and we are pleased to continue advancing our RSV vaccine (mRNA-1345), which uses our proprietary delivery technology,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “With this portfolio consolidation, we will continue to pursue RSV vaccines to protect the most vulnerable populations – young children and older adults. With our investments in science and manufacturing, we have taken eleven infectious disease vaccines into human clinical trials. The technology used in our core prophylactic vaccines modality has allowed us to accelerate research and development timelines and advance our mRNA vaccines into new areas of high unmet need. We look forward to continuing our productive relationship with Merck to advance our novel mRNA-based cancer vaccines.”

Conference Call and Webcast Information

Moderna will host a live conference call and webcast at 8:00 a.m. ET on Thursday, October 8, 2020. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 5596196. A webcast of the call will also be available under “Events and Presentations” in the Investors section of the Moderna website at investors.modernatx.com. The archived webcast will be available on Moderna’s website approximately two hours after the conference call.

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