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Moderna Raises $500M Financing for mRNA R&D, Manufacturing

Advancing to the Clinic

According to Moderna’s website, three of those candidates advanced into the clinic in the last two months of 2017.

In November, Moderna began a Phase I study of mRNA-1647, a prophylactic vaccine designed to treat cytomegalovirus (CMV). mRNA-1647 combines six mRNAs encoding for six viral proteins, including five proteins that comprise the CMV gH Pentamer complex (gH, gL, UL128, UL130, and UL131A), as well as another CMV antigen, the herpesvirus glycoprotein (gB) protein.

Also in November, Moderna launched the Phase I KEYNOTE-603 study of mRNA-4157, an mRNA-based personalized cancer vaccine being developed with Merck & Co. through a $100-million-plus mRNA partnership launched in January 2015. The vaccine is designed to encode for peptides containing neoantigens and other unique mutations present in each patient’s specific tumor. When injected in the body, the mRNA will direct cells to produce and express these neoantigens, according to the company.

Moderna says mRNA-4157 could potentially improve clinical outcomes associated with checkpoint inhibitor therapies—including Merck’s marketed anti-programmed death 1 (PD-1) cancer immunotherapy, Keytruda® (pembrolizumab). KEYNOTE-603 is expected to enroll up to 90 patients and will assess the safety, tolerability, and immunogenicity of mRNA-4157 alone in subjects with resected solid tumors and in combination with Keytruda.

In December, Moderna launched a Phase I study of mRNA-1653, a multivalent vaccine designed to immunize against human metapneumovirus (HMPV) and parainfluenza virus 3 (PIV3). mRNA-1653 combines mRNA encoding for a viral antigenic protein associated with HMPV and mRNA encoding for a viral antigenic protein associated with PIV3 into a single vaccine.

Moderna expects its first mid-stage pipeline candidate to be AZD-8601, a localized mRNA therapeutic encoding for vascular endothelial growth factor, VEGF-A, being developed with AstraZeneca. At the J.P. Morgan conference, Moderna announced plans for a Phase IIa study of AZD-8601, to be led by AstraZeneca, adding that design and target indication for the study would be detailed in coming weeks. Moderna and AstraZeneca are co-developing mRNA therapeutics under an up-to-$420-million-plus collaboration launched in 2013.

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