COVID-19 Vaccine Developer Moderna In The Spotlight With R&D Day, 2 Collaborations

Coronavirus vaccine developer Moderna Inc MRNA is issuing updates Thursday from its virtual R&D day. 

Moderna's Portfolio, Therapeutic Updates: Cambridge, Massachusetts-based Moderna announced at its R&D day progress across its clinical programs, which includes mRNA-1273, its late-stage vaccine candidate against SARS-CoV-2, and four other candidates in midstage development.

"As we continue to scale for commercialization, we are more committed than ever to our mission to deliver on the promise of mRNA medicines to treat or prevent serious diseases," said Stéphane Bancel, Moderna's CEO.

Moderna's three clinical-stage therapeutic areas are infectious diseases, oncology and rare diseases.

In the infectious diseases arena, the company said it has enrolled about 25,296 participants out of the targeted 30,000 — or about 84% — in the late-stage study of its mRNA-1273 program.

Of those participants, them 10,025 have received the second booster shot.

Moderna previously announced positive interim data from the Phase 2 study of its CMV vaccine candidate mRNA-1647 and said it plans to begin the Phase 3 study at a 100mcg dose in 2021.

Moderna has also received the nod to move its pediatric RSV vaccine candidate, codenamed mRNA-1345, into the clinics.

In a new development, the company said it plans to enter the seasonal flu business to capitalize on the high medical need for more effective flu vaccine.

In oncology, the company is developing mRNA-2416 as a monotherapy in an early stage trial. The first patients have been dosed in a Phase 2 dose-expansion study of the pipeline asset in combination with durvalumab for ovarian cancer.

Moderna's rare disease assets include mRNA-1944, which is being evaluated in a Phase 1 study against the chikungunya virus; mRNA-3705, a new-gen methlymalonic acidemia candidate; and mRNA-3927, a propionic acidemia candidate.

New data for mRNA-1944 from the Phase 1 study presented at the R&D day showed the vaccine candidate was generally safe and well-tolerated and produced dose-dependent increases in antibiodies against chikungunya.

Neutralizing antibodies were observed at all dose levels, the company said.

Moderna's Vertex Deal: Moderna announced late Wednesday a new collaboration deal with longtime partner Vertex Pharmaceuticals Incorporated (VRTX) for the discovery and development of lipid nanoparticles and mRNAs for the delivery of gene-editing therapies for cystic fibrosis.

The collaboration will initially focus on the discovery and optimization of novel LNPs and mRNAs that can deliver gene-editing therapies to cells in the lungs, the companies said.

Under the agreement, Moderna will receive $75 million upfront and will be eligible to receive up to $380 million in development, regulatory and commercial milestones, plus tiered royalties on any products that result from the collaboration.

Moderna's Hypertension Partnership: Separately, Moderna announced a collaboration with Chiesi Farmaceutici S.p.A. for developing mRNA therapeutics for the treatment of pulmonary arterial hypertension.

Moderna will lead discovery efforts, while Chiesi will assume the responsibility for development and commercialization and fund collaboration-related expenses, the company said.

The agreement provides for Moderna receiving $25 million upfront and potentially more than $400 million in development, regulatory and commercial milestones, as well as tiered double-digit royalties on net sales.

MRNA Price Action: Moderna shares were trading down 1.24% at $67.99 at last check Thursday. 

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