Merck, also known as MSD outside the U.S. and Canada, and Orna Therapeutics, a biotech company working on a new investigational class of engineered circular RNA (oRNA) therapies, are to collaborate on discovering, developing, and commercializing multiple programs, including vaccines and therapeutics, in the areas of infectious diseases and oncology.
Under the terms of the agreement, Merck will make an upfront payment to Orna of $150 million, which will be expensed by Merck in the third quarter of 2022 and included in non-GAAP results.
In addition, Orna will be eligible to receive up to $3.5 billion in development, regulatory, and sales milestones associated with the progress of the multiple vaccine and therapeutic programs, as well as royalties on any approved products derived from the collaboration.
Orna will retain rights to its oRNA-LNP technology platform and will continue to advance other wholly owned programs in areas such as oncology and genetic disease. Merck will also invest $100 million of equity in Orna’s recently completed series B financing round.
Orna’s proprietary oRNA technology creates circular RNAs (oRNAs) from linear RNAs by self-circularization. oRNA molecules have been shown to have greater stability in vivo than linear mRNA and have the potential to produce larger quantities of therapeutic proteins inside the body.
Newly synthesized oRNA molecules are more compactly packaged into custom lipid nanoparticles (LNPs), which Orna has engineered to target key tissues in the body.
New generation of vaccines
Preclinical data, including presentations at the 2022 American Society of Gene & Cell Therapy (ASGCT) annual meeting, have demonstrated the potential of oRNA expression and delivery as an approach for further development in multiple areas, including vaccines and oncology therapeutics.
“This broad strategic collaboration brings together Merck’s significant expertise in nucleic acid biology, clinical development, and manufacturing with Orna’s compelling circular RNA technology to explore the opportunity to develop a new generation of potential vaccines and therapeutics,” said Fiona Marshall, senior vice president and head of discovery, preclinical and translational medicine at Merck Research Laboratories.
“We look forward to working with the talented scientific and technical teams at Orna.”
“We are thrilled to collaborate with Merck, a company committed to breakthrough science, which has recognized the potential our platform can bring to patients. Our oRNA technology plus novel delivery solutions are designed to unlock the full potential of RNA in therapeutics and vaccines,” said Tom Barnes, CEO of Orna.
“The combined expertise of Orna and Merck aims to accelerate the development of RNA therapeutics for patients in need of better treatment options.”