On August 16, 2022, Merck (NYSE: MRK) and Orna Therapeutics each announced that they entered into a collaboration agreement relating to the discovery, development and commercialization of therapeutics and vaccines in the oncology and infectious disease spaces.

The deal centers around Orna’s “oRNA” technology which is reportedly directed to the creation of circular RNAs (oRNAs) from linear RNAs through “self-circularization.” The companies indicate that “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 … [and] are more compactly packaged into custom lipid nanoparticles (LNPs), which Orna has engineered to target key tissues in the body.”

Like Pfizer (through its collaboration with BioNTech) and Sanofi (through its acquisition of Translate BIO), Merck is another big pharma player that appears to be looking to gain a foothold in the mRNA space. For example, prior to this deal with Orna, Merck collaborated with Moderna in connection with its mRNA technology and taken other steps with mRNA, but “hasn’t yet broken through with an approved product.”

The companies have referenced the circular mRNA and “custom” LNP technology as a “new generation of potential vaccines and therapeutics,” possibly differentiating those therapies from existing ones, including the therapies used in the Moderna and BioNTech/Pfizer Covid-19 vaccines which utilize linear mRNA payloads carried by certain lipid formulations.

With respect to the financial terms, Merck will reportedly make a $150 million upfront payment to Orna, and Orna will be eligible to receive upwards of $3.5 billion in milestone payments based on applicable regulatory progress, as well as royalties on sales of approved products resulting from the collaboration. Orna will reportedly retain rights to its oRNA-LNP platform and Merck will invest $100 million in Orna’s Series B funding round.

See the Merck and Orna press releases for more details surrounding this deal.

Disclaimer: The information contained in this posting does not, and is not intended to, constitute legal advice or express any opinion to be relied up for legal purposes, investment purposes, or otherwise. If you would like to obtain legal advice relating to the subject matter addressed in this posting, please consult with your attorney. The information in this post is also based upon publicly available information, presents opinions, and does not represent in any way whatsoever the opinions or official positions of the entities or individuals referenced herein or Rothwell Figg.

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Photo of Dan Shores Dan Shores

Dan Shores is a Partner at Rothwell Figg.  Dan is a dedicated patent lawyer and strategist who believes in his clients and the power of their ideas. He focuses on serving biotech, medical device, energy, software, cybersecurity, and other technology-based companies and understands

Dan Shores is a Partner at Rothwell Figg.  Dan is a dedicated patent lawyer and strategist who believes in his clients and the power of their ideas. He focuses on serving biotech, medical device, energy, software, cybersecurity, and other technology-based companies and understands the myriad of challenges that such companies face when breaking through and establishing themselves in their respective markets. Dan works with clients to build robust patent portfolios, protect trade secrets, negotiate strategic collaborations, conduct due diligence and landscape investigations, and prepare for success in funding rounds and exits. An engineer by education, and having extensive experience in transactional, litigation, procurement, and strategic counseling matters for technology-based companies, Dan is a problem-solver who excels at deciphering key translational aspects of a broad array of technologies to maximize leverage in the context of clients’ desired implementation of such technologies whether as participants in dynamic markets or as first movers.

Dan has served companies utilizing the following technologies (without limitation): mRNA therapies; lipid nanoparticle delivery technologies; genetically engineered swine and organs for xenotransplantation; artificial intelligence for drug discovery; CAR-T therapies; oligonucleotide development; pharmaceutical treatment of rhinitis with levocetirizine; pharmaceutical treatment of hepatitis B with telbivudine; genetically-modified cotton seed; fiber-optic probes for tissue investigation; implantable glucose-sensing devices; high throughput genetic seed-chipping technology; cybersecurity threat assessment platforms; interactive media systems for healthcare institutions; artificial intelligence (various applications); identification systems for cable-based medical devices; identification of digital positions of interest on media items; heat-treated glass with multilayer low-emissivity coatings; automotive and agricultural equipment; pressure-sensitive adhesives; three dimensional printing of buildings and other structures; and integrated electronic securities marketplace systems.

Dan is a registered patent attorney licensed to practice before the United States Patent and Trademark Office, and is admitted to practice law in Massachusetts and in the District of Columbia. He is a member of the bars of the Supreme Court of the United States, United States Court of Appeals for the Federal Circuit, and United States District Court for the District of Massachusetts. Dan lives in Boston with his wife Lindsay and their two English Bulldogs Jarves and Rosie.