The financing round was led by returning investor ARCH Venture Partners.
California’s Nutcracker has developed an RNA manufacturing platform, which combines RNA biochemistry with microfluidic engineering, semiconductor-like biochips, and a proprietary nanoparticle delivery technology to create a fully automated and isolated manufacturing pathway.
With a platform capable of supporting RNA therapeutic development from discovery to clinic and commercialization, the company believes it is the first to offer such end-to-end tech.
It also champions the speed, scale and agility at which therapeutics can be developed and manufactured.
In development, for example, the system promises rapid and efficient selection of candidates. From a manufacturing perspective, the system can deliver mRNA therapies for any composition in an exact, repeatable and easily scalable and deployable process.
While mRNA tech has been brought to fame by the success of mRNA COVID-19 vaccines, the manufacture of RNA-based therapeutics with sufficient speed and scalability is an ongoing challenge for the field, explains Geoff Nosrati, chief business officer at the company.
“Nutcracker has approached this problem by viewing it as a combined biochemical and engineering challenge,” he told this publication.
“We have taken the three major steps of RNA drug manufacturing – amplifying a DNA template, transcribing (converting) it into RNA in vitro, and then packaging that RNA into a proprietary nanoparticle – and miniaturized them onto biochips with their own enclosed microfluidics pathway. With this, we now have a single machine, the Nutcracker Manufacturing Unit (NMU), that uses these biochips to execute the entire manufacturing process to produce GMP drug products, which we can scale up easily by bringing more NMUs online.”
Furthermore, the company says its tech’s end-to-end capabilities set it apart from other manufacturing methods.
“Starting from a target or a protein sequence, we can design and optimize the RNA drug substance, identify the optimal delivery approach from our extensive library of Nutshell nanoparticle delivery vehicles, and manufacture the drug substance and drug product using our Nutcracker Manufacturing Units. The ability to move rapidly from sequence-to-clinic and to scale manufacturing on-demand is also a key feature of our platform.
“To our knowledge, no other company has this kind of end-to-end capability. The flexibility and automation of the NMU itself is also unique to Nutcracker.”
Building the company
With the funding milestone, the next phase of Nutcracker’s evolution can begin, adds Nosrati.
“Nutcracker will be making targeted investments in equipment to support both the development of our platform as well as our therapeutic pipeline,” he said. “Additionally, while our core team is largely in place, we are still looking to add key team members as we move towards the clinic.
“Our platform was developed to facilitate RNA therapeutics development, and our expansion into therapeutics is part of the company’s long-term plan. We started this with our Series B financing and this Series C will only strengthen our vision. Besides covering typical drug discovery and development expenses, we also want to grow our medical team to support our therapeutics strategy.”
The company, which was founded in 2018, plans to initially focus on mRNA therapeutics for oncology (it has not yet announced any specific indications) but says the platform will ultimately enable the development and manufacturing of all RNA therapeutics.
“The recent success of the mRNA vaccines for COVID-19 has brought newfound energy around the use of RNA as a therapeutic tool,” said Igor Khandros, Ph.D., co-founder, and CEO of Nutcracker Therapeutics. “As a consequence, we have an unparalleled opportunity to bring this emerging class of medicines to treat patients suffering from very complex diseases.”
Meanwhile, Nutcracker has added Michael F. Bigham, former CEO and current executive chairman of the board of Paratek Pharmaceuticals, to its board of directors.
Bigham has more than 30 years of leadership experience in the biopharmaceutical and life science industries, including as a general partner at Abingworth LLP, President and CEO of Coulter Pharmaceuticals, and in various roles at Gilead Sciences, such as CFO and executive vice president operations.