Bildnachweis: Leon Nanodrugs, Sunriseforever – pixabay.
Personalised cancer therapies have long been considered one of medicine’s most promising frontiers. Recent clinical results from Merck and Moderna involving mRNA-based approaches have added fresh momentum. Yet, complex manufacturing processes and high costs remain major barriers to broader adoption. A start-up from Martinsried, near Munich, is providing the technology to produce individualised therapeutics more cost-efficiently.
Pharmatech company Leon Nanodrugs develops manufacturing systems for nanoparticles that can safely encapsulate mRNA-based active ingredients and deliver them into the body. Founded in 2010, the start-up initially explored technologies designed to improve the bioavailability of drugs with low solubility through micro and nano crystallisation. The team later shifted its focus to the production of lipid nanoparticles, the potential of which became widely known through their use in COVID-19 vaccines.
Highly scalable, cost-effective process
‘Our machines enable pharmaceutical companies to manufacture these drugs much more efficiently and cost-effectively,’ says managing director Dr Wolfgang Hofmann. At the heart of Leon’s technology is a specialised mixing chamber in which, using a patented process, RNA or DNA is combined with lipids under precisely controlled conditions. Unlike other approaches, Leon Nanodrugs’ process is highly scalable and allows rapid transition from the lab bench to large-scale clinical production without any costly process transfers, thereby maximising project NPVs and shortening time to market for by up to two years. Leon offers systems for both research and GMP pharmaceutical manufacturing. Hofmann sees particular potential in a device called Nanome. Designed for smaller production volumes, the system is especially well-suited for personalised therapies as well as orphan indications. ‘The Nanome device allows us to reduce the manufacturing cost of a single batch by up to 90%,’ Hofmann says. For Hofmann, the company’s mission brings his career full circle. Early in his career, he researched lentiviral gene therapy vectors at Harvard Medical School. Later, he moved into industry. Following positions at Novartis and the founding of a medical technology start-up, he spent 19 years at Fresenius in management, strategy, M&A, and ventures. In early 2025, he joined Leon Nanodrugs as managing director with a mandate to bring the already advanced technology to market readiness and drive commercialisation.
Enabling personalised mRNA therapies
Securing the necessary funding proved challenging – not only because of the difficult market environment. ‘Most biotech investors don’t want to invest in hardware, but rather in therapeutic approaches,’ Hofmann says. Moreover, he notes that a single-digit million-euro financing round is too small for many of the relevant funds. Nevertheless, the team closed an EUR 8 million round in late 2025. Family offices CD-Venture and Eckenstein-Geigy as well as LBBW Ventures joined forces with other private investors to expand on previous shareholdings by TVM Capital, Evotec, BayBG, and others. ‘Personalised mRNA therapies are now clinically validated, as the Moderna and Merck phase III results show,’ says Dr Frank Mühlenbeck, managing director at LBBW Venture Capital, and continues: ‘The open question is manufacturing: producing an individual batch for every patient-reliably and GMP-compliant. That is where Leon comes in, and why we invested.’
From R&D to serial production
Today, Leon employs 14 people, 13 of them in Munich and one in Boston. Manufacturing is handled by partners in Germany, the research systems are produced near Frankfurt, while the GMP systems are manufactured in Baden-Württemberg. According to Hofmann, working with established medical technology manufacturers also helps Leon gain traction in the highly regulated pharmaceutical market. Nanome is now in serial manufacturing. Industry interest is strong, Hofmann says, although procurement processes at pharmaceutical companies tend to be complex and lengthy. Leon Nanodrugs is currently raising a further EUR 7 million. ‘Lipid and polymer nanoparticles will play a central role in drug delivery in the future,’ Hofmann says. ‘And we have the technology that enables the next big step in manufacturing efficiency.’
