The Silicon Review
Drug development is the process of bringing a new drug molecule into clinical practice. In its broadest definition, this encompasses all steps from the basic research process of finding a suitable molecular target to supporting the commercial launch of the drug. Drug development comprises all the activities involved in transforming a compound from drug candidate (the end-product of the discovery phase) to a product approved for marketing by the appropriate regulatory authorities. Development accounts for about two-thirds of the total R&D costs. The cost per project is very much higher in the development phase and increases sharply as the project moves into the later stages of clinical development. Speed in development is an important factor in determining sales revenue, as time spent in development detracts from the patent protection period once the drug goes to market. As soon as the patent expires, generic competition sharply reduces sales revenue.
Lumen Bioscience is one such firm that is rethinking drug development from the ground up to emphasize speed, efficiency, ease of delivery, and whose approach is so innovative that traditional ways of thinking about IP and regulatory pathways. Lumen believes biologic drugs offer the fastest, safest, and most effective way to treat many prevalent diseases that traditional BioPharma tools have failed to solve. These cures are especially well suited to addressing the unintended consequences of antibiotics and the developing world. A lack of infrastructure makes traditional drugs unavailable to millions of vulnerable children and adults.
Offering a high-dose biologic drug regularly
Researchers worldwide have long suspected that spirulina would be a valuable tool for making biologic drugs if only it could be engineered, but these efforts failed for decades. Lumen was the ﬁrst to achieve this breakthrough, which in turn makes orally delivered biologics commercially viable for the first time. The firm designs and manufactures therapeutics against disease targets that have been inaccessible to the biopharmaceutical industry because of the astonishingly high cost of traditional methods. For the first time, Lumen can make antibodies and other biologics at a cost that allows for daily, high-dose, oral and topical delivery.
Its current programs target enormous markets, the treatment modes of action are well researched, and the unmet medical need is obvious. Being extraordinarily high in soluble protein, spirulina cells can express far more elevated amounts of therapeutic proteins than any other food crop (>60%). A gene encoding the therapeutic molecule (for example, an antibody) is introduced into the spirulina chromosome. When that spirulina strain is grown, the cell manufactures the therapeutic protein and stores it away inside the cells and tissues.
Moving fast to save millions of lives
In the traditional drug development world, it is common for companies to spend many years and huge sums of money developing extraordinarily expensive drugs intended to help relatively small groups of patients. Lumen focuses on the rapid development of biologic medications that will help hundreds of millions of people at costs far lower than previously thought possible.
Patented technology with unlimited potential
The astonishingly high cost of traditional drug development meant that using orally delivered biologics to address therapeutic targets in the GI tract and other topical sites wasn't commercially viable. That's no longer true. Lumen's patented biologic drug platform shortens the development process, reduces costs and risks, and accelerates time-to-market, making us the first company to make orally delivered antibody drugs commercially viable. The firm is creating its portfolio of commercially viable biologic therapies while establishing a foundation upon which an entirely new generation of scientific discoveries and therapies will be brought to market.
The passionate leader behind the triumph of Lumen Bioscience
Brian Finrow is the Co-Founder and Chief Executive Officer of Lumen Bioscience. He brings the skills and experience of a lawyer to a position that, in the biotech world, is more typically occupied by a scientist. Prior to co-founding Lumen, Brian oversaw complex negotiations with various major biopharma companies and managed IP strategy for Adaptive Biotechnologies, where he was Senior Vice President and General Counsel. As Senior Attorney at the law firm Cooley LLC, his practice focused on equity financing and M&A transactions and negotiating complex biotech licensing and collaboration deals. With over 15 years of legal and commercial experience at these market-leading, innovative firms, he is well-positioned to develop creative, win-win deal structures with other organizations.