Navigating a pharma or biotech startup company from preclinical proof of concept of some new and potentially useful technology to the stage of running clinical trials is hard at the best of times. To a first approximation, institutional investors, those with deep enough pockets to fund the enormous regulatory costs imposed upon drug manufacture and clinical trials, do not fund new directions, new mechanisms, truly novel therapies. We can debate whether those at fault are more the venture capitalists who run the funds or the limited partners who hold the purse strings, but the end result is a strong aversion to well understood risks – such as anything that is new. Investors like small tweaks on proven existing drugs, which is how we end up with overinvestment in strategies for lowering LDL cholesterol, despite the fact that none of these drugs is capable even in principle of reliably reversing cardiovascular disease.
On top of that, most of the last decade has been a decided gloomy market environment for drug development. Good technologies have fallen to the wayside. The latest to succumb is Covalent Biosciences, developer of catalytic antibodies. They are shutting down, preparing some scientific publications to explain the aspects of their platform and research not already published, and in a few years their patents will expire. Catalytic antibodies are in principle vastly more effective than normal antibodies, as the catalytic antibody can interact with countless target molecules rather than just one. The Covalent Biosciences team sought to apply this technology to transthyretin amyloidosis and Alzheimer’s disease, among other targets.
If we want to speculate as to the reasons why Covalent Biosciences failed to attract the necessary funding to run clinical trials, one might think that it was because they couldn’t have picked a worse period of years to work on transthyretin amyloidosis and Alzheimer’s disease. In the former case, therapies based on stabilizing transthryretin to prevent misfolding emerged to prove effective enough to give investors pause on funding other approaches yet to reach the clinic. In the latter case, amyloid-targeting immunotherapies deployed by large pharmaceutical companies have had their moment of success in recent years, eclipsing any alternative path to amyloid clearance for now.
Secondly, investors care about remaining patent life span, how much is left of the 20 years since the filing date. The high valuation of a drug development company derives from the legal monopoly over its technology given by a patent. Without that high valuation, a company cannot raise the enormous funds required by regulators set up manufacturing and run clinical trials. If a company goes too long without having successfully made the leap to the clinic, then its present and potential future value falters in the eyes of investors. Covalent Biosciences was working with core patents that were already well advanced in years.
One can hope that, once in the public domain, someone will advance the catalytic antibody platform and find uses for it. By the way that the biotech industry works, that will necessarily mean establishing some novel antibody or approach to catalytic antibodies in order to generate novel patents and start the clock ticking once more. Looking at what has happened elsewhere, this might take a decade or more to come to pass – look at how long it took for a company to emerge to pick up work on the DRACO antiviral approach. What we most likely won’t see is a company making use of the existing advances and drug candidates, for the reasons of valuation and funding noted above; off-patent technologies do not attract funding, but still have the same regulatory costs. This is the same reason that generic drugs and supplements are largely ignored by the clinical industry, even if they might be very useful, such as the dasatinib and quercetin combination to clear senescent cells. If you think that there really should be a better way to run medical research and development, well, you are not the only one!
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