Most pet owners will know from painful experiences that their beloved cats, dogs, and other mammalian pets are susceptible to many diseases that afflict humans, but they lack access to equally effective treatments. So why are IgG (immunoglobulin G) monoclonal antibodies, for example, which form the frontline therapy for many human illnesses, not widely available for our pets?
Lower profits deter developing treatments for pets
As mammals, pets and humans have similar biology underlying many diseases, that, with some adjustments to drug formulations, often enable biological therapeutics to be transferred between species. However, veterinary medicines tend to generate much lower revenues than their human equivalents. A blockbuster human therapeutic medicine can be expected to generate $1 billion annually and potentially much more. In animal medicine, a strong performer has an annual revenue threshold of around $20 million. This lower revenue potential limits investor appetite for developing new products bespoke for this market or even seeking to switch therapies across species, especially when the latter could mean sharing know-how or undermining patent estates.
Monoclonal antibodies are costly
IgG monoclonal antibodies are predominantly made using Chinese Hamster Ovary (CHO) cells, which are expensive for use in manufacturing and have limited scope for cost reductions. These high costs are commercially viable for human therapeutics but less so for the more price-sensitive animal health market, even for thoroughbred horses. With few exceptions, the manufacture of therapeutic biologics for animals fails to make a compelling commercial case for investment.
Patents prevent human treatments from being switched to pets
The patent estates of IgG monoclonal antibody therapeutics also tend to be fiercely guarded by litigious proprietors. This strongly disincentivises the transfer of applications to cats, dogs, and other mammals, especially given that sophisticated patent strategies frequently extend protection for much longer than the standard 20 years. Decades can pass before a biosimilar of an IgG monoclonal antibody (in other words, a generic version of the original medicine) is created for humans. The same is true for veterinary medicine.
New technology offers hope to pet owners
Fortunately, QTL technology applied to special antibody proteins called VHH can bypass these problems, enabling the creation of affordable therapeutics equivalent to monoclonal antibodies for pets, relieving suffering and extending their lives.
VHH are the variable domains of heavy-chain antibodies found in Camelidiae, which include camels, llamas, and alpacas. When designed correctly, VHH can replicate the therapeutic impacts of many IgG monoclonal antibodies. QTL technology, meanwhile, uses the power of evolution through breeding, screening, and the genomic analysis of baker’s yeast to optimise their manufacture. This innovative process enables the production of VHH in ways that were not previously possible, thereby improving manufacturing efficiency and considerably lowering costs.
Veterinary VHH therapeutics can reach the market quickly
VHH do not breach the patents of IgG monoclonal antibodies, clearing them for immediate development. Because QTL technology creates manufacturing solutions in optimised bespoke strains of baker’s yeast, the cost of manufacture is much lower, enabling prices that the pet market can sustain.
QTL technology reduces the cost of batches during the regulatory development process and avoids many uncertainties in establishing whether a suitable therapeutic candidate can be created. For an R&D program, this reduces the risk of delays or unbudgeted escalations in research costs that can quickly make a project unviable, especially when success is $20 million of sales, not $2 billion.
Based on meticulously researched and proven science in human therapeutics, this transformative combination of VHH and QTL technology could herald a new era for the treatment of all our mammalian pets.
