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Vol 22, No. 08, August 2018   |   Issue PDF view/purchase
The future of pharma: digital, personalized, and dynamic
Find out how new cancer medicines are being made, starting with dogs. by Andrew Hessel

The pharmaceutical industry, with its roots in traditional remedies, has always had its hits and misses. The application of scientific experimentation and development rigor has made the industry more rational, but plenty of luck is still required. A late-stage drug being advanced by a major pharmaceutical company has just a 20 per cent chance of being approved for clinical use. But synthetic biology may be changing these odds.

Synthetic biology is a fast-growing discipline that makes biological systems easier to engineer. It is genetic engineering done with digital technology. The field is based on DNA synthesis technologies that allows new DNA code to be chemically “printed”, plus advanced computer-aided design software. These combine to make programming living cells similar to programming computer systems.

Synthetic biology is booming. Researchers and developers are in high demand. SynBioBeta, an industry hub based in San Francisco, estimates that USD2 billion will flow towards companies in the field this year. But one area of R&D that has been largely overlooked by scientists and developers alike is the design and construction of viruses. This is surprising given that viruses have very small genomes, typically under 200,000 basepairs of code, making them easy to synthesize, and because they can both cause and cure (as is the case with gene therapies) human disease.

In the past, modifying viruses to study or domesticate them was slow and laborious work. But with DNA synthesis now good enough to write virus genomes in their entirety from scratch, precise virus engineering has become push-button. With genetic design software improving, and new DNA synthesis technologies coming online, we could see the emergence of a viral “app store”, opening the floodgates to new experiments, genetic therapies, and vaccines.

Arguably, the virus app store is overdue. Despite the first synthetic virus, poliovirus, being reported back in 2002, only another two dozen virus species have been made synthetically – or at least reported in scientific journals. This is a miniscule fraction of the millions, if not billions of natural virus species.

Humane Genomics (HGI), incorporated in 2017, is exploring the use of synthetic viruses as personalized cancer therapies. The conventional way of drug-making is to find a chemical or biological agent that works well for a group of people. The problem with this approach is that each instance of cancer is actually a unique disease. Cancer is an infection, only not with a microbe or virus that we have encountered in the world, but with some of our own cells gone rogue. Because we are each unique, our cancers are unique, which means cancer treatments must also be unique. Finding common, “druggable” targets is not just hard to do, it is pointless.

Fully personalized (n=1) therapies make the most sense for cancer. They also eliminate the most expensive and time-consuming part of drug development, the phased clinical trials required to ensure new drugs are safe for the “average” patient. With n=1 therapies, regulators approve the process, not the product. Along these lines, personalized CAR-T therapies won their first FDA approvals in 2017.

HGI is working to create custom virotherapies where viruses or virus-like particles are designed for a single patient. The iterative design-build-test process should work for any cell. Rather than pursue human trials, it starts with companion dogs. Dogs get many of the same cancers that we do, often involving the same genes and mutations. They are less susceptible to placebo effects and dosing irregularities. And because we consider our dogs family members, we want them to get the best care possible, even if this means seeking experimental treatments.

The process always begins with a single dog. A biopsy is obtained – a sample of the dog’s cancer. (A liquid biopsy can also be used, allowing identification of a cancer in the earlies stages). Cancerous and normal cells are then profiled, typically with the expressed RNA, or transcriptome, being sequenced. This information, which tells us which genes differentially turned on or off in the cancer compared to normal cells, is used to computationally design a custom synthetic virus that can specifically infect and cripple the cancer cell. Once validated in the laboratory, the virus is ready for clinical use. Each virus is only used once, on the dog for which it was made.

Personalized drug development could fundamentally change the way new cancer drugs are made. HGI can make a custom virus in a few months for about USD 50,000, while traditional drug development can run in the billions of dollars and take over a decade. Meanwhile, the rapid improvements being made in DNA synthesis, automation, and miniaturization could result in virotherapy development times and costs falling exponentially.

Best of all, every dog treated helps to refine the process for all subsequent treatments. In other words, this way of making medicine is continuously getting smarter and better over time. When dogs start getting better, more affordable cancer detection and treatments than the best human treatments, it should be relatively easy for doctors and regulators to adopt a new approach to cancer treatment.

HGI has chosen to follow in the footsteps of open source software developer Red Hat. This approach also allows the flexibility to use a different business model than the rest of the pharma industry. Being open allows collaboration with both academic and commercial groups while keeping legal costs under control. Instead of chasing blockbuster drugs with USD 1 billion in annual sales, HGI seek to become the “Netflix” of the pharma world, offering everyone personalized cancer drugs for a low monthly subscription. The success of Netflix versus the traditional studios should be inspiring to anyone seeking to create next-generation pharma.

If successful, the gaps between research, development, and the clinic will become closer and cancer will become a manageable disease, like most other infections. Not only is this more humane, solving cancer will free up an enormous amount of financial and intellectual resources towards curing other, more complicated diseases. This is a better future not just for the pharmaceutical industry, but for all humanity.

Andrew Hessel is the CEO of Humane Genomics Inc., a seed-stage company developing virus-based therapies for cancer, starting with dogs. He is a co-founder of the Genome Project-write, the international scientific effort working to engineer large genomes, including the human genome. His goal is to help people better understand and use living systems to meet the needs of society.

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