Developing an Antibody Therapeutic ASAP to Confront the Pandemic
By: Joe Lonsdale
Tags: Co Vid 19, Startup, Pharma, Pandemic, Antibody

Developing an Antibody Therapeutic ASAP to Confront the Pandemic

Swiftscale Biologics is Racing to Scale Up a Treatment for COVID-19 / Looking for Key Hires

The COVID-19 pandemic is a crisis that threatens to overwhelm the healthcare system and cause widespread mortality. The medical and pharmaceutical community must act quickly to develop treatments to prevent the unmitigated spread of this disease. One of the companies created last year in our 8VC build program, SwiftScale Biologics, is working hard to meet this challenge.

SwiftScale was co-founded last year by 8VC’s entrepreneur-in-residence, David Mace, along with professors Matthew DeLisa of Cornell and Michael Jewett of Northwestern who developed the foundational technology. They have developed a cell-free platform to enzymatically modify complex proteins. These modifications lead to proteins that closely resemble those found naturally in humans. With this technology, SwiftScale can produce vital antibody therapeutics at unmatched speed.

To this end, SwiftScale has engaged with Centivax in a promising antibody discovery effort to treat Covid-19. Centivax is a Bay Area biotherapeutics company founded by Dr. Jake Glanville, spun out from his first-in-class antibody discovery company Distributed Bio. Centivax is now rushing to generate potent neutralizing antibodies as therapeutics. Traditional manufacturing processes for these products, which take 9+ months, are too time-consuming to meet the needs of the current outbreak. SwiftScale Biologics has built a process that reduces the time it takes to scale production of these life-saving therapies to a single month. By combining Centivax’s ultra-fast therapeutic engineering with SwiftScale’s ultra-fast manufacturing, we can make a medicine in time for when it is needed most.

SwiftScale is looking for talented people to work with in contract manufacturing to help scale a curative antibody therapy for COVID-19 with the aim of reaching mass production scale before summer. Every day counts and we appreciate your help [more info and contact at bottom of article].

The World Health Organization returned from China with a sobering message to the world on COVID-19: we need to move quickly, or more people will suffer. As WHO Assistant Director General Dr. Aylward put it, “Speed is everything.” He said that more than three weeks ago. Since then, large events and social gatherings have been cancelled across the globe, beginning a new phase of social distancing which will hopefully arrest the virus’ spread. Still, thousands more have died from this disease. In developing needed treatments for this disease, it’s clear that we’re not yet moving fast enough. But the problem is that many of our development technologies aren’t capable of moving at the speed necessary to save lives.

Traditional chemical therapies, for example, take years to develop due to justified concerns about safety. Many drugs bind to both the target (in this case, the virus) and other tissues in the body. There’s a real danger that these drugs will hurt people instead of helping them, and it takes time and resources to make sure this won’t happen.

Vaccines also take too long to develop. As many of us have become painfully aware, a vaccine for COVID-19 is probably more than a year away. That’s in part because vaccines target healthy people. Even if a vaccine’s side effects are relatively small, not every patient who gets a vaccine would have gotten sick without it. Since vaccines are administered to millions of healthy people, the cost-benefit analysis is very different from that of a drug used to treat thousands of sick people. So patients who receive doses of a vaccine usually must be monitored for at least a month afterwards before we can be sure the vaccine works and the benefits outweigh any harmful side effects. A vaccine is no solution to our present crisis.

Antibody therapeutics for infectious diseases have fewer safety challenges, but they traditionally require over a year of screening and scaling up manufacturing before a clinical trial. Unlike traditional chemical therapies, antibodies specifically target the viral protein, so they are less likely to negatively interact with other proteins on healthy human tissue. Unlike vaccines, they are used to treat patients who are already critically ill and in danger of death. Therefore, antibody therapeutics have the potential to prove their worth in much shorter timespans. Unfortunately, these therapies traditionally take 12+ months to develop. Centivax’s computational immune-engineering technologies cut the bioengineering discovery and development time down to under three months.

Typically, even once antibodies are engineered, pharmaceutical companies must spend another 9+ months to optimize the manufacture and scaleup of these therapies. That’s because scientists have to grow huge quantities of cells that produce the antibodies in bathtub-sized vats. Every iteration and every attempt to improve the conditions in which the antibodies grow require a whole new batch. This serial process is incredibly labor-intensive.

SwiftScale Biologics cuts scale-up down to a single month. Instead of growing huge vats of cells, SwiftScale Biologics uses cell-free biology and novel fast-growing cells to produce tens of thousands of pinprick-sized samples at the same time and precisely measure the variable conditions of the samples. SwiftScale’s technology is able to reduce cycle times by two orders of magnitude and find the right conditions for antibody growth in a fraction of the time.

SwiftScale’s platform is built to deal with the present crisis. In the fight against a disease like COVID-19, every day counts. SwiftScale’s team expects to get mass production of the Centivax therapeutic up and running by summer, potentially averting further casualties and diminishing the impact of a resurgence of the virus in the fall (if it proves to be seasonal). With their platform, SwiftScale can bring the Centivax antibody therapeutic to clinical trial scale and quality in just one month. Borrowing from accelerated drug development practices in oncology, Centivax plans to proceed to a Phase I/II clinical trial on 400–600 patients as early as late-July. Given the scale of this pandemic, Centivax expects that recruiting patients for the trial should finish quickly. It will take less than six weeks to complete this Phase I/II trial. The first trial should conclude in early August, assuming timely GMP approval of the SwiftScale process and FDA approval of the Centivax IND.

If the first trial goes well, things will move quickly. As positive data comes in, Centivax will recruit patients for a second Phase II/III trial, while also potentially immediately enabling the drug to be distributed to hundreds of thousands of patients through “compassionate use.” Meanwhile, SwiftScale will continue ramping up manufacturing. The second trial will be structured similarly to the first but will include thousands of patients. Given the pressing nature of this crisis, SwiftScale will also begin partnering with CMOs now to begin manufacturing the drug at scale in mid-June. It will cost between $17m and $22m to start up production with enough capacity to make about 100,000 doses a month for 10 months at an additional marginal cost per dose. As demand for the drug increases, SwiftScale will continue aggressively scaling production. SwiftScale expects drugs to start coming off the manufacturing line in mid-June. Centivax expects that, provided red tape is resolved on the GMP, IND, and trial designs elements and the Phase I/II shows efficacy, a therapeutic could be ready for millions of patients by September. This timeline is ambitious, and unexpected delays are possible. But speed is more important now than ever.