March 1, 2017 (Vol. 37, No. 5)
Orig3n Collects Blood Samples, Secures Uniform Consent, and Maintains Diverse iPSC Holdings
Orig3n has industrialized the collection of blood to develop the world’s largest uniformly consented biorepository of induced pluripotent stem cells (iPSCs). These cells can be used for research or commercial purposes, free of the sorts of restrictions that often complicate the use of donated tissues. This emphasis on availability enhances the value of the cells as they progress from research through scale-up and commercialization.
As Robin Y. Smith, CEO of Orig3n, elaborates, “We found that consent forms from medical centers or universities often specified the use of donated cells for research only. Sometimes they were further restricted to specific diseases, programs, or investigators. Our approach gives broad availability to all investigators interested in looking at that sample.”
Orig3n calls its biorepository LifeCapsule. According to the company’s website, LifeCapsule constitutes “a living database of humanity.”
“With LifeCapsule,” says Smith, “we can build a sustainable bank of off-the-shelf cells for regenerative medicine, work with our partners, or develop our own in-house programs for cardiac analysis, diagnostics, and therapeutics.”
To collect blood samples, Orig3n goes directly to consumers. “We see them at marathons, sporting events, Comic-Cons, and other events,” explains Smith, “and we ask them to donate a bit of their blood.” In 2016, the company collected blood in 225 cities and processed up to 1,000 samples per day. Up to 300 phlebotomists may work special events on Orig3n’s behalf.
Orig3n also works with the National Parkinson’s Foundation, collecting samples from attendees at “Moving Days”—when Parkinson’s patients, families, and friends get together for tai chi exercise, walking, ballroom dancing, and similar events. “Because we draw blood from patients and nonafflicted family members, including children and parents, we have access to interesting cohorts that no one else can pull together,” Smith notes. “That’s a real asset.”
Orig3n also obtains samples from Tanzania. To do so, it digs clean water wells in a city and staffs the wells with a nurse who performs medical checkups and treatments, and asks if people would like to participate in the cell repository.
This approach promotes the greater good by supplying clean water to improve health, and by increasing the genetic diversity of blood samples for researchers and developers. Often, Smith elaborates, cell banks are very homogenous. This lack of diversity sometimes causes clinical trials to fail when they are expanded to larger populations.
Orig3n is producing cardiomyocytes and neurons from the iPSCs it produces from blood. The cardiomyocytes are 90% troponin T-positive and are reproducible. They are shipped live, and can survive five days in transit.
The company also is developing in-house programs to move its cardiomyocytes into the clinic. It also is contemplating a neurologic program, possibly with partners.
“This is low-hanging fruit,” Smith remarks. “Also, we have a lot of samples from which to build a platform.
“After performing a human leukocyte antigen (HLA) haplotype matching program from the cell bank, we found that it contained what are called superdonors—cells than can be used for treatments to multiple recipients without rejection. By looking at the HLA haplotypes, we found enough superdonors to cover 90% of the population in the United States.”
Orig3n, therefore, plans to scale up these cells. Manufacturing is expected to begin during the first half of 2017, and preclinical safety testing should commence by the end of 2017.
To help underwrite its research and de-risk the company for investors, Orig3n also has developed some direct-to-consumer products. Under the LifeProfile banner, it provides profiles of 6–24 genes for $29–149. Several profile types are available. Fuel assesses nutrition; Aura, skin health; and FitCode, fitness. And Superhero tests for, well, superhero attributes (intelligence, strength, and speed).
“The market pulled us into these products,” Smith says. “LifeProfile is a way to expose people to genetics that isn’t scary. It’s fun. This is an incredibly fast-growing business.”
Another consumer product gives blood donors perennial access to their immortalized iPSCs and information about how their samples are helping advance therapeutics. It is priced at $99 per year.
A Company of Entrepreneurs
Smith and his senior staff have a history as serial entrepreneurs. Smith founded three previous companies and was global head of R&D for PerkinElmer. Michael Fang, M.D., is Orig3n’s CMO. Dr. Fang founded two previous companies, one of which, CETA, was ranked #297 of Inc. Magazine’s list of the 5,000 fastest-growing private companies in the U.S. Other senior staff have held high-level positions in academia (such as helping direct the Harvard NeuroDiscovery Center’s Laboratory for Drug Discovery in Neurodegeneration) and business (such as helping market Apple’s iPhone and iPad).
While the acquisitions of Smith’s previous companies netted strong returns for investors, he has different plans in mind for Orig3n. “It’s not necessary for us to prove we can build another successful company,” he says. “Instead, we want to make a societal impact.”
Improving the healthcare system has the potential for one of the greatest impacts possible. Despite advances in genomics, physicians are still practicing trial-and-error medicine, Smith observes. Therefore, he and his team identified the most disruptive, innovative things they could do, and decided to apply their experience to an intractable problem.
“We’re not looking for an exit,” Smith insists. “We’re looking to develop regenerative products.”
Location: 27 Drydock Avenue, 6th Floor, Boston, MA 02210
Phone: (800) 316-7301
Principal: Robin Y. Smith, CEO
Number of Employees: 37
Focus: Orig3n maintains a uniformly consented repository of induced pluripotent stem cells. The company’s offerings include LifeCapsule (biorepository membership), LifeProfile (personalized genetic analysis), and LifeSystems (cellular models for researchers).