Flagship’s Sigilon grabs $80M to bring Robert Langer cell therapy tech into the clinic
Rogerio Vivaldi had never given much thought to industry.
A newly minted MD, he was working at a hospital in Rio De Janeiro when one of his professors asked if he might take on a case that required consistent follow-up: A 14-year-old boy with Gaucher’s, a rare genetic disorder that meant he was missing a key enzyme often called the cell’s recycling system. He had come in with enlarged organs and stunted growth.
But the parents were interested in trying a new treatment introduced that year, 1991, from Genzyme, one of the first major rare disease biotechs. It would replace the missing enzyme with a recombinant form. Vivaldi took the case. The boy recovered. He’s now 41, Vivaldi said, with two kids.
“Usually, I describe that moment as transforming the patient’s life,” Vivaldi told Endpoints News. “What people don’t realize is that moment also changed my life. I had no thought of going into biotech. I was a clinician.”
Vivaldi, though, would soon take a job at Genzyme and then a series of biotech C-suites before Flagship tapped him 2 years ago to lead one of its newer biotechs: Sigilon Therapeutics. And today, he’s helping pivot the company toward the clinic for the first of several chronic illnesses, announcing an $80.3 million Series B financing that will help push their lead drug into human testing.
“It’s kind of the physician experience with the patient experience: What should we do — as a new class of medicines — to really bring a functional cure for patients with chronic diseases?” Vivaldi said, citing his work with enzyme therapy and his own experience with type 1 diabetes.
Sigilon’s platform comes out of work from Robert Langer’s and Daniel Anderson’s labs at MIT and several grants from the Juvenile Diabetes Research Foundation. For years, biotech and academic researchers have known that a form of cell therapy known as islet cell transplant could offer a potential functional cure to diabetes, allowing a patient’s pancreas to once again pump out proper doses of insulin.
The problem, Vivaldi said, is that the body’s immune system tends to attack these new cells, covering it in fibrotic scar tissue and rendering it non-functional. The few hundred patients to receive the transplant in the last 20 years have had to take extensive doses of immuno-suppressives. One way researchers long theorized you could avoid these issues was by encapsulating the cells in polymers — like microscopic space suits. In 2016, Langer and Anderson made it work, at least in the lab, and launched Sigilon with Flagship.
“It creates a sphere or capsule where you could put many cells — between 25 and 45,000 cells in one single 1.5 milligram diameter,” Vivaldi said. “We create a space where the cells can be producing whatever we engineer the cells to produce.”
In 2018, Eli Lilly signed on to Sigilon’s diabetes program for $63 million upfront and $410 million in milestones. Sigilon insists, though, that the platform is much broader. The first clinical indication will come later this year in hemophilia A because, Vivaldi said, it’s easier to see they are getting activity in the blood rather than tissue. Beyond that, there are programs in hemophilia B and even a pair of lysosomal disorders — the same category as Gaucher’s — that have not proven as susceptible to enzyme replacement therapy.
They won’t be alone in competing on any of those indications. Other companies, such as Viacyte, are using other methods to get islet transplants to work, including by using pluripotent stem cells. And gene therapy is in early development for hemophilia, lysosomal disorders and even diabetes. Vivaldi, though, said they can use their therapy in far more patients. Some patients can’t get AAV, the vector used in most gene therapies, he noted, and gene therapy is generally for patients with more dire prognoses, as opposed to relatively healthy ones.
“The legitimacy of our technology is much broader,” Vivaldi said.