For years, researchers have striven to repair, restore, even replace diseased tissue or organs through therapies based on regenerated cells. Such therapies pose challenges ranging from manufacturing, to avoiding rejection in patients, in addition to standard safety and efficacy challenges.
Four years ago, a research team published a study in Science Translational Medicine showing success for a possible approach: they fabricated human artificial liver “seeds” in biomaterials that grew and expanded following implantation into mice whose livers were injured. After growing, those liver seeds demonstrated the ability to carry out normal liver functions, such as production of human proteins like transferrin and albumin.
“We and others are pursuing the development of a therapeutic ‘satellite liver’ that could be implanted in an ectopic location in a patient and provide functional support to the failing liver,” explained the team, led by Sangeeta Bhatia, MD, PhD, director of MIT’s Center for Nanomedicine, and Christopher S. Chen, MD, director of Boston University’s Biological Design Center.
Now, a company that holds an exclusive license to technology developed in the labs of Bhatia and Chen—Satellite Bio—is poised to commercialize their method of treating numerous disorders by replacing organ and tissue systems that break down during disease progression through a combination of tissue biology and bioengineering. Satellite hails the approach as “tissue therapeutics”—and the next frontier in regenerative medicine.
Satellite Bio recently emerged from stealth mode following two years in which it raised a combined $110 million in financing, consisting of a $19 million seed round completed in November 2020, followed by a $91 million Series A financing completed in April. The company will use its latest financing to establish a manufacturing platform, grow staff, and develop its pipeline of tissue therapeutics. Satellite Bio plans to advance its first product into the clinic over the next two years.
“Our first approach is actually based on liver conditions. The primary cell we’re using in our product is a hepatocyte, and we’re thinking about how to utilize that against a range of liver conditions,” Satellite Bio CEO Dave Lennon, PhD, told GEN Edge.
“The interesting thing is this [the company’s therapies] can treat rare diseases or can treat more common diseases that affect millions of patients. So, we’re thinking about things like metabolic disease, severe obesity, chronic liver disease, even potentially neurodegeneration as target areas for us to address with our tissue therapeutics approach,” Lennon said.
Programming and assembling
Satellite Bio’s tissue therapeutics approach begins by programming cells and assembling them into “satellites,” within thin sheets of implantable tissue designed for introduction into patients via minimally invasive surgery to restore, repair, or replace dysfunctional or diseased tissue or organs.
These satellites are the core of the company’s Satellite Adaptive Tissue (SAT) platform, which is designed for use with virtually any type of cell—including primary, induced pluripotent stem cell (iPSC)-derived or engineered cells—and can be deployed across a variety of clinical applications. The SAT platform uses endocrine and paracrine cells capable of secreting proteins.
“We use multiple cell types—usually a primary functional cell and a support cell that we aggregate into tissue seeds. Those tissue seeds are then embedded in a pro-engraftment biomaterial or pro-engraftment matrix that we can engineer into an implant,” Lennon explained.
“We imagine them as about credit card sized implants, but we can make them anywhere from the size of the tip of your finger to much bigger formats,” up to the size of a human hand, he added.
According to Satellite Bio, the SAT platform has advantages over organ-based approaches, cell encapsulation methods, and solid organ infused cell therapy, including engraftment and vascularization; viability and full repertoire of cell function in vivo; persistence and durability; and platform versatility.
“Once they’re in a patient, they engraft and vascularize, so they develop new blood vessels that grow into the graft itself and support those functional cells to accomplish their task, whether that’s to compensate for last function or to help prepare an existing tissue. Then they’re active and doing their job.”
Satellite Bio asserts that its SAT platform is broad enough to allow for partnering with larger biopharmas.
“The beauty of this platform is that it’s really a scaffold for any company that has a cell that they think can deliver therapeutic benefits to leverage,” said Laura Lande-Diner, PhD, Satellite Bio’s chief business officer. “We see us as being placed at the center of many different cell therapies. So, the natural partners or one type of natural partner could be companies that are developing cells of therapeutic value that will require a delivery vehicle that enables engraftment and vascularization.”
Additional partnerships are expected as Satellite Bio further develops operations that include material design, aggregation, and manufacturing, according to Lande-Diner.
“There are a number of elusive diseases that trigger organ failure that are very prevalent in the population. Those range from chronic diseases to acute diseases and they affect adults and children and there they have varying etiologies. But the common element is that there are multiple pathways that are dysfunctional and therefore require a sophisticated solution, as a cell or a tissue therapeutic can be,” she said.
Value creation opportunity
Added Lennon: “I think that’s going to generate a lot of excitement amongst the patient community, and a lot of opportunity to create real value for the healthcare system by introducing novel and innovative therapeutics that can make a real difference.”
“We’re making one of the more complicated products out there. We have multiple cell types, we have biomaterials, we’re doing this in an implant, and we’re creating a living tissue that we have to get to patients quickly.”
Those components, and the resulting complexity of manufacturing, offer opportunities for partnering in multiple steps of Satellite Bio’s production process, he explained.
“We really think our strategy is a mosaic approach. Where we have capabilities already developed in the industry and with partners, we will utilize those for our GMP manufacturing. What’s core to Satellite is our understanding of how to put those tissue seeds together, and embed them into the biomaterial, and package those for patient treatment,” Lennon said. “That’s the part of the process we will own.”
Satellite Bio is among several companies focused on developing therapeutics through a variety of tissue engineering technologies. Tissue engineering is projected to grow globally to $67.3 billion by 2026 from $24.1 billion in 2020—a compound annual growth rate of 18.7%, according to 360 Research Reports.
The field made headlines earlier this month, when 3DBio Therapeutics of Long Island City, NY, joined the Microtia-Congenital Ear Deformity Institute to announce that they had carried out a human ear reconstruction using 3DBio’s AuriNovo™ implant, a patient-matched, 3D-bioprinted living tissue ear implant. The procedure occurred during a Phase I/IIa clinical trial (NCT04399239) assessing the safety and preliminary efficacy of AuriNovo for patients with microtia, a rare congenital deformity where one or both outer ears are absent or underdeveloped.
In April, Vancouver, BC-based Aspect Biosystems launched a partnership with the Juvenile Diabetes Research Foundation to develop a bioengineered tissue therapeutic for type 1 diabetes, designed to provide insulin independence and control of blood sugar without the need for chronic immune suppression. The therapeutic will apply Aspect’s bioprinting technology, therapeutic cells, and materials science know-how.
Another company, Tucson, AZ-based Avery Therapeutics, has developed a tissue engineered graft (MyCardia™) for treatment of chronic heart failure consisting of a viable cardiac matrix of cardiomyocytes and fibroblasts manufacturable at scale, cryopreserved, and shipped at 4C. In June 2021, Avery executives met with FDA officials in a pre-IND meeting.
And last year, Durham, NC-based Humacyte, a developer of universally implantable bioengineered human tissue at commercial scale via its human acellular vessels technology, went public through a special purpose acquisition company (SPAC) reverse merger.
“We still plan on filing our first biologics licensing application (BLA) for the trauma indication late in 2022, maybe early 2023. We hope to file a BLA amendment later in 2023, once we have one-year results from our dialysis access trial,” Humacyte founder, president, and CEO Laura Niklason, MD, PhD, told GEN Edge earlier this year. “We would hope to be on the market by 2023 with our first indication.”
Differentiating approach
Lennon said Satellite Bio aims to stand out from competitors by thinking of itself as a developer of therapeutics rather than of regenerative medicine technologies.
“We’re not trying to grow organs in a dish. We’re not trying to replicate those kinds of engineering approaches,” Lennon said. “What we’re using engineering for is the application of cells as therapeutic approaches. We think this SAT platform allows us to construct therapeutics that can be implantable and allow for solid organ cells to become therapeutics.”
“Up to this point, there’s been a lot of promise in this field, but there’s been no way to actually materialize this,” Lennon added. “We think our approach and our delivery of the platform we’ve created actually is differentiating and will enable a whole series of cells to become therapeutic opportunities.”
Based in Cambridge, MA, Satellite Bio was founded in 2020 by Bhatia, who holds an observer seat on the board; Chen; and Arnav Chhabra, PhD, Satellite Bio Platform R&D head, a former graduate student under Bhatia. They built on work by researchers that included MIT’s Robert Langer, ScD, who a decade ago published a landmark analysis of the tissue engineering industry in Tissue Engineering Part B: Reviews (published by GEN publisher Mary Ann Liebert Inc.). Back then, GEN reported, the industry generated $3.5 billion in revenues and was beginning to attain profitability.
In July 2021, Lennon became Satellite Bio’s CEO following 15 years at Novartis, most recently serving as president, Novartis Gene Therapies, where he oversaw the approval and launch of Zolgensma, an adeno-associated virus (AAV)-based gene therapy that has been approved in more than 40 countries to treat spinal muscular atrophy—but which has gained almost as much public attention for its $2.1 million list price.
Lennon also led the expansion of Novartis’s gene therapy research and manufacturing footprint to more than 2,000 associates working at five sites.
Shortly after joining Satellite Bio, Lennon began work to raise the Series A round. The Series A was led by the Growth Fund of aMoon, a global healthtech and life sciences investment fund based in Israel. Also participating in the Series A were aMoon Growth’s co-lead for the seed stage, Lightspeed Venture Partners; another aMoon fund, aMoon Velocity; as well as Polaris Partners and its Polaris Innovation Fund. Joining them were new Series A investors that included Section 32, Catalio Capital Management, and Waterman Ventures.
The Series A round took about six months to raise, starting around October 2021, with Satellite Bio closing on the financing in March. During that time, the financial markets soured on biotech investment—though not Satellite’s investors.
“We saw the changing dynamics in some of the marketplace, but our core investor group came out of the seed round. We added a few new folks to our Series A. But overall, it’s a group that’s firmly committed to the future of Satellite Bio,” Lennon said.