Stealth CDMO Reveals Secrets Of The Cell-Therapy Industry
By Louis Garguilo, Chief Editor, Outsourced Pharma
For months, kept under stealth mode was an emerging cell-therapy company’s plans to spin out its development and manufacturing facility as a CDMO.
No, not a stealth biotech. A stealth CDMO. And yes, the emerging biotech had its own cGMP production plant.
Now that’s been revealed, we further learn this is the third iteration of this production facility, located in Gainesville, Florida, and it had started out as part of a CDMO.
All this presents us a unique view into the variable cell (and gene) therapy industry.
- Matthias Schroff, the new CEO of Inceptor Bio, the cell-therapy biotech from whence the CDMO (re-)emerged
- Bruce Thompson, the new CEO of Kincell Bio, the recently unsheathed, cell-therapy-focused CDMO
- Shailesh Maingi, the guiding investor, founder & chair of Kineticos Ventures, who is also on the board of both the biotech and the service provider, and who is the engine behind this reordering of facilities and strategies
- Frank Lis, new President & CEO of Kineticos, an experienced industry professional and key figure in the emergence of Catalent
Where to start? Let’s go to the biotech first.
What Just Happened?
Inceptor Bio is based in Morrisville, North Carolina, just outside of Raleigh. When Schroff joined as CEO in May (2023), the decision to carve out the company’s Florida development and manufacturing facility had been made and was in progress.
That cGMP facility had begun life as a component of the CDMO Arranta Bio (now part of Recipharm). Inceptor acquired and integrated the facility in October of 2021.
At the time, Inceptor said it would “transfer a core operating team to establish cell-therapy processes and supply for Inceptor Bio's clinical trials,” and Inceptor’s Advanced Manufacturing Platform (AMP+) would be used to create “a state-of-the-art cell-and-gene therapy GMP facility.”
But just two years later, Inceptor was spinning the facility out to again join the ranks of CDMOs, begging the questions:
- What happened in those interim years that drove Inceptor to this second decision? Why would a start-up biotech put itself through this? Was it some kind of strategic malfeasance?
- Why didn’t Inceptor start out working with external partners in the first place, like most all CGT start-ups?
- What about the workers? Those still at the facility must be experiencing career whiplash.
- And finally: Will the “new” CDMO thrive?
We’ll have all these questions answered in the by-and-by, particularly on the “strategy” side when we speak with the architect of all this, Shailesh Maingi.
But for now, Schroff lays down some track for us.
The Gainesville facility was purchased and integrated to assist in bringing Inceptor’s CAR T program into the clinic. However, a subsequent, strategic scientific decision curtailed those plans.
Inceptor decided to jettison that CAR T program. Instead, it would put its energies into a CAR M program – one further away from the clinic, and thus in no immediate need of a manufacturing facility.
“Actually, that’s why I joined Inceptor,” says Schroff. “I’m more from the development world, and my goal has been to bring a CAR M program into the clinic.”
“It’s nice to have manufacturing capabilities in-house, but it requires a high cost to maintain,” he explains.
“When there was the strategic shift from the CAR T program to the CAR M program, which was further back in development, the realization was we would be maintaining a facility and all the employees without utilizing them for the foreseeable future.”
At the same time, the interest by other emerging cell-therapy companies in accessing an experienced CDMO was also running high.
“Believe me,” says Schroff, “we aren’t the only small biotech with cell-based therapeutics that needs a CDMO, particularly one that will produce phase one clinical-trial material.”
Inceptor at least considered running Gainesville as its own CDMO – a biotech with a CDMO for other biotechs. Not farfetched in today’s world.
But there were concerns. Not least of which, says Schroff, “is the challenge with avoiding any real or perceived conflicts of interest if we owned the CDMO.”
On the other, positive side, Inceptor could eat its cake and have it, too. The company will continue to work with the Florida facility – now as a sponsor utilizing a “separate” but familiar CDMO.
Close-Knit Independence
“It made the most sense to have Kincell as independent, and we are happy to have them as a partner,” Schroff iterates. “
“We know they have the expertise and what they are capable of – they were literally part of our team. We kept internal our employees who are experts in drug development, where we will focus. Together, Inceptor and Kincell will move forward.”
Kincell for its part moves forward with $36 million in funding from Kineticos Ventures. Inceptor does maintain a percentage of ownership in Kincell, and the two shares board members.
That remaining connection does not influence the sponsor-provider partnership, Schroff avers. “Kincell needs new customers to thrive. They have to treat everyone equally.”
Kincell in fact is gearing up to produce initial clinical-trial material for Schroff. Intercept is also utilizing internal research facilities in North Carolina, and working with CRO partners to “establish the process of making these special CAR M cells, performing clinical-candidate characterization, enabling studies, all with the target of an IND filing the end of 2024.”
“Once we have defined the manufacturing process at a certain scale, we need to transfer all the knowledge to Kincell,” says Schroff.
In the meantime for Kincell there’s a growing cell-therapy start-up market to go after.
We often hear – and experience – just how fluid the cell (and gene) therapy ecosystem is. That sentiment is often directed at the roles CROs, CDMOs, and other service partners are playing.
Inceptor the biotech, Kincell the CDMO, and Kineticos Ventures funding the companies, display an interesting mosaic for us.
There’s plenty more to see here and learn from.