Despite hitting a speed bump over the summer, automated cell therapy manufacturing specialist Cellares has continued to sign new partners at a steady pace, now inking a second agreement with an Asia-based organization in just over a week.
The latest tie-up will see Cellares, which positions itself as an integrated development and manufacturing organization (IDMO), link arms with Seoul National University Hospital (SNUH) in South Korea.
Under the accord, for which financial details were not disclosed, the partners will assess whether SNUH’s gene-modified hematopoietic stem and progenitor cell (HSPC) manufacturing process can be translated to the Cell Shuttle, Cellares’ automated platform for cell therapy production.
In particular, SNUH, a translational medical center in South Korea’s capital, will assess the tech on an investigational cell therapy targeting paroxysmal nocturnal hemoglobinuria (PNH).
The production trial will incorporate a two-step transfection workflow using the integrated electroporator in Cellares’ Cell Shuttle configuration, CEO and co-founder Fabian Gerlinghaus said in an interview.
Electroporation uses electrical pulses to temporarily create openings in cell membranes, while transfection refers to the process of introducing genetic material or other substances into cells.
In Cellares’ setup, the company’s electroporator is integrated into a single-use cartridge, automating multiple steps in the manufacturing process. The cartridge moves through the Cell Shuttle, which Gerlinghaus has previously referred to as “basically a lab in a box.”
In testing SNUH’s manufacturing process on the Cell Shuttle, the partners are aiming to establish an automated production strategy that could underpin future U.S. clinical development of the Korean hospital’s PNH candidate, the Cellares CEO said.
Meanwhile, the emphasis on transfection and electroporation echoes the deal Cellares struck with Taiwan’s GenomeFrontier Therapeutics last week, with Gerlinghaus noting that both outfits’ non-viral cell therapy programs “require sophisticated electroporation workflows, which is, I’d say, one of the key areas where the cell shuttle is strongly differentiated in terms of capabilities.”
The Cell Shuttle, according to the Cellares helmsman, “is the only end-to-end cell therapy manufacturing platform that has onboard electroporation abilities and is proven in the clinic,” highlighting his company’s first-in-patient dosing milestone earlier this year as a “proof point.”
That dosing milestone with partner Cabaletta Bio in April has also had the added benefit of helping more than double Cellares’ customer base since the start of the year, Gerlinghaus said.
As Cellares builds up its roster of partners, the IDMO’s ultimate commercial manufacturing trajectory will likely be a “numbers game,” Gerlinghaus said.
While “not everyone is going to cross the finish line,” Gerlinghaus noted that Cellares has “signed a dozen customers this year.”
“We expect to keep going at this rate,” he continued, “and build a really sizeable portfolio of cell therapy companies on our platform and ultimately get a handful of drugs across the finish line to commercial manufacturing.”
The CEO espoused that continued confidence as Cellares comes off a setback over the summer, when the loss of a “large pharmaceutical customer” prompted a series of layoffs in California and New Jersey.
The partner was ultimately revealed to be Bristol Myers Squibb, which inked a deal in 2024 for Cell Shuttle capacity that was worth up to $380 million at the time.
But “BMS was only one customer out of many,” Gerlinghaus said, noting that the pharma has subsequently “made some public statements that we have publicly disagreed with strongly.”
“Specifically,” the CEO said his company disputes “the BMS characterization that the Cell Shuttle could not meet the requirements for commercial Breyanzi manufacturing,” referring to the pharma’s approved CAR-T therapy.
BMS has said its determination was specific to Breyanzi and its existing regulatory-approved manufacturing process, rather than a broader assessment of the Cell Shuttle platform.
Gerlinghaus stressed, citing the company’s own comments, that BMS’ determination was specific to that CAR-T cell therapy.
Moreover, the BMS program “ended before we generated comparability data that was sent to the FDA, so the FDA actually never made a comparability determination on Breyanzi,” Gerlinghaus explained. “Ultimately, BMS terminated the partnership before we could complete the work.”
Still, Cellares doesn’t appear to be letting the situation rattle its confidence.
In terms of the company’s overall trajectory moving forward, “the strategy really remains unchanged,” Gerlinghaus said.