It still feels as if the use of cell therapy is a fresh innovation, but inertia is the enemy of progress, and next-gen approaches are already here.
One biotech among a growing pack is the newly uncloaked Clade Therapeutics, which has brought in an impressive $87 million initial funding round led by Syncona with help from LifeSci Venture Partners, Emerson Collective and Bristol Myers Squibb.
These backers are getting behind the Cambridge, Massachusetts-based biotech’s so-called off-the-shelf, next-generation stem-cell-based medicines that they hope to deliver on a wider scale.
Current cell therapies are typically uses a patient’s own T cells, but an allogenic or off-the-shelf type of cellular immunotherapy involves using T cells from donors' circulating blood or sometimes umbilical cord blood.
But removing T cells from patients and then engineering them to be able to recognize and attack their cancers is a time-consuming and resource-intensive process that current CAR-T leaders Novartis and Gilead have pointed to in justifying the $300,000-$500,000 price tags on their products
This can allow a more scalable and potentially cheaper platform if it can replicated en masse and is already a major feature among early biotechs in the space such as Fate Therapeutics, Precision Biosciences and Allogene.
Clade, meaning a group of organisms believed to comprise all the evolutionary descendants of a common ancestor, said its platform tech works by “cloaking” human pluripotent stem cells and their adult derivatives enabling the development of immune-compatible cell transplantation therapies.
Its early focus, as with most in the area, is on cancer, though it did not go into specifics on targets.
“We have reached an era in medicine where insights across genetic engineering, regenerative medicine and immunology have enabled a revolution of cell medicines,” said Chad Cowan, Ph.D., CEO of Clade, and the man who helped launch CRISPR Therapeutics and more recently Sana.
“Clade was founded to overcome the clinical limitations of current cell therapies by addressing durability, patient compatibility, reproducibility and scalability to deliver on the transformative potential of this increasingly important therapeutic modality.”
The company comes out of stealth into a tough moment for these therapies, however. Allogene, a rival in the space, a month back was slapped with an FDA clinical hold on all of its AlloCAR T clinical trials in response to an abnormality that could theoretically cause cancer.
There are still a lot of unknowns, but the range of possible outcomes run from a short delay to Allogene’s programs right up to a more intractable problem for the entire off-the-shelf cell therapy space.
Analysts are mainly positive this can be cleared up, but it serves as a reminder of the inherent risks of working in new areas.