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So-called ‘off the shelf’ CAR-T treatments could change the field just as first products enter commercialization
It was big news last year when Novartis and Kite Pharma announced FDA approvals of CAR-T therapies for (among other diseases) acute lymphoblastic leukemia (ALL), deploying chimeric antigen receptor T cells based on patients’ own T cells. Subsequently, Gilead Sciences purchased Kite for $12 billion (a rather eye-popping figure for a company with one product, just commercialized; but then, Gilead became a top 10 global pharma company years ago by paying top dollar to acquire the rights to what became its extraordinarily successful hepatitis C portfolio).
Now—in what is an equally extraordinary action, both in speed and in valuation—Allogene Therapeutics has been formed by two ex-Kite executives, while simultaneously acquiring the rights to a portfolio of CAR-T development programs partially owned by Pfizer. Allogene is backed by a $300-million investment from a consortium of venture-capital and investment firms; Pfizer will retain a 25% ownership. Through a variety of cross-licensing and shared-commercialization rights, two other companies, Servier and Cellectis, are involved in the deal as well, and Allogene is taking over commercialization of a Cellectis development called UCART19, currently in Phase I trials.
Arie Belldegrun, MD, founder and former chairman of Kite, will serve as executive chairman of Allogene, and David Chang, PhD, former EVP and chief medical officer of Kite, will serve as president and CEO.
What makes the deal interesting medically is that Allogene is pursuing allogeneic CAR-T therapy, as opposed to the autologous versions commercial now. Autologous therapy requires extracting T cells from patients’ blood, then genetically manipulating those cells and re-infusing them into the patient. Allogeneic therapy would use T cells from compatible, health donors; in effect, one donor’s cells could treat many patients, and the therapy would be “off the shelf” ready for infusion upon diagnosis of a patient. (Calling this “off the shelf” is a highly unfortunate choice of terms, implying that this sophisticated and highly advanced therapy can be mass-produced and distributed, but give the venture-cap community credit for knowing how to hype a technology.)
Allogene isn’t inventing the allogeneic approach; this is something Cellectis has been pursuing for several years with a technique branded as Talen gene-editing technology. Cellectis has run trials with mixed results; but its progress, as well as a collective faith in the ability of researchers’ ability to make allogenic approaches work, propels the deal forward. There is the potential that allogeneic approach will enable CAR-T therapies to be less expensive and certainly easily to administer, since the extraction and production steps can be performed in bulk. But proof of that is several years away.
“We believe that under the strong scientific, clinical development and regulatory expertise of Allogene’s leadership team, the portfolio of CAR T assets contributed by Pfizer will be well-positioned to rapidly advance into potential innovative new therapies, and ultimately to reach patients in need more quickly,” opined Robert Abraham, SVP and group head of oncology R&D at Pfizer.