2:53 PM
Apr 13, 2018
 |  BioCentury  |  Product Development

Self-driving CARs

Why Pfizer and other large companies think CAR T technology needs its independence

Editor's Note: This article was updated on Sep 14, 2018 at 6:20 PM PDT

Novartis AG, Gilead Sciences Inc. and now Pfizer Inc. have taken different approaches to managing their CAR T cell assets, but the three companies appear to be converging on the notion that developing the technology requires a level of autonomy that is unavailable within the traditional biopharma operating model.

Each has chosen to house its CAR T cell pipelines in an entity that operates independently of the rest of its pharmaceutical operations.

Novartis, an early adopter of the modality, also was the first to decide it needed to be managed differently from small molecules or biologics. The pharma set up a dedicated cell and gene therapy unit in 2014, just as Kymriah tisagenlecleucel was about to enter a pivotal Phase II study. The pharma later folded the unit into its Novartis oncology business, which operates separately from the larger pharmaceuticals unit.

When Gilead acquired Kite Pharma Inc. last October, it took a similar decision, allowing the biotech to operate as an independent business unit.

Pfizer decided a greater degree of separation was necessary for the off-the-shelf CAR T cell therapies it was developing using TALEN gene editing technology from Cellectis S.A. The pharma announced April 3 that it would spin out the portfolio into newco Allogene Therapeutics Inc.

Both Novartis’ decision to fold cell and gene therapy into its oncology unit, and Pfizer’s decision to spin its CAR T portfolio out led analysts and investors to wonder aloud whether the pharmas were retreating from the technology.

But it appears that both moves reflect the unique needs of cell therapy development, particularly with respect to the interdependence of manufacturing, R&D and regulatory groups.

“It’s not about a lack of belief that cell-based therapies are going to be transformational in certain cancer types,” Pfizer’s Robert Abraham told BioCentury. “We needed to get this into the hands of a group that we had extremely high confidence in to optimize the use of the platform and who would have CAR T cells as a single mission objective.” Abraham is SVP and head of oncology R&D group at Pfizer.

Allogene launched with Kite’s former management team, $300 million in funding and 16 CAR T cell candidates. David Chang, former EVP and CMO of Kite, is president and CEO of Allogene. Former Kite Chairman, President and CEO Arie Belldegrun serves as executive chair.

“It’s not about a lack of belief that cell-based therapies are going to be transformational in certain cancer types.”

Robert Abraham, Pfizer

Two programs are disclosed: the Phase I UCART19 program and a preclinical CAR T targeting tumor necrosis factor (TNF) receptor superfamily member 17 (BCMA; TNFRSF17; CD269). The remaining CAR Ts are in preclinical development to treat hematologic malignancies and solid tumors.

Pfizer will have a 25% stake in the company. Pfizer did not disclose whether it retained any clawback rights or rights of first negotiation to any of Allogene’s 16 programs as monotherapies or as part of combinations with Pfizer agents.

Pfizer’s decision was based in...

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