Days af­ter woo­ing Christi Shaw to the helm at Kite, Gilead is once again tout­ing just how se­ri­ous it is about grow­ing its pi­o­neer­ing CAR-T and fol­low-up cell ther­a­py busi­ness. The sub­sidiary is build­ing a new fa­cil­i­ty ded­i­cat­ed to vi­ral vec­tor man­u­fac­tur­ing with­in a bi­o­log­ics site at Ocean­side, Cal­i­for­nia.

Tim Moore BMWS

Right now, Kite gets it vi­ral vec­tors — crit­i­cal start­ing ma­te­r­i­al for edit­ing the T cells to ac­ti­vate can­cer-killing ca­pa­bil­i­ties — from con­tract man­u­fac­tur­ers, said Tim Moore, EVP of tech­ni­cal op­er­a­tions. But amid a cell ther­a­py boom, the lim­its that place on com­mer­cial sup­ply and de­vel­op­ment is be­com­ing more ap­par­ent.

It’s not about ex­it­ing those pacts all to­geth­er, Moore em­pha­sized; rather, the new, 67,000-square-foot fa­cil­i­ty be com­ple­men­tary to what’s al­ready in place.

“We can still lever­age ex­ter­nal man­u­fac­tur­ing ca­pa­bil­i­ties but it’s go­ing to help ac­cel­er­ate our ca­pa­bil­i­ties and high­light our lead­er­ship in cell ther­a­py by leav­ing no stone un­turned,” he told me.

Un­der for­mer CEO John Mil­li­gan, Gilead had ini­ti­at­ed an ag­gres­sive ex­pan­sion on the cell ther­a­py man­u­fac­tur­ing front, plot­ting sites in the Nether­lands, Mary­land and Cal­i­for­nia last May. Daniel O’Day took it a notch up, re­veal­ing in his first an­a­lyst call weeks ago that bring­ing in a new CEO for the stand­alone Kite would be a top pri­or­i­ty. And he went for an in­dus­try heavy­weight in Shaw, the re­cent pres­i­dent of Eli Lil­ly’s Bio­Med­i­cines unit who has a per­son­al sto­ry to tell about can­cer.

Kite ex­pects to have the Ocean­side site com­plete and li­censed in the sec­ond half of 2021, Moore said. There will be some hir­ing for day-to-day op­er­a­tions, though he didn’t spec­i­fy how many.

So­cial im­age: Gilead, AP Im­ages

Dupixent, the blockbuster anti-inflammatory drug from Sanofi and Regeneron, has cleared a high-stakes Phase III study in chronic obstructive pulmonary disease, the companies announced Thursday morning.

If they hold up in a second, identical trial, the data pave the way for Dupixent to become the first biologic to treat patients whose COPD remains uncontrolled despite being on maximal standard-of-care inhaled therapy — the patient population studied in the pivotal program. The companies had spotlighted this as a key readout as they look to expand the Dupixent franchise and explore its full potential.

Incyte touted an accelerated approval for its PD-1 retifanlimab in a rare skin cancer on Wednesday, roughly a year and a half after the drug suffered a rejection in squamous cell carcinoma of the anal canal (SCAC).

Retifanlimab, marketed as Zynyz, was approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a fast-growing skin cancer typically characterized by a single, painless nodule. It’s roughly 40 times rarer than melanoma, according to the nonprofit Skin Cancer Foundation — but incidence is growing, particularly among older adults, Incyte said in its announcement.

Novartis is calling off a UK-based trial for Leqvio in the primary prevention of cardiovascular events in patients with high cholesterol, the company confirmed on Wednesday.

The Swiss pharma giant made the decision after “careful evaluation,” a spokesperson told Endpoints News via email. The trial, dubbed ORION-17, was planned in partnership with England’s National Health Service (NHS) and was part of the company’s strategy to establish Leqvio as a standard of care in cardiovascular disease management.