Pfiz­er $PFE and Gilead $GILD are join­ing hands on a new com­bo pro­gram that will tie the CAR-T star Yescar­ta with an ear­ly-stage drug that has been bounc­ing around the clin­ic for the last few years.

Pfiz­er’s utomilum­ab (PF-05082566) is al­so in com­bo stud­ies with Keytru­da and Ky­owa Hakko Kirin’s an­ti-CCR4 an­ti­body moga­mulizum­ab. It’s a 4-1BB ag­o­nist, which re­searchers be­lieve could prove a key play­er in spurring an amped up T cell at­tack on can­cer cells among pa­tients with large B-cell lym­phoma.

David Chang

The pact be­tween Pfiz­er and Gilead’s new sub­sidiary Kite is just the lat­est ex­am­ple of the plans now un­der­way to beef up the pipeline at the CAR-T com­pa­ny as it goes toe-to-toe with No­var­tis, which scored the first land­mark FDA ap­proval in CAR-T with the roll­out of Kym­ri­ah.

The race now is to pro­duce bet­ter, safer and more ef­fec­tive ther­a­pies to suc­ceed the first two pi­o­neers.

Pfiz­er’s had utomilum­ab in ear­ly-stage test­ing for years now, list­ing it at the bot­tom of its Phase I chart for ex­per­i­men­tal on­col­o­gy drugs. The phar­ma gi­ant has a de­vel­op­ment al­liance in place with MD An­der­son, but there hasn’t been a lot of hu­man da­ta yet to eval­u­ate its po­ten­tial.

Kite’s David Chang not­ed:

We are pleased to col­lab­o­rate with Pfiz­er on this study with utomilum­ab, which adds to the grow­ing num­ber of com­bi­na­tion ap­proach­es we are ex­plor­ing with Yescar­ta for pa­tients liv­ing with lym­phoma.

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.

Codiak BioSciences has filed for Chapter 11 bankruptcy, spelling an end to the employment of most executives, including founder Doug Williams, as the biotech says it “expects to consummate a sale.”

The eight-year journey at Codiak is nearing an end with Williams; CFO Linda Bain; medical chief David Mauro; scientific head Sriram Sathyanarayanan; legal and compliance chief Yalonda Howze; and SVP of HR Nicole Barna all packing up their bags in the first few days of April. Chief technology officer Konstantin Konstantinov will stay.