Ab­b­Vie is join­ing its fel­low Big Phar­ma com­peti­tors and jump­ing in­to the Treg space.

In a col­lab­o­ra­tion deal an­nounced ear­ly Mon­day morn­ing, the Chica­go-based phar­ma com­pa­ny said it would be team­ing up with pri­vate biotech Cu­gene to ad­vance a sin­gle Treg pro­gram tar­get­ing IL-2. Ab­b­Vie is shelling out $48.5 mil­lion up­front to col­lab­o­rate and will pay an undis­closed sum of mile­stones and roy­al­ties.

Ab­b­Vie al­so gets the op­tion to ob­tain an ex­clu­sive li­cense for cer­tain IL-2-tar­get­ing Treg pro­grams, in­clud­ing the one in­volved in Mon­day’s deal, dubbed CUG252. The can­di­date, Cu­gene’s lead, is of­fi­cial­ly de­scribed as a “Treg-se­lec­tive IL-2 mutein” de­signed to treat au­toim­mune and in­flam­ma­to­ry dis­eases.

Re­searchers hope to treat these con­di­tions us­ing Treg cells, which po­lice the im­mune sys­tem and can rec­og­nize the body’s own pro­teins. They are able to tell oth­er im­mune cells not to at­tack when they see cells stud­ded with those re­cep­tors, but can go awry in cer­tain dis­eases when the im­mune sys­tem at­tacks healthy cells.

By si­mul­ta­ne­ous­ly tar­get­ing IL-2, the can­di­date at­tempts to use Tregs to fight such con­di­tions while al­so tamp­ing down on un­de­sired IL-2 ac­tiv­i­ty.

Ab­b­Vie is join­ing an in­creas­ing­ly crowd­ed Treg space that’s seen in­vest­ment from Mer­ck, Take­da, Am­gen, Eli Lil­ly, Sang­amo and a suite of up-and-com­ing biotechs. The ball has re­al­ly got­ten rolling in the last 18 months or so, par­tic­u­lar­ly af­ter Mer­ck’s $1.85 bil­lion buy­out of Pan­dion in Feb­ru­ary 2021.

Tru­ist Se­cu­ri­ties an­a­lyst Robyn Kar­nauskas notes it’s still way too ear­ly to anoint a win­ner or fron­trun­ner in this Big Phar­ma race. Ab­b­Vie’s deal with Cu­gene serves more as an­oth­er val­i­da­tion point for the path­way, while dou­bly boost­ing Ab­b­Vie’s al­ready dom­i­nant po­si­tion in the im­munother­a­py space.

The deal could al­so give a com­pet­i­tive edge to Sang­amo, Kar­nauskas said, which is the on­ly com­pa­ny in the clin­ic with an “en­gi­neered CAR-Treg cell ther­a­py.”

For Cu­gene, mean­while, this deal like­ly puts the biotech on the map as there is lit­tle known about it — the com­pa­ny has yet to put out one of its own press re­leas­es. A com­pa­ny web­site does de­tail some of its pipeline, where Cu­gene out­lines its goals to go af­ter sol­id tu­mors with oth­er pro­grams. But CUG252 re­mains the com­pa­ny’s on­ly clin­i­cal pro­gram thus far.

“To­day’s agree­ment high­lights Cu­gene’s unique pre­ci­sion en­gi­neer­ing plat­form that has yield­ed mul­ti­ple prod­uct can­di­dates, in­clud­ing CUG252,” Cu­gene CEO Luke Li said in a state­ment Mon­day.

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

FDA Commissioner Rob Califf joined the heads of the CDC and NIH in the hot seat today before a key House subcommittee, explaining that there needs to be a much faster, more coordinated way to oversee vaccine safety, and that foreign biopharma inspections, halted for years due to the pandemic, are slowly ramping up again.

Califf, who stressed to the House Energy and Commerce’s Subcommittee on Health that the CDC also needs better data, made clear that the FDA’s ability to monitor the safety of vaccines “would also benefit greatly by a coordinated federal public health data reporting authority.”