Prep­ping for a rapid-fire launch, Kite Phar­ma gets a pass from FDA on axi-cel pan­el re­view

The FDA has ev­i­dent­ly learned all it wants at this point from its out­side on­col­o­gy ex­perts on CAR-T. Kite Phar­ma’s close­ly-watched CAR-T drug axi-cel is get­ting a pass on an ad­comm meet­ing, which may sig­nal a quick thumbs up from reg­u­la­tors.

Kite $KITE ex­ecs think so, say­ing to­day that they will be ful­ly launch-ready by Sep­tem­ber in case an ear­ly OK comes through. And that bull­ish stance earned a 7% boost to its share price to­day.

David Chang, Kite

In a Q2 call with an­a­lysts Tues­day morn­ing, Kite R&D chief David Chang told an­a­lysts the FDA had no­ti­fied the biotech that reg­u­la­tors will not be or­ga­niz­ing a pan­el re­view with out­side ex­perts for axi-cel. No­var­tis was first up in Ju­ly, gain­ing unan­i­mous back­ing for CTL019 from an FDA pan­el in the lead­up to an ear­ly-Oc­to­ber PDU­FA date.

No­var­tis had been seen as the clear front-run­ner in the race to get on the mar­ket first, but with the FDA fin­ish line blur­ring, they may now both launch al­most si­mul­ta­ne­ous­ly.

“We are ex­treme­ly en­cour­aged by the re­cent ad­vi­so­ry com­mit­tee meet­ing” for No­var­tis, Chang said, which he sees as a like­ly har­bin­ger for Kite. “The FDA has in­formed us that they will not sched­ule an ad­vi­so­ry com­mit­tee meet­ing” for axi-cel. This fol­lows an FDA in­spec­tion of its man­u­fac­tur­ing fa­cil­i­ty and its treat­ment cen­ters in the lead-up to an ac­cel­er­at­ed re­view and fi­nal de­ci­sion.

Kite faces a No­vem­ber 29 dead­line for its mar­ket­ing de­ci­sion from the FDA, but the com­pa­ny says it’s ready to start mak­ing the per­son­al­ized ther­a­py and start ship­ping al­most im­me­di­ate­ly.

These pi­o­neer­ing CAR-T drugs of­fer a prover­bial game-chang­ing ap­proach in treat­ing blood can­cers. T cells are ex­tract­ed from pa­tients and armed with chimeric anti­gen re­cep­tors, turn­ing them in­to can­cer fight­ers that are pumped in­to a po­tent mix that is then in­fused in­to the pa­tient.

To say that Kite has been an­tic­i­pat­ing the launch for sev­er­al years now is an un­der­state­ment. Axi-cel is wide­ly viewed as a block­buster in the mak­ing, and Kite has been build­ing man­u­fac­tur­ing op­er­a­tions and a com­mer­cial group with plans to hit the ground run­ning, hit­ting a vein-to-vein turn­around time on this ther­a­py of 17 days. In the mean­time, its R&D group to­day sig­naled that they have filed for an IND to start Phase I work on KITE-585, its next-gen ap­proach that tar­gets BC­MA.

“With the an­tic­i­pat­ed events on the hori­zon for the re­main­der of 2017,” said CEO Arie Bellde­grun, “the po­ten­tial for CAR-T to be­come one of the most pow­er­ful an­ti-can­cer agents for cer­tain pa­tients may fi­nal­ly be re­al­ized.”

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Bris­tol-My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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New safe­ty da­ta ex­pose po­ten­tial weak­ness as Pfiz­er's abroc­i­tinib takes on Dupix­ent in eczema

Last September, when Pfizer celebrated positive data from a second Phase III study of abrocitinib, many watchers applauded the efficacy but were still waiting to see whether the JAK1 inhibitor is “safe enough to be a formidable competitor to Dupixent,” the clear leader in the atopic dermatitis field. The full slate of safety data are now out and, according to one analyst, the answer is: probably not.