Bris­tol-My­ers beefs up big can­cer drug pipeline, buy­ing IFM drugs in $2.3B-plus deal

Gary Glick, cred­it: Uni­ver­si­ty of Michi­gan

At­las Ven­ture has an­oth­er block­buster biotech flip to boast about — while keep­ing an up­start in the port­fo­lio. And it’s a big one.

Just a lit­tle more than a year af­ter the At­las-in­cu­bat­ed IFM Ther­a­peu­tics achieved liftoff with a $27 mil­lion A round, with a co-lead in­vest­ment from Abing­worth, Bris­tol-My­ers Squibb has stepped in with a buy­out. Bris­tol-My­ers re­searchers are now carv­ing out the work the biotech has done on two pro­grams pro­mot­ing an in­nate im­mune re­sponse to can­cer, and spin­ning out the sig­nif­i­cant re­main­der in­to a new com­pa­ny al­so helmed by IFM co-founder Gary Glick.

To com­plete the deal, Bris­tol-My­ers is pay­ing a whop­ping $300 mil­lion up­front, with a lit­tle more than $1 bil­lion in mile­stones on each of the pre­clin­i­cal pro­grams. And there’s an un­spec­i­fied pay­ment due to se­cure an op­tion on one of its in­nate im­mune sys­tem pro­grams that al­so caught the bio­phar­ma’s eye as well as more biobucks for any oth­er drugs the are de­vel­oped out of the tech­nol­o­gy.

IFM was aimed at a prime tar­get when it jumped in­to view last sum­mer. The two lead can­cer projects look to use small mol­e­cules to ac­ti­vate NL­RP3 and STING, revving up in­nate im­mune re­spons­es that can play a com­ple­men­tary role with adap­tive im­mune ther­a­pies, like Bris­tol-My­ers’ big PD-1 drug Op­di­vo, which thwart a mech­a­nism can­cer cells use to evade an at­tack by im­mune sys­tem T cells. In­nate im­mu­ni­ty at­tacks as an im­me­di­ate guard — or first line of de­fense — against an in­vad­ing pathogen, and among oth­er things can re­cruit cells to the fight.

The biotech now will go on to con­cen­trate on the flip side of that coin: Rein­ing back in­nate im­mune at­tacks, tamp­ing down cy­tokine pro­duc­tion and re­duce chron­ic in­flam­ma­tion tied to au­to-in­flam­ma­to­ry con­di­tions like NASH, IBD and gout. And that work in­cludes NL­RP3 and some re­lat­ed mem­bers of the NLR fam­i­ly.

It’s that NL­RP3 an­tag­o­nist that Bris­tol-My­ers wants an op­tion on.

Thomas Lynch

Bris­tol-My­ers is pay­ing more than 10 times the A-round in cash for this com­pa­ny, which will not go un­no­ticed in At­las cir­cles to­day. At­las part­ner Jean-François Formela was chair­man of the com­pa­ny.

For Bris­tol-My­ers, which is look­ing to reignite its once-dom­i­nant check­point ef­fort, it rep­re­sents an­oth­er op­por­tu­ni­ty to steal a march against a slew of ri­vals all look­ing to sec­ond- and third-gen­er­a­tion tie-ups as they an­gle to keep and grow a ma­jor seg­ment of the mar­ket. Its busi­ness de­vel­op­ment group un­der Paul Bion­di has a cold and steady eye when it comes to tech deals, look­ing for ways to gain an ad­van­tage in core fields through this kind of ex­ter­nal ac­qui­si­tion.

“Tar­get­ing in­nate im­mu­ni­ty path­ways rep­re­sents a po­ten­tial­ly dif­fer­en­ti­at­ed ap­proach in im­muno-on­col­o­gy de­signed to ini­ti­ate and aug­ment im­mune re­spons­es that may help the body’s nat­ur­al de­fens­es bet­ter rec­og­nize and at­tack tu­mors,” said Thomas Lynch, ex­ec­u­tive vice pres­i­dent, chief sci­en­tif­ic of­fi­cer, Bris­tol-My­ers Squibb. “The ad­di­tion of STING and NL­RP3 ag­o­nist pro­grams broad­ens our abil­i­ty to in­ves­ti­gate ad­di­tion­al path­ways across the im­mune sys­tem and com­ple­ments our im­muno-on­col­o­gy port­fo­lio. We look for­ward to ad­vanc­ing the de­vel­op­ment of these im­por­tant pro­grams ini­ti­at­ed by Gary Glick, his lead­er­ship team and lead­ing aca­d­e­m­ic and in­dus­try ex­perts across im­munol­o­gy and on­col­o­gy.”

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

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.

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.

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.