Trou­bled In­fin­i­ty ax­es 100 staffers, shut­ters tri­als and re­wards top ex­ecs af­ter Ab­b­Vie walks away from deal

Back in the fall of 2014, a rest­less Ab­b­Vie stepped in with a $275 mil­lion up­front pay­ment to part­ner with In­fin­i­ty Phar­ma­ceu­ti­cals on du­velis­ib, its oral PI3k-delta/gam­ma in­hibitor for blood can­cers. To­day, af­ter du­velis­ib failed to im­press the phar­ma com­pa­ny in a mid-stage study, Ab­b­Vie is walk­ing away from their part­ner­ship and In­fin­i­ty is ax­ing 100 staffers to con­serve cash.

In­fin­i­ty’s trou­bles hit af­ter du­velis­ib hit its pri­ma­ry end­point for in­do­lent non-Hodgkin lym­phoma in a Phase II with a 46% over­all re­sponse rate. Zy­delig and Rit­ux­an both did bet­ter than that, though, spurring some big ques­tions over what kind of fu­ture the drug could have on the mar­ket.

Ab­b­Vie im­me­di­ate­ly sus­pend­ed a com­bi­na­tion study with vene­to­clax, and now In­fin­i­ty says the study is be­ing ter­mi­nat­ed. The biotech is al­so clos­ing BRAVU­RA, a Phase III study of du­velis­ib in pa­tients with re­lapsed iNHL, and CON­TEM­PO, a Phase Ib/2 study of du­velis­ib in treat­ment-naïve pa­tients with fol­lic­u­lar lym­phoma.

But the Cam­bridge, MA-based biotech is not giv­ing up on du­velis­ib. Nei­ther are the ex­ec­u­tives who are pur­su­ing a ques­tion­able strat­e­gy in con­tin­u­ing to try and blaze a path to the FDA.

In an 8-K filed with the SEC, In­fin­i­ty laid out a se­ries of 6-fig­ure re­ten­tion bonus­es for CEO Ade­lene Perkins, R&D chief Ju­lian Adams along with the CFO and chief com­mer­cial of­fi­cers. Perkins is in line for $334,750; Adams gets $249,000; Lawrence Bloch gets $209,000 and Su­jay Kan­go gets $205,000. That’s half of their base pay.

The news kicked up a fuss on Twit­ter, though TheStreet’s Adam Feuer­stein lat­er re­port­ed all re­main­ing staffers at the biotech are in line for a 50% re­ten­tion bonus.

Ade­lene Perkins, In­fin­i­ty CEO

A spokesper­son for In­fin­i­ty broke it down like this for End­points: “The num­ber of peo­ple el­i­gi­ble for a re­ten­tion bonus is 79 (65 re­main­ing plus 14 of the 100 im­pact­ed who are stay­ing past la­bor day but con­clud­ing work by 12/30).  Each of those em­ploy­ees gets a bonus up to 50% but it’s on a pro-rat­ed ba­sis.  The pay­ment dates are 12/30/16 and 7/1/17.

“Ex­am­ple:  If you make 100K, and work un­til De­cem­ber 30th, you get 25K.  If you were to work un­til Ju­ly 1, 2017, you would get an­oth­er 25K.  If you were to be ter­mi­nat­ed Sept 30th, you get $12,500K (pro-rat­ed with start date of re­ten­tion pro­gram be­ing Ju­ly 1 of this year).”

In a state­ment, Perkins says the com­pa­ny plans to pur­sue an ap­proval with the FDA, mix­ing its Phase II da­ta with re­sults from an on­go­ing Phase III in search of an ac­cel­er­at­ed ap­proval. Topline da­ta is ex­pect­ed from the Phase III in the next few months. And if that flies with reg­u­la­tors they’ll turn to their FRES­CO study to serve as a con­fir­ma­to­ry study for full ap­proval in fol­lic­u­lar lym­phoma.

“Da­ta re­port­ed to date have demon­strat­ed that du­velis­ib is clin­i­cal­ly ac­tive with a man­age­able safe­ty pro­file, and we be­lieve that it could play an im­por­tant role in the fu­ture treat­ment of pa­tients with hema­to­log­ic ma­lig­nan­cies, par­tic­u­lar­ly for re­laps­ing and/or re­frac­to­ry pa­tients,” Perkins not­ed. We are now ex­plor­ing strate­gic op­tions for the pro­gram that could en­able the sub­mis­sion of glob­al reg­u­la­to­ry ap­pli­ca­tions and com­mer­cial­iza­tion for du­velis­ib.”

Wed­bush an­a­lyst David Nieren­garten wasn’t sur­prised by Ab­b­Vie’s ex­it. But with In­fin­i­ty al­so shift­ing fo­cus to an ear­ly-stage drug in the pipeline, it’s go­ing to face an­oth­er up­hill strug­gle to gain con­vinc­ing da­ta in a very com­pet­i­tive field.

“IPI-549 is a PI3K-gam­ma in­hibitor cur­rent­ly in Ph 1 study as monother­a­py and in com­bi­na­tion with an an­ti-PD1 an­ti­body,” he says. “IN­FI has shown pre­clin­i­cal­ly that com­bi­na­tion of IPI-549 with check­point in­hibitors re­sults in syn­er­gis­tic an­ti-tu­mor ac­tiv­i­ty in mouse mod­els. How­ev­er, giv­en the large num­ber of on­go­ing check­point in­hibitor com­bi­na­tion tri­als, we would ex­pect IPI-549 to have to demon­strate com­pelling ac­tiv­i­ty to gen­er­ate sig­nif­i­cant in­vestor in­ter­est. With sig­nif­i­cant cost re­duc­tions not ex­pect­ed un­til 2017, we mod­el for YE cash to be ap­prox­i­mate­ly $58M.”

This is Perkins’ third ma­jor cri­sis at In­fin­i­ty, fol­low­ing the fail­ure of two ear­li­er lead pro­grams in can­cer. Whether it can sur­vive this one, though, is still un­cer­tain.

 

J&J team shows off 'break­through' BC­MA CAR-T da­ta, and it's every bit as good as they had ex­pect­ed

Just hours after J&J’s oncology team bragged about scoring a breakthrough therapy designation for their BCMA CAR-T drug, they pulled the wraps off the multiple myeloma data for JNJ-4528 that impressed the FDA.

Following up on some attention-grabbing data initially presented by their Chinese development partners at Legend 2 years ago during ASCO, investigators say they tracked some jaw-dropping results that confirmed the early promise of a therapy that’s shaking up a crowded field led by bluebird bio.

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Jake Van Naarden, Josh Bilenker, Nisha Nanda (Credit: Loxo, Aisling Capital)

Josh Bilenker and his Loxo crew are tak­ing the reins on on­col­o­gy R&D at Eli Lil­ly, culling the weak and map­ping a new path

Josh Bilenker, Jake Van Naarden and Nisha Nanda came out of Eli Lilly’s $8 billion Loxo Oncology buyout with a bundle of cash and plenty of choices on what they could do next. Start a new company, go public. Live on the beach in 5-star luxury. Contemplate the stars — in their own observatory.

So what are they doing?

They formed a new executive team that is taking over the management of Eli Lilly’s hundreds-strong oncology R&D group — essentially using Loxo as a base for a bold new experiment in Big Pharma R&D in an attempt to create a true biotech environment with the deep pockets of a top-15 industry player. They’ve recruited David Hyman from Memorial Sloan Kettering to join the team as chief medical officer. And the mandate includes culling out the oncology pipeline, highlighting their star prospects and going after new programs wherever they can find the best prospects.

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J&J's Mathai Mammen at an Endpoints News event in Boston, June 2018 (Photo: Rob Tannenbaum for Endpoints News)

J&J fronts $750M cash to grab a failed can­cer drug that’s been re­pur­posed as a pow­er­ful an­ti-in­flam­ma­to­ry

J&J has stepped up with one of its blockbuster drug buys, agreeing to pay Austin-based XBiotech $XBIT $750 million in cash and up to $600 million more in milestones for their late stage-ready anti-inflammatory drug bermekimab — which some longtime biotech observers may recognize as a failed cancer therapy with a disaster-prone past.

The drug targets the IL-1a pathway. J&J $JNJ R&D chief Mathai Mammen is cutting a check for a drug that has produced positive mid-stage data in patients suffering from a skin condition called hidradenitis suppurativa with another mid-stage program underway for atopic dermatitis.

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One of Wall Street’s most high-pro­file hedge funds push­es Alex­ion's CEO to the auc­tion block — and he's not budg­ing

Fresh off buying Barnes & Noble and prodding AT&T with some heavy-handed criticism after picking up a $3.2 billion stake in the company, the activist — and supremely high profile — hedge fund Elliott Management has stepped up with some M&A advice for Alexion’s management team.
And the execs on the team $ALXN are giving them a polite — but very firm — stiff arm Friday morning.
In a release out early Friday, the big biotech said that the Elliott team had been in touch to encourage them to sell the company. But that’s not on the agenda.

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Samantha Budd Haeberlein. Biogen via YouTube

UP­DAT­ED: Skep­tics pounce as Bio­gen de­tails pos­i­tive sub­group analy­sis on ad­u­canum­ab — and both sides are dig­ging in

“Exhilarating.” “A major advance.” “A milestone achievement.” If one had just tuned into the panel comments on Biogen’s presentation at CTAD, it would seem that the biotech had an impressive, disease-modifying Alzheimer’s drug in aducanumab.

But off the stage, reactions to their admittedly complicated dataset and the biotech’s explanation for resurrecting a drug that failed its futility analysis were a lot more mixed, with analysts continuing to question whether the evidence is substantial enough to warrant an FDA approval and raising new doubts on the safety side.

In an investor call later in the day, execs noted that they are not planning another study and stood by their intention, publicized in October to much surprise, to submit regulatory filings based on what they have.

“We don’t file willy nilly,” said Al Sandrock, head of R&D. “We only go to filing when we believe that there is a benefit-risk argument based on science, based on data. And if you look at our history, we haven’t done filings right and left without good reason.”

Biogen had a theory going into the Clinical Trials on Alzheimer’s Disease meeting.

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Un­lock the full End­points ex­pe­ri­ence for your com­pa­ny — and sup­port our mis­sion of in­de­pen­dent bio­phar­ma re­port­ing

I want to give readers a quick update on the most important part of our business model — premium subscriptions. We have some crucial financial goals we hope to achieve by the end of the year, and the team here in Lawrence is ready to ship some swag to kick off this limited December promotion.

We offer two premium plans — Enterprise for companies ($1,000/year, unlimited people), and Insider for individuals ($200/year). This month of December will be the last chance to enroll at the original rates — which have remained flat since we launched them in 2017.

Jasper Ther­a­peu­tics launch­es out of Stan­ford with new ap­proach to stem cell treat­ment

The first girl in the trial came in with chronic diarrhea and the immune system of an untreated HIV patient. Born with a rare genetic disease that impeded her ability to make B and T cells, she had once been given a stem cell transplant but it didn’t take.  Back in the hospital, she was injected with a new experimental antibody and then given a new stem cell transplant. Soon, she gained weight. The diarrhea stopped.

Ex-Cel­gene ex­ec Ter­rie Cur­ran puts her Phath­om team in place; Car­away taps Mar­tin Williams as CEO

→ Gastrointestinal disease-focused Phathom Pharmaceuticals has shaken up its leadership team. The company has tapped former Celgene exec Terrie Curran as CEO, succeeding David Socks, who is transitioning to interim CFO. Curran was president of Celgene’s global inflammation and immunology franchise — helping with the sale of Otezla for $13.4 billion to Amgen — and has held a previous stint at Merck. In addition to Curran, the company also welcomed former Omeros CMO Eckhard Leifke as CMO, ex-Celgene exec Joseph Hand as chief administrative officer, and former general counsel for Cyclerion Therapeutics Larry Miller as general counsel. They also replaced Chris Slavinsky on the board with Takeda exec Asit Parikh.

UCB buffs up in block­buster pso­ri­a­sis race as bimek­izum­ab beats Hu­mi­ra in head-to-head

Just weeks after boasting head-to-head victories over first placebo and then J&J’s IL-23 contender Stelara in clearing psoriasis, the results are in for UCB’s last Phase III trial, in which bimekizumab went up against the world’s best-selling drug.

Only topline results are provided for today’s readout of the BE SURE study, so we won’t find out just how superior bimekizumab proved against Humira on the co-primary endpoints — standard scores known as PASI90 and IGA measuring the impact and severity of the disease — until a scientific conference in 2020.