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.

 

Jude Samulski, Marianne De Backer

Bay­er buys a biotech ‘race horse’ with a $4B deal — $2B in cash — aimed at go­ing big in­to gene ther­a­py

In the latest sign that Big Pharma wants a leading place in the push to develop a new generation of cell and gene therapies, Bayer is stepping up today with a $2 billion cash deal to buy out one of the fast-moving pioneers in the field, while adding up to $2 billion more in milestones if the new pharma subsidiary can deliver the goods.

As part of a continuing series of deals engineered by Bayer BD chief Marianne De Backer, the pharma player has snapped up Asklepios, more commonly referred to in more casual fashion as AskBio. And they are paying top dollar for a Research Triangle Park-based company that raised $225 million a little more than a year ago to back the brainchild of Jude Samulski, the gene therapy pioneer out of the University of North Carolina Gene Therapy Center.

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Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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Cedric Francois, Apellis CEO (Optum via YouTube)

UP­DAT­ED: So­bi bets $250M cash, about $1B in mile­stones for rights to a C3 ther­a­py be­ing pushed through 5 piv­otal tri­als

A couple years after licensing Novimmune’s emapalumab and turning around a quick FDA OK, Stockholm-based Sobi is betting up to $1.2 billion for rights to another rare disease drug.

The company is shelling out $250 million upfront and adding up to $915 million in milestones for rights to develop and commercialize Apellis Pharmaceuticals’ drug pegcetacoplan outside the US. Together, the companies will see the systemic C3 therapy through five registrational trials in hematology, nephrology and neurology.

Christian Rommel (via Roche)

Bay­er fol­lows R&D deal spree by raid­ing Roche's can­cer group for its new re­search chief

The day after Bayer signed off on a $4 billion deal designed to put the company among the leaders in gene therapy development, the pharma giant has recruited a new chief for its R&D division. And they opted for an expert in the cancer field.

Christian Rommel, Roche’s head of discovery and early-stage oncology development, has been tapped to take over the job. Joerg Moeller, who got the top research post after early and late-stage development roles were combined 2 years ago, is hitting the exit “to pursue other career opportunities.”

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Once re­ject­ed, Kala's dry eye drug now gains en­try to a field where No­var­tis is groom­ing its own block­buster

When the FDA slapped a rejection on Kala Pharma’s dry eye drug last August, the biotech’s execs promised investors that a third Phase III study — they had already started at that point — would reverse their fortune.

Today they made good on that promise, clinching an approval for Eysuvis, an ocular corticosteroid being positioned as a first-line, short term treatment of dry eye disease.

Boasting a technology invented by Bob Langer out of MIT, Eysuvis is a corticosteroid, loteprednol etabonate, delivered by mucus-penetrating particles. It promises to enhance penetration into target tissue on the ocular surface, achieving an effect quicker than systemic corticosteroids and stronger than over-the-counter eye drops.

Albert Bourla, AP

UP­DAT­ED: Where's the Pfiz­er ef­fi­ca­cy read­out? CEO Bourla says 'soon,' but you're go­ing to have to wait for it

Pfizer CEO Albert Bourla had promised repeatedly that the pharma giant would know if its leading Covid-19 vaccine is effective by the end of this month — now just a few days away.

Instead, the company reported early Tuesday that it has yet to conduct any interim efficacy analyses. And it won’t now until sometime next month.

The news was included in a slide for their Q3 report.

In the morning Q3 call with analysts, Bourla says that they expect efficacy data “soon,” but noted that they wouldn’t be able to say anything until all the administrative work was done on the interim, which would take about a week. And he added that Pfizer isn’t going to say anything else about that hot topic until they have the data in hand.

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UP­DAT­ED: Re­searchers shut­ter 2 Covid-19 stud­ies as mon­i­tors flag Eli Lil­ly an­ti­bod­ies as a flop for pneu­mo­nia, hos­pi­tal­ized pa­tients — but EUA hunt con­tin­ues

Two weeks after the safety data monitoring group advised researchers to hit the hold button on a clinical trial of Eli Lilly’s antibody bamlanivimab (LYCoV55) for patients hospitalized with Covid-19, the trial overseers are back with fresh directions to shutter the study after losing faith that the drug could help this group of patients.

The monitors concluded, however, that there were no safety issues involved, which will likely encourage continued belief that Lilly can still nail down an emergency marketing application for less-sick patients.

Three years in­to a PhI­II pro­gram for a failed Duchenne MD drug, Cataba­sis hauls down the flag and ad­mits de­feat

Three years ago, Catabasis CEO Jill Milne and the crew insisted they had found good reason for great cheer once they plumbed the data from their failed study for the Duchenne MD drug edasalonexent. Plunging into the extended open-label data, they said, you could find solid evidence of efficacy. And that justified a try in Phase III.

But they were wrong.

Monday, after the bell, the little biotech acknowledged that their pivotal attempt following the mid-stage flop was another failure. The primary, change in baseline on the North Star Ambulatory Assessment, and the secondary on timed function tests both came up short of statistical significance.

Ul­tragenyx slams the brakes on rare dis­ease study af­ter all 5 pa­tients are hit with a se­ri­ous set­back

Ultragenyx $RARE and its partners at GeneTx have been forced to halt early-stage study for a drug to treat rare cases of Angelman syndrome after all 5 of the patients being treated for the first time experienced a severe adverse event at the highest dose.

The patients in the study experienced “lower extremity weakness believed to be related to local inflammation due to GTX-102,” triggering a red light on dosing and enrollment.

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