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.

 

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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Christophe Bourdon, Leo Pharma CEO

Leo Phar­ma looks 'be­yond the skin' in atopic der­mati­tis aware­ness cam­paign

As Leo Pharma aims to take on heavyweight champ Dupixent in atopic dermatitis, the company is launching “AD Days Around the World,” an awareness campaign documenting real patient stories across Europe.

The project, unveiled on Monday, spotlights four patients: Marjolaine, Laura, Julia and África from France, Italy, Germany and Spain, respectively, in short video clips on the challenges of living with AD, the most common form of eczema.