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 Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

Some can­cer pa­tients now have to find oth­er op­tions as Bris­tol My­er­s' Abrax­ane falls in­to short­age from man­u­fac­tur­ing woes

When Beth Hogan, a metastatic pancreatic cancer patient, showed up for her infusion at Yale’s Smilow Cancer Hospital in New Haven, CT on Oct. 11, she said she was informed that day that she would not be receiving Bristol Myers Squibb’s Abraxane, part of her combo treatment, because of a shortage.

“I was told we don’t know when you can have it,” she told Endpoints News via email, adding that she doesn’t expect to receive any Abraxane this coming Monday at her treatment appointment either, and she doesn’t know when things will change.

Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

Up­dat­ed: Bio­gen sells just $300K worth of Aduhelm in Q3, as ques­tions on long-term vi­a­bil­i­ty re­main

Barely anyone is accessing Biogen’s controversial Alzheimer’s treatment, with the company reporting just $0.3 million in Aduhelm sales in the third quarter. Although investors will be looking to the longer term, when CMS may decide to cover the drug and open the floodgates for more reimbursement, use of the drug is currently stalled.

Since June, when the FDA first signed off on the drug under its accelerated pathway, Biogen said Wednesday that it’s sold a total of $2 million worth of Aduhelm. That’s a far cry from the peak Wall Street sales estimate of about $9 billion in annual sales, and even a ways away from the sell-side consensus of about $17 million in Q3 sales.

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Eli Lil­ly or­dered to pay roy­al­ties on block­buster di­a­betes drugs, though ex­act dam­ages are un­clear

A federal court found Eli Lilly in breach of a royalty agreement with an Arizona company, likely sending the case — which deals with Lilly’s blockbuster diabetes drugs — to a trial.

The Arizona District Court ordered Lilly to pay the royalties to Tucson, AZ-based Research Corporation Technologies, per an opinion delivered Tuesday, stemming from a 1990 agreement involving materials used in manufacturing Lilly’s insulin products. Lilly had agreed to pay a 2% royalty on worldwide sales, and the exact amount of damages will be determined in a trial, Judge Scott Rash wrote.

Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.