Pfiz­er’s PhI­II kid­ney can­cer study for In­ly­ta flops as in­ves­ti­ga­tors flag a dead end on out­comes

Pfiz­er has lost out on a Phase III bid to re­vive flag­ging sales of its VEGF in­hibitor In­ly­ta (ax­i­tinib). 

Re­searchers say their drug, ini­tial­ly ap­proved as a sec­ond-line kid­ney can­cer drug 6 years ago, failed to make a fa­vor­able im­pact on pa­tients at high risk of re­cur­ring kid­ney can­cer, un­able to beat out a place­bo for main­tain­ing dis­ease-free rates. The tri­al was stopped af­ter in­de­pen­dent mon­i­tors called it on clear ev­i­dence of fu­til­i­ty.

Mace Rothen­berg, Pfiz­er

That’s not what Pfiz­er want­ed to hear as it looked for new ways to back stop a suf­fer­ing Su­tent fran­chise, and it was par­tic­u­lar­ly un­wel­come af­ter In­ly­ta rev­enue slipped in Q4. Late last year Pfiz­er won an ap­proval to mar­ket Su­tent for this high-risk cat­e­go­ry in kid­ney can­cer, even though the ex­pert pan­el they called on to re­view the ap­pli­ca­tion split their vote, with sev­er­al mem­bers un­hap­py with the drug’s risk pro­file.

The phar­ma gi­ant, though, is push­ing ahead with high­er hopes for its clin­i­cal work on a com­bi­na­tion of In­ly­ta with its PD-L1 check­point avelum­ab — de­vel­oped by Mer­ck KGaA — though avelum­ab has had a cou­ple of oth­er set­backs as well. And Su­tent will like­ly be over­whelmed fair­ly soon by the wave of I/O drugs seek­ing ex­pand­ed ap­proval. 

The FDA grant­ed Pfiz­er’s check­point com­bo a break­through des­ig­na­tion for re­nal cell car­ci­no­ma last De­cem­ber.

Pfiz­er, though, hedged its bets on this gam­ble, so it won’t have to eat the costs. SFJ Phar­ma­ceu­ti­cals su­per­vised the work and pro­vid­ed the fund­ing, with this pro­gram one of a slate of stud­ies in which it gam­bles in­vestor cash for phar­ma part­ners look­ing for some cre­ative ways to ex­pand their pipeline work while keep­ing a lid on R&D costs. SFJ al­so con­duct­ed a tri­al for Pfiz­er’s da­comi­tinib in Asia. That drug is now un­der FDA re­view.

“We are dis­ap­point­ed by the out­come of this study as we had hoped the ef­fi­ca­cy that IN­LY­TA has demon­strat­ed as a sec­ond-line treat­ment in pa­tients with ad­vanced re­nal cell car­ci­no­ma would car­ry over to pa­tients with ear­li­er stage dis­ease, where it would de­lay or pre­vent dis­ease re­lapse. That goal was not achieved. We will con­duct ad­di­tion­al analy­ses on the da­ta that may pro­vide in­sight in­to this re­sult. Stud­ies eval­u­at­ing IN­LY­TA in com­bi­na­tion with im­mune check­point in­hibitors for pa­tients with a va­ri­ety of ad­vanced stage can­cers, in­clud­ing RCC, will con­tin­ue,” said can­cer R&D chief Mace Rothen­berg.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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Joshua Liang, Clover Biopharmaceuticals CEO

With world still in sore need of dos­es, Clover says its Covid-19 vac­cine is 67% ef­fec­tive in Phase III

With concerns about the Delta variant rising and much of the world still in desperate need of vaccine doses, a Chinese biotech announced Wednesday that a new shot has shown positive results in a large trial against Covid-19, including new variants.

Clover Biopharmaceuticals announced Wednesday that its vaccine candidate showed 79% efficacy against the Delta variant in a Phase II/III trial dubbed Spectra, and 67% effective against Covid-19 overall.

Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

A few years ago Jean Bennett found herself in a surprising place for a woman who invented the first gene therapy ever approved in the United States: No one, it seemed, wanted her work.

Bennett, who designed and co-developed Luxturna, approved in 2018 for a rare form of blindness, had kept building new gene therapies for eye diseases at her University of Pennsylvania lab. But although the results in animals looked promising, pharma companies and investors kept turning down the pedigreed ophthalmology professor.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.