Seat­tle Ge­net­ics grabs Im­munomedics’ tu­mor drug in $2B deal, shoot­ing for a quick OK

Clay Sie­gall, Seat­tle Ge­net­ics

You can count Seat­tle Ge­net­ics as the new flag car­ri­er for Im­munomedics’ sol­id tu­mor drug IM­MU-132. The biotech is pay­ing $300 mil­lion to claim glob­al rights on the drug, com­mit­ting up to $1.7 bil­lion more in mile­stones.

That mile­stone mon­ey should get rolling soon. Seat­tle Ge­net­ics will now take the lead on a Phase III study for metasta­t­ic triple neg­a­tive breast can­cer. And once the BLA is filed, it’s ob­lig­at­ed to pay over the first of its mile­stone mon­ey as Seat­tle Ge­net­ics looks to vault to an ap­proval as ear­ly as late 2017.

“In just over three years, we have brought IM­MU-132 through clin­i­cal de­vel­op­ments in mul­ti­ple in­di­ca­tions, and have ad­vanced the TNBC in­di­ca­tion to a po­ten­tial ac­cel­er­at­ed ap­proval and launch by late 2017 or ear­ly 2018, which could make IM­MU-132 avail­able to pa­tients deal­ing with a high­ly ma­lig­nant form of breast can­cer,” not­ed Mor­ris Plains, NJ-based Im­munomedics CEO Cyn­thia L. Sul­li­van.

Seat­tle Ge­net­ics $SGEN in­vestors drove the stock down 6%, while Im­munomedics $IM­MU saw their shares rise on­ly 7%.

IM­MU-132 (sac­i­tuzum­ab govite­can) fits square­ly in Seat­tle Ge­net­ics’ com­fort zone. It is an armed an­ti­body that con­tains SN-38, the ac­tive metabo­lite of irinote­can, de­signed for pre­cise de­liv­ery to avoid off-tar­get tox­i­c­i­ty.

The deal — with a $250 mil­lion in an up­front and an ad­di­tion­al $50 mil­lion for ad­di­tion­al ex-US rights — falls just days af­ter Sul­li­van and her crew tout­ed the lat­est up­date on the drug and its plans to seek an ac­cel­er­at­ed ap­proval. At a re­cent re­view, the com­pa­ny said:

(P)atients ex­pe­ri­enced two com­plete and 23 par­tial re­spons­es, while an ad­di­tion­al three pa­tients with ini­tial par­tial re­spons­es are await­ing con­fir­ma­tion. Over­all, 81% of pa­tients treat­ed with IM­MU-132 showed tu­mor shrink­age from base­line mea­sure­ments. The clin­i­cal ben­e­fit rate (com­plete and par­tial re­mis­sions, and pa­tients with sta­ble dis­ease) at six months or lat­er com­put­ed to 44%. The me­di­an du­ra­tion of re­sponse for those with ob­jec­tive re­spons­es was al­most 11 months. It was em­pha­sized that these are in­ter­im re­sults, since 20 pa­tients are con­tin­u­ing treat­ment; a fi­nal out­come must await analy­sis of all pa­tients en­rolled.

An­a­lysts though, have fret­ted about this drug in the re­cent past, in­clud­ing wor­ries about the man­u­fac­tur­ing process, which Seat­tle Ge­net­ics is like­ly to tack­le quick­ly.

Af­ter TNBC, Seat­tle Ge­net­ics plans to go af­ter new in­di­ca­tions as it fol­lows up on Phase II stud­ies in urothe­lial can­cer, small-cell lung can­cer and non-small-cell lung can­cer. And Seat­tle Ge­net­ics CEO Clay Sie­gall says the late-stage tu­mor drug will fit neat­ly in its pipeline of an­ti­body drug con­ju­gates. He said:

This pro­gram would com­ple­ment our rich pipeline of late- and ear­ly-stage pro­grams, po­ten­tial­ly al­low­ing us to bring a new ther­a­py for triple-neg­a­tive breast can­cer to pa­tients in need. We have suc­cess­ful­ly demon­strat­ed our ex­per­tise in the de­vel­op­ment, man­u­fac­tur­ing and com­mer­cial­iza­tion of AD­Cs in on­col­o­gy, and we look for­ward to work­ing with Im­munomedics to ad­vance this pro­gram.

In ad­di­tion to the cash and mile­stones, Seat­tle Ge­net­ics is al­so buy­ing in­to Im­munomedics, pay­ing $14.7 mil­lion for shares at a slight pre­mi­um and re­serv­ing the right to buy more lat­er at the same price. Seat­tle Ge­net­ics has the right to make up to a $57 mil­lion eq­ui­ty in­vest­ment for up to a 9.9% stake in Im­munomedics.

Right af­ter the deal was an­nounced, Im­munomedics said it would post­pone its an­nu­al meet­ing as its in­vestors took time to ab­sorb the im­pli­ca­tions of the pact.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Emma Walmsley, GlaxoSmithKline CEO (Kevin Dietsch/Pool via CNP/Alamy)

Glax­o­SmithK­line hus­tles the 7th PD-1 past the fin­ish line with Jem­per­li. But how big will up­take be?

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Although the numbers are not dramatically higher than what the companies collectively spent in the first quarter of 2020, some like GlaxoSmithKline, Teva, Merck and Johnson & Johnson have already increased their quarterly lobbying spend in 2021 by about $1 million more each when compared to recent quarters in 2020.

House Committee on Oversight and Reform Chairwoman Carolyn Maloney (Getty Images)

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JP Gabriel, Ocugen

JP Gabriel watched from the bleach­ers as the pan­dem­ic raged. Now head of sup­ply chain at Ocu­gen, he's ready to bat

The world was in the middle of the most pressing public health risk his generation had ever seen, and JP Gabriel felt like he was sitting on the sidelines. As a VP of biologics and mRNA manufacturing at Ultragenyx, Gabriel watched from the sidelines as players like Pfizer/BioNTech and Moderna used mRNA tech to chase their own Covid-19 vaccines.

This month, Gabriel got the chance to get his hands dirty against the pandemic — but it won’t be with mRNA.

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