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.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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Am­gen takes next step with its Chi­na am­bi­tions, out-li­cens­ing drugs to Fo­s­un Phar­ma

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.

As court case looms, Bris­tol My­ers touts la­bel ex­pan­sion for Breyanzi

As Bristol Myers Squibb braces for a court battle over a costly delay — at least for Celgene shareholders — for its CAR-T lymphoma treatment Breyanzi, the pharma giant is touting a label expansion in the second-line setting.

Breyanzi, also known as liso-cel, snagged a win on Friday in adults with large B-cell lymphoma (LBCL) who: don’t respond to chemotherapy, or relapse within 12 months; don’t respond or relapse after 12 months; or are not eligible for hematopoietic stem cell transplant after chemo due to their age or comorbidities.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.