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.

Belgian biotech Confo Therapeutics has landed $183 million, plus potential royalties, in a drug-discovery deal with Daiichi Sankyo.

Early Thursday, Confo Therapeutics put out word of the deal that will be focused on small molecule antagonists to go after an undisclosed target that the company says is associated with CNS diseases.

Confo CEO Cedric Ververken told Endpoints News that Daiichi originally reached out to learn about the biotech’s technology. He added that Confo, founded in 2015, will use its platform to drug a GPCR target that Daiichi has struggled with internally.

When Vigil Neuroscience filed its IPO papers in late 2021, the biotech revealed that the FDA had just cleared its Phase I trial — but with a partial clinical hold that limited dosing to under a certain level.

More than a year later, the FDA has lifted the hold.

Vigil is now free to dose VGL101, an antibody targeting TREM2, at levels higher than 20 mg/kg in its ongoing and future clinical trials in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), an inherited condition that affects the brain and spinal cord.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.