Tech con­glom­er­ate buys Me­di­da­ta for $5.7B; Alexan­dria teams up with Co­lum­bia for sec­ond Launch­Labs; So­bi all in on ema­palum­ab

→ Clin­i­cal tri­al soft­ware provider Me­di­da­ta is get­ting ac­quired in a $5.8 bil­lion deal. The all-cash buy­er, Das­sault Sys­temes, is a French tech­nol­o­gy com­pa­ny that’s his­tor­i­cal­ly fo­cused on 3D de­sign and en­gi­neer­ing. “Life sci­ence is go­ing to go through an ac­cel­er­at­ed dig­i­ti­za­tion of its own process­es, ba­si­cal­ly,” Das­sault CEO Bernard Charles told CN­BC. Hav­ing pow­ered op­er­a­tions and da­ta analy­sis for hun­dreds of bio­phar­ma com­pa­nies, CROs and re­searcher cen­ters, Me­di­da­ta’s plat­form is poised to lead the vir­tu­al trans­for­ma­tion in the in­dus­try, he added.

→ Swedish rare dis­ease play­er So­bi is re­struc­tur­ing its op­er­a­tions to fo­cus on hema­tol­ogy and im­munol­o­gy. Dis­cov­ery, ear­ly re­search and part­ner R&D pro­grams out­side of those core ar­eas are be­ing axed, claim­ing 90 po­si­tions and a cou­ple of projects that will now be di­vest­ed. One of the stars of the pipeline will be Gam­i­fant (ema­palum­ab), an in­ter­fer­on gam­ma in­hibitor it had li­censed from Novim­mune but now de­cides to ac­quire out­right. The deal, which adds over $100 mil­lion to the $400 mil­lion orig­i­nal pact, al­so cov­ers em­ploy­ees in­volved in the pro­gram as well as a pri­or­i­ty re­view vouch­er.

→ Mar­quee bio­phar­ma re­al es­tate de­vel­op­er Alexan­dria is open­ing its sec­ond Launch­Labs in New York City, team­ing up with Co­lum­bia Uni­ver­si­ty to in­cu­bate star­tups emerg­ing from there and peer in­sti­tu­tions. As with Alexan­dria Launch­Labs, mem­ber com­pa­nies have ac­cess to of­fice and lab space, men­tor­ship and net­work­ing op­por­tu­ni­ties, as well as seed cap­i­tal to get things go­ing. The pre­vi­ous co­hort of 20 star­tups have gone on to raise more than $300 mil­lion in fi­nanc­ing, Alexan­dria said.

De­nali has scored or­phan drug and rare pe­di­atric dis­ease des­ig­na­tions for its pre­clin­i­cal pro­gram DNL310. The drug is de­signed to re­place the de­fi­cient IDS en­zyme in pa­tients with Hunter Syn­drome us­ing a re­com­bi­nant form of IDS en­gi­neered to cross the blood-brain bar­ri­er us­ing De­nali’s sig­na­ture tech. A Phase I/II is planned for next year.

Sor­ren­to is weigh­ing an IPO for Scilex, a re­con­fig­u­ra­tion of the biotech it ac­quired for $47.6 mil­lion back in 2016. Af­ter ZTli­do was ap­proved by the FDA, Sor­ren­to merged Scilex with an­oth­er sub­sidiary Sem­nur, which had a non-opi­oid cor­ti­cos­teroid gel in Phase III stud­ies, en­vi­sion­ing a com­mer­cial com­pa­ny fo­cused on pain man­age­ment.

→ Des­per­ate for a turn­around and still mired in dra­ma with its ex-CEO, MiMedx has se­cured a three-year loan from Blue Torch Fi­nance to­tal­ing $75 mil­lion. With the cash in­fu­sion, in­ter­im CFO Ed Borkows­ki said, ex­ecs can work on plan­ning and com­plet­ing the fi­nan­cial re­state­ment.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Caught in a stand­off with its con­tract man­u­fac­tur­er over Covid-19 vac­cine, In­ovio files suit in an at­tempt to break free while ri­vals race ahead

Inovio was one of the first vaccine developers to snag attention for a jab that their execs said promised to end the Covid-19 pandemic. Using their own unique DNA tech, CEO Joseph Kim said it took just 3 hours to work it out.

But while rivals are racing to the finish line with ambitious plans to make vast quantities of their vaccines with billions of dollars of deals, Inovio is still stuck at the starting line on manufacturing.