David Hal­lal brings his first cell ther­a­py com­pa­ny in­to the fold, and it's tied to a ma­jor league fi­nanc­ing deal

David Hal­lal wasn’t kid­ding around when he said that his start­up El­e­vate­Bio was ready to do busi­ness.

David Hal­lal AlloVir

The ex-Alex­ion CEO is un­veil­ing his first port­fo­lio deal for his $150 mil­lion cell and gene ther­a­py start­up El­e­vate­Bio this morn­ing. And it’s tied in­to a ma­jor league fi­nanc­ing round that puts Hal­lal’s team right on the thresh­old of a Phase III cam­paign, with an im­me­di­ate need to ramp up man­u­fac­tur­ing and start lay­ing the foun­da­tion for po­ten­tial com­mer­cial work.

Bay­lor spin­out AlloVir, which has been op­er­at­ing in Hous­ton up to now as Vira­Cyte, is tak­ing up of­fi­cial res­i­dence in Cam­bridge un­der the guid­ance of the El­e­vate­Bio team, which will lend its ex­per­tise to build up man­u­fac­tur­ing and more need­ed for a loom­ing Phase III piv­otal study and com­mer­cial­iza­tion prep. The biotech will keep its small re­search team in Hous­ton, which will now co­or­di­nate with Hal­lal’s group.

AlloVir, which had large­ly been run on grant mon­ey to date, is al­so get­ting a $120 mil­lion megaround to pay the bills for late-stage de­vel­op­ment. And the raise in­cludes some big names, in­di­cat­ing that a large amount of ven­ture mon­ey is avail­able for more deals. The round was led by Fi­deli­ty Man­age­ment and Re­search Com­pa­ny, with Gilead Sci­ences, F2 Ven­tures, Red­mile Group, In­vus, EcoR1 Cap­i­tal, Sam­sara Bio­Cap­i­tal, and Leerink Part­ners Co-in­vest­ment Fund chip­ping in.

Ann Leen AlloVir

AlloVir had come to a cross­roads, says Hal­lal, in talks with po­ten­tial phar­ma part­ners but al­so with “a hope the AlloVir founders could stay with their in­no­va­tion as long as pos­si­ble and even see it get to pa­tients.”

“It’s an im­mune sys­tem in a dish,” is how com­pa­ny CSO and Bay­lor pro­fes­sor Ann Leen de­scribes it. The cells are ex­tract­ed from healthy pa­tients with the right char­ac­ter­is­tics, then ex­pand­ed and prepped for use on pa­tients whose im­mune sys­tems have been com­pro­mised.

“It’s not ge­net­i­cal­ly mod­i­fied,” stress­es Leen. “We can man­u­fac­ture re­al­ly huge num­bers of these cells.”

A uni­ver­si­ty spin­out can do a great job with the sci­ence right through the Phase II read­out, she adds. But Phase III, scal­ing up man­u­fac­tur­ing and think­ing of a glob­al plan is an­oth­er ball­game en­tire­ly.

Why AlloVir as the first El­e­vate­Bio port­fo­lio com­pa­ny?

It’s not a big op­er­a­tion, just a hand­ful of staffers, says Hal­lal. He likes the tech­nol­o­gy and the peo­ple in­volved. It al­so un­der­scores his in­ter­est in build­ing up a full range of port­fo­lio com­pa­nies, from ear­ly-stage right through to a late-stage play­er like AlloVir. And more deals like this are com­ing.

A lit­tle less than 2 years ago, AlloVir ran their lead prod­uct Vi­ra­lym-M through a Phase II pro­gram, test­ing their off-the-shelf T-cell im­munother­a­py on 38 stem cell trans­plant pa­tients suf­fer­ing from 45 dif­fer­ent drug-re­sis­tant vi­ral in­fec­tions trig­gered by 5 tar­get­ed virus­es. 

Here’s the nut graph from their re­lease at the time:

Vi­ra­lym-M achieved a 92% over­all clin­i­cal re­sponse af­ter a sin­gle in­fu­sion and demon­strat­ed ef­fi­ca­cy against all five tar­get­ed virus­es with the fol­low­ing cu­mu­la­tive re­sponse rates in in­fec­tions re­frac­to­ry to stan­dard ther­a­py: 100% for BK virus (n=16), 94% for cy­tomegalovirus (n=17), 71% for ade­n­ovirus (n=7), 100% for Ep­stein-Barr virus (n=2) and 67% for hu­man her­pesvirus-6 (n=3). Thir­ty-one pa­tients were treat­ed for a sin­gle vi­ral in­fec­tion and sev­en pa­tients were treat­ed for mul­ti­ple si­mul­ta­ne­ous in­fec­tions. No­tably, rapid dis­ease al­le­vi­a­tion was re­port­ed in pa­tients with BK-as­so­ci­at­ed he­m­or­rhag­ic cys­ti­tis (BK-HC), which can cause in­ca­pac­i­tat­ing pain, sig­nif­i­cant blood loss, and po­ten­tial­ly re­nal fail­ure. 

Hal­lal and Leen de­scribe AlloVir as a plat­form com­pa­ny, with plans to ex­tend their re­search work in­to new pro­grams as well as tak­ing on im­mune-com­pro­mised pa­tients fol­low­ing sol­id or­gan trans­plants. 

Now they have mon­ey for all of that, plus Phase III.


Im­age: Allovir

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.

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.

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Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

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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New safe­ty da­ta ex­pose po­ten­tial weak­ness as Pfiz­er's abroc­i­tinib takes on Dupix­ent in eczema

Last September, when Pfizer celebrated positive data from a second Phase III study of abrocitinib, many watchers applauded the efficacy but were still waiting to see whether the JAK1 inhibitor is “safe enough to be a formidable competitor to Dupixent,” the clear leader in the atopic dermatitis field. The full slate of safety data are now out and, according to one analyst, the answer is: probably not.