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 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.


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