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

UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,400+ biopharma pros reading Endpoints daily — and it's free.

Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

Suf­fer­ing No­var­tis part­ner Cona­tus is pack­ing it in on NASH af­ter a se­ries of un­for­tu­nate tri­al events

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Gene ther­a­py biotech sees its stock rock­et high­er on promis­ing re­sults for rare cas­es of but­ter­fly dis­ease

Shares of Krys­tal Biotech took off this morn­ing $KRYS af­ter the lit­tle biotech re­port­ed promis­ing re­sults from its gene ther­a­py to treat a rare skin dis­ease called epi­der­mol­y­sis bul­losa.

Fo­cus­ing on an up­date with 4 new pa­tients, re­searchers spot­light­ed the suc­cess of KB103 in clos­ing some stub­born wounds. Krys­tal says that of 4 re­cur­ring and 2 chron­ic skin wounds treat­ed with the gene ther­a­py, the KB103 group saw the clo­sure of 5. The 6th — a chron­ic wound, de­fined as a wound that had re­mained open for more than 12 weeks — was par­tial­ly closed. That brings the to­tal so far to 8 treat­ed wounds, with 7 clo­sures.

Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.

Ab­b­Vie gets a green light to re­sume re­cruit­ing pa­tients for one myelo­ma study — but Ven­clex­ta re­mains un­der a cloud

Three months af­ter reg­u­la­tors at the FDA forced Ab­b­Vie to halt en­rolling pa­tients in its tri­als of a com­bi­na­tion us­ing Ven­clex­ta (vene­to­clax) to treat drug-re­sis­tant cas­es of mul­ti­ple myelo­ma, the agency has green-light­ed the re­sump­tion of one of those stud­ies, while keep­ing the rest on the side­lines.

The CANO­VA (M13-494) study can now get back in busi­ness re­cruit­ing pa­tients to test the drug for a pop­u­la­tion that shares a par­tic­u­lar ge­net­ic bio­mark­er. To get that per­mis­sion, Ab­b­Vie — which is part­nered with Roche on this pro­gram — was forced to re­vise the pro­to­col, mak­ing un­spec­i­fied changes in­volv­ing risk mit­i­ga­tion mea­sures, pro­to­col-spec­i­fied guide­lines and an up­dat­ed fu­til­i­ty cri­te­ria.

Bris­tol-My­ers star Op­di­vo fails sur­vival test in a matchup with Nex­avar aimed at shak­ing up the big HCC mar­ket

Bris­tol-My­ers Squibb has suf­fered an­oth­er painful set­back in its years-long quest to ex­pand the reach of Op­di­vo. The phar­ma gi­ant this morn­ing not­ed that their Check­mate-459 study com­par­ing Op­di­vo with Bay­er’s Nex­avar in front­line cas­es of he­pa­to­cel­lu­lar car­ci­no­ma — the most com­mon form of liv­er can­cer — failed to hit the pri­ma­ry end­point on over­all sur­vival.

This was a sig­nif­i­cant mile­stone in Bris­tol-My­ers’ tal­ly of PD-1 cat­a­lysts this year. Nex­avar (so­rafenib) has been the stan­dard of care in front­line HCC for the past decade, though Op­di­vo has been mak­ing head­way in sec­ond-line HCC cas­es, where it’s go­ing toe-to-toe with Bay­er’s Sti­var­ga (re­go­rafenib) af­ter re­cent ap­provals shook up the mar­ket.

Dean Hum. Nasdaq via YouTube

Gen­fit goes to Chi­na with a deal worth up to $228M for NASH drug

Fresh off the high of its Nas­daq IPO de­but, and the low of com­par­isons to Cymabay — whose NASH drug re­cent­ly stum­bled — Gen­fit on Mon­day un­veiled an up to $228 mil­lion deal with transpa­cif­ic biotech Terns Phar­ma­ceu­ti­cals to de­vel­op its flag­ship ex­per­i­men­tal liv­er drug — elafi­bra­nor — in Greater Chi­na.

The deal comes weeks af­ter Gen­fit $GN­FT is­sued a fiery de­fense of its dual PPAR ag­o­nist elafi­bra­nor, when com­peti­tor Cymabay’s PPARδ ag­o­nist, se­ladel­par, fiz­zled in a snap­shot of da­ta from an on­go­ing mid-stage tri­al. The main goal at the end of 12 weeks was for se­ladel­par to in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in liv­er fat con­tent, but da­ta showed that pa­tients on the place­bo ac­tu­al­ly per­formed bet­ter.