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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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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Benjamin Oakes, Scribe Therapeutics CEO

CEO of Doud­na spin­out: With­in five years, genome ed­i­tors will have a 're­al­ly big im­pact' on pa­tients' lives

“CRISPR-by-design” is the idea behind Scribe Therapeutics, a company spun out from Jennifer Doudna’s Nobel-winning lab that’s competing in a closely-tracked field of genome editor companies just starting to make their way to the clinic.

After nabbing $100 million last March for its Series B funding round, Scribe is taking a different tack from some of its competitors, crafting a new enzyme isolated from bacteria called CasX, which has now been tweaked extensively and may be targeted to a range of genome-related diseases, offering a plethora of therapeutic options.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.