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

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.


ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology


ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development


CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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SEC calls out lit­tle Ther­a­peu­tic­sMD for its in­sid­er con­tacts with an­a­lysts to boost share price, then halt rout

Back in May 2017, following an FDA rejection, TherapeuticsMD saw its share price plummet to the lowest levels in two years. The little Florida biotech eventually found its way back to the good side of regulators, scoring a curious OK a year later for its therapy preventing vaginal pain during sex. But the SEC is now accusing it of selectively disclosing nonpublic information in attempts to manipulate its stock.

In two instances in June and July of 2017, TherapeuticsMD allegedly violated the Regulation Fair Disclosure rule by sharing material information with certain sell-side analysts and not the public, resulting in a more favorable stock move than otherwise would be expected.

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Therapists Marcela Ot'alora and Bruce Poulter are trained to conduct MDMA-assisted psychotherapy. In this reenactment, they demonstrate how they help guide and watch over a patient who is revisiting traumatic memories while under the influence of MDMA. (Photo: Multidisciplinary Association for Psychedelic Studies)

MD­MA, now in Phase III, shows promise as a PTSD treat­ment

The first time Lori Tipton tried MDMA, she was skeptical it would make a difference.

“I really was, at the beginning, very nervous,” Tipton said.

MDMA is the main ingredient in the club drug known as ecstasy or molly. But Tipton wasn’t taking pills sold on the street to get high. She was trying to treat her post-traumatic stress disorder by participating in a clinical trial.

After taking a dose of pure MDMA, Tipton lay in a quiet room with two specially trained psychotherapists. They sat next to her as she recalled some of her deepest traumas, such as discovering her mother’s body after Tipton’s mother killed two people and then herself in a murder-suicide.

Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

UP­DAT­ED: As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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Ted Ashburn. Oncorus

Cowen, Per­cep­tive lead $79.5M Se­ries B for 's­tand­out' biotech shep­herd­ing on­colyt­ic virus to clin­ic

As several Big Pharma players secure biotech partners in the oncolytic virus space for new immuno-oncology combos, Cowen and Perceptive Advisors have come out with their own bet on a startup that promises to shine.

The marquee investors are joining MPM, Deerfield, Celgene, Astellas, Arkin and UBS in backing the drug developer, Oncorus, which will now deploy the $79.5 million in Series B cash toward clinical development of its lead program. Other new investors include Surveyor Capital, Sphera Funds, IMM Investment, QUAD Investment Management, UTC Investment, SV Investment Corp and Shinhan Investment-Private Equity, the last five of which are Korean-based funds.

Fu­til­i­ty analy­sis au­gurs de­feat in piv­otal tri­al test­ing of Nu­Cana's lead drug in metasta­t­ic pan­cre­at­ic can­cer

Nearly two years after making its public debut, UK-based NuCana’s mission to make chemotherapies more potent and safer was dealt a blow, after a pivotal study testing its lead experimental drug halted enrollment in a hard-to-treat advanced form of cancer, following a futility analysis.

The drug, Acelarin, is being evaluated for use in metastatic pancreatic cancer patients who were not considered suitable for combination chemotherapy. In the late-stage ACELARATE study — which compared the experimental drug against the chemotherapy gemcitabine — 200 patients had been enrolled by the sponsor, Clatterbridge Cancer Centre, before an analysis from an independent safety and data monitoring panel suggested the study’s main goal would not be met.