Arie Bellde­grun rais­es $300M, grabs Pfiz­er’s al­lo­gene­ic CAR-T port­fo­lio and launch­es a ground­break­ing dri­ve to com­mer­cial­iza­tion

Af­ter pi­o­neer­ing one of the first per­son­al­ized CAR-T ther­a­pies to be ap­proved by the FDA, Kite vets Arie Bellde­grun and re­search chief David Chang have now launched a new biotech with a whop­ping $300 mil­lion in cash fi­nanc­ing and a col­lab­o­ra­tion with Cel­lec­tis af­ter bag­ging the full port­fo­lio of off-the-shelf CAR-T drugs in de­vel­op­ment at Pfiz­er.

Bellde­grun — who came away with a for­tune of more than $600 mil­lion from the sale of the biotech to Gilead — tells me he gained swift back­ing from a broad syn­di­cate to cre­ate Al­lo­gene Ther­a­peu­tics. And they’re jump­ing out of stage left with a deal that gives them con­trol of Pfiz­er’s CAR-T port­fo­lio, which in­cludes rights to the ear­ly-stage UCART19 al­lied with Paris-backed Cel­lec­tis.

In ex­change, Pfiz­er is get­ting a 25% stake in Al­lo­gene, which im­me­di­ate­ly vaults from out of nowhere in­to a lead­ing po­si­tion among de­vel­op­ers of off-the-shelf CAR-T ther­a­pies, look­ing to leapfrog the first gen­er­a­tion of per­son­al­ized CAR-Ts that use reengi­neered pa­tient cells.

“We have every one of the in­ter­est­ing tar­gets that I’m aware of,” says Bellde­grun, the new­ly mint­ed ex­ec­u­tive chair­man at Al­lo­gene, with Chang tak­ing the CEO job. And they’re ready to get to work with Cel­lec­tis, Servi­er and every­one else en­gaged in the “Man­hat­tan project” of bring­ing the first al­lo­gene­ic CAR-T to mar­ket.

“This is the biggest project,” Bellde­grun says. “This is where cel­lu­lar ther­a­py will find its way.”

David Chang

Bellde­grun and Chang told me in a pre­view of the an­nounce­ment Mon­day evening that the deal be­gan to come to­geth­er the night they were cel­e­brat­ing the close of the Kite sale, when one of the bankers in­volved told them about a po­ten­tial deal he knew of.

In­stead of a leisure­ly va­ca­tion break, what fol­lowed was 5 months of in­tense ne­go­ti­a­tions, in which Bellde­grun got a close, up­front look at the 16 tar­gets that a team of 70 Pfiz­er in­ves­ti­ga­tors have been work­ing on for the past 4 years, along with UCART19, the 17th pro­gram in the deal.

“I looked at the da­ta and said ‘David, we need to do this, it’s a gold mine.’ It’s a deal I couldn’t refuse,” says Bellde­grun. “We know it’s the fu­ture.”

In­stead of a lengthy and ex­pen­sive per­son­al­ized au­tol­o­gous ap­proach that re­quires the ex­trac­tion and reengi­neer­ing of pa­tient cells in­to a po­tent ther­a­py that has proved par­tic­u­lar­ly ef­fec­tive in blood can­cers, Bellde­grun will now look to per­fect a gene edit­ing process that can de­vel­op 50 to 100 ther­a­peu­tic batch­es from a sin­gle donor. If it works, it will be cheap­er and faster than the first CAR-Ts, Yescar­ta and Kym­ri­ah.

This was a deal that in­volved “mul­ti­ple” bid­ders, says Bellde­grun, will­ing to pay a sig­nif­i­cant amount to buy in. But he says he and Chang were able to put to­geth­er the win­ning of­fer by keep­ing Pfiz­er close­ly en­gaged in the start­up and a clin­i­cal dri­ve that could get them to the thresh­old of com­mer­cial­iza­tion in just a few years.

With back­ers deeply im­pressed by their $12 bil­lion sale of Kite to Gilead, Bellde­grun and Chang are work­ing with in­vest­ments from TPG, Vi­da Ven­tures, Bell­Co Cap­i­tal, the Uni­ver­si­ty of Cal­i­for­nia Of­fice of the Chief In­vest­ment Of­fi­cer and Pfiz­er.

The pair of en­tre­pre­neurs are get­ting a team of about 50 Pfiz­er in­ves­ti­ga­tors to trans­fer over in the deal, tak­ing over Pfiz­er space for now in South San Fran­cis­co as they scout their own new digs. And Bellde­grun says they have al­ready lined up a string of “top notch” play­ers to join the com­pa­ny. 

You can ex­pect the pay­roll to dou­ble in the next year, he adds.

An­dré Chouli­ka

The deal teams Bellde­grun and Chang with Cel­lec­tis CEO An­dré Chouli­ka, the French biotech ex­ec who’s been steer­ing the first off-the-shelf CAR-T in­to hu­man stud­ies. Servi­er and Pfiz­er launched a land­mark tri­al of Cel­lec­tis’ UCART19 for acute lym­phoblas­tic leukemia, get­ting the green light to ex­pand from the UK in­to US sites a year ago.

I ran in­to Chouli­ka at an an­a­lysts meet­ing Bellde­grun or­ga­nized for Kite in New York a cou­ple of years ago. It struck me as odd see­ing the al­lo­gene­ic leader at the ri­val au­tol­o­gous gath­er­ing, but Chouli­ka tells me it was part of a long re­la­tion­ship that has con­verged in­to this new deal.

“Arie and my­self have been talk­ing for a long time,” Chouli­ka told me. The mu­tu­al re­spect they de­vel­oped, he says, com­bined with Kite’s ster­ling rep for ex­e­cu­tion, helped bring it all to­geth­er.

“I was con­vinced that Kite would be the win­ner in the au­tol­o­gous space,” says Chouli­ka. And he thinks the new team at Al­lo­gene, com­bined with Cel­lec­tis’ know-how on gene edit­ing, will ac­cel­er­ate the work on their lead ther­a­py, with a shot at com­mer­cial­iza­tion work in late 2021 or ’22.

The tech­nol­o­gy may be still ap­pear to be quite ear­ly, but Bellde­grun paints a pic­ture of glob­al in­vestors ea­ger to get in now. 

The $300 mil­lion came to­geth­er in a mat­ter of weeks, says Bellde­grun, who adds that it would have been easy to raise twice that amount. For now, he’s not short of cash — and he says he and Chang al­so put their own mon­ey in­to the deal. As they go for­ward, con­sid­er­ing the need to build their own ded­i­cat­ed man­u­fac­tur­ing, he ex­pects they’ll be able to raise more cash as need­ed.

So why not take the mon­ey from the Kite deal and take an ex­tend­ed va­ca­tion?

“I think at the end it’s not mon­ey that dri­ves what we do,” says Chang, who was cleared to leave Kite in Feb­ru­ary af­ter stay­ing on for the tran­si­tion. “It’s re­al­ly the ac­tiv­i­ty that will sat­is­fy you, or some­thing that’s deep down in you.”

Tillman Gerngross, Adagio Therapeutics CEO

An­ti­body leg­end Till­man Gern­gross is el­bow­ing his way in­to the Covid-19 R&D cru­sade: 'I don’t see this end­ing any­time soon'

One of the most influential — and outspoken — scientists at work in the field of antibody discovery is jumping into the frenzied race to create new therapeutics to treat and prevent Covid-19. And he’s operating with the conviction that the current outbreak now once again spreading like wildfire will create plenty of demand for what he has in mind.

Dartmouth professor and Adimab CEO Tillman Gerngross tells me he’s raised $50 million from a group of close VCs to spin out a new company — Adagio Therapeutics — with a full C-suite team assembled to hire up a staff and keep rolling toward the clinic.

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Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

John Furey, Imvax CEO

A neu­ro­sur­geon spent the past 30 years de­vel­op­ing a neoanti­gen tu­mor vac­cine. Now he has $112M for a piv­otal test

As a neurosurgeon, David Andrews knew there wasn’t much he could do for his glioma patients after resecting — rarely fully — their tumor. Even with the best treatment and care available, median overall survival is just somewhere between 14 and 16 months.

Then in the 1990s, his mentor at Thomas Jefferson University introduced him to Renato Baserga, a pathologist who had been studying the effect of using antisense oligonucleotide to knock out the insulin-like growth factor type 1 receptor in cancers. As IGF-R1 drives tumor growth and metastasis, the preclinical reasoning went, implanting a molecule targeting the receptor together with the tumor material near lymph nodes can slow down the spread of the cancer.

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New biotech Exalys, seek­ing to pre­vent post­op­er­a­tive delir­i­um, launch­es with $15 mil­lion in Se­ries A

An old group of former colleagues will be reuniting to lead a new biotech venture aimed at cultivating a portfolio to treat neuroinflammatory disorders.

Led by Rick Orr, who ran the biotech Adynxx, the group is launching the startup Exalys on Thursday with $15 million in Series A funding from venture firms Catalys Pacific and Domain Associates. The nascent company’s first project will focus on preventing postoperative delirium, licensing a platform of EP4 receptors from Japanese pharma Eisai.

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One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

GSK’s Shin­grix leader Guil­laume Pfe­fer has jumped on board Flag­ship to helm a biotech hy­brid as Afeyan’s lat­est CEO-part­ner

After spending 4 years in a senior post with GlaxoSmithKline’s star team positioning Shingrix for a blockbuster approval, Guillaume Pfefer is headed back to the biotech world — in style.

Pfefer has signed on to join Noubar Afeyan’s busy group of partners at Flagship, and he’s taking the helm of an upstart — which today is being merged with another Flagship startup — with some grand plans of its own. The announcement this morning notes that Pfefer will run Kintai Therapeutics, one of the grads of the Flagship labs.

Donald Trump and Anthony Fauci (AP Images)

Covid-19 roundup: Rus­sia hack­ers tar­get US, UK vac­cine and drug re­searchers; Fau­ci fires back at White House cam­paign to un­der­mine him

Russia has tried to steal a Covid-19 vaccine and therapeutics researcher from pharmaceutical and academic institutions in the US, UK and Canada, Britain’s National Cyber Security Centre said Thursday.

The NCSC said that hacking attempts came from a group known as APT129, also known as “Cozy Bear,” that “almost certainly operate as part of Russian intelligence services.” The Canadian Communication Security Establishment, US Department for Homeland Security, the Cybersecurity Infrastructure Security Agency, and the National Security Agency shared the assessment, the NCSC said.

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BioAt­la rakes in $72.5M Se­ries D, ad­vanc­ing re­search for pH-de­tect­ing can­cer treat­ments

A little over a year after agreeing to a worldwide collaboration with hefty Chinese biotech BeiGene worth up to $270 million, BioAtla is ready for another haul.

The San Diego-based biotech pulled in a $72.5 million haul for their Series D financing, which the company announced Wednesday. Funds will go toward their four main clinical programs developing cancer treatments, two of which are currently in Phase II, BioAtla president and former Celgene COO Scott Smith said.