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.”

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.

Patrick Enright, Longitude co-founder (Longitude)

As its biotechs hit the pan­dem­ic ex­it, Lon­gi­tude rais­es $585M for new neu­ro, can­cer, ag­ing and or­phan-fo­cused fund

The years have been kind to Longitude Capital. This year, too.

A 2006 spinout of Pequot Capital, its founders started their new firm just four years before the parent company would go under amid insider trading allegations. Their first life sciences fund raised $325 million amid the financial crisis, they added a second for $385 million and then in, 2016, a third for $525 million. In the last few months, the pandemic biotech IPO boom netted several high-value exits from those funds, as Checkmate, Vaxcyte, Inozyme and Poseida all went public.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Isaac Veinbergs, Libra CEO

With $29M in Se­ries A, Boehringer-backed Li­bra looks to tack­le neu­rode­gen­er­a­tion through cel­lu­lar clean­ing

Can the natural process by which cells clean out toxic proteins be harnessed to create potential treatments for neurodegenerative disorders?

That’s the question Libra Therapeutics will be trying to answer, as the new biotech officially launched Wednesday morning with $29 million in Series A financing. The company has three preclinical programs at the ready, with its lead candidate targeting ALS and frontotemporal dementia. But CEO Isaac Veinbergs said he hopes to develop therapies for a wide range of diseases, including Parkinson’s, Alzheimer’s and Huntington’s.

Gene Wang, Immetas co-founder and CEO (file photo)

Im­metas Ther­a­peu­tics nabs $11M Se­ries A to nar­row their bis­pe­cif­ic work tar­get­ing in­flam­ma­tion in age-re­lat­ed dis­eases

How does a biotech celebrate its two-year anniversary? For Immetas Therapeutics, it’s with an $11 million Series A round and a game plan to fight age-related disease.

Co-founders Gene Wang and David Sinclair came together years ago around the idea that inflammation is the ultimate process driving age-related illnesses, including cancer. The duo launched Immetas in 2018 and packed the staff with industry experts. Wang, who says he’s always had an entrepreneurial spirit, has held lead roles at Novartis, GSK, Bristol Myers Squibb and Merck. He’s worked on blockbuster drugs like Humira, Gardasil, Varubi and Zolinza. And now, he’s channeling that spirit as CEO.

News brief­ing: PureTech plans Nas­daq de­but with sec­ondary list­ing; GoodRx prices $725M IPO

London Stock Exchange-listed PureTech Health announced Wednesday that it’s looking to extend to Nasdaq. But due to its “strong cash position,” the biotech says it isn’t issuing any new shares in the potential secondary listing.

The company’s shares closed at £256.50 Tuesday on the London Stock Exchange. Its candidate LYT-100 is currently in Phase I development for various indications, including lymphatic flow disorders and fibrotic and inflammatory disorders. PureTech is expecting a Phase Ib readout in lymphatic flow disorders later this year, and is also planning to launch a Phase II study for the drug to treat respiratory conditions experienced after Covid-19.

Rep. Andy Harris (R-MD) (Tasos Katopodis/Pool via AP Images)

The mi­cro-cap that tapped a mask-skep­tic con­gress­man for their Covid DSMB is ap­ply­ing for an EUA. Their ev­i­dence? 21 pa­tients

NeuroRx, the tiny biotech that came under fire last week after Politico reported they selected a congressman and two other acquaintances of the CEO to supervise their Covid-19 drug trial, announced today that they will ask the FDA to authorize their drug based on the results of just 21 patients.

Such an application would test the agency’s standards of evidence for an EUA, which have already come under scrutiny after controversial authorizations for convalescent plasma and hydroxychloroquine. The only other company to discuss their intention to file for an EUA, Eli Lilly, did so after results came back from a randomized control study testing their antibody in over 450 patients.