New in­vestors pool $120M to bankroll Al­lo­gene's off-the-shelf CAR-T pipeline in dri­ve to stay in the lead

It was clear from Al­lo­gene Ther­a­peu­tics’ day 1 that Arie Bellde­grun and David Chang were in no short­age of in­vestors ea­ger to back their al­lo­gene­ic CAR-T ther­a­pies: They gath­ered $300 mil­lion in short or­der from a syn­di­cate that fea­tures Pfiz­er, TPG and Vi­da Ven­tures.

The pair of Kite vets have dri­ven the point home again with a $120 mil­lion pri­vate fi­nanc­ing an­nounced Thurs­day morn­ing as they worked to fill out the full team of ex­ecs who will run the show.

David Chang

A con­sid­er­able num­ber of first-time in­vestors jumped on board: Per­cep­tive Ad­vi­sors (which led the fi­nanc­ing), Deer­field Man­age­ment, Fi­deli­ty Man­age­ment, Franklin Tem­ple­ton In­vest­ments, Jen­ni­son As­so­ci­ates, Sur­vey­or Cap­i­tal (a Citadel com­pa­ny), and “ad­di­tion­al large mu­tu­al funds.”

“We are very pleased to sig­nif­i­cant­ly ex­pand our in­vestor base with sup­port from a dis­tin­guished syn­di­cate who un­der­stand the cell ther­a­py land­scape,” said Chang, co-founder and CEO, in a state­ment. “Our goal is to main­tain our lead­er­ship in al­lo­gene­ic CAR T ther­a­py and be the first com­pa­ny to de­vel­op and com­mer­cial­ize an al­lo­gene­ic CAR T prod­uct. This fi­nanc­ing will help us ac­cel­er­ate the de­vel­op­ment of our broad port­fo­lio and in­vest in world class tech­ni­cal op­er­a­tions to make po­ten­tial­ly life­sav­ing cell ther­a­pies more read­i­ly ac­ces­si­ble to pa­tients.”

It’s a big goal that won’t come cheap. And Al­lo­gene is in for the long haul.

“While we are in a very strong fi­nan­cial po­si­tion fol­low­ing our $300 mil­lion fi­nanc­ing in April, we re­ceived much in­ter­est in Al­lo­gene from new in­vestors,” chief com­mu­ni­ca­tions of­fi­cer Chris­tine Cas­siano elab­o­rat­ed in an email. “As we look ahead, it was im­por­tant to not on­ly strength­en our cash po­si­tion, but to build re­la­tion­ships with some very high cal­iber in­vest­ment firms.”

Arie Bellde­grun

Al­lo­gene emerged overnight as a top can­di­date to com­mer­cial­ize the first off-the-shelf CAR-T ther­a­pies by grab­bing Pfiz­er’s port­fo­lio of 16 pre­clin­i­cal tar­gets as well as a part­ner­ship on UCART19, a Phase I as­set co-de­vel­oped by Cel­lec­tis. It’s cur­rent­ly based out of Pfiz­er’s old digs at South San Fran­cis­co,

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, Al­lo­gene is look­ing 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.

Bellde­grun and Chang — who rose to star sta­tus af­ter run­ning and even­tu­al­ly sell­ing Kite to Gilead for $12 bil­lion — have been re­cruit­ing es­teemed ex­ecs to help car­ry out that vi­sion.

Al­i­son Moore joined as chief tech­ni­cal of­fi­cer in June fol­low­ing a ca­reer at Am­gen and Genen­tech; two months lat­er Susie Jun, for­mer­ly of Am­gen and Gilead, jumped from Ab­b­Vie-Stem­cen­trx to be­come the chief de­vel­op­ment of­fi­cer; then there’s David Tillet, SVP of qual­i­ty, who came on board days ago af­ter con­sult­ing with the biotech for some time.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of face plants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Maureen Hillenmeyer, Hexagon Bio CEO

Hexa­gon Bio rais­es $61M to con­tin­ue ef­forts to turn fun­gi in­to drugs

A year after raising a $47 million launch round, the fungi-loving drug hunters at Hexagon Bio have more than doubled their coffers.

Hexagon announced today that it raised another $61 million for its efforts to design cancer and infectious disease drugs based on insights mined from the DNA in millions of species of fungi. The new financing brings Hexagon’s committed funding to over $108 million.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

A few years ago Jean Bennett found herself in a surprising place for a woman who invented the first gene therapy ever approved in the United States: No one, it seemed, wanted her work.

Bennett, who designed and co-developed Luxturna, approved in 2018 for a rare form of blindness, had kept building new gene therapies for eye diseases at her University of Pennsylvania lab. But although the results in animals looked promising, pharma companies and investors kept turning down the pedigreed ophthalmology professor.

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Blue­bird sends blood dis­or­der drug to FDA for ap­proval; CG On­col­o­gy en­ters col­lab­o­ra­tion with Roche for Tecen­triq

Bluebird bio announced it completed the rolling submission of its BLA to the FDA for betibeglogene autotemcel gene therapy.

The therapy, designed for patients with beta-thalassemia who require regular red blood cell transfusions, was previously granted breakthrough therapy designation for treating transfusion-dependent beta-thalassemia (TDT). If approved, beti-cel will be the first hematopoietic stem cell ex-vivo gene therapy for patients in the US.