Arie Bellde­grun and David Chang score record IPO, now they plan to win the race to a his­toric FDA OK

Arie Bellde­grun and David Chang are once again in the race of a life­time — and they plan to stay in the lead to the first pi­o­neer­ing FDA OK in the field.

The two ex-Kite ex­ecs have pulled off the biggest biotech IPO of their gen­er­a­tion, up­siz­ing the of­fer­ing to 18 mil­lion shares and pric­ing at $18 a share — the top of the range.

Arie Bellde­grun

The Al­lo­gene of­fer­ing brought in $324 mil­lion, peg­ging the mar­ket val­ue of the com­pa­ny at $2.2 bil­lion, and un­der­writ­ers will soon have a chance to boost that some more. That sum edges out Ax­o­vant, which raised $315 mil­lion in 2015 to back an Alzheimer’s drug that turned out to be a com­plete bust.

“So far I have not seen a com­pa­ny that is all about al­lo­gene­ic,” Bellde­grun tells me in a phone in­ter­view, dis­cussing the off-the-shelf ap­proach to CAR-T they scooped up from Pfiz­er. “This is a huge op­por­tu­ni­ty.”

“We want to be in the lead,” he adds.

To do that, Al­lo­gene can now re­ly on a war chest filled with the bulk of the mon­ey raised in a mon­ster, $744 mil­lion fundrais­ing blitz through the year.

The next big tran­si­tion point comes in the first half next year, when they go in­to the clin­ic with their lead ther­a­py. If they stay on sched­ule — fol­low­ing an al­ways haz­ardous course of clin­i­cal de­vel­op­ment — Chang says they could grab piv­otal da­ta by the end of 2021. In the mean­time, they’ll al­so ush­er in an­oth­er clin­i­cal pro­gram in 2019, with an­oth­er ther­a­py that could pur­sue mul­ti­ple in­di­ca­tions in on­col­o­gy.

The pair have been there be­fore, rac­ing No­var­tis on per­son­al­ized CAR-T ther­a­pies. The phar­ma gi­ant just bare­ly edged them out. But that was a tech­nol­o­gy that was 15 years in the mak­ing, says Bellde­grun. Now they have a host of new tools, like gene edit­ing, at their dis­pos­al. And by carv­ing out a Pfiz­er group with 40 core staffers and a 4-year track record in pre­clin­i­cal work, they plan to make rel­a­tive­ly quick work of this new race.

We’ll see lat­er to­day how in­vestors like the lat­est biotech uni­corn to hit the Nas­daq, where Bellde­grun and Chang made their mark with Kite Phar­ma — which sold to Gilead for $12 bil­lion, mak­ing in­vestors a bit gid­dy.

David Chang

Over the last 6 months they’ve raised $744 mil­lion for the com­pa­ny in the wake of in-li­cens­ing Pfiz­er’s off-the-shelf CAR-T port­fo­lio, a fig­ure that would have been con­sid­ered some­thing of a pipe dream be­fore 2018 came around.

Now that the mon­ey blitz is done, open­ing up a 3-year run­way to an ap­point­ment with the FDA, the com­pa­ny will con­tin­ue a quest to de­vel­op the world’s first off-the-shelf CAR-T, a sci­en­tif­ic chal­lenge that could swipe aside the pi­o­neer­ing per­son­al­ized drugs that are now on the mar­ket at No­var­tis and Gilead.

They’ve al­ready dou­bled the size of the orig­i­nal team, and more hires are to come. Al­lo­gene al­so has some am­bi­tious plans to es­tab­lish a lead­ing man­u­fac­tur­ing ef­fort, which will be key to their ul­ti­mate suc­cess in the field.

Gold­man Sachs & Co, J.P. Mor­gan Se­cu­ri­ties, Cowen and Com­pa­ny, and Jef­feries are act­ing as the joint book-run­ning man­agers for the of­fer­ing. 

This year we’ve seen a rapid surge in new biotech IPOs, which was large­ly un­ex­pect­ed af­ter a cou­ple years of steady run­ning. And once again Bellde­grun and Chang have their tim­ing down per­fect­ly. In­evitably, a deal like this will raise ques­tions about just how hot things are on the Nas­daq right now, and whether we’re in a bub­ble.

But it’s not over yet.

Sanofi brings in 4 new ex­ec­u­tives in con­tin­ued shake-up, as vac­cines and con­sumer health chief head out the door

In the middle of Sanofi’s multi-pronged race to develop a Covid-19 vaccine, David Loew, the head of their sprawling vaccines unit, is leaving – part of the final flurry of moves in the French giant’ months-long corporate shuffle that will give them new-look leadership under new CEO Paul Hudson.

The company also said today that Alan Main, the head of their consumer healthcare unit, is out, and they named 4 executives to fill new or newly vacated positions, 3 of whom come from both outside both Sanofi and from Pharma.

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As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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Ab­b­Vie wins an ap­proval in uter­ine fi­broid-as­so­ci­at­ed heavy bleed­ing. Are ri­vals My­ovant and Ob­sE­va far be­hind?

Women expel on average about 2 to 3 tablespoons of blood during their time of the month. But with uterine fibroids, heavy bleeding is typical — a third of a cup or more. Drugmakers have been working on oral therapies to try and stem the flow, and as expected, AbbVie and their partners at Neurocrine Biosciences are the first to make it across the finish line.

Known chemically as elagolix, the drug is already approved as a treatment for endometriosis under the brand name Orilissa. It targets the GnRH receptor to decrease the production of estrogen and progesterone.

David Chang, Allogene CEO (Jeff Rumans)

Head­ed to PhII: Al­lo­gene CEO David Chang com­pletes a pos­i­tive ear­ly snap­shot of their off-the-shelf CAR-T pi­o­neer

Allogene CEO David Chang has completed the upbeat first portrait of the biotech’s off-the-shelf CAR-T contender ALLO-501 at virtual ASCO today, keeping all eyes on a drug that will now try to go on to replace the first-wave personalized pioneers he helped create.

The overall response rate outlined in Allogene’s abstract for treatment-resistant patients with non-Hodgkin lymphoma slipped a little from the leadup, but if you narrow the patient profile to treatment-naïve patients — removing the 3 who had previous CAR-T therapy who didn’t respond, leaving 16 — the ORR lands at 75% with a 44% complete response rate. And 9 of the 12 responders remained in response at the data cutoff, offering a glimpse on durability that still has a long way to go before it can be completely nailed down.

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Roger Perlmutter, Merck R&D chief (YouTube)

Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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As­traZeneca’s $7B ADC suc­ceeds where Roche failed, im­prov­ing sur­vival in gas­tric can­cer

Another day, another win for Enhertu.

The antibody-drug conjugate AstraZeneca promised up-to $7 billion to partner on has had a quite a few months, beginning with splashy results in a Phase II breast cancer trial, a rapid approval and, earlier this month, breakthrough designations in both non-small cell lung cancer and gastric cancer.

Now, at ASCO, the British pharma and their Japanese partner, Daiichi Sankyo, have shown off the data that led to the gastric cancer designation, which they’ll take back to the FDA. In a pivotal, 187-person Phase II trial, Enhertu shrunk tumors in 42.9% of third-line patients with HER2-positive stomach cancer, compared with 12.5% in a control arm where doctors prescribed their choice of therapy. Progression-free survival was 5.4 months for Enhertu compared to 3.5 months for the control.