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.

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

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Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

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No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

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As­traZeneca gains EU nod for di­a­betes triple; Am­gen and Duke launch re­al-world PC­SK9 ob­ser­va­tion­al study

→ Weeks after winning EU approval to start marketing dapagliflozin as Forxiga, AstraZeneca has racked up another OK for a triplet combo involving the SGLT2 diabetes drug. Named Qtrilmet, the pill combines Forxiga with the DPP-4 inhibitor Onglyza (saxagliptin) and the bedrock drug metformin in a modified-release format. That 3-in-1 approach proved superior in reducing average blood glucose levels to a number of other dual combinations across 5 Phase III trials, including Forxiga plus metformin, Onglyza with metformin, or glimepiride with metformin.

Five drugs, in­clud­ing two No­var­tis ther­a­pies, win EMA en­dorse­ment

As is custom, an EMA panel on Friday issued its weekly recommendations on marketing applications submitted by drug developers. This week, the agency backed the use of five new therapies — including two Novartis drugs — but issued no negative reviews.

Novartis’ S1P drug for relapsing forms of multiple sclerosis (MS) drug, Mayzent (known chemically as siponimod), which was approved by the FDA in March — has been given the nod by the EMA. The Swiss drugmaker already sells its other MS drug, Gilenya, in both regions.

Atom­wise's X-37 spin­out gets $14.5 mil­lion to launch AI dis­cov­ery ef­forts

The folks behind Atomwise’s spinout X-37 like to think in cosmological metaphors, and you can think of their AI drug development model as probes sent into space from a central station. That station just got $14.5 million in Series A funding from DCVC Bio, Alpha Intelligence Capital and Hemi Ventures to back those missions.

X-37 uses Atomwise’s AI platform to identify drug targets and – unlike the parent company, which largely sticks to computers  – bring those into a wet lab and preclinical testing.  In addition to AI professionals, it’s led in by part by drug developers from Velocity Pharmaceutical Development.

Ab­bott Lab­o­ra­to­ries CEO Miles White pass­es ba­ton down to suc­ces­sor; Lon­za CEO Marc Funk hits the ex­it

→ Abbott Laboratories has named a successor to CEO Miles White after he announced that he was stepping down in March after 21 years of service. Robert Ford, the company’s COO and president, will take the helm. Ford is known for his work in the $25 billion merger between St. Jude Medical into Abbott in January 2017. White will remain with the company as executive chairman of the board. 

→ After snapping up Novartis’ Swiss facility, Novartis Center of Excellence, in July, Lonza has announced that their CEO, Marc Funk, is hitting the exit for “personal reasons.” Funk has been the CEO of the company for less than a year — brought onto the company back in March. In the meantime, chairman Albert Baehny will serve as interim CEO. 

UCB adds on more pos­i­tive PhI­II da­ta for IL-17A/17F in­hibitor bimek­izum­ab, clear­ing a path to the FDA

A month after posting positive top-line data from their first Phase III trial of the IL-17A/17F inhibitor bimekizumab, Belgium’s UCB says they’ve added more upbeat results from their second late-stage test in moderate-to-severe plaque psoriasis.

That leaves the company on track for regulatory submissions in the middle of next year, says CMO Iris Loew-Friedrich.
Their drug beat out a placebo on the co-primaries — a 90% improvement in PASI 90 (the Psoriasis Area and Severity Index) and Investigator Global Assessment (IGA) response of clear or almost clear (IGA 0/1) at week 16, compared to placebo. Investigators also boasted of hitting some key secondaries.
UCB is angling to enter an increasingly crowded market space.
In their first of 3 Phase III studies for bimekizumab, researchers touted top-line wins on statistically significant results on clearing plaque psoriasis, including a victory over J&J’s IL-23 contender Stelara on key endpoints. The drug targets both IL-17A and IL-17F, a modification on the IL-17A strategy laid out for Taltz (Eli Lilly) and Cosentyx (Novartis). And the new group also includes J&J’s Tremfya and AbbVie’s Skyrizi.

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