William Cao (Bloomberg via Getty)

Nas­daq rings in its first biotech IPOs of 2021: a CAR-T spe­cial­ist from Chi­na, a can­cer port­fo­lio play, and a SPAC

There was once a time when stel­lar CAR-T da­ta from Chi­na would come — in a sense — out of nowhere and be greet­ed with sur­prise, or even out­right skep­ti­cism.

It wasn’t that long ago, but those days are now gone. This is a time a CAR-T ther­a­py orig­i­nat­ing from Chi­na can be de­vel­oped in the pub­lic eye, down to every cut of da­ta, by a com­pa­ny bound by Amer­i­can rules of dis­clo­sure.

Case in point: Gra­cell Biotech­nolo­gies, a Shang­hai-based out­fit that’s grab­bing Nas­daq’s first biotech IPO list­ing along­side Cam­bridge, MA-based Cul­li­nan On­col­o­gy.

“We know val­u­a­tion at Nas­daq is prob­a­bly the low­est (com­pared to Hong Kong or Shang­hai), but the rea­son for us to go for Nas­daq was — is still — very clear,” co-founder and CEO William Cao told End­points News. “We’re a tech­nol­o­gy play com­pa­ny; in­no­va­tion is our soul and spir­it.”

By to­day’s stan­dards, Gra­cell’s raise of $209 mil­lion is some­what mod­est. But with the back­ing of mar­quee in­vestors like Lil­ly Asia Ven­tures, Morn­ing­side, Or­biMed, Temasek, Vi­vo Cap­i­tal and Welling­ton, Cao is less con­cerned about the mon­ey than gain­ing pres­ence in the US, where he is plan­ning an R&D cen­ter and mul­ti­ple tri­als.

The break­through suc­cess­es of No­var­tis, Kite and — per­haps to a less­er ex­tent — Juno back in 2016 and 2017 did much more than in­spire the next gen­er­a­tion of US and Eu­ro­pean star­tups bran­dish­ing new tech­nolo­gies to make more durable cell ther­a­pies, faster, Cao re­flect­ed. Af­ter re­tir­ing from the helm of CB­MG, the com­pa­ny he co-found­ed which in 2018 be­came No­var­tis’ man­u­fac­tur­ing part­ner in Chi­na, he took a stint as a ven­ture part­ner at 6 Di­men­sions, look­ing for start­up ideas to in­vest in.

Mar­ti­na Ser­sch

The fan­cy new ideas and great sci­en­tists teams he en­coun­tered, though, lacked the busi­ness acu­men to solve what he termed in­dus­tri­al chal­lenges — bot­tle­necks such as lengthy pro­duc­tion times and a “clum­sy” process were much more press­ing to him.

“I’m less in­ter­est­ed in ad­vanc­ing very fu­tur­is­tic CAR-T de­sign or TCR de­sign and I’m more in­ter­est­ed in how to solve the prac­ti­cal is­sues,” he said.

He soon got to work set­ting up his own shop, con­fer­ence-hop­ping around the US and Chi­na to ac­quaint him­self with the lat­est sci­ence as well as top tal­ent that he lat­er hand­picked for his team. Gra­cell was built on two tech­nolo­gies: FasT­CAR, which promis­es to short­en man­u­fac­tur­ing turn­around time to 22-36 hours; and Tru­U­CAR, its take on al­lo­gene­ic CAR-T. It has its own pro­duc­tion site in Suzhou to keep the key process­es in-house.

The C-suite now fea­tures Kevin Xie, the for­mer pres­i­dent at Fo­s­un Health­care, as CFO and Mar­ti­na Ser­sch as CMO.

“So I saw the mul­ti­ple myelo­ma da­ta,” said Ser­sch, who helped Am­gen de­vel­op its mul­ti­ple myelo­ma strat­e­gy be­fore jump­ing to Mus­tang Bio. “And at the time, I re­mem­ber William was not con­vinced of the da­ta. But when I saw the da­ta I said, wow, this looks very promis­ing. If this is hold­ing through and true through a cou­ple of more months for fol­lowup, you may have some­thing re­al­ly mean­ing­ful.”

Kevin Xie

In its F-1 fil­ing, Gra­cell re­port­ed that GC012F, its au­tol­o­gous CAR-T ther­a­py tar­get­ing both BC­MA and CD19, has treat­ed 16 pa­tients with re­lapsed/re­frac­to­ry MM and that 15 of them achieved and main­tained a re­sponse. The high­est dose co­hort record­ed a 100% strin­gent com­plete re­sponse rate for the six evalu­able pa­tients.

“Most pa­tients ex­pe­ri­enced Grade 1 or Grade 2 CRS, on­ly two pa­tients ex­pe­ri­enced Grade 3, and no pa­tient ex­pe­ri­enced Grade 4 or Grade 5 CRS or ICANS of any grade,” the com­pa­ny wrote.

It will be no easy task com­pet­ing with ei­ther the well-fund­ed US play­ers from Al­lo­gene to Lyell and Sana, or the ti­tan-backed joint ven­tures like JW, Fo­s­un/Kite and Al­lo­gene/Over­land. But Gra­cell is plung­ing full speed ahead with a reg­is­tra­tional tri­al in Chi­na that it just got cleared for and plans to start US tri­als in 2021.

For Cao, Chi­na’s in­fra­struc­ture for in­ves­ti­ga­tor-ini­ti­at­ed tri­als is Gra­cell’s se­cret trans­la­tion­al weapon, al­low­ing for quick first-in-hu­man tests of prod­uct de­sign.

“To a cer­tain ex­tent, that’s the most im­por­tant fac­tor we’ve been en­joy­ing that re­al­ly en­abled us. I don’t think every­body — all the peo­ple re­al­ize how pow­er­ful it is for im­mune cell ther­a­py,” Cao said.

Patrick Baeuer­le’s hub-and-spoke mod­el earns Cul­li­nan $249M pub­lic de­but

In chip­ping in­to Cul­li­nan On­col­o­gy’s up­sized $249.9 mil­lion raise, in­vestors are nei­ther buy­ing in­to a sin­gle drug nor a plat­form. Rather, they are lav­ish­ing on a taster menu of some of the hottest ideas on fight­ing can­cer.

Patrick Baeuer­le

The ethos of the com­pa­ny, which was found­ed by biotech vet and MPM part­ner Patrick Baeuer­le, is per­haps summed up in this line from the prospec­tus: “(W)e think about cap­i­tal al­lo­ca­tion and risk as much as we think about drug de­vel­op­ment.”

That means cen­tral­iz­ing R&D, BD and ad­min­is­tra­tive work in one hold­ing com­pa­ny while bet­ting on as many dif­fer­ent ap­proach­es as pos­si­ble — and cut­ting any weak­lings loose mer­ci­less­ly. The 17 full-time staffers (along­side one part-timer and two con­sul­tants) are de­ployed to the sev­en pro­grams as need­ed.

CLN-081 is the first drug in the clin­ic and the on­ly tar­get­ed ther­a­py in the mix, tar­get­ing NSCLC with EGFR ex­on 20 in­ser­tion mu­ta­tions. Oth­er tech ap­proach­es rep­re­sent­ed in­clude bis­pecifics, NK cell-en­gag­ing an­ti­body, cy­tokine fu­sion pro­tein, as well as TCR-based ther­a­py.

Cul­li­nan filed for its IPO short­ly af­ter pre­sent­ing what they called ini­tial clin­i­cal da­ta on it, and just on the heels of an­nounc­ing a $131 mil­lion Se­ries C.

With $153M SPAC, Lo­cust Walk grabs a seat the head of the deal ta­ble

Hav­ing long billed it­self as a life sci­ence trans­ac­tion firm, Lo­cust Walk is ready to strike a deal of its own.

Chris Ehrlich

Its blank check com­pa­ny, Lo­cust Walk Ac­qui­si­tion Corp, is the first SPAC to gain a list­ing on Nas­daq through an IPO that brought in $153 mil­lion. The mon­ey will now go to­ward snap­ping up a promis­ing pri­vate com­pa­ny to be merged with the new­ly pub­lic shell.

As with oth­er deals of this kind, the peo­ple are re­al­ly what in­vestors are putting their mon­ey be­hind. In this case, Chris Ehrlich, Lo­cust Walk’s se­nior man­ag­ing di­rec­tor and glob­al head of strate­gic trans­ac­tions, is grab­bing the CEO post and tak­ing the lead on the quest to find a suit­able ac­qui­si­tion tar­get.

He will be joined by Daniel Gef­fken, the founder and man­ag­ing di­rec­tor at Dan­forth Ad­vi­sors, as CFO; Brain At­wood of Ver­sant as chair­man; as well as a hand­ful of di­rec­tors in­clud­ing Bar­bara Kosacz, Kro­nos’ COO and Eliz­a­beth Bhatt, the chief busi­ness and strat­e­gy of­fi­cer of Ap­plied Mol­e­c­u­lar Trans­port.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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IPO track­er: 2021 gets start­ed with a flur­ry of new of­fer­ings

A global pandemic couldn’t slow down what turned out to be a record year for biotech IPOs. With the calendar turning toward 2021, the Endpoints News team is prepped to track each new filing this year, and the outcome. We’re off to another hot start at least.

Below, you’ll find the companies that have filed to go public, in addition to those that have already priced. Through the first two business weeks of January, there have already been 9 biotechs that have filed or priced, and the number is only expected to grow. We’ll keep the tracker updated as it does.

Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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David Southwell (L) and Christoph Westphal

Har­vard spin­out kicks off 2021 with a crossover round and sights set on the clin­ic

Several months after striking an alliance with Novartis, TCR therapy-focused TScan Therapeutics has reeled in a crossover round that should hold it over for the next two years as it eyes a public debut.

The Christoph Westphal portfolio company had been arranging the crossover for the last few months, CEO David Southwell said. Just before Christmas, they nailed down what he called a “really blue-chip” syndicate of four new investors, including BlackRock, RA Capital Management and two undisclosed funds. They closed on the $100 million Series C just over a week ago, and waited until Monday morning to announce it.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.