JW Ther­a­peu­tics hauls in $300M IPO just as liso-cel-in­spired CAR-T nears the fin­ish line in Chi­na

Close to two years af­ter Juno Ther­a­peu­tics dis­ap­peared from Nas­daq, a CAR-T biotech it spawned is set­tling on a stock ex­change on the oth­er side of the globe.

James Li

JW Ther­a­peu­tics, a joint ven­ture be­tween Juno and WuXi AppTec, raised $300 mil­lion in its IPO on the Hong Kong Stock Ex­change — build­ing on $190 in ven­ture mon­ey since launch­ing in 2018.

The pitch is all about bring­ing cell ther­a­py break­throughs to Chi­na, tap­ping in­to Amer­i­can con­nec­tions that ex­tend in­to Lyell, a new start­up led by Juno co-founder Rick Klaus­ner, and Eu­re­ka, a long­time part­ner of Juno. WuXi, a glob­al CRO, brings ex­per­tise in process de­vel­op­ment and man­u­fac­tur­ing to the mix.

Full grasp on the com­plex­i­ties of tin­ker­ing with cells is cru­cial to the suc­cess of any CAR-T play­ers, CEO James Li pre­vi­ous­ly told End­points News, and that’s why he doesn’t see the mar­ket crowd­ing out any time soon.

Fo­s­un Kite (al­so a joint ven­ture) and J&J-part­nered Leg­end (now list­ed on Nas­daq) are among the pi­o­neers. Then there’s Gra­cell and CARs­gen lead­ing a slew of new­er en­trants.

“What peo­ple don’t re­al­ize is it takes a much longer time ac­tu­al­ly if you want to have a com­mer­cial­ly vi­able process, to have some­thing mean­ing­ful you can com­mer­cial­ize,” he said.

With its first po­ten­tial ap­provals JW is repli­cat­ing the trail blazed by its US coun­ter­parts. The lead pro­gram, CD19-tar­get­ed rel­ma-cel, is cur­rent­ly un­der re­view at the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion; it’s a spin on Juno’s liso-cel (now be­ing shep­herd­ed to the FDA by Bris­tol My­ers via Cel­gene) with the same CAR back­bone, and the ini­tial in­di­ca­tion is third-line dif­fuse large B cell lym­phoma.

Be­hind that there’s a BC­MA pro­gram for which JW plans to file an IND in the first half of 2021, the com­pa­ny wrote in its IPO ap­pli­ca­tion,

Even though the first gen­er­a­tion of CAR-T ther­a­pies — led by No­var­tis Kym­ri­ah and Gilead’s Yescar­ta — tar­get­ing hema­to­log­i­cal can­cers has yet to be avail­able in the coun­try, JW is al­ready look­ing in­to sol­id tu­mors through its pacts with Lyell and Eu­re­ka. The new pro­ceeds will al­so help fu­el new deals.

“To me, it’s the fu­ture of cell ther­a­py,” Li said.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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Eric Kelsic, Dyno Therapeutics CEO

Dyno's Er­ic Kel­sic fills the tank in his quest for bet­ter AAV with a group of big-name sup­port­ers on board

Adeno-associated viruses (AAV) for gene therapy have received a ton of scrutiny throughout the field’s history after a smattering of safety scares and their limited therapeutic range. Hoping to crack the field wide open through a capsid design revolution, Eric Kelsic and his team at Dyno have drummed up immense excitement — and now a hefty war chest.

Dyno Therapeutics has bagged a $100 million Series A with backing from the likes of round leader Andreessen Horowitz and new investor Casdin Capital in its quest to use AI to design better AAV capsids for gene therapy, the company said Thursday.

Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Gold­man Sachs jumps aboard Bain-backed 503(b) com­pound­ing phar­ma­cy with a $275M debt loan to sup­ply hos­pi­tals

Long the bane of the FDA’s existence, compounding pharmacies have seen a minor resurgence in the past year as short-term saviors for hospital drug shortages. Now, a 503(b) company specializing in hospital meds has earned a big backer to keep expanding its 200-drug strong portfolio.

Goldman Sachs and Owl Rock Capital Partners have doled out a $275 million debt loan to QuVa Pharma, a 503(b)-certified outsourcing facility providing compounded drugs to hospitals, the company said Thursday.

Bill Lis, Jasper Therapeutics

Jasper and its stem cell con­di­tion­ing an­ti­body earn a tick­et to Nas­daq in lat­est SPAC re­verse merg­er

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

Another biotech SPAC deal has landed as the glut of blank-check companies continues to make waves in the industry.

Thursday’s winner is Jasper Therapeutics, joining forces with Amplitude Healthcare Acquisition Corp. in a $100 million reverse-merger, Jasper announced. The deal also comes with a PIPE financing of an additional $100 million, setting Jasper up with a $490 million market cap once the merger closes in the third quarter.

Brent Saunders (Richard Drew, AP Images)

OcuWho? Star deal­mak­er turned aes­thet­ics czar Brent Saun­ders flips back in­to biotech. But who’s he team­ing up with now?

Brent Saunders went on a tear of headline-blazing deals building Allergan, merging and rearranging a variety of big companies into one before an M&A pact with Pfizer blew up and sent him on a bout of biotech drug deals. That didn’t work so well, so under pressure, he got his buyout at AbbVie — which needed a big franchise like Botox. And it was no big surprise to see him riding the SPAC wave into a recent $1 billion-plus deal that left him in the executive chairman’s seat at an aesthetics outfit — now redubbed The Beauty Health Company — holding a big chunk of the equity.

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