Gilead swoops in with $567M deal to buy CAR-T 2.0 play­er Cell De­sign Labs

Arie Bellde­grun

Gilead has swooped in on the first of sev­er­al planned new buy­outs to build out its CAR-T op­er­a­tions ac­quired in the $12 bil­lion Kite buy­out. And it’s start­ing with a com­pa­ny that Kite’s Arie Bellde­grun be­lieved held the key to the next-gen cell ther­a­pies that will even­tu­al­ly over­take the pi­o­neers.

The com­pa­ny is Cell De­sign Labs, found­ed on the tech­nol­o­gy or­ches­trat­ed by UC San Fran­cis­co star re­searcher Wen­dell Lim. Gilead has agreed to buy the com­pa­ny, launched with on­ly $34 mil­lion in in­vest­ment cash from Klein­er Perkins, Kite and oth­ers, for up to $567 mil­lion.

We don’t know how much of that is in cash.

John Mil­li­gan, Gilead CEO

“We have been work­ing with Cell De­sign Labs for al­most 18 months, and tru­ly ap­pre­ci­ate the ground­break­ing na­ture of their tech­nol­o­gy plat­forms,” com­ment­ed David D. Chang, the head of R&D at Kite. “We’ve al­ready in­te­grat­ed Throt­tle Switch in­to our CAR-T pipeline and look for­ward to ex­plor­ing the full depth and breadth of the tech­nolo­gies of Gilead, Kite and Cell De­sign Labs to ex­pand the cell ther­a­py tool­box.”

Wen­dell Lim

Gilead promised that it would re­fo­cus its M&A strat­e­gy around CAR-T af­ter it bought Kite and leaped out front of the CAR-T race. And CEO John Mil­li­gan clear­ly plans to keep that promise.

I cov­ered this com­pa­ny back in the fall of 2016. Here’s a seg­ment on what Lim was work­ing on re­gard­ing cell ther­a­py 2.0. It was very cool.

The Howard Hugh­es Med­ical In­sti­tute in­ves­ti­ga­tor has his sights set on a very high bar. Build­ing on ear­li­er work on syn­thet­ic Notch (syn­Notch) — where he tin­kered with the Notch sen­sor so it could pro­gram a cell ther­a­py to go af­ter a par­tic­u­lar can­cer cell tar­get and then is­sue in­struc­tions to turn genes on or off — Lim be­lieves you can use syn­Notch to es­sen­tial­ly cre­ate a cell bot that can be mus­tered in­to armies of pa­trolling ther­a­peu­tics.

In what amounts to de­vel­op­ing liv­ing mi­cro de­vices, Lim be­lieves the tech­nol­o­gy can be used to pro­gram T cells to pro­duce check­point in­hibitors, bis­pe­cif­ic an­ti­bod­ies and cus­tomiz­able cy­tokines, among oth­er things. And it can al­so all be in­te­grat­ed in­to CAR-T with a sui­cide switch.

“The way I view the last cou­ple of years and months” of CAR-T work, says Cell De­sign CEO and co-founder Bri­an At­wood, “these are a first-gen­er­a­tion cruise mis­sile. They went to an ad­dress and blew up. The prod­ucts in the clin­ic to­day are pret­ty crude. For ALL and CLL pa­tients, they’re pret­ty amaz­ing, but there’s no con­trol­la­bil­i­ty. That’s Wen­dell’s thing.”

 

Mer­ck ex­pands scope of Zymeworks an­ti­body al­liance, adding close to $900M in mile­stones

Nearly a decade after first partnering with Merck, Vancouver-based biotech Zymeworks has expanded its collaboration with the pharma giant once again.

Zymeworks re-upped with Merck in a new licensing agreement, granting the New Jersey pharma giant the right to develop up to 3 additional multispecific antibody candidates. In exchange, the biotech will receive an undisclosed upfront payment — Merck is always loath to discuss cash terms — and nearly $900 million in combined regulatory ($411 million) and commercial ($480 million) milestones.

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The home run count: The $100M+ mega-round boom in biotech in­spired a $6.7B feed­ing fren­zy — so far this year

Over the last 6 months there’s been a blizzard of money piling up drifts of the green stuff through the biotech landscape. And the forecast calls for more cash windfalls ahead.

Even as a global pandemic has killed more than half a million people, blighted economies and divided nations over the proper response, it’s also helped ignite an unprecedented burst of big-time investing. And not just in Covid-19 deals, as we’ve looked at before.

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Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Nello Mainolfi (Kymera via YouTube)

Out to re­vive R&D, a resur­gent Sanofi pays $150M cash to part­ner up with a pi­o­neer­ing pro­tein degra­da­tion play­er

Frank Nestle was appointed Sanofi’s global head of immunology and inflammation research therapeutic area just days before dupilumab, the blockbuster-to-be IL-4 antibody, would be accepted for priority review. After four years of consolidating immunology expertise from multiple corners of the Sanofi family and recruiting new talents to build the discovery engine, he’s set eyes on a Phase I-ready program that he believes can grow into a Dupixent-sized franchise.

For­bion spot­lights late-stage plays, carves out new €250M growth fund

Having staked its rep on picking out a mix of biotech investment opportunities across the “build,” “enable,” “growth” continuum, Forbion is launching its first fund dedicated to late-stage opportunities.

Forbion Growth Opportunities Fund’s first close brought in €185 million ($208 million). Existing investors Pantheon, KfW Capital and the European Investment Fund came on board, joined by new backers Eli Lilly, Horizon Therapeutics, Belgian Growth Fund and New Waves Investments.

UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Atul Deshpande, Harbour BioMed chief strategy officer & head, US operations (Harbour BioMed)

An­oth­er biotech IPO set-up? Multi­na­tion­al biotech leaps from round to round, scoop­ing up cash at a blis­ter­ing pace

A short four months after announcing a $75 million haul in Series B+ fundraising, the multinational biotech Harbour BioMed pulled in another round of investments and eclipsed the nine-digit mark in the process.

Harbour completed its Series C financing, the company announced Thursday morning, raising $102.8 million and bringing its total investment sum to over $300 million since its founding in late 2016. The biotech plans to use the money to transition early-stage candidates from the discovery phase, fund candidates already in the clinic, and prep late-stage candidates for commercialization.

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Covid-19 roundup: CDC de­bat­ing who should get first avail­able vac­cines; EU in Gilead talks af­ter US gob­bled first remde­sivir dos­es

The federal government has now spent billions of dollars accelerating the development of a Covid-19 vaccine, and yet they’ve remained hush-hush on who, precisely, would actually get inoculated once the first doses are approved and available. Internally, though, they have been debating it.

The CDC and an advisory committee of outside health experts have been working since April to devise a ranking system that would determine who receives a vaccine and when, The New York Times reported. The question of who is first in line for inoculation is important because no matter how many doses developers can make or how quickly they can make them, doses will still come out in batches; 300 million inoculations will not appear overnight.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

A new study points to $6.5B in pub­lic sup­port build­ing the sci­en­tif­ic foun­da­tion of Gilead­'s remde­sivir. Should that be re­flect­ed in the price?

By drug R&D standards, Gilead’s move to repurpose remdesivir for Covid-19 and grab an emergency use authorization was a remarkably easy, low-cost layup that required modest efficacy and a clean safety profile from just a small group of patients.

The drug OK also arrived after Gilead had paid much of the freight on getting it positioned to move fast.

In a study by Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University in Waltham, MA, researchers concluded that the NIH had invested only $46.5 million in the research devoted to the drug ahead of the pandemic, a small sum compared to the more than $1 billion Gilead expected to spend getting it out this year, all on top of what it had already cost in R&D expenses.

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