The Broad wins an­oth­er — per­haps fi­nal — bat­tle in the war over Feng Zhang's CRISPR patents

Ed­i­tas $ED­IT and its ri­vals’ long run­ning le­gal bat­tle over the IP for the CRISPR/Cas9 tech used to ed­it genes may well be over.

A fed­er­al ap­peals court has ruled in fa­vor of the Broad In­sti­tute, con­firm­ing an ear­li­er US patent board de­ci­sion that their patents from the lab of in­ves­ti­ga­tor Feng Zhang did not “in­ter­fere” with the ones sought by UC.

And the judges came down so solid­ly in fa­vor of the Broad that there’s like­ly lit­tle hope for any con­tin­u­ing ap­peals moves — though the UC sys­tem quick­ly put out a state­ment say­ing they’re still eval­u­at­ing their op­tions on lit­i­gat­ing the is­sue.

The Broad, which quick­ly her­ald­ed the rul­ing, not­ed that their patents “are for genome edit­ing in eu­kary­ot­ic (in­clud­ing an­i­mal, hu­man, and plant) cells, while the claims in UCB’s ap­pli­ca­tion were based on stud­ies in cell-free sys­tems and not di­rect­ed to genome edit­ing in eu­kary­ot­ic cells.” The in­sti­tute con­tin­ued:

It is time for all in­sti­tu­tions to move be­yond lit­i­ga­tion. We should work to­geth­er to en­sure wide, open ac­cess to this trans­for­ma­tive tech­nol­o­gy.

Ed­i­tas, which has been di­rect­ly in­volved in pro­tect­ing these patents, will sec­ond that mo­tion. But it’s un­like­ly that the biotechs sup­port­ed by UC’s Jen­nifer Doud­na and her col­league Em­manuelle Char­p­en­tier — in­clud­ing CRISPR Ther­a­peu­tics $CR­SP — will be hap­py about the news.

From to­day’s rul­ing:

The Board per­formed a thor­ough analy­sis of the fac­tu­al ev­i­dence and con­sid­ered a va­ri­ety of state­ments by ex­perts for both par­ties and the in­ven­tors, past fail­ures and suc­cess­es in the field, evi- dence of si­mul­ta­ne­ous in­ven­tion, and the ex­tent to which the art pro­vid­ed in­struc­tions for ap­ply­ing the CRISPR- Cas9 tech­nol­o­gy in a new en­vi­ron­ment. In light of this ex­haus­tive analy­sis and on this record, we con­clude that sub­stan­tial ev­i­dence sup­ports the Board’s find­ing that there was not a rea­son­able ex­pec­ta­tion of suc­cess, and the Board did not err in its de­ter­mi­na­tion that there is no in­ter­fer­ence-in-fact.

We have con­sid­ered UC’s re­main­ing ar­gu­ments and find them un­per­sua­sive.

The UC sys­tem, though, may not be done wran­gling over the sub­ject. They of­fered this state­ment on Mon­day af­ter­noon:

We are eval­u­at­ing fur­ther lit­i­ga­tion op­tions. We al­so look for­ward to prov­ing that Drs. Doud­na and Char­p­en­tier first in­vent­ed us­age in plant and an­i­mal cells – a fact that is al­ready wide­ly rec­og­nized by the glob­al sci­en­tif­ic com­mu­ni­ty – as the Doud­na-Char­p­en­tier team’s sev­er­al pend­ing patent ap­pli­ca­tions that cov­er use of CRISPR-Cas9 in plant and an­i­mal cells are now un­der ex­am­i­na­tion by the patent of­fice.

And af­ter the mar­ket closed Mon­day af­ter­noon, CRISPR, In­tel­lia and Cari­bou — all al­lied with the Doud­na/Char­p­en­tier side — of­fered a col­lec­tive har­rumph.

“The Fed­er­al Cir­cuit, like the PT­AB, did not de­cide whether UC or the Broad ac­tu­al­ly first in­vent­ed the CRISPR/Cas9 genome edit­ing tech­nol­o­gy,” they not­ed. “The Fed­er­al Cir­cuit opin­ion al­so does not pre­clude oth­er pro­ceed­ings, ei­ther at the USP­TO or in the courts, to de­ter­mine which re­search group is the ac­tu­al in­ven­tor and, thus, the prop­er own­er of the tech­nol­o­gy.”


Im­age: Feng Zhang. MIT

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)

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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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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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Ed Engleman (Stanford Blood Center)

Stan­ford star on­col­o­gy sci­en­tist Ed En­gle­man helped cre­ate the im­munother­a­py field. Now he wants to shake up neu­rode­gen­er­a­tion R&D

Over the last generation of drug R&D, Ed Engleman has been a standout scientist.

The Stanford professor co-founded Dendreon and provided the scientific insights needed to develop Provenge into a pioneering — though not particularly marketable — immunotherapy. He’s spurred a slate of startups, assisted by his well-connected perch as a co-founder of Vivo Capital, and took the dendritic cell story into its next chapter at a startup called Bolt.

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Nello Mainolfi (Kymera via YouTube)

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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.

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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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Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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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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