Big Phar­ma joins £200M UK Biobank se­quenc­ing project; Monopar sets terms for $40M IPO

The UK Biobank is kick­ing off an am­bi­tious £200 mil­lion project to un­der­take whole-genome se­quenc­ing of 450,000 par­tic­i­pants, prob­ing the role that ge­net­ics plays in a range of com­mon and chron­ic ail­ments in­clud­ing de­men­tia, men­tal ill­ness, can­cer and heart dis­ease. Am­gen, As­traZeneca, Glax­o­SmithK­line and J&J pooled £100 mil­lion to­tal in ex­change for 9 months of ex­clu­sive ac­cess, while The Well­come Trust char­i­ty and the UK gov­ern­ment each pro­vid­ed £50 mil­lion.

The Well­come Sanger In­sti­tute in Cam­bridge and de­CODE ge­net­ics in Ice­land — a sub­sidiary of Am­gen — have been com­mis­sioned to con­duct the se­quenc­ing.

Gilead is hand­ing out a $10 mil­lion mile­stone pay­ment for the HIV deal they struck with Durect in Ju­ly. At the time, Gilead spent a mod­est $25 mil­lion in cash for the rights to jump on the plat­form at Durect, which has been us­ing its tech­nol­o­gy to come up with an ex­tend­ed-re­lease ver­sion of bupi­va­caine. The lat­est cash comes out of the $75 mil­lion promised for de­vel­op­ment and reg­u­la­to­ry mile­stones. On top of that, Gilead has re­served $70 mil­lion in sales goal cash and $150 mil­lion for each new de­vel­op­ment pro­gram it adds to its pipeline out of the pact.

Monopar Ther­a­peu­tics has an­nounced the terms for its IPO. The Wil­mette, Illi­nois-based com­pa­ny plans to of­fer 4.4 mil­lion shares at a price range of $8 to $10 to raise $40 mil­lion, it said in a fil­ing on Tues­day. At the mid­point of the pro­posed range, Monopar would com­mand a ful­ly di­lut­ed mar­ket val­ue of $130 mil­lion.

Co-found­ed by Christo­pher Starr af­ter he stepped down as Rap­tor CEO, the biotech’s pipeline in­cludes va­lidive — ob­tained from France’s Onx­eo in 2017  — for se­vere oral mu­cosi­tis in­duced by chemora­dio­ther­a­py in head and neck can­cer pa­tients and cam­siru­bicin, a can­cer drug aimed at soft tis­sue sar­co­ma. Jon­esTrad­ing is the sole bookrun­ner on the deal. The com­pa­ny plans to list un­der the sym­bol $MN­PR.

On­co­Cell MDx — a pan dis­ease im­munogenomics plat­form com­pa­ny fo­cused on non­in­va­sive blood-based tests — has raised $22.2 mil­lion in Se­ries B fi­nanc­ing. The round was led by Sav­itr Cap­i­tal along with ex­ist­ing in­vestors. Found­ed on tech­nolo­gies cre­at­ed by Amin Kas­sis at Har­vard med­ical school, On­co­Cell has raised more than $30 mil­lion to date to de­tect and oth­er dis­eases us­ing a sin­gle blood sam­ple. It plans to launch a blood test for the de­tec­tion and grad­ing of ag­gres­sive prostate can­cer next year.

→ The decades of fail­ure to de­vel­op a drug to fight Alzheimer’s dis­ease has con­vinced The Na­tion­al In­sti­tute on Ag­ing to con­fer a five-year fed­er­al grant of up to $53.4 mil­lion to Brown Uni­ver­si­ty and Boston-based Har­vard Med­ical af­fil­i­ate, He­brew Se­nior­Life, to sup­port tri­als aimed at im­prov­ing care for peo­ple with de­men­tia.

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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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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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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Zai Lab inks Chi­na deal with Turn­ing Point with $25M up­front; Xen­cor, Atre­ca team up on bis­pecifics

Zai Lab is paying out a $25 million upfront for the rights to sell Turning Point Therapeutics’ lead drug repotrectinib in Greater China. The San Diego-based biotech is also in line for up to $151 million in milestones, along with mid-to-high teen royalties. Zai plans to add sites to the Phase II trial of the drug, which is designed to treat ROS1-positive advanced NSCLC in patients who were not previously treated with a TKI.

FDA bars the door — for now — against Mer­ck’s star can­cer drug af­ter Roche beat them to the punch

Merck has been handed a rare setback at the FDA.

After filing for the accelerated approval of a combination of their star PD-1 drug Keytruda with Eisai’s Lenvima as a first-line treatment for unresectable hepatocellular carcinoma, the FDA nixed the move, handing out a CRL because Roche beat them to the punch on the same indication by a matter of weeks.

According to Merck:

Ahead of the Prescription Drug User Fee Act action dates of Merck’s and Eisai’s applications, another combination therapy was approved based on a randomized, controlled trial that demonstrated overall survival. Consequently, the CRL stated that Merck’s and Eisai’s applications do not provide evidence that Keytruda in combination with Lenvima represents a meaningful advantage over available therapies for the treatment of unresectable or metastatic HCC with no prior systemic therapy for advanced disease. Since the applications for KEYNOTE-524/Study 116 no longer meet the criteria for accelerated approval, both companies plan to work with the FDA to take appropriate next steps, which include conducting a well-controlled clinical trial that demonstrates substantial evidence of effectiveness and the clinical benefit of the combination.

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Covid-19 roundup: Mod­er­na sticks to Ju­ly for its Phase III as ru­mors swirl; Fol­low­ing US lead, EU buys up Covid-19 treat­ments

The Phase III might be delayed from its original early July goal, but Moderna says it will still kick off the pivotal study for what could ultimately be the first Covid-19 vaccine before the end of the month.

A day after Reuters reported that squabbling between the Cambridge biotech and government regulators had held up the trial by about two weeks, Moderna released a statement saying that they had completed enrollment of their 650-person Phase II trial and were on track to begin Phase III by the end of the month. The protocol for that study, which is meant to prove whether or not the vaccine can prevent people from becoming sick, has been finalized, they said.

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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Stephen Hahn, AP

Trump and Navar­ro press again for hy­drox­y­chloro­quine. Can the FDA stay in­de­pen­dent?

Tuesday morning, economist and Trump advisor Peter Navarro walked onto the White House driveway and promptly brought a political cloud back onto the FDA.

Speaking to a White House pool reporter, Navarro said that four Detroit doctors were, based on a single disputed study, filing for the FDA to again issue an emergency authorization for hydroxychloroquine, the anti-malarial pill that President Trump hyped for months as a Covid-19 treatment over the objections of his own scientists. Then, while avoiding directly calling for the FDA to OK the drug, blasted the agency. He said its decision to pull an earlier authorization “was based on bad science” and “had a tremendously negative effect” on doctors and patients.

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Boehringer In­gel­heim ties the knot with Num­ab on new an­ti­bod­ies; Ca­balet­ta inks pact with Ar­ti­san

→ Switzerland’s Numab Therapeutics has added Boehringer Ingelheim to its roster of collaborators. And they will start with two projects aiming at developing new drugs for difficult-to-treat lung and gastrointestinal cancers and patients with geographic atrophy. “Numab’s technology platform fits well with our internal antibody discovery and engineering capabilities and will enhance our efforts to deliver transformative antibody-based therapeutics to patients,” said Paige Mahaney, an SVP at Boehringer Ingelheim.