Vir chief Scan­gos picks Her­bert ‘Skip’ Vir­gin to run R&D; Arde­lyx forges $160M deal with Ky­owa Hakko Kirin

Her­bert “Skip” Vir­gin

A month ago George Scan­gos blazed through a biotech buy­out, two bil­lion-dol­lar drug de­vel­op­ment deals and more than $500 mil­lion in fi­nanc­ing to build a pipeline of new ther­a­pies for in­fec­tious dis­eases at his start­up biotech Vir. Now he’s se­lect­ed Her­bert “Skip” Vir­gin as R&D chief and CSO. Vir­gin is join­ing Vir from Wash­ing­ton Uni­ver­si­ty School of Med­i­cine in St. Louis, Mis­souri, where he has served as the Ed­ward Mallinck­rodt Pro­fes­sor and Chair of the De­part­ment of Pathol­o­gy & Im­munol­o­gy since 2006.

Arde­lyx $ARDX is pick­ing up a $30 mil­lion up­front in a pact with Ky­owa Hakko Kirin cov­er­ing the Japan­ese rights to its late-stage drug tena­panor for car­diore­nal dis­eases. The li­cens­ing deal al­so in­cludes $130 mil­lion in mile­stones and high-teens for the roy­al­ties.

PNC Bank is ac­quir­ing The Trout Group, the in­vestor re­la­tions and strate­gic ad­vi­so­ry firm that boasts a glob­al list of clients in­clud­ing Toca­gen, Gen­fit and Zai Lab. Un­der the de­fin­i­tive agree­ment, an­nounced Mon­day, Trout will be com­bined with PNC sub­sidiary Sole­bury Com­mu­ni­ca­tions — a sim­i­lar but not in­dus­try-spe­cif­ic firm — to be­come Sole­bury Trout Com­mu­ni­ca­tions. Trout founder/CEO Jonathan Fass­berg will be re­tained as one of three co-CEOs, serv­ing along­side Sole­bury’s Jeff Gross­man and Lisa Wol­ford. The new com­pa­ny will be dou­ble the size of 30-strong Trout, and will like­ly ex­pand ac­cess to biotech bank­ing busi­ness for PNC.

→ Lim­it­ed sup­ply of cus­tomized virus­es cru­cial to the de­liv­ery of gene ther­a­py is hold­ing up biotechs de­vel­op­ing such nov­el treat­ment, The New York Times re­ports. With an ex­pen­sive and ar­du­ous pro­ce­dure, the few firms ca­pa­ble of man­u­fac­tur­ing these dis­abled virus­es for clin­i­cal tri­als are “swamped with or­ders and re­quests.” A GEN col­umn pub­lished ear­li­er this month de­scribes the is­sue as a “ca­pac­i­ty crunch,” with Bio­Plan As­so­ci­ates es­ti­mat­ing that the CMO short­fall in world­wide cell/gene ther­a­py is 5 times cur­rent ca­pac­i­ty. A ready source of virus is be­com­ing para­mount; so much so that Bio­Marin has de­cid­ed to build its own man­u­fac­tur­ing plant. As CMO Mil­li­pore­Sig­ma’s Udit Ba­tra tells the NYT, “It’s a re­al is­sue.”

Scot­land’s Sym­promics is col­lab­o­rat­ing with UCL on a gene ther­a­py for Parkin­son’s dis­ease. Their first tar­get look­ing to con­trol gene ex­pres­sion will be Young-On­set Parkin­son’s dis­ease.

Gilead’s Solval­di is fi­nal­ly sell­ing in Chi­na, and the biotech gi­ant $GILD is charg­ing just shy of $9,000 for a 12-week reg­i­men — a frac­tion of the US price of $84,000. The launch, first re­port­ed by Chi­nese out­lets, comes two months af­ter the he­pati­tis C drug nailed an ap­proval from the CF­DA. Chi­na ac­counts for 10 out of 130 mil­lion hep C pa­tients world­wide, Caix­in ob­serves. Solval­di is the first di­rect an­ti-vi­ral agent in Chi­na, but it won’t be the last. Bris­tol-My­ers Squibb $BMY and John­son & John­son $JNJ are al­ready rac­ing to mar­ket their own prod­ucts af­ter nab­bing CF­DA ap­provals on Gilead’s heels.

→ The FDA has giv­en Cy­tomX $CT­MX the OK on its IND for the com­pa­ny’s CT­LA-4 pro­body ther­a­peu­tic, be­ing de­vel­oped in part­ner­ship with Bris­tol-My­ers Squibb. CT­LA-4 is the tar­get of BMS’ check­point in­hibitor Yer­voy, and is the first tar­get to get to the clin­ic un­der the com­pa­nies’ part­ner­ship formed in 2014. The IND ac­cep­tance gets Cy­tomX a $10 mil­lion mile­stone pay­ment, bring­ing the to­tal pay­ments from the deal to over $275 mil­lion — with $4.8 bil­lion still avail­able in po­ten­tial mile­stones.

→ Cincin­nati biotech Cin­Rx just closed $10 mil­lion in a Se­ries B to ad­vance sev­er­al drug can­di­dates in di­verse in­di­ca­tions, rang­ing from large mar­kets to or­phan in­di­ca­tions. The com­pa­ny plans to file an IND in the first half of 2018 for its most ad­vanced pro­gram, CIN-102, for the treat­ment of gas­tro­pare­sis. This lat­est round, led by undis­closed new and ex­ist­ing in­vestors, fol­lows a $26 mil­lion Se­ries A closed in 2015. The com­pa­ny’s pipeline in­cludes treat­ments for gas­troin­testi­nal dis­or­ders in­clud­ing IBS, along with car­dio­vas­cu­lar dis­ease and der­ma­tol­ogy.

Brit­tany Meil­ing and John Car­roll con­tributed to this re­port.

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.

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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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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Sin­gu­lar fo­cus on ROR1 earns Velos­Bio $137M to fund PhI ADC and oth­er pro­grams

Years after selling Acerta to AstraZeneca for $7 billion, largely on the promise of its BTK inhibitor, Dave Johnson has once again gathered hefty financial support behind a new cancer target.

Matrix Capital Management and Surveyor Capital are leading a $137 million round for VelosBio, which has recently begun a Phase I study for its lead antibody-drug conjugate targeted against ROR1. Johnson took up the CEO post in October 2018.