Cy­tokine storms force Mir­na to shut­ter a tri­al; Ar­tios gath­ers $33M for can­cer drug work

Mir­na CEO Paul Lam­mers

A se­ries of se­vere cas­es of cy­tokine re­lease syn­drome forced Austin, TX-based Mir­na Ther­a­peu­tics to shut down a Phase I study of its lead mi­croR­NA drug, MRX34. Mir­na al­so opt­ed not to start an­oth­er study un­til it can an­a­lyze the sit­u­a­tion. Their shares $MIRN cratered in the news, drop­ping 23%. “We made the dif­fi­cult de­ci­sion to close the study af­ter a fifth, im­mune-re­lat­ed se­ri­ous ad­verse event was re­cent­ly re­port­ed by one of our clin­i­cal sites,” not­ed CEO Paul Lam­mers. “This pa­tient ex­pe­ri­enced se­vere (Grade 4) cy­tokine re­lease syn­drome and is un­der­go­ing treat­ment. We have no­ti­fied the U.S. FDA and the Ko­re­an FDA of our de­ci­sion and are in the process of clos­ing the tri­al.”

Cam­bridge, UK-based Ar­tios Phar­ma is launch­ing with a $33.2 mil­lion ven­ture round led by SV Life Sci­ences. The biotech is run by Niall Mar­tin, an ex­pe­ri­enced PARP play­er, who is fo­cused on ad­vanc­ing drugs that de­rail the nat­ur­al DNA re­pair mech­a­nisms in place that can al­low can­cer to spread. The com­pa­ny in-li­censed two DDR pro­grams from Can­cer Re­search Tech­nol­o­gy and plans to ad­vance the first in­to the clin­ic with the A round.

Arie Bellde­grun, Kite CEO

Kite Phar­ma­ceu­ti­cals, one of the lead­ers of the CAR-T de­vel­op­ment race, has forged a li­cens­ing deal with the NIH cov­er­ing TCR drugs for KRAS mu­tat­ed anti­gens. The deal paves the way to clin­i­cal stud­ies, which Kite says will get un­der­way this year. “Kite has tak­en an im­por­tant step to­ward build­ing the first ther­a­peu­tic fran­chise of its kind for can­cers dri­ven by KRAS mu­ta­tions and has fur­ther ex­pand­ed its ef­forts in build­ing a TCR port­fo­lio across key class­es of anti­gens, in­clud­ing can­cer testis and vi­ral anti­gens,” said Kite CEO Arie Bellde­grun.

Cam­bridge, MA-based blue­bird bio $BLUE says that its Lenti­Glo­bin her­a­py has joined the Pri­or­i­ty Med­i­cines club at the EMA, Eu­rope’s ver­sion of the break­through drug des­ig­na­tion.

Zaf­gen’s shares were buoyed af­ter the Boston-based biotech said it had be­gun dos­ing pa­tients in a Phase I study of ZGN-1061. The biotech’s lead weight drug im­plod­ed in a late stage study re­cent­ly, forc­ing the com­pa­ny to start over with a pre­clin­i­cal next-gen ther­a­py.

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.

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

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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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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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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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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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.