Gain­ing steam in PD-1/L1 race, Roche re­ports pos­i­tive PhI­II OS da­ta on Tecen­triq com­bo in NSCLC

Roche trot­ted out some ear­ly OS da­ta Mon­day morn­ing from its com­bo study of Tecen­triq in lung can­cer, re­port­ing that the com­bo met its co-pri­ma­ry end­point and helped pa­tients live longer.

The da­ta will back up the com­pa­ny’s up­com­ing bid for ap­proval of the drug com­bo as a front-line ther­a­py, mak­ing Roche a stronger con­tender among ri­vals Bris­tol-My­ers Squibb and Mer­ck as the PD-1/L1 mar­ket leader war wages on.

San­dra Horn­ing

Roche’s close­ly watched Phase III IM­pow­er150 study of a triple com­bo of Tecen­triq, Avastin and chemo showed a sur­vival ben­e­fit “across key sub­groups,” in­clud­ing those with vary­ing lev­els of PD-L1 ex­pres­sion. Genen­tech, a mem­ber of the Roche group, said its com­bo helped pa­tients live “sig­nif­i­cant­ly longer” than those tak­ing Avastin plus car­bo­platin and pa­cli­tax­el.

“We are pleased that the IM­pow­er150 study demon­strat­ed a clin­i­cal­ly mean­ing­ful sur­vival ben­e­fit for peo­ple re­ceiv­ing their ini­tial treat­ment for this type of ad­vanced lung can­cer,” said San­dra Horn­ing, Genen­tech’s CMO and head of glob­al prod­uct de­vel­op­ment, in a state­ment. “These re­sults add to the grow­ing body of ev­i­dence sup­port­ing the role of com­bin­ing Tecen­triq with Avastin. We will sub­mit these ad­di­tion­al da­ta to glob­al health au­thor­i­ties and hope to bring this po­ten­tial treat­ment op­tion to pa­tients as soon as pos­si­ble.”

While the com­bo with Tecen­triq, Avastin, and chemo met its OS co-pri­ma­ry end­point, the com­pa­ny not­ed that leav­ing out Avastin didn’t per­form so well.

At this in­ter­im analy­sis, the study found that sub­sti­tut­ing Avastin with Tecen­triq in the com­bi­na­tion with car­bo­platin and pa­cli­tax­el did not show a sta­tis­ti­cal­ly sig­nif­i­cant OS ben­e­fit in peo­ple with ad­vanced NSCLC com­pared to a com­bi­na­tion of Avastin plus car­bo­platin and pa­cli­tax­el. The study will con­tin­ue as planned to the fi­nal analy­sis.

The new OS da­ta comes af­ter Roche re­port­ed out sol­id PFS da­ta in De­cem­ber. The com­bo demon­strat­ed a dou­bling in 12-month pro­gres­sion-free sur­vival rates among a broad group of front­line lung can­cer pa­tients, set­ting the stage for a quick reg­u­la­to­ry OK on both sides of the At­lantic. Com­par­ing the triple against Avastin and chemo alone, re­searchers tracked a 38% re­duc­tion in the risk of dis­ease pro­gres­sion, with the pro­gres­sion-free sur­vival rate hit­ting 8.3 months for the triple against 6.8 months for the dou­ble. The haz­ard ra­tio (HR) was 0.62. In a sub­group of peo­ple de­fined by a bio­mark­er (T-ef­fec­tor “Teff” gene sig­na­ture ex­pres­sion Teff WT), the PFS hit an im­pres­sive 11.3 months for the triple.

Roche al­so re­port­ed out good news just days ago from the same com­bo in squa­mous NSCLC. At an in­ter­im point, that tri­al, called IM­pow­er131, showed the com­bo beat out chemo on PFS with a sta­tis­ti­cal­ly sig­nif­i­cant out­come but had yet to show an over­all sur­vival ben­e­fit.

IM­pow­er150 is one of eight Phase III lung can­cer stud­ies un­der­way at Genen­tech, eval­u­at­ing Tecen­triq alone or in com­bi­na­tion with oth­er med­i­cines. Three more Phase III lung can­cer stud­ies are ex­pect­ed to re­port this year.

 

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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Andrew Kruegel, Kures president and co-founder (Columbia Tech Ventures via Vimeo)

Af­ter psilo­cy­bin and ke­t­a­mine, a new biotech comes along de­vel­op­ing a drug Scott Got­tlieb fought

Andrew Kruegel was six years into his chemistry work at Columbia University, when, one day in August 2016, he learned he might have only 30 days before the government made him destroy his research.

Kruegel had been studying kratom, a leaf long used in Southeast Asia as a stimulant or for pain. It had opioid-like properties, he found, but seemed to offer pain relief without the addictive potential or respiratory side effects of traditional opioids — a riddle that might help illuminate how human opioid receptors work.

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The home run count: The $100M+ mega-round boom in biotech in­spired a $7.3B 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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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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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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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)

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.

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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