The num­ber of I/O can­cer drugs in the clin­ic con­tin­ues to swell at an ex­plo­sive pace -- of­fer­ing new hope, fresh con­cerns

The jug­ger­naut of im­muno-on­col­o­gy drug re­search around the world con­tin­ues to rapid­ly gain speed and mass, of­fer­ing pa­tients with vir­tu­al­ly every can­cer type the prospect of new com­bi­na­tions or monother­a­pies that may bend the course of their dis­ease, ac­cord­ing to a new study map­ping the glob­al land­scape of I/O. But it al­so rais­es fresh con­cerns about com­modi­ti­za­tion and pa­tient re­cruit­ment as the num­ber of PD-1/L1s on the mar­ket con­tin­ues to mul­ti­ply, with hun­dreds more com­ing from be­hind in the pipeline.

Vanes­sa Hub­bard-Lucey

A team at the Can­cer Re­search In­sti­tute has been study­ing the field for the past 2 years, track­ing tri­al ac­tiv­i­ty around the globe as I/O con­tin­ues to at­tract block­buster-sized in­vest­ments in pur­suit of new stan­dards of can­cer med­i­cine. And the num­bers at the end of 2018 have swelled sig­nif­i­cant­ly in most cat­e­gories.

Source: Can­cer Re­search In­sti­tute

Click on the im­age to see the full-sized ver­sion

Some of the high­lights from their re­port — which was pub­lished in Na­ture Re­views Drug Dis­cov­ery — in­clude:

— World­wide the num­ber of I/O drugs in 6 key class­es has hit 3,394 — up 67% in one year. Those drugs in­volved 417 tar­gets like CD19, at the top of the list, fol­lowed by PD-1, PD-L1 and HER2. A year ago they were track­ing 2,031 drugs in­volv­ing 273 tar­gets.

— The group count­ed 2,250 clin­i­cal tri­als un­der­way for PD-1/L1 agents, an in­crease of 748 from a year ago. And there are 1,176 com­bi­na­tion stud­ies un­der­way, with a to­tal of 240 dif­fer­ent tar­gets.

— With a hand­ful of cell ther­a­pies ap­proved, CRI tracked 448 in pre­clin­i­cal de­vel­op­ment. Nine are in Phase III and 227 are in Phase II. The spike in cell ther­a­py work has pushed it in­to the lead among all 6 cat­e­gories tracked, well ahead of can­cer vac­cines and leav­ing on­colyt­ic virus­es be­hind — though that field is still grow­ing as well.

The US eas­i­ly re­mains the leader in the ge­og­ra­phy of I/O re­search, but Chi­na has been com­ing on strong as the num­ber 2 coun­try en­gaged in new re­search in­volv­ing I/O. And a num­ber of home grown PD-1/L1 drugs are near­ing ap­proval in Chi­na, with im­pli­ca­tions for the rest of the world.

Source: Can­cer Re­search In­sti­tute

Click on the im­age to see the full-sized ver­sion

Par­tic­u­lar­ly ex­cit­ing, says Vanes­sa Hub­bard-Lucey, di­rec­tor of the CRI Clin­i­cal Ac­cel­er­a­tor, is that “al­most all can­cer types are be­ing stud­ied with PD-1/L1 ther­a­pies in clin­i­cal tri­als, in­clud­ing many rare can­cers.”

But while all the num­bers con­tin­ue to steam ahead, there has been a sig­nif­i­cant de­cline in one key cat­e­go­ry: pa­tient re­cruit­ment has slowed 70% in 4 years, they say. And that un­der­scores a dra­mat­ic need to ex­pand the num­ber of pa­tients who can be re­cruit­ed for cur­rent and up­com­ing drug tri­als.

One of the rea­sons why I/O is so pop­u­lar is due to the mega-block­buster check­point suc­cess­es at Mer­ck and Bris­tol-My­ers Squibb. But while the lead­ers con­tin­ue to do well, every­one else look­ing to score gains of their own in a field like PD-1/L1 will be fac­ing a myr­i­ad of ri­vals be­ing ad­vanced for every con­ceiv­able tar­get. And a crush of com­peti­tors could well end up com­modi­tiz­ing the field, which is one rea­son why you’re see­ing so many com­bo stud­ies un­der­way. 

The lead­ers want to main­tain their lead, and the bio­phar­mas com­ing from be­hind want to find a way to break in with some­thing new.

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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Gilead boasts of pos­i­tive remde­sivir da­ta on mor­tal­i­ty — but their analy­sis pro­vokes the skep­tics

Gilead is surging again off data that suggest its antiviral remdesivir might improve survival.

The new data come from an analysis Gilead conducted comparing the death rate and recovery time of patients in one of its remdesivir trials to a group of 800 patients “with similar baseline characteristics and disease severity” who received only standard-of-care around the same time. The result, they said, suggested that patients who received remdesivir had a 62% better chance at surviving than those who did not.

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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Nick Galakatos, Blackstone global head of life sciences

Nick Galakatos and the Black­stone team now have a record $4.6B to in­vest in bio­phar­ma, with a big fo­cus on push­ing com­pa­nies over the top

Nick Galakatos and his team at Blackstone Life Sciences have seen their biggest opportunities swell up in mostly established players who don’t have all the money they need to accomplish everything on the to-do list. And right now, with the industry booming, that’s a long list with some hefty needs.

The Blackstone team has neatly tied up the largest private fund ever raised in life sciences for making big dreams come true in biopharma. Late Thursday, Blackstone put out word that they had closed their highly anticipated fund with the projected $4.6 billion all in.

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Hal Barron, GSK

Win or lose on the mar­ket­ing OK, the FDA just gunned down GSK’s bright hopes for their BC­MA ther­a­py

The FDA’s ODAC — the Oncologic Drugs Advisory Committee — has a well-known bias in favor of adding new cancer drugs to the market, even if efficacy is at best marginal and serious safety issues demand careful management.

Doctors want as many arrows in their quiver as they can get. And when patients are dying after failing multiple drugs, why not give it a go one more time?

GlaxoSmithKline, though, is about to test out how their new BCMA antibody drug conjugate belantamab mafodotin can do after being mauled in an in-house FDA review, ahead of the Tuesday expert panel discussion. Even if the agency goes ahead with an expected green light, this drug will likely be constrained to a small niche — icing any plans they may have for making waves in oncology anytime soon.

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Covid-19 roundup: BioN­Tech go­ing head-to-head with Mod­er­na as PhI­II mR­NA launch looms; Tri­al on Shin­zo Abe’s once-fa­vorite an­tivi­ral is in­con­clu­sive

It’s a race to the Phase III finish line now for the 2 leading mRNA vaccines in the pipeline for Covid-19.

BioNTech chief Ugur Sahin told the Wall Street Journal that his company will start Phase III testing of their vaccine later this month, setting them up to lateral the data to regulators before the end of this year.

That puts them essentially on the exact same schedule as Moderna is dedicated to. The Massachusetts rival to BioNTech also expects to launch Phase III this month. Lots of rumors have circulated about delays and conflict among the scientists advancing the Moderna jab, but the biotech has consistently stuck to its plan to start a late-stage pivotal this month.

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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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