In­vestors fret as VBI's hep B vac­cine fails key sec­ondary PhI­II study goal

Sobered by mount­ing costs, Dy­navax $DVAX last month made the de­ci­sion to fo­cus all its re­sources on its 2017-ap­proved he­pati­tis B vac­cine Hep­lisav-B, which ri­vals and su­per­sedes the ef­fi­ca­cy and con­ve­nience pro­file of GSK’s $GSK es­tab­lished En­ger­ix-B. The Cal­i­for­nia-based com­pa­ny will be on the look­out for an­oth­er com­peti­tor — VBI Vac­cines, which on Mon­day un­veiled late-stage da­ta on its hep B vac­cine: Sci-B-Vac.

Sci-B-Vac, which has al­ready se­cured ap­proval in Is­rael and 10 oth­er coun­tries, is in Phase III de­vel­op­ment in North Amer­i­ca and Eu­rope. It is en­gi­neered to mim­ic all three sur­face anti­gens of the hep B virus to in­duce a po­tent im­mune re­sponse and is be­ing de­vel­oped to work at low­er dos­es than ex­ist­ing hep B vac­cines.

VBI on Mon­day broke out da­ta from the PRO­TECT study, in which 1,607 sub­jects aged 18 years and old­er were ei­ther giv­en a three-dose course of Sci-B-Vac (10 µg) or a three-dose course of En­ger­ix-B (20 µg).

Sci-B-Vac failed to show that two dos­es of the drug were equal­ly ef­fec­tive as three dos­es of En­ger­ix-B in the study — a key sec­ondary end­point. In­vestors were not im­pressed, and the Cam­bridge, Mass­a­chu­setts-based com­pa­ny’s shares $VBIV cratered 58% tak­ing VBI in­to pen­ny stock ter­ri­to­ry at 81 cents be­fore the open­ing bell on Mon­day.

Mean­while, the VBI vac­cine was found to be as pro­tec­tive as En­ger­ix-B at the end of the third vac­ci­na­tion — meet­ing the main goal of the study. In fact, da­ta showed that the rate of sero­pro­tec­tion (an an­ti­body re­sponse ca­pa­ble of pre­vent­ing in­fec­tion) — was 91.4% for Sci-B-Vac-treat­ed sub­jects, ver­sus 76.5% for En­ger­ix-B — a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence.

In ad­di­tion, the sero­pro­tec­tion rate (SPR) in sub­jects aged 45 and over was 89.4% for Sci-B-Vac, ver­sus 73.1% for En­ger­ix-B af­ter the third vac­ci­na­tion — meet­ing the co-pri­ma­ry end­point. It al­so cleared oth­er sec­ondary goals in sub-analy­ses strat­i­fied by age, gen­der, body mass in­dex, di­a­bet­ic sta­tus and smok­ing sta­tus.

Jeff Bax­ter VBI

Da­ta from an­oth­er late-stage tri­al, CON­STANT, com­par­ing Sci-B-Vac and En­ger­ix-B is ex­pect­ed by the end of 2019. Pend­ing the suc­cess­ful com­ple­tion of CON­STANT, VBI is on to sub­mit mar­ket­ing ap­pli­ca­tions in the U.S., Eu­rope, and Cana­da next year, com­pa­ny chief Jeff Bax­ter said on Mon­day.

Hep B is trans­mit­ted through con­tact with blood and bod­i­ly flu­ids of an in­fect­ed per­son and is a high­ly in­fec­tious virus, 50 to 100 times more in­fec­tious than HIV — even slight laps­es in in­fec­tion con­trol can re­sult in pa­tient-to-pa­tient trans­mis­sion. Since the ear­ly 1990’s the Unit­ed States has im­ple­ment­ed vac­ci­na­tion pro­grams in new­born chil­dren, but those born be­fore re­main sus­cep­ti­ble. CDC da­ta now sug­gests 95% per­cent of new hep B in­fec­tions in the Unit­ed States oc­cur in adults, as there is no stan­dard­ized sys­tem for vac­ci­nat­ing peo­ple af­ter school age, and par­tic­u­lar­ly since spikes in in­jec­tion drug use may be lead­ing to acute out­breaks.

Af­ter be­ing linked to a string of in­ex­plic­a­ble safe­ty is­sues, Hep­lisav-B was fi­nal­ly ap­proved in No­vem­ber 2017. De­spite its check­ered path to the fin­ish line, the vac­cine’s ef­fi­ca­cy and con­ve­nience pro­file su­per­sedes En­ger­ix-B.

So­cial im­age: Shut­ter­stock

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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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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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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