FDA forces trou­bled Ad­vax­is to halt en­roll­ment on its PhI­II study for lead drug ax­al­imo­gene

A lit­tle more than a month af­ter Am­gen qui­et­ly walked away from its $65 mil­lion up­front to part­ner with Ad­vax­is $ADXS on ax­al­imo­gene filolis­bac, the biotech is re­port­ing that the FDA has slapped the pro­gram with a par­tial hold or­der­ing a stop to new en­roll­ment in the Phase III. And this isn’t the first time.

Ac­cord­ing to the com­pa­ny’s re­lease, reg­u­la­tors trig­gered the hold on their study for cer­vi­cal can­cer due to “re­quests for ad­di­tion­al in­for­ma­tion per­tain­ing to cer­tain AX­AL chem­istry, man­u­fac­tur­ing and con­trols (CMC) mat­ters.” No new safe­ty is­sues were iden­ti­fied, ac­cord­ing to the biotech.

Now a pen­ny stock biotech, Ad­vax­is shares closed at just 31 cents to­day, down 10%. And the shares dropped 15% more af­ter the news hit.

Ad­vax­is is ad­vanc­ing ther­a­pies that use live at­ten­u­at­ed Lis­te­ria mono­cy­to­genes which are en­gi­neered to se­crete anti­gen/ad­ju­vant fu­sion pro­teins. And they’re not sim­ple to de­vel­op. The ther­a­py us­es bac­te­ria to kick up an im­mune re­sponse by trig­ger­ing a T cell at­tack on can­cer cells.

Ken­neth Berlin

“FDA’s re­view of the AX­AL In­ves­ti­ga­tion­al New Drug (IND) ap­pli­ca­tion was prompt­ed by our pro­pos­al to mod­i­fy the AIM2CERV tri­al’s analy­sis plan to in­clude, among oth­er things, al­lowance for a sec­ond for­mal in­ter­im analy­sis for both safe­ty and ef­fi­ca­cy,” said Ken­neth Berlin, Ad­vax­is’ CEO. “The pri­ma­ry fo­cus of the items raised by the Agency re­lates to pro­vid­ing ad­di­tion­al clar­i­fy­ing de­tails for CMC in­for­ma­tion pre­vi­ous­ly pro­vid­ed in sup­port of Phase 3 de­vel­op­ment and which will help sup­port a fu­ture Bi­o­log­ics Li­cense Ap­pli­ca­tion. We have al­ready be­gun ef­forts to ad­dress the Agency’s re­quests for in­for­ma­tion and are work­ing to re­spond as prompt­ly as we can.”

That event fol­lows an ear­li­er clin­i­cal hold on their lead pro­gram in com­bi­na­tion with As­traZeneca’s PD-L1 check­point Imfinzi fol­low­ing a pa­tient death, though the hold was lat­er lift­ed. Af­ter a months-long holdup in H1 2018, re­searchers came up with new guide­lines aimed at pre­vent­ing any fu­ture in­stances of acute res­pi­ra­to­ry fail­ure that killed the pa­tient.

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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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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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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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.

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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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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