Scripps-led con­sor­tium scores $129M NIH grant to work on vac­cine for stub­born HIV

Sci­en­tif­ic ef­fort in­to de­vel­op­ing a vac­cine against the HIV has proved elu­sive, as the virus rapid­ly mu­tates and its out­er spike pro­tein op­er­ates as an in­vis­i­bil­i­ty cloak, al­low­ing it to out­wit the im­mune sys­tem’s de­fen­sive ar­se­nal. On Wednes­day, a con­sor­tium of sci­en­tists led by Scripps Re­search un­veiled a $129 mil­lion grant from the Na­tion­al In­sti­tutes of Health (NIH) that will help shep­herd vac­cines — en­gi­neered to com­bat a pletho­ra of HIV strains — in­to the clin­ic.

HIV was once a death sen­tence, but is now con­sid­ered a chron­ic ill­ness. For those al­ready af­flict­ed, an­ti­retro­vi­ral ther­a­py must be tak­en every sin­gle day to sup­press the virus or un­bri­dled repli­ca­tion can over­whelm the im­mune sys­tem and even­tu­al­ly cause AIDS. Dai­ly pills al­so rack up ex­pen­sive bills in the Unit­ed States, with month­ly ex­pen­di­ture on treat­ment hit­ting thou­sands per month — de­pend­ing on the reg­i­men, in­sur­ance provider and re­bates/dis­counts. Then there’s pre­ven­ta­tive treat­ment or PrEP (pre-ex­po­sure pro­phy­lax­is), in which in­di­vid­u­als at high risk for HIV (typ­i­cal­ly men who have sex with men) take med­i­cines dai­ly to low­er their chances of con­tract­ing the in­fec­tion. Ac­cord­ing to the CDC, dai­ly PrEP re­duces the risk of get­ting HIV via sex­u­al in­ter­course by more than 90%.

Still, there are near­ly 37 mil­lion peo­ple liv­ing with HIV/AIDS glob­al­ly, ac­cord­ing to World Health Or­ga­ni­za­tion fig­ures from 2017, a year which al­so saw 940,000 pa­tients suc­cumb to the dis­ease. Ac­cord­ing to Scripps, de­spite ex­ist­ing pre­ven­tion mea­sures, glob­al­ly 1.8 mil­lion peo­ple ac­quired HIV in 2017 (about one per­son every 15 sec­onds).

Den­nis Bur­ton Scripps Re­search

A key chal­lenge re­searchers face is that one HIV-af­flict­ed per­son can car­ry hun­dreds of thou­sands of vari­ants of the virus at any giv­en point. Scripps’ sci­en­tist Den­nis Bur­ton and his col­leagues ini­ti­at­ed their quest in 2009 when they dis­cov­ered two po­tent an­ti­bod­ies in the blood cells of a woman liv­ing with HIV that ap­peared ca­pa­ble of neu­tral­iz­ing 70% of 162 HIV ref­er­ence strains rep­re­sen­ta­tive of the glob­al epi­dem­ic.

Tak­ing a cue from this find­ing, Bur­ton et al. iden­ti­fied sta­ble re­gions on HIV’s out­er coat that could be tar­get­ed by bn­Abs to de­vel­op im­muno­gens. These mol­e­cules in an­i­mal stud­ies demon­strat­ed the abil­i­ty to con­fer long-last­ing pro­tec­tion against ex­po­sure to mul­ti­ple HIV strains. This work was sup­port­ed by a $77 mil­lion NIH grant which ran out this June.

This new cap­i­tal in­jec­tion will be used to re­fine the im­muno­gens, de­vel­op scal­able man­u­fac­tur­ing ap­pa­ra­tus­es, and test the im­muno­gens in ear­ly-stage hu­man clin­i­cal tri­als. In part­ner­ship with the In­ter­na­tion­al AIDS Vac­cine Ini­tia­tive, the con­sor­tium of re­searchers are set to launch their first hu­man clin­i­cal tri­al this year, Scripps said.

The promise of an HIV vac­cine first be­came ap­par­ent in 2009, when a tri­al in Thai­land test­ed a com­bi­na­tion of two vac­cines. In the tri­al, one vac­cine was giv­en in four dos­es and then “boost­ed” by two dos­es con­tain­ing both vac­cines. The analy­sis showed the group re­ceiv­ing the vac­cine(s) had an in­fec­tion rate 31.2% low­er than the group that re­ceived the place­bo — while this da­ta was not com­pelling enough to make the cut for ap­proval, the lessons of this tri­al are now be­ing used for a va­ri­ety of oth­er ef­forts.

Last year, a study pub­lished in the Lancet jour­nal from a sim­i­lar­ly struc­tured study of­fered en­cour­ag­ing re­sults. Re­searchers from NIH, Har­vard, J&J $JNJ and else­where used the same process of dos­ing a vac­cine and then fol­lowed up the ini­tial ad­min­is­tra­tion with ‘boost­er’ dos­es in non-in­fect­ed pa­tients at low risk of HIV. Da­ta showed the vac­cine reg­i­mens were well tol­er­at­ed and in­duced ro­bust im­mune re­spons­es in healthy in­di­vid­u­als — they are now be­ing test­ed in sub-Sa­ha­ran Africa.

So­cial im­age: Shut­ter­stock

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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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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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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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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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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For­bion spot­lights late-stage plays, carves out new €250M growth fund

Having staked its rep on picking out a mix of biotech investment opportunities across the “build,” “enable,” “growth” continuum, Forbion is launching its first fund dedicated to late-stage opportunities.

Forbion Growth Opportunities Fund’s first close brought in €185 million ($208 million). Existing investors Pantheon, KfW Capital and the European Investment Fund came on board, joined by new backers Eli Lilly, Horizon Therapeutics, Belgian Growth Fund and New Waves Investments.

Mer­ck ex­pands scope of Zymeworks an­ti­body al­liance, adding close to $900M in mile­stones

Nearly a decade after first partnering with Merck, Vancouver-based biotech Zymeworks has expanded its collaboration with the pharma giant once again.

Zymeworks re-upped with Merck in a new licensing agreement, granting the New Jersey pharma giant the right to develop up to 3 additional multispecific antibody candidates. In exchange, the biotech will receive an undisclosed upfront payment — Merck is always loath to discuss cash terms — and nearly $900 million in combined regulatory ($411 million) and commercial ($480 million) milestones.

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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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