BAR­DA looks to get the jump on next pan­dem­ic with VC arm tar­get­ing 'trans­for­ma­tive' tech

Five years af­ter Con­gress first called for it — and a year and a half af­ter a pan­dem­ic broke out — BAR­DA, the US’s top pan­dem­ic pre­pared­ness agency, is launch­ing its own VC fund.

The new fund will in­vest in tech­nolo­gies that could be de­ployed against fu­ture out­breaks or oth­er pub­lic health emer­gen­cies. It fol­lows a sim­i­lar mod­el to oth­er pub­lic health VCs, such as the Gates Foun­da­tion’s fund, giv­ing cap­i­tal to ear­ly-stage com­pa­nies with promis­ing plat­form tech­nolo­gies in ex­change for as­sur­ances they use it part­ly for in­fec­tious dis­eases that might not have a sig­nif­i­cant mar­ket.

Sandeep Pa­tel

Sandeep Pa­tel, di­rec­tor of BAR­DA’s di­vi­sion of Re­search, In­no­va­tion and Ven­tures, name-checked mR­NA vac­cines, a tech­nol­o­gy that was be­ing de­vel­oped in large part for can­cer be­fore Covid-19, but which an­oth­er branch of the gov­ern­ment — DARPA — in­vest­ed in as a pan­dem­ic pre­pared­ness tool.

It’s “look­ing at what’s po­ten­tial­ly trans­for­ma­tive,”  he told End­points News. “mR­NA rep­re­sent­ed a kind of new class of vac­cines. What’s the equiv­a­lent of that we can in­vest in for the fu­ture, ei­ther in vac­cines, treat­ments or di­ag­nos­tics? Or even things that cut across those ar­eas.”

Fit­ting­ly for a long-over­looked gov­ern­ment agency de­pen­dent on Con­gress for cash, the fund is for now mod­est. BAR­DA has com­mit­ted on­ly $10 mil­lion this year and $50 mil­lion over the next five years to the VC, al­though Pa­tel said that they hope to raise that up to $500 mil­lion over the next decade. He not­ed that Pres­i­dent Joe Biden’s new bud­get in­cludes $50 mil­lion for year one of the ef­fort, should it be passed.

They al­so plan to match their own in­vest­ments with pri­vate cap­i­tal. Con­gress au­tho­rized the VC fund in 2016 as part of the 21st Cen­tu­ry Cures Act, but Pa­tel said they need­ed time to fig­ure out its mod­el. Af­ter so­lic­it­ing bids in the fall, the agency an­nounced it will team with GHIC, a Gates-fund­ed non-prof­it that will look to mar­shal more con­ven­tion­al VCs to bur­nish BAR­DA’s ef­forts.

De­spite its pre-pan­dem­ic his­to­ry, the new fund fits in­to a broad­er push to de­vel­op tech­nolo­gies, in­fra­struc­ture and oth­er ca­pa­bil­i­ties to pre­vent the next pan­dem­ic, join­ing gov­ern­ment and aca­d­e­m­ic ef­forts to de­vel­op pan-vi­ral vac­cines and in­dus­try ef­forts to reimag­ine bi­o­log­ics man­u­fac­tur­ing, so any fu­ture pan­dem­ic vac­cine or treat­ment could be rapid­ly scaled.

It’s a de­par­ture from where BAR­DA has spent much of the funds in the past, when it di­rect­ed tens of mil­lions of dol­lars to get in­di­vid­ual prod­ucts — of­ten an­tibi­otics with­out an im­me­di­ate com­mer­cial mar­ket — through late-stage stud­ies.

Pa­tel said they’ll in­vest in com­pa­nies — around five to nine per year — that have clear­er com­mer­cial ap­pli­ca­tions out­side of pub­lic health emer­gen­cies, so it will be sus­tain­able with­out heavy pub­lic fund­ing and ready if a cri­sis strikes. As with oth­er non-prof­it ven­ture ef­forts, any re­turns from those in­vest­ments would be fun­neled back in­to the fund to be re-in­vest­ed. He com­pared it to In-Q-Tel, the CIA’s VC arm.

What could those tech­nolo­gies or com­pa­nies be? Pa­tel wouldn’t dive in­to too many specifics, but he threw out nee­dle-free vac­cines, which BAR­DA has al­ready mod­est­ly in­vest­ed in,  and new meth­ods for rapid­ly scal­ing man­u­fac­tur­ing — any­thing that could turned around faster for Covid-28, or what­ev­er strikes next.

“There’s a lot, there’s a long list here, we’re in the process of set­ting pri­or­i­ties,” Pa­tel said. “Clear­ly Covid-19 has showed us some lessons”

So­cial im­age: Rick Bright (Pho­to by Greg Nash / POOL / AFP) (Pho­to by GREG NASH/POOL/AFP via Get­ty Im­ages)

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, and more

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By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

The IPO 4-1-1: Four fil­ings, a pric­ing and a with­draw­al head­line this week's Nas­daq ac­tion as raise ap­proach­es $7.5B

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

Another week, another horde of biotechs is doing the Nasdaq dance.

This week saw four companies file their SEC paperwork ahead of expected debuts, another hit Nasdaq on Friday and a sixth formally withdrew its bid to go public. Aerovate Therapeutics, Ocean Biomedical and Acumen Pharmaceuticals all penciled in initial raises of $100 million, while Dermata Therapeutics is estimating a modest $18 million raise.

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Keiichi Fukuda, Heartseed CEO

Fresh off $598M deal with No­vo Nordisk, a Japan­ese stem cell com­pa­ny is on its way to the clin­ic with a dif­fer­ent ap­proach to treat­ing heart fail­ure

A common approach to treating heart failure with induced pluripotent stem cells involves grafting sheets of cells onto the surface of the heart to improve vascularization and blood flow. It’s the easiest method of transplantation — but you run the risk of not making an electrical connection with the heart and the cells not synchronizing with the patient’s heart muscle.

So what if you could inject spherical clusters of heart cells directly into the heart muscle wall? For Heartseed, that’s now the $37 million question.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

Reshma Kewalramani, Vertex CEO (BIO via YouTube)

UP­DAT­ED: Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

It’s been several months since Vertex culled one of its small molecules for alpha-1 antitrypsin deficiency (AATD), taking a big hit after evidence of liver damage surfaced in a key Phase II trial. Now we learned that the company has whiffed on its second shot, and there’s nothing left in the clinic to treat the rare genetic disease — but that won’t stop it from trying.

Despite avoiding the safety issues that plagued the last candidate, Vertex $VRTX is taking the axe to VX-864 after Phase II results revealed the magnitude of the drug’s response is “unlikely to translate into substantial clinical benefit.” As a result of the news, the company’s stock fell 12.5% after hours.

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