Cure­Vac’s In­g­mar Ho­err tells us why he re­turned to take on a pan­dem­ic; NGM los­es a pres­i­dent

In­g­mar Ho­err

On Tues­day, In­g­mar Ho­err stood up from his seat at the head of Cure­Vac’s board of di­rec­tors meet­ing in Frank­furt, Ger­many and walked out the door.

For 18 years, Ho­err had led the com­pa­ny he found­ed, stew­ard­ing it even when in­vestors re­buffed both him and his ap­proach, be­fore 2 years ago hand­ing it off to Daniel Menichel­la, a long­time biotech busi­ness ex­ec­u­tive who could fu­el the fi­nan­cial half of things. Now the world was fac­ing a pan­dem­ic and Cure­Vac might be able to build a vac­cine and the board, Ho­err said, want­ed some­one who knew the sci­ence back in charge.

When he walked back in, he was no longer chair­man and Menichel­la was no longer CEO. Ho­err had con­trol again.

“Dan was do­ing a re­al­ly good job in terms of busi­ness de­vel­op­ment,” Ho­err told End­points News, cit­ing a re­cent deal Menichel­la signed with Gen­mab. “But now it’s a dif­fer­ent phase for the com­pa­ny. Now it’s a tech phase.”

The sud­den switch, an­nounced Tues­day and with­out com­ment from Menichel­la, prompt­ed spec­u­la­tion. “Was it some­thing he said?” asked one pub­li­ca­tion, not­ing that he had just spo­ken with Pres­i­dent Trump along­side oth­er vac­cine and an­tivi­ral de­vel­op­ers.

But an in­ter­view with Ho­err sug­gest­ed that the switch was symp­to­matic of the pro­found in­flu­ence this cri­sis can have on a biotech like Cure­Vac, one that hasn’t de­vel­oped a sin­gle ap­proved treat­ment over two decades but now finds it­self with one of the most promis­ing tech­nolo­gies to com­bat the grow­ing out­break. Al­though oth­er com­pa­nies build­ing treat­ments or vac­cines against Covid-19 have main­tained that their oth­er pro­grams will con­tin­ue un­abat­ed, Ho­err ac­knowl­edged that their search for an mR­NA vac­cine had all but con­sumed the biotech.

“We have a chal­lenge,” Ho­err said. “We re­al­ly have to work with just the coro­n­avirus out­break.”

An ac­ci­den­tal dis­cov­ery 

When the out­break be­gan, Cure­Vac re­spond­ed quick­ly. Along­side Mod­er­na in Cam­bridge, they were one of two main com­pa­nies de­vel­op­ing mR­NA vac­cines, tech­nol­o­gy that al­lows you to quick­ly build a vac­cine out of ge­net­ic code alone. Pub­lic health of­fi­cials had in re­cent years in­creas­ing­ly iden­ti­fied it as a promis­ing tech­nique to re­spond to out­breaks, and Cure­Vac had re­la­tion­ships with the NIH and the Cen­ter for Epi­dem­ic Pre­pared­ness, which then ful­ly bankrolled their coro­n­avirus vac­cine ap­proach.

Al­though Mod­er­na will be the first com­pa­ny with a Covid-19 vac­cine in the clin­ic, Ho­err claims cred­it for in­vent­ing mR­NA vac­cines and with good rea­son.

As a grad­u­ate stu­dent at the Uni­ver­si­ty of Tübin­gen in the 90s, he set out to study DNA ther­a­pies, a pop­u­lar field at the time. He in­ject­ed one group of mice with DNA to test the im­mune re­sponse. He in­ject­ed a sec­ond group with RNA as a con­trol, as­sum­ing the RNA would dis­in­te­grate in the cell. But when he went to look at the read­outs, the mice that re­ceived RNA had a much bet­ter re­sponse.

“And I was think­ing, ‘wow, I mis­matched a bit,’ maybe I was do­ing the wrong vial,” Ho­err said.

He tried again, emerg­ing with the same re­sult. He be­gan to think about how ef­fec­tive RNA looked and how easy it was to man­u­fac­ture. It could be used for can­cer vac­cines, height­en­ing an im­mune re­sponse around the tu­mor. This was around the same time that Katal­in Karikó and Drew Weiss­man at the Uni­ver­si­ty of Penn­syl­va­nia were do­ing their ear­ly for­ays in­to RNA vac­cines, even­tu­al­ly de­vel­op­ing tech­nol­o­gy that would be li­censed to Mod­er­na and BioN­Tech, which has al­so ex­plored a Covid-19 vac­cine and this week was ru­mored to be dis­cussing an ef­fort in col­lab­o­ra­tion with Pfiz­er.

“I had it al­ready in my mind that this stuff was great, but I didn’t know what to do with it. I didn’t know I’d have to open a GMP fa­cil­i­ty be­fore start­ing the tri­al,” Ho­err said. “It was a huge moun­tain in front of me and I think at that time I was a bit naïve.”

Ho­err found­ed Cure­Vac in 2000. In the ear­ly years, most sci­en­tif­ic in­ter­est was still around DNA and Ho­err couldn’t find in­vestor mon­ey. To get by, the biotech syn­the­sized RNA and sold it to folks who worked in RNA in­ter­fer­ence or oth­er syn­thet­ic RNA ther­a­pies. Slow­ly, they got enough in­vest­ment to fo­cus ful­ly on re­search. The first pro­grams were in can­cer, but in 2011, they start­ed a vac­cine pro­gram. The first tar­get was ra­bies. Al­ready, though, Ho­err was think­ing about pan­demics. This was 2 years af­ter H1N1 flu brought the first pan­dem­ic of the 21st cen­tu­ry.

“I was al­ready think­ing in 2011 about out­break sce­nario, but you know what? No one was in­ter­est­ed,” he said, cit­ing in­vestors and even a large foun­da­tion that turned him down.

Even­tu­al­ly, they got fund­ing from DARPA, the US agency that has long seen stop­ping pan­demics as part of its de­fense man­date. CEPI was found­ed in 2017 in the wake of the Ebo­la out­break and soon teamed up with Cure­Vac on mul­ti­ple projects, in­clud­ing a mo­bile ma­chine that can quick­ly “print” thou­sands of dos­es of mR­NA vac­cines wher­ev­er it’s sta­tioned around the world.

A pro­to­type of that ma­chine has been built, but Ho­err laments it’s not yet com­plete. He spent his first cou­ple days as CEO run­ning from meet­ing to meet­ing, catch­ing up on Cure­Vac’s op­er­a­tions as the com­pa­ny re­fines their coro­n­avirus vac­cines can­di­date.

He talks hur­ried­ly, even in his sec­ond lan­guage, about the out­break and the ways in which Cure­Vac might re­spond. Al­though pub­lic health of­fi­cials such as An­tho­ny Fau­ci have said it will like­ly be at least a year to 18 months be­fore there’s a vac­cine ready for hu­mans, Ho­err is imag­in­ing all the ways their vac­cine might be mo­bi­lized rapid­ly: If shown safe in a few dozen vol­un­teers, he said, it could po­ten­tial­ly be giv­en to health­care work­ers. He said they are in talks with reg­u­la­tors, who are as­sess­ing the sit­u­a­tion.

Be­cause Cure­Vac’s vac­cines — which have nev­er made it to ap­proval but have some tri­al da­ta back­ing them —  can be made in 1 mi­cro­gram dos­es, they can be made much faster than, say, Mod­er­na’s vac­cines. Ho­err says they could build mil­lions of dos­es by sum­mer, when they hope to start tri­als, and over a bil­lion in a year or year and half.

Twen­ty years in, it’s the biggest test Cure­Vac could imag­ine fac­ing, and Ho­err said he’s ready.

“I’m hap­py to de­liv­er some­thing,” Ho­err said. “You know, all the time, 20 years we weren’t re­al­ly de­liv­er­ing any­thing. We were do­ing lots of pa­per­work, and a lot of columns and a lot of read­out da­ta, but I feel now we get trac­tion in help­ing peo­ple and not too far from now.”

by Ja­son Mast

Prog­en­ics Phar­ma­ceu­ti­cals EVP and CFO Patrick Fab­bio has joined Wind­MIL Ther­a­peu­tics as its CFO, ef­fec­tive March 30. Fab­bio was for­mer­ly CFO of elec­tro­Core Med­ical and the VP of fi­nance at NPS Phar­ma­ceu­ti­cals. The Bal­ti­more-based Wind­MIL is so named from its process of tap­ping mem­o­ry T cells in the bone mar­row, called MILs (mar­row in­fil­trat­ing lym­pho­cytes).

→ Af­ter serv­ing at NGM Bio­phar­ma­ceu­ti­cals for near­ly a decade, Aet­na Wun Tromb­ley is step­ping down as pres­i­dent and COO to as­sume the role of CEO at an undis­closed pri­vate­ly held com­pa­ny. Tromb­ley joined the com­pa­ny in 2011 as head of busi­ness de­vel­op­ment. Pre­vi­ous­ly, she held posts at No­var­tis and McK­in­sey & Com­pa­ny.

→ Along with the news that the FDA has grant­ed break­through des­ig­na­tion for JNJ-6372 — a bis­pe­cif­ic against metasta­t­ic non-small cell lung can­cer – Gen­mab has named An­tho­ny Manci­ni EVP and, in a new­ly-cre­at­ed role, COO. Manci­ni has held a num­ber of po­si­tions at Bris­tol My­ers Squibb for the last 24 years and re­cent­ly led the phar­ma gi­ant’s in­no­v­a­tive med­i­cines unit that fo­cus­es on im­munol­o­gy and car­dio­vas­cu­lar dis­eases.

→ On the heels of buy­ing Qi­a­gen for $11.5 bil­lion, Ther­mo Fish­er has named Paul Park­er as its strat­e­gy and cor­po­rate de­vel­op­ment chief. Park­er co-chaired the glob­al M&A group at Gold­man Sachs for six years, and be­fore that, he head­ed M&A at Bar­clays.

→ With Markus En­zel­beger tak­ing over as en­tre­pre­neur-in-res­i­dence at Ver­sant Ven­tures, his pre­de­ces­sor Rober­to Ia­cone has been tapped for the EiR role at Ar­ix Bio­science in Lon­don. Be­fore Ver­sant, Ia­cone was at Roche for 10 years, where he led the Rare Dis­eases Re­search Di­vi­sion.

Mihrib­an Tu­na Adap­tate

F-star vet Mihrib­an Tu­na has joined the ranks of Gam­maDelta spin­off Adap­tate Bio­ther­a­peu­tics as CSO. Dur­ing her 11 year stint at F-star, Tu­na was re­spon­si­ble for lead­ing drug dis­cov­ery. Pri­or to that, she served at GSK.

→ French biotech Eye­ven­sys, which fo­cus­es on non-vi­ral gene ther­a­py de­vel­op­ment for oph­thalmic dis­eases, has made some new lead­er­ship moves this week. Founder Francine Be­har-Co­hen has stepped in­to the new­ly-cre­at­ed role of chief in­no­va­tion of­fi­cer; Thier­ry Bor­det has been pro­mot­ed to CSO; and Ger­ald Ca­gle is now chair­man of Eye­ven­sys’ board.

→ As Cor­bus waits for a po­ten­tial FDA ap­proval of its en­do­cannabi­noid drug lenaba­sum — which was cit­ed by RBC as one that could be vul­ner­a­ble to dis­rup­tions in its timetable be­cause of the coro­n­avirus out­break — James Rindone has stepped in as the Mass­a­chu­setts biotech’s head of com­mer­cial op­er­a­tions & an­a­lyt­ics.

→ Cit­ing fam­i­ly rea­sons, Pharm­ing Group CFO Robin Wright plans to step down and will al­so not put him­self up for re-elec­tion as a mem­ber of the Nether­lands-based biotech’s man­age­ment board. His tenure will end ef­fec­tive May 20.

Akcea Ther­a­peu­tics, which fo­cus­es on de­vel­op­ing drugs to treat se­ri­ous and rare dis­eases, has ap­point­ed Lisa John­son-Pratt as SVP, new prod­uct strat­e­gy. John­son-Pratt has al­so spent time at Glax­o­SmithK­line (VP, glob­al fi­nance op­er­a­tions) and Mer­ck (most re­cent­ly busi­ness unit di­rec­tor, Viet­nam). In ad­di­tion, Akcea pro­mot­ed Joshua Pat­ter­son to gen­er­al coun­sel. Pat­ter­son joined the com­pa­ny in March 2018 as VP, le­gal and cor­po­rate sec­re­tary. Pre­vi­ous­ly, Pat­ter­son served in roles at Io­n­is and Amylin Phar­ma­ceu­ti­cals.

Rodolphe Cler­val has joined Paris-based HO­RA­MA, a clin­i­cal stage gene ther­a­py com­pa­ny cen­tered on oph­thalmic dis­eases, as CBO. Be­fore his ar­rival at HO­RA­MA, Cler­val co-found­ed and was al­so CBO at En­terome.

→ AAV gene ther­a­py com­pa­ny AskBio has en­list­ed Tim Kel­ly as pres­i­dent of man­u­fac­tur­ing. In his new role, Kel­ly will fo­cus on over­see­ing all man­u­fac­tur­ing func­tions at AskBio and its Vi­ral­gen af­fil­i­ate. Pri­or to his ap­point­ment, Kel­ly was the pres­i­dent and CEO of KBI Bio­phar­ma.

Man­isha Narasimhan PRWeb

→ Alde­vron, spe­cial­iz­ing in the pro­duc­tion of plas­mid DNA, pro­teins, mR­NA and an­ti­bod­ies for its clients, has tapped Bris­tol My­ers vet Vi­jay Sura­pa­neni as VP of bio­man­u­fac­tur­ing op­er­a­tions. Sura­pa­neni hops aboard from Catal­ent Phar­ma So­lu­tions and has pre­vi­ous ex­pe­ri­ence from Con­va­Tec.

→ Al­ler­gan ex­ec Man­isha Narasimhan has joined San Diego-based Cy­tonus Ther­a­peu­tics‘ board of di­rec­tors. Narasimhan serves as Al­ler­gan’s SVP of strate­gic ini­tia­tives, port­fo­lio in­no­va­tion and in­vestor re­la­tions.

Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

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David Liu (Casey Atkins Photography courtesy Broad Institute)

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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In the lat­est big in­vest­ment in gene ther­a­py man­u­fac­tur­ing, Bio­gen com­mits $200M to a ma­jor new fa­cil­i­ty in NC

You’d be forgiven for thinking that the only R&D effort of any consequence at Biogen belongs to aducanumab, its controversial Alzheimer’s drug. But behind the uproar around that drug, the big biotech has a full scale pipeline in play that includes a growing focus on developing gene therapies.

Now Biogen plans to build up the kind of manufacturing muscle that will give it an advantage in gaining FDA approvals — where CMC is always key — and then marketing them around the world.

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Eli Lil­ly claims a TKO in its long-run­ning ti­tle fight with No­vo Nordisk for the block­buster di­a­betes mar­ket — but there’s a hitch

Eli Lilly isn’t just gunning for a better diabetes drug in tirzepatide. They want to cut ahead of Novo Nordisk’s blockbuster rival Ozempic (semaglutide) on the obesity front as well. But a newly-claimed win in a head-to-head Phase III showdown over reducing A1C while shedding pounds — complete with clear evidence of superiority over the approved rival — could prove a tough sell right now.

Let’s start with the latest data from Lilly.

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In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Hal Barron, Endpoints UKBIO19

GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slapdown, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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