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.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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SQZ Biotech slash­es head­count by 60% as founder/CEO hits ex­it — while Syn­log­ic lays off 25%

It’s a tough time for early-stage companies developing highly promising, but largely unproven, new technologies.

Just ask SQZ Biotechnologies and Synlogic. The former is bidding farewell to its founder and CEO and slashing the headcount by 60% as it pivots from its original cell therapy platform to a next-gen approach; the latter — a synthetic biology play founded by MIT’s Jim Collins and Tim Lu — is similarly “optimizing” the company to focus on lead programs. The resulting realignment means 25% of the staffers will be laid off.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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