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.

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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No­vavax snags Ben Machielse for CMC and pro­motes a trio of staffers; Mar­ty Du­vall lands an­oth­er CEO post at On­copep­tides

Novavax has been making waves recently by securing a $384 million commitment from CEPI to cover R&D and manufacturing for its Covid-19 vaccine while also spending $167 million on a 150,000 square-foot facility. The Maryland biotech continues to shore up its leadership team as well, bringing in Ben Machielse as their EVP of CMC just a couple weeks after nabbing AstraZeneca vet Filip Dubrovsky as their new CMO. Machielse was president and CEO of Vtesse from 2014-17, and before that, he also spent more than 11 years at MedImmune and was EVP of operations for the back half of his tenure.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Look­ing for 'ex­ter­nal in­no­va­tion,' Boehringer In­gel­heim re­serves $500M+ for new Shang­hai hub

Now that Boehringer Ingelheim’s bet on contract manufacturing in China has paid off, the German drugmaker is anteing up more to get into the research game.

Boehringer has set aside $507.9 million (€451 million) for a new External Innovation Hub to be built in Shanghai over five years. The site will become one of its “strategic pillars” as the team strives to get 71 approvals — either for new products or indications — by 2030, said Felix Gutsche, president and CEO of Boehringer Ingelheim China.

Vas Narasimhan, Novartis CEO (Patrick Straub/​EPA-EFE/​Shutterstock)

No­var­tis pays $678M for kick­back scheme as Vas Narasimhan tries to dis­tance phar­ma gi­ant from shady be­hav­ior

Novartis has reached another large settlement to resolve misconduct allegations, agreeing to pay more than $678 million to settle claims that it had spent hundreds of millions of dollars on lavish dinners, so-called speaking fees and expensive alcohol “that were nothing more than bribes” to get doctors to prescribe Novartis medications.

The top-shelf alcohol and lavish meals included a $3,250 per person night at Nobu in Dallas, a $672-per person dinner at Washington DC’s Smith & Wollensky and a $314 per person meal at Sushi Roku in Pasadena, according to the Justice Department complaint. There were at least 7 trips to Hooters and fishing trips in Alaska and off the Florida coast. Each of these events were supposed to be “speaker programs” where doctors educated other doctors on a drug, but the DOJ alleged many were “bogus” wine-and-dine events where the drug was barely mentioned, if at all.  (“Nobody presented slides on the fishing trips,” the complaint says.)

Dan Gold, MEI Pharma CEO

De­vel­op­ment part­ners at MEI, Helsinn dump a high-risk PhI­II AML study af­ter con­clud­ing it would fail sur­vival goal

Four years after Switzerland’s Helsinn put $25 million of cash on the table for an upfront and near-term milestone to take MEI Pharma’s drug pracinostat into a long-running Phase III trial for acute myeloid leukemia, the partners are walking away from a clinical pileup.

The drug — an HDAC inhibitor — failed to pass muster during a futility analysis, as researchers concluded that pracinostat combined with azacitidine wasn’t going to outperform the control group in the pivotal.

Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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