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.

Bob Nelsen at the Milken Institute Global Conference on April 29, 2019 in Beverly Hills, California. (Photo by Michael Kovac/Getty Images)

ARCH chief Bob Nelsen has $1.5B to prove 2 sim­ple points: ‘We’re in the most in­no­v­a­tive time ever’ and in­vestors are stay­ing

ARCH co-founder and managing director Bob Nelsen has a well known yen for the home run swing, betting big on potentially transformative meds and tech and the biotech teams he helps bring together. He thrives and bleeds on the cutting edge. And now Nelsen and the ARCH group have debuted 2 big funds to prove that this is the time for the best of biotech to shine — deadly pandemic be damned.

Two new funds, ARCH Venture Fund X and ARCH Venture Fund X Overage, gathered a combined $1.46 billion. And that’s a record. ARCH Venture Fund IX and ARCH Venture Fund IX Overage closed in 2016 with a combined $1.1 billion. ARCH Venture Fund VIII and ARCH Venture Fund VIII Overage closed in 2014 with a combined $560 million.

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UP­DAT­ED: Have a new drug that promis­es to fight Covid-19? The FDA promis­es fast ac­tion but some de­vel­op­ers aren't hap­py

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

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Noubar Afeyan, Flagship

Step­ping out along­side ARCH's record raise, Flag­ship adds a $1.1B mon­ster fund of its own

ARCH’s unveiling this morning of 2 new funds bulging with $1.5 billion in cash for biotech startups was just the first round of today’s venture news.

Right on its heels we have another monster fund debuting at Flagship Pioneering, another big venture group known for making huge bets on cutting-edge tech — the kind it brews up in its labs.

And this one weighs in at $1.1 billion, which will operate in tandem with the $1.1 billion in funds Flagship rolled out last year.

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Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Mene Pangalos via YouTube

As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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Daniel O'Day (AP Images)

Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

In addition to trying to reassure patients that they will once again have an avenue to pursue access, O’Day also reassured some analysts who had been fretting that China’s quick comeback from the coronavirus outbreak could derail its ultra-fast schedule for testing the drug in patients. The data are still expected in a few weeks, he says in the letter, putting the readout in April.

O’Day emphasizes that Gilead intends to pursue a pricing approach that will make this drug widely available — if it proves effective and safe. But no one is quite sure just what the longterm value would be, given the work being done on a variety of vaccines that may be rolled out as early as this fall — at least to the most heavily threatened groups.

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Mer­ck scores new ad­vance on tu­mor-ag­nos­tic front as Keytru­da beat chemo-based reg­i­mens in a type of col­orec­tal can­cer

Back in 2017, before the term “tumor agnostic” really took hold among cancer drug developers, Merck became the first to secure such an approval for Keytruda as a second-line treatment for patients characterized by a biomarker — rather than where the cancer started in the body. Now it’s looking to break fresh ground with a new slate of data suggesting the drug’s utility in the frontline setting for colorectal cancer.