Franz-Werner Haas, CureVac CEO (Thomas Kienzle/AFP via Getty Images)

Covid-19 roundup: Cure­Vac backs out of man­u­fac­tur­ing con­tracts as de­mand dwin­dles; De­spite PhII/III flop, biotech keeps look­ing for sil­ver lin­ing

Cure­Vac ter­mi­nat­ed con­tracts with two com­pa­nies who had signed on to help the Ger­man drug mak­er man­u­fac­ture its mR­NA Covid-19 vac­cine in Eu­rope, as po­ten­tial de­mand for its shot has dwin­dled.

Con­tracts with Wack­er for the man­u­fac­tur­ing of mR­NA drug sub­stance and Celonic for the man­u­fac­tur­ing and for­mu­la­tion of the mR­NA drug sub­stance for the drug, dubbed CVn­CoV, are no more. The com­pa­ny has held on to ex­ist­ing agree­ments with Rentschler Bio­phar­ma and No­var­tis for mR­NA pro­duc­tion, and said that those will not be af­fect­ed.

The com­pa­ny at­trib­uted the de­ci­sion to what it called “the re­duced short-term peak de­mand for vac­cines fol­low­ing the first wave of the pan­dem­ic vac­ci­na­tion ef­forts,” in com­bi­na­tion with change in de­mand for its can­di­date.

The an­nounce­ment comes a few months af­ter the com­pa­ny failed a piv­otal Covid-19 vac­cine tri­al, when it was on­ly 48% ef­fec­tive. The com­pa­ny chalked up the fail­ure to vari­ants, specif­i­cal­ly the Lamb­da vari­ant out of Pe­ru, al­though that ar­gu­ment found lit­tle trac­tion with ex­perts.

The com­pa­ny has said it’s still com­mit­ted to seek­ing reg­u­la­to­ry ap­proval with the EMA. Mean­while, vac­ci­na­tion rates in Eu­rope have risen to the high­est in the world, sur­pass­ing the Unit­ed States.

“The de­vel­op­ment from a very high, short-term pan­dem­ic de­mand to broad­er avail­abil­i­ty of vac­cines has led us to re-eval­u­ate our im­me­di­ate man­u­fac­tur­ing ca­pac­i­ty re­quire­ments in or­der to align the ca­pac­i­ty with ac­tu­al com­mer­cial and clin­i­cal ca­pac­i­ty needs for CVn­CoV,” COO Malte Gre­une said in a press re­lease. “We would like to thank both our man­u­fac­tur­ing part­ners for their ded­i­ca­tion and ef­fort in achiev­ing our com­mon goal to com­bat the pan­dem­ic with this key tech­nol­o­gy.”

Fi­nan­cial terms sur­round­ing the can­cel­la­tion weren’t dis­closed, per an agree­ment be­tween both sides, the press re­lease said. — Josh Sul­li­van

An­oth­er ther­a­py fails to help se­vere pa­tients — but biotech isn’t giv­ing up

More than a year af­ter the pan­dem­ic sent a horde of biotechs in­to a fren­zied cam­paign to re­pur­pose their drugs for Covid-19, the search is still prov­ing elu­sive.

Red­Hill Bio­phar­ma’s opa­ganib is the lat­est can­di­date to dis­ap­point, as it failed to meet the pri­ma­ry end­point — the pro­por­tion of pa­tients breath­ing room air with­out oxy­gen sup­port by Day 14 — of a Phase II/III study for se­vere pa­tients.

All 475 pa­tients in the tri­al were hos­pi­tal­ized with se­vere Covid-19 pneu­mo­nia. They were giv­en ei­ther opa­ganib or place­bo on top of stan­dard of care.

But Red­Hill isn’t throw­ing in the tow­el just yet. Point­ing to the drug’s “strong an­tivi­ral mech­a­nism and ef­fect against vari­ants” ob­served in a pre­vi­ous Phase II study, ex­ecs say re­searchers are still an­a­lyz­ing the da­ta to see if they can find sil­ver lin­ings such as sub­group ben­e­fits. Be­sides, they say, the drug ap­pears to have good tol­er­a­bil­i­ty with bal­anced ad­verse events in the drug and place­bo arms.

“While we are dis­ap­point­ed with the da­ta not reach­ing sta­tis­ti­cal sig­nif­i­cance, we do see a trend that needs to be in­ves­ti­gat­ed that opa­ganib may pro­vide ben­e­fit to pa­tients ear­li­er in the course of the dis­ease,” said CEO Dror Ben Ash­er.

Tout­ed as an oral, first-in-class sphin­go­sine ki­nase-2 (SK2) se­lec­tive in­hibitor, opa­ganib is de­signed to tar­get a key en­zyme in hu­man cells that virus­es are be­lieved to co-opt as they repli­cate.

The biotech is al­so test­ing RHB-107 (up­amo­stat) in non-hos­pi­tal­ized symp­to­matic Covid-19 pa­tients. — Am­ber Tong

12- to 15-year-olds now el­i­gi­ble for vac­cine in UK

With a re­duced dis­rup­tion of ed­u­ca­tion in mind, the British gov­ern­ment has giv­en the OK to ado­les­cents ages 12 to 15 to re­ceive the Covid-19 vac­cine, the coun­try’s health min­is­ter said in a state­ment.

Vac­ci­na­tions will be­gin in Eng­land next week, and Scot­land, Wales and North­ern Ire­land will set their own health pol­i­cy.

“I have ac­cept­ed the rec­om­men­da­tion from the Chief Med­ical Of­fi­cers to ex­pand vac­ci­na­tion to those aged 12 to 15 — pro­tect­ing young peo­ple from catch­ing COVID-19, re­duc­ing trans­mis­sion in schools and keep­ing pupils in the class­room,” health min­is­ter Sajid Javid said.

The Pfiz­er-BioN­Tech vac­cine will be of­fered, as im­muno­com­pro­mised chil­dren in that age group were al­ready el­i­gi­ble for that shot. — Josh Sul­li­van

On heels of man­u­fac­tur­ing agree­ment for mR­NA vac­cine, Prov­i­dence CEO trash­es gov­ern­ment 

On Tues­day, Prov­i­dence Ther­a­peu­tics an­nounced that it was team­ing with the high­ly scru­ti­nized Emer­gent Bioso­lu­tions to get help de­vel­op­ing its mR­NA Covid-19 vac­cine can­di­date. Just a day ear­li­er, its CEO went on tele­vi­sion and trashed the Cana­di­an gov­ern­ment for its role in do­mes­tic vac­cine pro­duc­tion.

CEO Brad Soren­son went on the Bloomberg News Net­work and called out Prime Min­is­ter Justin Trudeau and his ad­min­is­tra­tion, say­ing he’s done the “ab­solute min­i­mum”  to sup­port Cana­di­an biotech, in­clud­ing Prov­i­dence, while throw­ing mon­ey at for­eign com­pa­nies to get them to come to Cana­da.

“We could’ve been sup­ply­ing vac­cines to the world and we could’ve been adding to the so­lu­tion as op­posed to dri­ving up prices and adding to the prob­lem,” he said in an in­ter­view.

Last week, Re­silience an­nounced that it will start mak­ing mR­NA for Mod­er­na’s Covid-19 vac­cine at its new site in Cana­da. The com­pa­ny land­ed a $163 mil­lion con­tract from the gov­ern­ment of Cana­da, while Mod­er­na al­so struck a deal for its own plant in Au­gust, and Ab­Cellera got $125.6 mil­lion to help build its 130,000-square-foot fa­cil­i­ty to de­vel­op an­ti­bod­ies and of­fer pre­pared­ness for fu­ture pan­demics.

“In March of 2020, we were one month be­hind Mod­er­na,” he said. “Mod­er­na re­ceived a bil­lion dol­lars in sup­port from Warp Speed and you can see where they’re at now. Prov­i­dence re­ceived no sup­port from the Cana­di­an gov­ern­ment un­til al­most a year lat­er and even then, we re­ceived $10 mil­lion, which is nom­i­nal at best.” — Josh Sul­li­van

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Tillman Gerngross, Adagio CEO

Q&A: Till­man Gern­gross ex­plains why his Covid mAb will have an edge over an al­ready crowd­ed field

If anyone knows about monoclonal antibodies, it’s serial entrepreneur, Adimab CEO, and Dartmouth professor of bioengineering Tillman Gerngross.

Even the name of Gerngross’ new antibody startup Adagio Therapeutics is meant to reflect his vision behind the development of his Covid-19 mAb: slowly, he said, explaining that “everyone else, whether it’s Regeneron, Lilly, or AstraZeneca, Vir, they all valued speed over everything.”

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FDA's vac­cine ad­comm unan­i­mous­ly sup­ports Mod­er­na's boost­er in same pop­u­la­tions as Pfiz­er's boost­er

The FDA’s vaccine advisory committee on Thursday voted 19-0 in support of expanding Moderna’s Covid-19 vaccine EUA for booster doses for certain high-risk individuals. FDA is expected to authorize the Moderna booster shortly.

Similarly to the Pfizer booster shot, Moderna’s will likely be authorized for those older than 65, adults at high risk of severe Covid-19, and adults whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of Covid-19. But unlike the Pfizer adcomm, where FDA had to scramble to get the committee to vote in favor of a booster, this committee was unanimous with the Moderna shot.

David Kessler testifies during a Senate hearing in May (Jim Lo Scalzo/Pool via AP Images)

Biden's fight with Mod­er­na over pro­vid­ing vac­cines for the poor­est coun­tries in­ten­si­fies

With about $10 billion in taxpayer funds invested in Moderna so far, it would seem that the company would be more understanding of pleas from President Joe Biden and the federal government to provide more vaccine doses to low- and middle-income countries.

But the Biden-Moderna feud over supplying the world with doses of mRNA vaccines is now spilling into the public, with Biden’s chief science officer of the government’s Covid-19 response David Kessler explaining the details in an online panel discussion moderated by Yale law professor Amy Kapczynski on Wednesday.

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