Covid-19 roundup: Cure­Vac finds big vac­cine part­ner in Bay­er; Slaoui will stay on as Biden con­sul­tant

Aside from do­nat­ing chloro­quine in the ear­ly days of the pan­dem­ic, Bay­er has large­ly stayed out of the spot­light as oth­er Big Phar­mas deal and in­vest their way in­to lead­ing roles in de­vel­op­ing Covid-19 vac­cines and ther­a­peu­tics.

But that’s chang­ing to­day as Bay­er puts its weight be­hind Cure­Vac, a fel­low Ger­man play­er, and its mR­NA vac­cine can­di­date.

The com­pa­nies are en­ter­ing a “col­lab­o­ra­tion and ser­vices agree­ment,” which will see Bay­er take up re­spon­si­bil­i­ties in de­vel­op­ment, sup­ply and key ter­ri­to­ry op­er­a­tions — lever­ag­ing its ex­per­tise in ar­eas like clin­i­cal op­er­a­tions, reg­u­la­to­ry af­fairs, phar­ma­covig­i­lance, sup­ply chain and on-the-ground in­fra­struc­ture in cer­tain coun­tries.

“We are high­ly com­mit­ted to mak­ing our ca­pa­bil­i­ties and net­works avail­able to help end this pan­dem­ic,” Ste­fan Oel­rich, pres­i­dent of the phar­ma di­vi­sion, said in a state­ment.

Cure­Vac’s vac­cine uti­liz­ers mes­sen­ger RNA, a rel­a­tive­ly new tech­nol­o­gy that’s twice over with the first emer­gency use au­tho­riza­tions in the US. While it falls sig­nif­i­cant­ly be­hind the lead­ers at BioN­Tech (part­nered with Pfiz­er) and Mod­er­na (teamed up with the NIH), hav­ing just start­ed Phase III in De­cem­ber, ex­ecs have tout­ed a small­er re­quired dose and low­er stor­age tem­per­a­ture as at­trib­ut­es that might still give it a chance at hav­ing a big im­pact giv­en the enor­mous de­mand. The ex­ist­ing sup­ply is al­so dis­pro­por­tion­ate­ly flow­ing to­ward af­flu­ent coun­tries, leav­ing plen­ty of poor­er re­gions wait­ing.

Both Glax­o­SmithK­line and the Ger­man gov­ern­ment have backed that longterm goal, fea­tur­ing promi­nent­ly in a mas­sive $640 mil­lion round just be­fore Cure­Vac cruised to a $213 mil­lion IPO. GSK made it clear it’s bank­ing on the tech plat­form to de­liv­er mul­ti­ple mR­NA-based vac­cines as well as an­ti­bod­ies against oth­er in­fec­tious dis­eases to come.

As with BioN­Tech and Mod­er­na, Covid-19 would serve as the first big test of its ca­pa­bil­i­ties as it’s nev­er brought a prod­uct to mar­ket be­fore.

In­volv­ing Bay­er in the process, Cure­Vac said, should fa­cil­i­tate the sup­ply of “sev­er­al hun­dred mil­lion dos­es around the world” once reg­u­la­tors clear the shot. The EU has pre-or­dered 405 mil­lion dos­es and the com­pa­ny is still beef­ing up its man­u­fac­tur­ing net­work.

OWS chief Mon­cef Slaoui to get new ti­tle as Biden con­sul­tant

Mon­cef Slaoui, the for­mer Glax­o­SmithK­line ex­ec who’s been spear­head­ing the sci­en­tif­ic ef­fort to de­vel­op vac­cines and ther­a­pies for Covid-19 as sci­en­tif­ic chief of Op­er­a­tion Warp Speed, will serve as a con­sul­tant to the in­com­ing Biden ad­min­is­tra­tion.

Slaoui has ac­cept­ed an of­fer to be­come a con­sul­tant when the tran­si­tion hap­pens, STAT and Bloomberg re­port­ed, cit­ing a call with re­porters. POLITI­CO added that it will be a re­duced role that lasts around four to six weeks.

It marks an ex­ten­sion of the time with gov­ern­ment for Slaoui, who’s in­di­cat­ed that he planned to step down by ear­ly this year once two vac­cines and two ther­a­peu­tics have been au­tho­rized. To­geth­er with Gen. Gus­tave Per­na, the chief op­er­at­ing of­fi­cer, Slaoui was tasked with putting to­geth­er and sup­port­ing a port­fo­lio of can­di­dates that might help end the pan­dem­ic.

A part­ner at ven­ture firm Medicxi and board mem­ber of Mod­er­na pri­or to his ap­point­ment to OWS, Slaoui has come un­der scruti­ny and crit­i­cism for his ties to the in­dus­try, in­clud­ing his bio­phar­ma stock hold­ings. De­mo­c­ra­t­ic Sen. Eliz­a­beth War­ren has called for his res­ig­na­tion. But he’s fierce­ly fought back against the at­tacks, vowed to re­sign if pol­i­tics in­ter­feres with sci­ence and, more re­cent­ly, called on the White House to al­low his peo­ple to make con­tact with Biden’s tran­si­tion team.

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

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Anthony Fauci, NIAID director (AP Images)

As new Covid-19 task force gets un­der­way, threat looms of vac­cine, mon­o­clon­al an­ti­body-re­sis­tant vari­ants

Hours before President Biden’s Covid-19 team gave their first virtual press conference, the famed AIDS researcher David Ho delivered concerning news in a new pre-print: SARS-CoV-2 B.1.351, the variant that emerged in South Africa, is “markedly more resistant” to antibodies from convalescent plasma and vaccinated individuals.

The news for several monoclonal antibodies, including Eli Lilly’s bamlanivimab, was even worse: Their ability to neutralize was “completely or markedly abolished,” Ho wrote. Lilly’s antibody cocktail, which was just shown to dramatically reduce the risk of hospitalizations or death, also became far less potent.

Eli Lil­ly demon­strates that 2 an­ti­bod­ies beat 1 for guard­ing against se­vere Covid-19. But can that solve the first an­ti­body’s prob­lem amid slow up­take?

It seems safe to say that two antibodies are better than one.

Eli Lilly released the largest results yet on Tuesday for their Covid-19 neutralizing antibody cocktail, announcing that the combo reduced deaths and hospitalizations in coronavirus patients by 70%. Across 1,000 patients, there were 11 such events in the treatment group and 36 in the placebo group.

The breakdown for deaths alone was even starker: 10 in the placebo group and 0 in the treatment group. Lilly added that the drug hit secondary endpoints for reducing viral load and alleviating symptoms, although they did not disclose numbers.

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George Yancopoulos (L) and Len Schleifer (Regeneron)

Re­gen­eron touts pos­i­tive pre­lim­i­nary im­pact of its Covid an­ti­body cock­tail, pre­vent­ing symp­to­matic in­fec­tions in high-risk group

Regeneron flipped its cards on an interim analysis of the data being collected for its Covid-19 antibody cocktail used as a safeguard against exposure to the virus. And the results are distinctly positive.

The big biotech reported Tuesday morning that their casirivimab and imdevimab combo prevented any symptomatic infections from occurring in a group of 186 people exposed to the virus through a family connection, while the placebo arm saw 8 of 223 people experience symptomatic infection. Symptomatic combined with asymptomatic infections occurred in 23 people among the 223 placebo patients compared to 10 of the 186 subjects in the cocktail arm.

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Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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