Ugur Sahin, BioNTech CEO (Frank Rumpenhorst/dpa via AP Images)

'Don't freak out': Ugur Sahin takes a dif­fer­ent tone on Omi­cron than his mR­NA coun­ter­part — re­ports

Where­as some pub­lic health of­fi­cials and bio­phar­ma lead­ers — in­clud­ing Mod­er­na CEO Stéphane Ban­cel — are sound­ing the alarm over the new Omi­cron coro­n­avirus vari­ant, BioN­Tech chief Ugur Sahin is press­ing a more cau­tious ap­proach.

In in­ter­views Tues­day with the Wall Street Jour­nal and Reuters, Sahin cau­tioned that lit­tle is yet known of the vari­ant’s abil­i­ty to cause se­vere Covid-19, and T cell re­spons­es among the vac­ci­nat­ed would like­ly re­main strong. Though the biotech is still con­duct­ing lab tests to de­ter­mine whether an­ti­body pro­tec­tion will be di­min­ished, Sahin isn’t press­ing the pan­ic but­ton.

“Our mes­sage is: Don’t freak out, the plan re­mains the same: Speed up the ad­min­is­tra­tion of a third boost­er shot,” Sahin told WSJ on Tues­day.

The com­ments stand in stark con­trast to an in­ter­view Ban­cel gave to the Fi­nan­cial Times ear­li­er this week, in which he pre­dict­ed a sig­nif­i­cant drop in vac­cine ef­fec­tive­ness against Omi­cron. Ban­cel hedged, not­ing he didn’t know how steep the drop would be, but stressed that “all the sci­en­tists I’ve talked to … are like, ‘This is not go­ing to be good.’”

Omi­cron has shak­en glob­al mar­kets since South African sci­en­tists first de­tect­ed the vari­ant last week, and coun­tries around the world are is­su­ing new trav­el bans in the hopes of stem­ming the tide. The vari­ant has been par­tic­u­lar­ly no­table for its high num­ber of mu­ta­tions, lead­ing to fears it may be more con­ta­gious than the Al­pha or Delta strains and in­fect vac­ci­nat­ed peo­ple more eas­i­ly.

But Sahin told WSJ he thinks those who re­ceived their shots — es­pe­cial­ly those that got a boost­er — would still be pro­tect­ed against se­vere dis­ease re­sult­ing in hos­pi­tal­iza­tion or death. The CEO high­light­ed that the shot pro­duced by BioN­Tech and Pfiz­er has large­ly low­ered se­vere dis­ease risk from oth­er vari­ants and said most Delta break­through in­fec­tions are mild.

He said the same would like­ly hold true for Omi­cron, as T cells con­tin­ue to of­fer pro­tec­tion even if the virus evades an­ti­bod­ies. The re­duc­tion in an­ti­body pro­tec­tion against Omi­cron is yet to be de­ter­mined, he told Reuters, but he is ex­pect­ing some loss against mild and mod­er­ate dis­ease.

Even so, Sahin is stay­ing calm.

“To my mind there’s no rea­son to be par­tic­u­lar­ly wor­ried. The on­ly thing that wor­ries me at the mo­ment is the fact that there are peo­ple that have not been vac­ci­nat­ed at all,” Sahin told Reuters.

While re­searchers await an­swers on on­go­ing lab tests, the virus and emerg­ing vari­ants aren’t go­ing away any time soon. The pan­dem­ic has al­ready cre­at­ed a boon for Pfiz­er and Mod­er­na, with the for­mer al­so de­vel­op­ing an an­tivi­ral pill it says is 89% ef­fec­tive in re­duc­ing se­vere dis­ease in in­fect­ed in­di­vid­u­als.

Pfiz­er al­so like­ly has a leg up on Mer­ck, an­oth­er com­pa­ny work­ing on an oral treat­ment. In an ad­comm yes­ter­day, ad­vis­ers nar­row­ly vot­ed to rec­om­mend au­tho­riz­ing the Mer­ck pill de­spite ques­tions about ef­fi­ca­cy and con­cerns over us­ing the ther­a­py in preg­nant women.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

BREAK­ING: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,200+ biopharma pros reading Endpoints daily — and it's free.

Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,200+ biopharma pros reading Endpoints daily — and it's free.

Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,200+ biopharma pros reading Endpoints daily — and it's free.

Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,200+ biopharma pros reading Endpoints daily — and it's free.

Marcelo Bigal, Ventus Therapeutics CEO

No­vo Nordisk joins No­var­tis, Roche in NL­RP3 are­na, bet­ting $70M cash on NASH, car­diometa­bol­ic us­es

As a drug target, the NLRP3 inflammasome has drawn serious interest from Big Pharma, inspiring a series of M&A deals from Novartis and Roche on top of venture investments by others. Now Novo Nordisk is jumping on the bandwagon — and the Danish pharma giant is taking the target where it knows best.

Novo Nordisk is getting its NLRP3 inhibitors from Ventus Therapeutics, a Versant-backed startup that set out to make some of the best NLRP3 drugs out there by incorporating new insights into the structure of the target complex.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,200+ biopharma pros reading Endpoints daily — and it's free.