President Donald Trump, left, listens as Moncef Slaoui, a former GlaxoSmithKline executive, speaks about the coronavirus in the Rose Garden of the White House, Friday, May 15, 2020, in Washington. (AP Photo/Alex Brandon)

Mon­cef Slaoui piv­ots from Mod­er­na's board to the helm of Pro­ject Warp Speed. His task: Overnight suc­cess

Bioreg­num Opin­ion Col­umn by John Car­roll

Mon­cef Slaoui stepped off Mod­er­na’s board of di­rec­tors on Fri­day and piv­ot­ed straight in­to the high pro­file role head­ing the Trump ad­min­is­tra­tion’s Pro­ject Warp Speed, where he’ll be in charge of ac­cel­er­at­ing Mod­er­na’s — and oth­ers — vac­cines to a rapid re­lease for a pan­dem­ic weary world.

The news be­came of­fi­cial mid-day Fri­day af­ter nu­mer­ous re­ports ear­li­er that he had been picked off the short list of can­di­dates.

Slaoui’s role on Mod­er­na’s board earned a com­pen­sa­tion pack­age val­ued at $490,000 last year, some­thing con­sumer ad­vo­cates quick­ly fixed on as a con­flict of in­ter­est. It’s un­like­ly that crit­ics will be sat­is­fied by Slaoui’s res­ig­na­tion, though Mod­er­na has al­ready done quite well for it­self with­out any added help from Slaoui. The biotech has ben­e­fit­ed ex­ten­sive­ly from ma­jor sup­port from BAR­DA and the NIH and will con­tin­ue to en­joy close con­tacts in Wash­ing­ton, in­clud­ing at the FDA.

As the lead de­vel­op­er in the US of a new vac­cine, Mod­er­na al­so of­fers the White House a Boston-based com­pa­ny that can po­ten­tial­ly pro­vide a US hero to re­solve the pan­dem­ic. So it’s like­ly Trump’s fa­vorite play­er with or with­out Slaoui’s in­volve­ment.

Mod­er­na CEO Stéphane Ban­cel is part of a small band of vac­cines ex­ecs who be­lieves it’s pos­si­ble to do some­thing that would have been con­sid­ered im­pos­si­ble at the be­gin­ning of the year: hus­tle a new vac­cine straight through a Phase I-III pro­gram in a mat­ter of months and come up with just enough piv­otal ef­fi­ca­cy and safe­ty da­ta to start dis­tri­b­u­tion in the fall.

While bil­lions of peo­ple ea­ger­ly want that, there’s al­so been some sig­nif­i­cant push­back from a va­ri­ety of ex­perts in the field who won­der if it’s re­al­ly fea­si­ble to be able to field a Covid-19 vac­cine in less than 2 years — in it­self some­thing of a mir­a­cle in a sec­tor where de­vel­op­ment can take years and some­times decades.

Slaoui’s po­si­tion will have al­ready been mold­ed by his board post. And it will fit neat­ly in­to the ad­min­is­tra­tion’s own view that they can make it hap­pen. Speak­ing at the White House to­day, he men­tioned see­ing un­pub­lished da­ta — pre­sum­ably Mod­er­na’s — that sug­gest­ed suc­cess is close at hand, ac­cord­ing to Politi­co.

“These da­ta made me feel even more con­fi­dent that we will be able to de­liv­er a few hun­dred mil­lion dos­es of vac­cine by the end of 2020,” he said.

We won’t have long to wait.

Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

David Meline (file photo)

Mod­er­na’s new CFO took a cut in salary to jump to the mR­NA rev­o­lu­tion­ary. But then there’s the rest of the com­pen­sa­tion pack­age

David Meline took a little off the top of his salary when he jumped from the CFO post at giant Amgen to become the numbers czar at the upstart vaccines revolutionary Moderna. But the SEC filing that goes with a major hire also illustrates how it puts him in line for a fortune — provided the biotech player makes good as a promising game changer.

To be sure, there’s nothing wrong with the base salary: $600,000. Or the up-to 50% annual cash bonus — an industry standard — that comes with it. True, the 62-year-old earned $999,000 at Amgen in 2019, but it’s the stock options that really count in the current market bliss for all things biopharma. And there Meline did well.

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Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.