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.

Eli Lilly CEO David Ricks (Evan Vucci/AP Images)

A P val­ue of 0.38? NE­JM re­sults raise new ques­tions for Eli Lil­ly's vaunt­ed Covid an­ti­body

Generally, a P value of 0.38 means your drug failed and by a fair margin. Depending on the company, the compound and the trial, it might mean the end of the program. It could trigger layoffs.

For Eli Lilly, though, it was part of the key endpoint on a trial that landed them a $1.2 billion deal with the US government to supply up to nearly 1 million Covid-19 antibodies.

So what does one make of that? Was the endpoint not so important, as Lilly maintains? Or did the US government promise a princely sum for a pedestrian drug?

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Daphne Koller, Getty

Bris­tol My­er­s' Richard Har­g­reaves pays $70M to launch a neu­rode­gen­er­a­tion al­liance with a star play­er in the ma­chine learn­ing world

Bristol Myers Squibb is turning to one of the star upstarts in the machine learning world to go back to the drawing board and come up with the disease models needed to find drugs that can work against two of the toughest targets in the neuro world.

Daphne Koller’s well-funded insitro is getting $70 million in cash and near-term milestones to use their machine learning platform to create induced pluripotent stem cell-derived disease models for ALS and frontotemporal dementia.

Eli Lilly CEO David Ricks at the Rose Garden, May 26, 2020 (Evan Vucci/AP Images)

Eli Lil­ly lines up a block­buster deal for Covid-19 an­ti­body, right af­ter it failed a NI­AID tri­al

Two days after Eli Lilly conceded that its antibody bamlanivimab was a flop in hospitalized Covid-19 patients, the US government is preparing to make it a blockbuster.

The pharma giant reported early Wednesday that it struck a deal to supply the feds with 300,000 vials of the drug at a cost of $375 million — once it gets an EUA stamp from the FDA. And once that 2-month supply deal is done, the government has an option on another 650,000 doses on the same terms — which could potentially add another $812 million.

CMO Merdad Parsey (Gilead)

Gilead hits the brakes on a tri­fec­ta of mid- and late-stage stud­ies for their trou­bled fil­go­tinib pro­gram. It's up to the FDA now

Gilead $GILD execs haven’t decided exactly what to do with filgotinib in the wake of the slapdown at the FDA on their rheumatoid arthritis application, but they’re taking a time out for a slate of studies until they can gain some clarity from the agency. And without encouraging guidance, this drug could clearly be axed from the pipeline.

In their Q3 report out Wednesday afternoon, the company says researchers have “paused” a Phase III study for psoriatic arthritis along with a pair of Phase II trials for ankylosing spondylitis and uveitis. Late-stage studies for ulcerative colitis and Crohn’s are continuing, but you can see for yourself how big a hole this leaves in the inflammatory disease pipeline, with obvious implications if the company abandons filgo altogether.

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Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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Hal Barron, GSK R&D chief

GSK's Hal Bar­ron ax­es a once-prized drug from J&J, con­tin­u­ing shift away from res­pi­ra­to­ry

Hal Barron’s revamp of the GlaxoSmithKline pipeline continued yesterday, as the British pharma announced they axed an asthma drug they once promised over $200 million to acquire.

Then led by CEO Andrew Witty and R&D chief Patrick Vallance, GSK picked up the drug, known elegantly as GSK3772847, from J&J in 2016, hoping to expand on the beachhead in asthma they had established the year prior with Breo Ellipta. They promised up to $227 million in upfront payments and milestones.

Ar­cus and As­traZeneca part­ner on a high stakes an­ti-TIG­IT/PD-L1 PhI­II can­cer study, look­ing to im­prove on a stan­dard of care

For AstraZeneca, the PACIFIC trial in Stage III non-small cell lung cancer remains one of the big triumphs for AstraZeneca’s oncology R&D group. It not only made their PD-L1 Imfinzi a franchise player with a solid advance in a large niche of the lung cancer market, the study — which continues to offer data on the long-range efficacy of their drug — also helped salve the vicious sting of the failure of the CTLA-4 combo in the MYSTIC study.

Re­gen­eron posts sec­ond look on Covid-19 an­ti­body cock­tail, boost­ing its case for EUA — but what about symp­tom al­le­vi­a­tion?

Regeneron has revealed a second cut of data on its Covid-19 antibody cocktail in the outpatient setting — data that it has sent straight to the FDA to boost its emergency use authorization request.

The new results reinforce what’s reported from the same trial last month, Regeneron said, incorporating a total of 799 non-hospitalized patients with mild-to-moderate disease. REGN-COV2 reduced viral load and patient medical visits (anything ranging from hospitalizations, emergency room, urgent care visits to physician office and telemedicine visits), meeting all the key endpoints.

No­var­tis buys a new gene ther­a­py for vi­sion loss, and this is one pre­clin­i­cal ven­ture that did­n't come cheap

Cyrus Mozayeni got excited when he began to explore the academic work of Ehud Isacoff and John G. Flannery at UC Berkeley.

Together, they were engaged in finding a gene therapy approach to pan-genotypic vision restoration in patients with photoreceptor-based blindness, potentially restoring the vision of a broad group of patients. And they did it by using a vector to deliver the genetic sequence for light sensing proteins.

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