Leonard Schleifer, Regeneron CEO (AP Images)

What hap­pens when the N-of-1 is the pres­i­dent of the US? Re­gen­eron is about to find out

Pres­i­dent Trump is tak­ing a very per­son­al in­ter­est in an­oth­er ex­per­i­men­tal drug for Covid-19.

Fri­day af­ter­noon, af­ter he had test­ed pos­i­tive for coro­n­avirus, the White House put out a state­ment say­ing that Trump had tak­en an 8 gram dose of Re­gen­eron’s an­ti­body cock­tail — the high dose that ap­peared to do bet­ter than the low dose in terms of bat­ting down vi­ral loads.

Right af­ter word ar­rived that Trump had tak­en the ex­per­i­men­tal ther­a­py, he was trans­ferred to Wal­ter Reed — news that im­me­di­ate­ly height­ened fears about his con­di­tion. The Wash­ing­ton Post not­ed that Trump and his team de­cid­ed to make the move while he could still walk.

The pres­i­dent’s physi­cians didn’t stop with the cock­tail. Late Fri­day night, the pres­i­dent’s spokesper­son stat­ed that the doc­tors start­ed a course of remde­sivir, the Gilead drug that won the first emer­gency use au­tho­riza­tion from the FDA on mod­est­ly pos­i­tive tri­al re­sults.

Ear­li­er in the week Re­gen­eron — led by CEO Len Schleifer and chief sci­en­tist George Yan­copou­los — had stirred a mixed re­ac­tion to its first cut of the da­ta on their cock­tail, es­sen­tial­ly pro­vid­ing proof-of-con­cept da­ta for the drug with­out sol­id ev­i­dence of ef­fi­ca­cy in eas­ing the path of the pa­tients with ini­tial­ly mild cas­es of Covid-19.

While Re­gen­eron of­fered da­ta demon­strat­ing that the drug could re­duce the need for med­ical vis­its among pa­tients with a low im­mune re­sponse, the num­bers in­volved were far too low to of­fer any clear pic­ture reg­u­la­tors nor­mal­ly need for an OK. The use of the drug may in­di­cate that Trump is among the most vul­ner­a­ble group.

Trump, though, has a his­to­ry of tout­ing drugs based on lit­tle to no ev­i­dence they work. He took hy­droxy long af­ter the da­ta point­ed to its in­ef­fec­tive­ness. And he pushed the FDA to pro­vide an emer­gency OK for con­va­les­cent plas­ma on thin ev­i­dence that it could work to fight the virus.

Trump’s re­sponse to the Re­gen­eron cock­tail, re­al or sim­ply self-di­ag­nosed, could have enor­mous con­se­quences for the biotech — though adding remde­sivir could make it near im­pos­si­ble to tease out a re­sponse now. The star an­ti­body drug mak­er is seek­ing an emer­gency OK and may soon have the pres­i­dent in their cor­ner if he pulls through quick­ly.

Any se­ri­ous set­backs from here, though, could threat­en to turn Trump in­to an in­flu­en­tial op­po­nent.

So far right now, the pres­i­dent is a very big N of 1. And the ini­tial mar­ket re­sponse is all pos­i­tive. Re­gen­eron’s stock surged 5% af­ter hours Fri­day — not bad when you start with a mar­ket cap of $60 bil­lion.

Trump him­self of­fered a late-night thumbs up:

Bio­phar­ma com­pa­nies don’t typ­i­cal­ly like get­ting com­pas­sion­ate use re­quests for their drugs, see­ing lit­tle up­side when they work and a big down­side when they don’t. But as Schleifer told Katie Thomas at the New York Times: “When it’s the pres­i­dent of the Unit­ed States, of course, that gets — ob­vi­ous­ly — gets our at­ten­tion.”

Al­so of note: Trump had a choice in ex­per­i­men­tal an­ti­bod­ies. Eli Lil­ly tout­ed its ap­proach be­fore Re­gen­eron ar­rived on the scene, and their ther­a­py — which dis­ap­point­ed a num­ber of an­a­lysts on the first snap­shot of da­ta — didn’t make the cut. That can’t sit well at the phar­ma gi­ant.

In ad­di­tion to the cock­tail, Trump al­so is tak­ing zinc, vi­t­a­min D, famo­ti­dine, mela­tonin and a dai­ly as­pirin.

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

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Alaa Halawaa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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Rohan Palekar, 89bio CEO

89bio’s PhII da­ta add to quick suc­ces­sion of NASH read­outs as field seeks turn­around

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.

FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Roche and Lil­ly team up to de­vel­op blood test to de­tect ear­ly signs of Alzheimer's

Eli Lilly is teaming up with Roche to help develop a blood test to detect early signs of Alzheimer’s disease and determine whether a patient should go for further confirmatory testing.

Roche’s Elecsys Amyloid Plasma Panel (EAPP) measures pTau 181 protein assay and APOE E4 assay in human blood plasma – elevations in pTau 181 are present in the early stages of Alzheimer’s, while the presence of APO E4 is the most common genetic risk factor for the disease.

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Flare Therapeutics biochemists Yong Li (L) and Valerie Vivat

A $123M Flare will get Third Rock on­col­o­gy biotech in­to the clin­ic this year

Flare Therapeutics will start its first human trial this year with an investigational urothelial cancer drug after pulling together a $123 million Series B from Big Pharmas, VCs and its incubator, Third Rock Ventures.

Launched in 2021 on the idea that a biotech could finally succeed at drugging the much-sought-after but stubborn transcription factor, Flare Therapeutics said Wednesday it is now primed for the clinic after closing its large financing haul earlier this year. The raise is a relatively stark figure in a tough startup financing environment but further buoys the upbeat signals coming out of other Third Rock biotechs in recent weeks, including the $200 million CARGO Therapeutics and $100 million Rapport Therapeutics rounds.

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Francesco Marincola, newly-appointed Sonata Therapeutics CSO

Kite's head of re­search leaves for Flag­ship start­up Sonata

Another leader is departing Kite Pharma, and will to spend the “last part” of his career exploring how cancer evades the immune system.

Kite’s senior VP and global head of cell therapy research Francesco Marincola left the Gilead CAR-T unit last week for Sonata Therapeutics. Flagship last May unveiled the startup, which was pieced together from two fledgling biotechs Inzen and Cygnal Therapeutics. As CSO, Marincola will lead Sonata’s push to reprogram cancer cells to make them more immunogenic.

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Vipin Garg, Altimmune CEO

Al­tim­mune’s shares halved af­ter in­ter­im look at PhII weight loss drug da­ta

Altimmune’s attempt to catch up to Novo Nordisk and Eli Lilly’s GLP-1 drugs hit an investor snag Tuesday after the biotech shared interim Phase II weight loss data.

The Maryland biotech’s pemvidutide is a GLP-1/glucagon dual receptor agonist meant to activate GLP-1 receptors to squash appetite and glucagon to ramp up energy use. The 2.4 mg dose showed a placebo-adjusted weight loss of 9.7% at week 24 of 48, which Jefferies analysts said would be comparable to Novo Nordisk’s semaglutide (Wegovy) and Eli Lilly’s tirzepatide (Mounjaro).

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Josep Bassaganya-Riera, NImmune Biopharma

Ex­clu­sive: Af­ter get­ting his drug back, Lan­dos founder as­sem­bles new start­up for the big PhI­II test

By the time Josep Bassaganya-Riera stepped down as founding CEO of Landos Biopharma in 2021, the company had racked up Phase II data for its top autoimmune program, completed what he called a positive end-of-Phase-II meeting with the FDA and plans to launch pivotal Phase III trials.

Since then, though, the new leaders at Landos have reshuffled their plans for the drug, omilancor, first announcing they will run a Phase IIb ahead of a Phase III and eventually shelving it altogether.

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