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.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

In search of elu­sive NASH break­through, Pfiz­er spot­lights com­bo ap­proach

Pfizer’s second crack at steering a NASH candidate through a battered field seems to be going better than the first.

The pharma giant has scored the FDA’s fast track designation for an experimental combination therapy as a treatment for NASH with liver fibrosis. The combo consists of ervogastat, a diacylglycerol O-acyltransferase 2 inhibitor (DGAT2i), and clesacostat, an acetyl-CoA carboxylase inhibitor (ACCi).

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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AS­CO ab­stracts mint some ear­ly win­ners, but Io­vance, Spring­Works get hit by mas­sive loss­es

Before cancer-focused biotechs start their trek to the first in-person American Society of Clinical Oncology (ASCO) annual conference since the pandemic began, investors have taken a good look at the teasers for the data scheduled to be presented — and started placing bets.

With its power to confer overnight fame, ASCO is a stage where impressive or surprise debut performances can go a long way. On the other hand, disappointing details could be punishing.

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Covid-19 roundup: CDC study shows good pro­tec­tion from mR­NA boost­er plus J&J's sin­gle-dose vac­cine; White House launch­es test-to-treat Paxlovid site

Concerns about rare but life-threatening blood clots have limited the use of J&J’s Covid-19 vaccine — once pitched as the only one-shot option in the mix — with the FDA cutting it off except in limited circumstances. Yet there’s some good news for those who did receive it: A single booster dose of an mRNA vaccine for recipients of a single priming dose of Ad26.COV2.S (the J&J vaccine) provided protection close to that of a three-dose mRNA vaccine regimen.

Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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