Dupix­ent clears PhI­II tri­al in new dis­ease as block­buster looks to ex­pand past Re­gen­eron-Sanofi split

Sanofi and Re­gen­eron may be split­ting up, but their bil­lion-dol­lar ba­by, Dupix­ent, keeps on grow­ing.

Al­ready gross­ing over $2 bil­lion last year based on FDA ap­provals for asth­ma and atopic der­mati­tis and a form of rhi­nos­i­nusi­tis, Dupix­ent may be near­ing a fourth in­di­ca­tion: Eosinophilic esophagi­tis (EoE), an in­flam­ma­to­ry dis­ease marked by the buildup of white blood cells in the esoph­a­gus and which af­fects around 160,000 US pa­tients an­nu­al­ly.

On Fri­day, the com­pa­nies an­nounced the first part of their Phase III EoE tri­al met both pri­ma­ry end­points and all sec­ondary end­points. Across 81 pa­tients, those on the Dupix­ent arm saw a 69% drop in dis­ease sever­i­ty, as mea­sured by a pa­tient sur­vey called the Dys­pha­gia Symp­tom Ques­tion­naire, com­pared to a 32% drop in the place­bo arm. The Dupix­ent pa­tients al­so saw a 60% re­duc­tion in eosinophils – the white blood cells whose buildup dri­ves the dis­ease – in their esoph­a­gus, com­pared to 5% in the con­trol group.

Ad­verse event re­ports were 86% in the drug arm and 82% in the place­bo.

John Reed Sanofi

“These da­ta demon­strate Dupix­ent’s po­ten­tial to con­tin­ue to ad­dress treat­ment gaps across the spec­trum of type 2 in­flam­ma­to­ry dis­eases as com­mon as asth­ma and as rare as eosinophilic esophagi­tis,” Sanofi R&D chief John Reed said in a state­ment.

Dupix­ent had been de­vel­oped as part of a part­ner­ship be­tween Sanofi and Re­gen­eron that be­gan in 2013, and was seen as the key suc­cess of that deal when the pair be­gan de­cou­pling last year and, this week, when Sanofi sig­naled it would sell off the vast ma­jor­i­ty of its 23.2 mil­lion Re­gen­eron shares.

Al­though asth­ma and eczema are like­ly to re­main Dupix­ent’s bread-and-but­ter mar­kets, the $5 to $10 bil­lion peak sales es­ti­mates that some an­a­lysts have pegged for the drug are de­pen­dent in part on ap­prov­ing new in­di­ca­tions, par­tic­u­lar­ly as JAK in­hibitors look to nab more of the mar­ket. The drug was ap­proved for chil­dren be­tween the ages of 6 and 11 with atopic der­mati­tis this week. Tri­als are al­so un­der­way for pruri­go nodu­laris, chron­ic spon­ta­neous ur­ticaria and bul­lous phemphigold.

Dupix­ent, an IL-13/IL-4 in­hibitor, would have few ri­vals for EoE, a con­di­tion that is gen­er­al­ly treat­ed with di­et, steroids and acid sup­pres­sors. The tri­al still has two more parts to it, in­clud­ing dif­fer­ent dos­ing and ex­tend­ed treat­ment.

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President Trump (left) and NIAID chief Anthony Fauci in the White House press room, April 22, 2020 (Michael Reynolds/Sipa via AP Images)

White House tries to dis­cred­it An­tho­ny Fau­ci — could he be on his way out?

For two months in late winter and early spring, Anthony Fauci and President Trump stood in uneasy co-existence at White House briefings — an unlikely truce between an infectious disease official who had helped combat AIDS and Ebola and a president who repeatedly denied the danger of a virus that would go on to kill 100,000 Americans, repeatedly rejected masks and certain social distancing efforts, and promoted a drug with little scientific basis.

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Stéphane Bancel, Moderna CEO (Andrew Harnik/AP Images)

A top an­a­lyst turns the spot­light on Mod­er­na, fu­el­ing a fast-and-fu­ri­ous Street race over the fu­ture of mR­NA

Four months ago, one of the favorite talking points on the biopharma social media wave length was whether Moderna shares $MRNA were priced right or were wildly inflated.

After all, said the naysayers, the company had never actually pushed a treatment to an approval. Did messenger RNA really work, coding cells to make a drug or a vaccine? And how about all that chatter about how ‘secretive’ they are, or were?

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En­gi­neer­ing an on/off switch for CAR-T out of yeast and Juras­sic Park

Almost as soon as CAR-T emerged in the mid-2010s as a near-cure for some cancers, so did a question: How do you give this without risking killing patients?

At the time, James Patterson was wrapping an MD-PhD at a yeast lab at London’s Francis Crick Institute. Yeast may seem an unlikely place to find a fix for cancer therapy, but reading through other researchers’ solutions to CAR-T’s toxicity, Patterson wondered if a method long used by yeast biologists called auxotrophy might be useful. You genetically modify cells to make them dependent on a particular nutrient. Then you can make them live or die — proliferate or deplete — by giving or taking away that nutrient.

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Albert Bourla, AP

Covid-19 roundup: CanSi­no eyes more over­seas PhI­II sites as Cana­da tri­al re­port­ed­ly stalls; In­di­an drug­mak­er surges on 30-per­son da­ta

Having leveraged connections in Canada for a planned Phase III trial of its Covid-19 vaccine, CanSino is venturing out to a few more others as it plots a global late-stage program.

“We are contacting Russia, Brazil, Chile and Saudi Arabia, and it’s still in discussion,” Dongxu Qiu, executive director and co-founder of CanSino, said at a conference in Suzhou, China, per Reuters.

The trial is likely to start “pretty soon,” he added, with plans to recruit 40,000 participants total.

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Steve Arkinstall, Revitope CEO

Mass­a­chu­setts biotech Re­vi­tope scores first col­lab­o­ra­tion thanks to dual-en­gag­ing T cell plat­form

Revitope Oncology began 2020 hopeful that its cancer immunology platform would be finally ready to flourish. On Monday night, that platform nabbed the biotech its first collaboration.

The Massachusetts-based company has agreed to a licensing agreement with Shanghai-based Junshi Biosciences in which Revitope can receive up to $160 million in development and commercial milestones, plus royalties. In addition, Junshi will make a direct equity investment of $10 million, equal to 9.99% of Revitope shares, as the two companies work to develop a dual-antigen targeting cancer therapies.

Play­ing catch-up, Roche out­lines plans for a PhI­II he­mo­phil­ia A pro­gram — next year

For now, the big focus in the hemophilia A gene therapy race has been centered on frontrunner BioMarin, with an expected OK just weeks away, and the crew from Sangamo/Pfizer, which has been looking to play catch-up with a pivotal study in the works.

But now Roche’s new gene therapy division at Spark has updated its own schedule, saying they’re looking at a Phase III start sometime next year as they optimize the dose and immunomodulatory regimen in order to avoid any future mishaps that could derail the program.

CEO John Oyler at the Endpoints/PharmCube BIIS18 conference in Shanghai (Photo: Endpoints News)

Chi­na's BeiGene now has $5B+ cash in its cof­fers. How's the Am­gen-part­nered biotech go­ing to spend it?

When Amgen wagered $2.7 billion to grab a 20.5% stake in BeiGene late last year, execs saw themselves buying into a “world-class operation” that would help them tap into the world’s most populous country and a growing biopharma powerhouse.

It turns out they were just getting started.

Over the weekend, BeiGene $BGNE brought in a hefty $2.08 billion — $421 million from Amgen — through a direct offering of its Nasdaq shares exclusively involving existing investors. New York-based hedge fund Baker Bros. Advisors also bought a chunk of new shares.

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Levi Garraway, Roche CMO

Roche’s PD-L1 play­er Tecen­triq fails PhI­II for ovar­i­an can­cer

Roche’s hit-and-miss record on Tecentriq has posted another miss.

The pharma giant reported this morning that the PD-L1 checkpoint failed a Phase III trial for women with advanced, front line ovarian cancer, one of several hard-to-hit cancers that’s defied a variety of approaches. Much of the new R&D in ovarian cancer remains focused on PARP, where AstraZeneca’s Lynparza holds sway.

In this trial Roche combined their PD-L1 Tecentriq with Avastin. But it’s been one of dozens of Phase III trials in the works for the checkpoint crew, as more companies angle to jump into the market behind the two leaders — Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo.