In­cyte scores speedy FDA re­view for JAK cream in atopic der­mati­tis; Lil­ly backs $90M raise for Re­gor

In­cyte’s stal­wart JAK in­hibitor Jakafi has raced out to block­buster sales with­out the safe­ty bur­den of oth­er drugs in the class. Now, the drug­mak­er’s quest to re­for­mu­late the drug for eas­i­er use could be near­ing fruition — but big chal­lengers await.

The FDA will give a pri­or­i­ty re­view to In­cyte’s top­i­cal cream re­for­mu­la­tion of JAK in­hibitor Jakafi in atopic der­mati­tis, the drug­mak­er an­nounced Fri­day.

The agency will base its re­view on da­ta from the TRuE-AD pro­gram, which has test­ed more than 1,200 patiet­nts with rux­oli­tinib cream, In­cyte said. The cream’s re­view date is set for June 21.

A top­i­cal ap­pli­ca­tion for AD would be a big step up in terms of pa­tient ease of use over Sanofi and Re­gen­eron’s Dupix­ent, an in­jec­tion that is the lead­ing drug on the mar­ket for that in­di­ca­tion. An ap­proval would al­so boost In­cyte’s block­buster Jakafi pro­gram, which raked in $1.94 bil­lion in 2020.

Un­like oth­er JAKs, in­clud­ing Eli Lil­ly’s Olu­mi­ant, which In­cyte de­vel­oped, Jakafi doesn’t sport the black box warn­ing la­bel for se­ri­ous in­fec­tions, ma­lig­nan­cies and throm­bo­sis com­mon to the class. — Kyle Blanken­ship

Lil­ly Asia Ven­tures backs a big B round for Shang­hai-based Re­gor

A group of Big Phar­ma vets from Pfiz­er and Am­gen have round­ed up a $90 mil­lion B round to back clin­i­cal de­vel­op­ment work at their Shang­hai-based start­up Re­gor Ther­a­peu­tics.

Found­ed by a team that in­cludes 2 Pfiz­er vets, CEO Xi­ayang Qiu and Min Zhong, and CTO Wenge Zhong, for­mer­ly with Am­gen’s Chi­na R&D op­er­a­tion, Re­gor has been build­ing up its plat­form tech with a fo­cus on on­col­o­gy, meta­bol­ic dis­eases and au­toim­mune dis­eases.

The Chi­nese phar­ma com­pa­ny Qilu Phar­ma­ceu­ti­cal Group put up the A round for the com­pa­ny launch in 2018. Now there’s a whole new syn­di­cate, led by Lil­ly Asia Ven­tures, a pro­lif­ic ven­ture group with a fin­ger in many pies in Chi­na. Loy­al Val­ley Cap­i­tal, Lant­i­ng Cap­i­tal, TF Cap­i­tal and Ver­tex Ven­tures Chi­na all joined in.

“With the next decade comes a his­tor­i­cal mo­ment for Chi­na’s leap up­wards. We are de­light­ed to col­lab­o­rate with vet­er­an sci­en­tists, lead­ing en­tre­pre­neurs and in­vest­ment part­ners in bio­phar­ma in­dus­try,” not­ed Andy Lin, found­ing part­ner of Loy­al Val­ley Cap­i­tal. — John Car­roll

Eu­rofins Sci­en­tif­ic adds new CRO to port­fo­lio

Eu­rofins Sci­en­tif­ic, an in­ter­na­tion­al group of lab­o­ra­to­ries head­quar­tered in Lux­em­bourg, just bought a new CRO.

Gilles Mar­tin

The bio­an­a­lyt­i­cal test­ing com­pa­ny an­nounced Thurs­day that it had ac­quired Bea­con Dis­cov­ery, a CRO fo­cused on G-pro­tein cou­pled re­cep­tor re­search. Fi­nan­cial terms of the deal were not dis­closed, and Bea­con will be en­veloped in­to the Eu­rofins Dis­cov­ery CRO um­brel­la once the deal clos­es in the com­ing weeks.

Eu­rofins says the move will sup­port and ac­cel­er­ate drug dis­cov­ery re­search and de­vel­op­ment in or­der to cap­i­tal­ize on the grow­ing R&D out­sourc­ing mar­ket.

“Bea­con Dis­cov­ery adds the ex­per­tise in GPCR tar­gets and drug dis­cov­ery and de­vel­op­ment ex­pe­ri­ence that will ad­vance our of­fer­ing in in­te­grat­ed drug dis­cov­ery ser­vices for our clients,” Eu­rofins CEO Gilles Mar­tin said in a state­ment. — Max Gel­man

Chi­na’s Sci­wind hauls in $37M Se­ries B

Chi­nese biotech Sci­wind Bio­sciences has some new dough to throw around. The com­pa­ny an­nounced Fri­day it had com­plet­ed a $37 mil­lion Se­ries B round, led by LYFE Cap­i­tal and joined by ex­ist­ing in­vestors, Leg­end Cap­i­tal and Haibang Ven­ture Cap­i­tal.

Sci­wind fo­cus­es on chron­ic meta­bol­ic and im­muno­log­i­cal dis­eases, and has com­plet­ed a Phase I study of its lead pro­gram, XW003. Sci­wind is ex­pect­ed to launch sev­er­al Phase II tri­als for the can­di­date in 2021, in­clud­ing in Type II di­a­betes, obe­si­ty and NASH. — Max Gel­man

David Meek (Photographer: Marlene Awaad/Bloomberg via Getty Images)

Scoop: Fer­ring, Black­stone’s $570M gene ther­a­py ven­ture has im­plod­ed af­ter CMC is­sues stymied a once high-pro­file quest

Back in late 2019, FerGene looked golden. It had a gene therapy for bladder cancer — spun out of Ferring — at the FDA, with a priority review and breakthrough status indicating that great things awaited on the near horizon.

Ferring backed up the venture with $170 million, with Nick Galakatos’ Blackstone Life Sciences chipping in another $400 million with great fanfare to get the company running. David Meek jumped from the CEO job at Ipsen to run it all, and a little over a year ago much of the executive team was assembled to bring it all home.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

The End­points 20 un­der 40, biotech's new nor­mal, Stéphane Bancel's one re­gret, 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.

What a week! We were proud to present a slate of special reports that showcase the breadth and depth Endpoints is striving to deliver, and it’s truly a team effort. None of this can happen without our readers — so thank you for your support.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 106,300+ biopharma pros reading Endpoints daily — and it's free.

Stéphane Bancel at the Endpoints #JPM20 breakfast panel in San Francisco, January 2020 (Photo: Jeff Rumans, Endpoints News)

The CHIC in­ter­view: Stéphane Ban­cel on Mod­er­na's overnight trans­for­ma­tion, the new time­line on vac­cine de­vel­op­ment and his one re­gret in 2020

The China Healthcare Investment Conference — better known as CHIC — took place last week in Shanghai at the Ritz-Carlton Pudong. Endpoints partnered with CHIC this year in an effort to highlight the global nature of drug development, and John Carroll conducted two virtual “fireside chats” that was broadcast to attendees. We’ll be sharing both with the Endpoints Premium audience, and first up is a one-on-one interview with Moderna’s Stéphane Bancel.

John Carroll has been covering Moderna and Bancel since the very beginning. He started their conversation by noting it was the first time he’s taken a drug from a company he’s covered from its inception. They go on to discuss how Moderna is being transformed by cash-flow earlier than expected, Bancel’s one big regret in 2020, and much more.

Their conversation is below, and we hope you enjoy.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

As­traZeneca un­veils next-gen PARP in­hibitor, look­ing to fol­low up on suc­cess of first-gen suc­cess sto­ry Lyn­parza

AstraZeneca’s PARP inhibitor Lynparza has raced out to blockbuster sales on the premise of killing tumor cells by inhibiting their ability to adequately heal. But Lynparza isn’t a perfect molecule, and the British drugmaker is now rolling out a potential successor drug it hopes can achieve similar efficacy without the notorious side effects.

AstraZeneca rolled out early data on its PARP1-selective, next-gen inhibitor AZD5305 at the virtual AACR meeting Saturday, hoping to highlight the drug’s chances at following up — and improving — the science behind blockbuster drug Lynparza.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 106,300+ biopharma pros reading Endpoints daily — and it's free.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP viaGetty Images)

Sanofi CEO Paul Hud­son dives deep­er in­to mR­NA, buy­ing out an un­der-the-radar Fred Hutch spin­out

Sanofi CEO Paul Hudson may not be fully on board with the mRNA revolution, but he evidently still believes in the technology’s potential.

On Friday afternoon, Sanofi announced that they bought out the little-known mRNA biotech Tidal Therapeutics, hoping to leverage their technology to treat cancer and immunological disorders. Spun out of the Fred Hutch institute in 2019 and seeded at Cambridge’s LabCentral, the young company will now receive $160 million in cash and $310 million in potential milestones.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 106,300+ biopharma pros reading Endpoints daily — and it's free.

The End­points 100 sur­vey: CEOs changed the way biotechs op­er­ate dur­ing the pan­dem­ic. Things will nev­er be the same again

With the US at the front of the line for new Covid-19 vaccines, the biotech industry is looking at the near-term end of the pandemic — or at least a more manageable easing of the rules established during the lockdown. But only a relative handful of CEOs expect things to return to the way they were in a pre-pandemic era. Most are planning to go forward with a whole new set of guidelines for staffers — and flexibility lies at the heart of what’s ahead as people are cleared to go back to the office.

We surveyed our group of Endpoints 100 executives, mostly CEOs, to take the industry’s pulse. This was the latest in close to 5 years of surveys. And several common themes were clear.

First, after a rip-roaring spin on Wall Street as a wave of new IPOs delivered fresh billions to drug hunters, there’s a  record level of excitement about asset valuations and access to capital. The vast majority are expanding this year with new hires. And a remarkable 88% of the 82 executives who took the survey say they won’t be returning to the business-as-usual style they were accustomed to in a pre-pandemic world.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

EMA finds link be­tween ‘very rare’ but some­times fa­tal blood clots and As­traZeneca vac­cine

The EMA said Wednesday that very rare but sometimes fatal blood clots should be listed as a side effect for AstraZeneca’s Covid-19 vaccine.

The EMA’s safety committee said the change to the vaccine label is part of an in-depth review of 62 cases of cerebral venous sinus thrombosis (CVST) and 24 cases of splanchnic vein thrombosis reported in the EU drug safety database as of March 22. Eighteen of the cases were fatal.

Anthony Sun, Zentalis CEO (Zentalis)

Zen­tal­is keeps the heat on As­traZeneca with ear­ly WEE1 da­ta show­ing a group of 'ex­cep­tion­al' re­spon­ders

Long a target for drugmakers, the DNA damage repair pathway has picked up some new steam in recent years with Big Pharma placing its bets. One of the leading candidates there is a WEE1 enzyme inhibitor from AstraZeneca, and now a small biotech player is looking to play catch up.

Zentalis’ WEE1 inhibitor, ZN-c3, posted partial responses across a slate of tumor types with a tolerable safety profile as monotherapy for solid tumor patients who are either treatment-resistant or have no established standard of care, according to interim Phase I data presented as a late breaker Saturday at the virtual AACR annual meeting.

AACR roundup: Ar­cus rolls out PhI da­ta on adeno­sine block­er for CRC; Co­di­ak's en­gi­neered ex­o­some for IL-12 shows ear­ly promise

Arcus Biosciences’ adenosine blocker etrumadenant showed some benefit in extending patients’ lives as part of a Phase I/Ib trial in third-line-or-later colorectal cancer patients, according to data presented Saturday at the virtual AACR annual meeting.

Etrumadenant, a dual adenosine A2aR/A2b receptor antagonist, is designed to inhibit adenosine’s role in preventing lympocytes like CD8+ effector T cells and NK cells from infiltrating the tumor microenvironment, the company said. A combination of etrumadenant and chemotherapy regimen FOLFOX-6 posted a median PFS of 4.2 months, a median OS of 13.6 months and an objective response rate of 9.1%. The drug showed consistent benefits in BRAF/RAS mutated cancer cells, the company said.