Let's go to Chi­na: Join End­points in Shang­hai for the first US-Chi­na Bio­phar­ma In­no­va­tion & In­vest­ment Sum­mit — Oc­to­ber 22-23 #BI­IS18

Re­cent­ly I told read­ers about a new part­ner­ship we struck in Chi­na, one that would help il­lu­mi­nate our on­line news cov­er­age of bio­phar­ma in an area of the world that has at­tract­ed a break­through lev­el of in­ter­est this year. Now we’re tak­ing it a step fur­ther, invit­ing End­points News read­ers to Chi­na for our in­au­gur­al 2-day in­dus­try con­fer­ence we’re host­ing in Shang­hai: BI­IS — US-Chi­na Bio­phar­ma In­no­va­tion & In­vest­ment Sum­mit.

We’re host­ing this event be­cause it’s an ab­solute­ly crit­i­cal time for US com­pa­nies to de­vel­op their own Chi­na strat­e­gy, both for the re­gion­al deals they want as well as col­lab­o­ra­tions with a new gen­er­a­tion of Chi­nese re­searchers and ex­ec­u­tives.

Along with our part­ners in Chi­na, Pharm­Cube, we’ve in­vit­ed a group of transpa­cif­ic in­dus­try VIPs to head­line this two-day event, sched­uled for Oc­to­ber 22 and 23 at the Four Sea­sons in Shang­hai’s Pudong dis­trict.

Saman­tha Du

Just a few of the in­dus­try lead­ers we’ve con­firmed for the sum­mit are Saman­tha Du, the founder and CEO of Zai Lab; Jonathan Wang, co-founder of Or­biMed Asia; and Vivek Ra­maswamy, the founder and CEO of Roivant Sci­ences. New speak­ers are be­ing added fre­quent­ly, which you can check out on the event web­site here.

Vivek Ra­maswamy

Over the past year we’ve seen the Chi­na biotech scene boom with bil­lions of dol­lars in new in­vest­ment cash pour­ing in­to a host of star­tups. Most of these new-breed com­pa­nies are turn­ing first to fill­ing the tech gap that sep­a­rates Chi­na from the West, but you can al­ready see pipelines be­ing grown with new drugs that will be aimed at a world mar­ket.

Jonathan Wang

This two-day sched­ule will be packed with pan­els and pre­sen­ta­tions aimed at giv­ing you an in­side look at the key play­ers in Chi­na and the US, and the drugs that are now fill­ing the coun­try’s fast-grow­ing pipeline.

Like our pop­u­lar an­nu­al events at JP Mor­gan and BIO, and the up­com­ing UK R&D sum­mit in Lon­don, the Chi­na-US sum­mit will be helmed by End­points ed­i­tor and founder John Car­roll, who’s been study­ing the Chi­nese biotech mar­ket over the course of his 16 years of bio­phar­ma cov­er­age.

We’ve been chron­i­cling the reg­u­la­to­ry, fi­nan­cial, and sci­en­tif­ic trends that have led to this in­flec­tion point in Chi­na’s bio­phar­ma scene. And BI­IS is the event where you can wit­ness the dy­nam­ics and meet the peo­ple in­volved first­hand. We hope to see you there. Check out the event and reg­is­ter at this link: #BI­IS18 Event Site

— Ar­salan Arif is the founder and pub­lish­er of End­points News. You can reach him at aa@end­pointsnews.com or @AKAarsalan on Twit­ter.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Sanofi preps a multi­bil­lion-dol­lar buy­out of an mR­NA pi­o­neer af­ter falling be­hind in the race for a Covid-19 jab — re­port

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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Anthony Sun, Zentalis and Zentera CEO (Zentalis)

With clin­i­cal tri­als lined up for Zen­tal­is drugs, Chi­na's Zen­tera sets its sights on more deal­mak­ing and an IPO

As Zentalis geared up for an AACR presentation of early data on its WEE1 inhibitor earlier this year, its Chinese joint venture Zentera wasn’t idle, either.

Zentera, which has headquarters in Shanghai, had already nabbed clearance to start clinical trials in China for three of the parent company’s drugs. In May — just a month after Zentalis touted three “exceptional responses” out of 55 patients for their shared lead drug, ZN-c3 — it got a fourth CTA approval.

UP­DAT­ED: Watch out Glax­o­SmithK­line: As­traZeneca's once-failed lu­pus drug is now ap­proved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; 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.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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FTC pulls re­main­ing case against Ab­b­Vie; New EU clin­i­cal tri­als sys­tem com­ing in 2022; Abing­worth bets big on CymaBay

The Federal Trade Commission on Friday withdrew its remaining case against AbbVie after the Supreme Court declined to review a lower court’s ruling.

The punt by SCOTUS means that while the Illinois pharma company illegally blocked patients’ access to lower-cost alternatives to its testosterone drug AndroGel, the FTC will no longer be able to return about $500 million directly to AndroGel consumers.