Ning Li (Junshi)

Af­ter chim­ing in an­ti­body to Covid-19 fight, Jun­shi drops $30M to kick off mR­NA joint ven­ture in Chi­na

A pi­o­neer­ing biotech in Chi­na has its eyes on mR­NA.

Jun­shi Bio­sciences — which made its name as the first do­mes­tic drug­mak­er to steer a PD-(L)1 across the fin­ish line at the NM­PA — is team­ing up with fel­low Shang­hai biotech Im­mor­na on a joint ven­ture that will be ded­i­cat­ed to both con­ven­tion­al non-repli­cat­ing mR­NA drugs and self-repli­cat­ing ver­sions.

The ini­tial in­vest­ment from Jun­shi comes in at around $30 mil­lion (RMB$200 mil­lion), a quar­ter of which will be used to buy up 50% of the JV, with the po­ten­tial to in­ject up to $123 mil­lion to­tal (RMB$799 mil­lion). What Im­mor­na brings to the ta­ble is its plat­form, the val­ue of which is es­ti­mat­ed at RMB$50 mil­lion.

While the over­whelm­ing suc­cess­es of mR­NA vac­cines against Covid-19, both clin­i­cal­ly and fi­nan­cial­ly, have in­spired a fer­vent search in the US and Eu­rope for the next Mod­er­na and BioN­Tech, Chi­nese in­vestors and com­pa­nies ap­pear much less en­thu­si­as­tic so far. The vac­cines that have so far been ap­proved and de­ployed in Chi­na are based on the much old­er ap­proach of in­ac­ti­vat­ed virus­es.

But au­thor­i­ties have al­so sig­naled that mR­NA could have a role to play, hav­ing ini­tial­ly sup­port­ed home­grown ef­forts at Wal­vax. More re­cent­ly, reg­u­la­tors com­plet­ed a re­view of BioN­Tech’s vac­cine — to be dis­trib­uted by part­ners at Fo­s­un — with the ex­pec­ta­tion that the coun­try would need mR­NA jabs as boost­ers, Caix­in re­port­ed.

Through a part­ner­ship with Eli Lil­ly, Jun­shi has been in­volved in the pan­dem­ic fight by con­tribut­ing an an­ti­body, dubbed ete­se­vimab, that was paired with Ab­Cellera-dis­cov­ered bam­lanivimab.

The vi­sion for the mR­NA joint ven­ture, though, goes much broad­er than Covid-19. What Jun­shi saw, in CEO Ning Li’s words, is the po­ten­tial for mR­NA in­dus­tri­al­iza­tion — and solv­ing prob­lems on the glob­al scale with Chi­nese IP. It’s a mis­sion that Li has em­braced since start­ing Jun­shi in 2012 fol­low­ing stints at the FDA and Sanofi’s reg­u­la­to­ry de­part­ment.

“As the mR­NA Tech­nol­o­gy Plat­form grad­u­al­ly ma­tures, its po­ten­tial in a va­ri­ety of fields — in­clud­ing in­fec­tious dis­eases, can­cer, rare dis­eases, and oth­er dis­eases — has be­come in­creas­ing­ly ev­i­dent,” he said in a state­ment, adding that those ther­a­peu­tic ar­eas align with Jun­shi’s own R&D fo­cus.

Found­ed in 2019, Im­mor­na closed a mod­est Se­ries A ear­ly this year and has since re­vealed a big-name deal with I-Mab, which was sim­i­lar­ly in­ter­est­ed in can­cer. As BioN­Tech re­mind­ed the world in its re­cent ac­qui­si­tion of Kite’s TCR tech and man­u­fac­tur­ing site, that can be a siz­able op­por­tu­ni­ty for mR­NA vac­cines, too.

Im­mor­na CEO Zi­hao Wang high­light­ed im­munother­a­py and in­fec­tious dis­ease pre­ven­tion as the main ap­pli­ca­tions to ex­plore ini­tial­ly.

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.

Stéphane Bancel, AP Images

Mod­er­na takes on a low-risk pact with CAR-T play­er Au­to­lus for mR­NA-based can­cer drugs

Moderna’s Covid-19 vaccine has transformed the once-backwater biotech into one of the most highly valued drugmakers in the world in the span of a year. But what does the future hold for Moderna’s star turn? A small-scale discovery pact could offer a clue.

Moderna will hold exclusive rights to four mRNA-based immuno-oncology candidates using proprietary binding tech from Autolus, a biotech best known for its work on “off-the-shelf” CAR-T therapies, the partners said Monday.

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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Ipsen con­tin­ues its shop­ping spree with a $1B-plus deal for Ex­i­cure's next-gen oligonu­cleotides

Ipsen has been on a deal-making spree the last few weeks, shelling out more than a billion dollars in two separate deals to work on a mid-stage levodopa-induced dyskinesia (LID) candidate and a preclinical BAX inhibitor in several cancers. But on Monday, the company inked its largest collaboration deal yet.

Ipsen is putting down $20 million upfront and up to $1 billion in biobucks for exclusive options to two of Exicure’s discovery-stage spherical nucleic acid (SNA) treatments for Huntington’s disease and Angelman syndrome.

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

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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.