Juno, WuXi JV in Chi­na score $100M in fresh fund­ing as it sets stage for first CAR-T ap­proval

Chi­na’s on­col­o­gy-fo­cused biotech hub has raised al­ready mil­lions in ven­ture fund­ing and lured pow­er­ful glob­al bio­phar­ma part­ners to ad­dress the high rates of can­cer in the coun­try. In yet an­oth­er ex­am­ple, the joint ven­ture be­tween Juno and to WuXi’s AppTec has raised a siz­able $100 mil­lion in a fresh round of fund­ing.

The Shang­hai-based com­pa­ny, chris­tened JW Ther­a­peu­tics (an ini­tial each from its root com­pa­nies), was cre­at­ed to mar­ry Juno’s CAR-T de­vel­op­ment ex­pe­ri­ence and WuXi’s AppTec’s mus­cu­lar man­u­fac­tur­ing ca­pac­i­ty. In 2018, it scored $90 mil­lion to take its lead ex­per­i­men­tal B cell ma­lig­nan­cy-fo­cused drug, JW­CAR029, in­to the clin­ic and build a new man­u­fac­tur­ing plant.

Now, as the drug is be­ing ush­ered in­to mid-stage de­vel­op­ment, JW has raised an­oth­er $100 mil­lion in a round led by CPE and Mi­rae As­set, joint­ed by CR-CP Life Sci­ence Fund and Oriza Hold­ings, as well as ex­ist­ing in­vestors in­clud­ing Loy­al Val­ley Cap­i­tal, Temasek, Se­quoia Cap­i­tal Chi­na, ARCH Ven­ture Part­ners. Juno (bought out by Cel­gene, which was swal­lowed by Bris­tol My­ers Squibb) along with WuXi al­so con­tributed.

Apart from Temasek, Se­quoia Cap­i­tal Chi­na, and ARCH Ven­ture Part­ners, the funds will be used to bol­ster the com­pa­ny’s CAR-T pipeline and gear up com­mer­cial­iza­tion ca­pac­i­ty to sup­port po­ten­tial launch­es.

In re­cent years, big US and glob­al drug­mak­ers have al­lied with can­cer biotech com­pa­nies as an en­try point or as a way to ex­pand their foot­print in the pop­u­lous coun­try marred by high rates of can­cer and a bur­geon­ing life sci­ences in­dus­try.

Days ago, Sanofi tied up with Al­pham­ab On­col­o­gy — which made a splashy $230 mil­lion in its pub­lic de­but on the Hong Kong Stock Ex­change (HKEX) late last year — to col­lab­o­rate on a bis­pe­cif­ic an­ti­body fo­cused on treat­ing breast can­cer.

In­novent Bi­o­log­ics, which raised a con­sid­er­able $421 mil­lion in its HKEX de­but in 2018, snagged Roche as a part­ner on Tues­day in a deal that grants it ac­cess to the Swiss drug­mak­er’s bis­pe­cif­ic an­ti­body and CAR-T tech­nol­o­gy. In­novent, in col­lab­o­ra­tion with Eli Lil­ly, was the first drug­mak­er to get a home­grown Chi­nese check­point in­hibitor across the fin­ish line in the coun­try — in late 2018, the PD-1 agent Tyvyt (sin­til­imab) scored ap­proval for pa­tients with re­lapsed/re­frac­to­ry clas­si­cal Hodgkin’s lym­phoma. There are a hand­ful of check­point in­hibitors on the Chi­nese mar­ket now, in­clud­ing Jun­shi’s Tuoyi, Mer­ck’s flag­ship Keytru­da and BeiGene’s tislelizum­ab.

BeiGene too has close ties with the Unit­ed States, the world’s largest phar­ma­ceu­ti­cals mar­ket. In ad­di­tion to a cadre of part­ner­ships with small and mid-sized US drug de­vel­op­ers, the com­pa­ny sells a raft of Cel­gene (now Bris­tol My­ers) drugs in Chi­na, while Am­gen has tak­en a hefty 20.5% stake in the drug­mak­er.

Dri­ven part­ly by high rates of pol­lu­tion and smok­ing, can­cer is the lead­ing cause of death in Chi­na. An es­ti­mat­ed 4.3 mil­lion new can­cer cas­es and 2.9 mil­lion new can­cer deaths oc­curred in Chi­na in 2018, ac­cord­ing to a 2019 analy­sis. Com­pared to the USA and UK, Chi­na has low­er can­cer in­ci­dence but a 30% and 40% high­er can­cer mor­tal­i­ty than the two na­tions re­spec­tive­ly, the au­thors found.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust of the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

President Trump walks past HHS secretary Alex Azar (Getty Images)

Azar falls in line un­der Trump again. Ex­perts say he's re­in­forc­ing a dark sig­nal sent to the FDA

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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David Berry (Flagship)

Flag­ship's next big tech­no­log­i­cal bet? The cloud

Earlier this month, Flagship announced their big bet on the software half the industry is talking about, launching the AI and machine learning startup. Now, they and a couple other investors are gambling $100 million on a software that much of the public generally thinks of as a cool, IT afterthought: cloud computing.

The idea, says founder and Flagship partner David Berry, is one of scale: The sheer magnitude of biological data that you can store on cloud technology is unprecedented. And that size, when leveraged properly, can allow you to ask questions and form insights that are similarly unprecedented.

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Laura Shawver (Silverback Therapeutics)

Fol­low­ing a hefty Se­ries B, Sil­ver­back Ther­a­peu­tics quick­ly pulls in $85M for 'an im­por­tant growth phase'

Months after reeling in a $78 million Series B round, Silverback Therapeutics has hooked an even larger Series C.

The Seattle-based company announced Wednesday that it netted $85 million from a slate of new and previous investors. The quick boost could be a sign that an IPO is on the way.

In an email, Silverback CEO Laura Shawver told me she was “not able to provide any additional comments about Silverback” beyond what was shared in the company’s news release. In the prepared statement, she said the company is at “an important growth phase.”

Covid-19 roundup: Op­er­a­tion Warp Speed's 7th vac­cine is live at­ten­u­at­ed; Small biotech touts big suc­cess where gi­ants have failed

Operation Warp Speed is stacking its vaccine portfolio with a “TBD” new candidate: a live attenuated vaccine that can be administered in a single dose, potentially as an oral formulation rather than an injection.

Sound familiar?

That could be because the unannounced candidate appears to match the profile of an inoculation being developed by Merck, according to Bloomberg, which first reported the development based on a presentation by Moncef Slaoui.

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On­ly five months af­ter a Se­ries A launch, Taysha goes pub­lic with $157M IPO

As has been the trend in 2020, Taysha Gene Therapies has become the latest biotech to make a quick ascent from a small, privately-funded company to enjoying its very own Nasdaq ticker.

The Dallas-based biotech raised $157 million for its IPO after pricing shares at $20 apiece Thursday, the high-point of its expected range. Initially pegging $100 million in financing, Taysha offered a little less than 8 million shares and will trade under the $TSHA symbol.

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CDC’s Robert Redfield, NIAID’s Anthony Fauci, Admiral Brett Giroir at HHS, and FDA’s Stephen Hahn prepare to testify at a House hearing on June 23 (Getty)

'Ex­treme­ly po­lit­i­cal' — Trump neuters FDA's at­tempt to strength­en vac­cine EUA

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.