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.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Chi­na opens the door for biotech in­vestors in Hong Kong to buy Shang­hai stocks, and vice ver­sa

When Shanghai’s STAR board began opening its doors to biotech, it was considered not just a rival to Nasdaq but also the stock exchange in Hong Kong. Those perceptions may take an amicable turn as China expands a mutual access program with the city.

The changes mean investors in mainland China will be able to own Hong Kong biotech chapter stocks, while those in Hong Kong — a much more internationally connected group — would have access to those listed on STAR. In effect, it turns the Shanghai market into a globally accessible exchange overnight while also broadening a key source of revenue for HKEX.

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UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.

Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

Eu­ro­pean Union aims to es­tab­lish patent workaround in case of emer­gen­cies while try­ing to strength­en its own IP

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.