Lil­ly Asia Ven­tures leads As­traZeneca spin­out's $100M push in­to Chi­na's grow­ing R&D hub in Wuxi

Three years af­ter launch­ing with three pre­clin­i­cal as­sets from As­traZeneca’s R&D cen­ter in Shang­hai and $132.5 mil­lion in cash, Dizal Phar­ma has drawn mar­quee new in­vestors in for a $100 mil­lion re­load.

Xi­aolin Zhang

Un­der CEO Xi­aolin Zhang, the team — most of whom tran­si­tioned from As­traZeneca’s (now-de­funct) In­no­va­tion Cen­ter Chi­na — has shep­herd­ed the lead as­set in­to the clin­ic for non-small cell lung can­cer and an un­named au­toim­mune dis­ease. INDs for a sec­ond can­cer drug are in and three oth­ers are on close on its heels, with a fi­nal chron­ic kid­ney dis­ease drug part­nered with As­traZeneca tugged at the bot­tom of the pipeline.

Now Dizal is ready to move away from Shang­hai and plant its roots in Wuxi, where a new bio­phar­ma hub is shap­ing up in the high-tech dis­trict.

Lil­ly Asia Ven­tures is lead­ing the in­vest­ment in­to the new head­quar­ters, with par­tic­i­pa­tion from Se­quoia Cap­i­tal, Trin­i­ty and Wuxi New­Force Fund. The cash will fund the build­out of every­thing from R&D and op­er­a­tions to pro­duc­tion and sales/dis­tri­b­u­tion.

Back in 2017, As­traZeneca chief Pas­cal So­ri­ot cel­e­brat­ed Dizal as a “ground-break­ing joint ven­ture” that com­bines the phar­ma gi­ant’s dis­cov­ery mus­cles with the re­sources and net­work of the pri­vate eq­ui­ty firm SDIC Fund.

For the next two years the com­pa­ny’s pri­or­i­ty in Chi­na ap­peared to be on health­care man­age­ment through its Chi­na Com­mer­cial In­no­va­tion Cen­ter, which was es­tab­lished in Wuxi ear­li­er in 2017.

Yet as reg­u­la­to­ry re­forms swept up bar­ri­ers for the whole in­dus­try and home­grown biotech fledg­lings be­gan spring­ing up with glob­al am­bi­tions, it didn’t take long for As­traZeneca to dive back in­to the new R&D wave.

Just last year, it boot­ed up a new glob­al R&D cen­ter in Shang­hai and added an AI in­no­va­tion group, dou­bling its head­count in the city to around 1,000.

Then there was the $1 bil­lion Health­care In­dus­tri­al Fund it cre­at­ed with a lead­ing Chi­nese in­vest­ment bank, ded­i­cat­ed to do­mes­tic com­pa­nies and part­ners — in­clud­ing those based in the biopark it built to­geth­er with the mu­nic­i­pal gov­ern­ment of Wuxi, dubbed I-Cam­pus.

Dizal’s move to Wuxi ef­fec­tive­ly makes it a neigh­bor of I-Cam­pus — and its start­up res­i­dents.

While it start­ed out with a fo­cus on on­col­o­gy, car­dio­vas­cu­lar and meta­bol­ic dis­eases, the biotech now lists lung can­cer, chron­ic kid­ney dis­ease, in­flam­ma­to­ry bow­el dis­ease and an­ti-virus as its main fo­cus. Track­ing close­ly with As­traZeneca’s R&D in­ter­ests, Dizal’s lead drug is a JAK1 in­hibitor and the sec­ond most ad­vanced as­set blocks EGFR.

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

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

Patrick Enright, Longitude co-founder (Longitude)

As its biotechs hit the pan­dem­ic ex­it, Lon­gi­tude rais­es $585M for new neu­ro, can­cer, ag­ing and or­phan-fo­cused fund

The years have been kind to Longitude Capital. This year, too.

A 2006 spinout of Pequot Capital, its founders started their new firm just four years before the parent company would go under amid insider trading allegations. Their first life sciences fund raised $325 million amid the financial crisis, they added a second for $385 million and then in, 2016, a third for $525 million. In the last few months, the pandemic biotech IPO boom netted several high-value exits from those funds, as Checkmate, Vaxcyte, Inozyme and Poseida all went public.

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PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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Covid-19 roundup: J&J be­gins piv­otal Phase III tri­al for vac­cine; Con­tro­ver­sial hu­man chal­lenge tri­als to be­gin in Lon­don — re­port

Johnson & Johnson announced it’s beginning a pivotal Phase III trial for its Covid-19 candidate, JNJ-78436735 — the first single-dose vaccine in this stage.

The Phase III trial, dubbed ENSEMBLE, will enroll 60,000 patients worldwide, making it the largest Phase III study of a Covid-19 vaccine to date. J&J said the candidate achieved positive interim results in a Phase I/IIa study, which will be published “imminently.” There’s a possibility that the first batches will be ready for potential emergency use in early 2021, according to the biotech.

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Isaac Veinbergs, Libra CEO

With $29M in Se­ries A, Boehringer-backed Li­bra looks to tack­le neu­rode­gen­er­a­tion through cel­lu­lar clean­ing

Can the natural process by which cells clean out toxic proteins be harnessed to create potential treatments for neurodegenerative disorders?

That’s the question Libra Therapeutics will be trying to answer, as the new biotech officially launched Wednesday morning with $29 million in Series A financing. The company has three preclinical programs at the ready, with its lead candidate targeting ALS and frontotemporal dementia. But CEO Isaac Veinbergs said he hopes to develop therapies for a wide range of diseases, including Parkinson’s, Alzheimer’s and Huntington’s.

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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Gene Wang, Immetas co-founder and CEO (file photo)

Im­metas Ther­a­peu­tics nabs $11M Se­ries A to nar­row their bis­pe­cif­ic work tar­get­ing in­flam­ma­tion in age-re­lat­ed dis­eases

How does a biotech celebrate its two-year anniversary? For Immetas Therapeutics, it’s with an $11 million Series A round and a game plan to fight age-related disease.

Co-founders Gene Wang and David Sinclair came together years ago around the idea that inflammation is the ultimate process driving age-related illnesses, including cancer. The duo launched Immetas in 2018 and packed the staff with industry experts. Wang, who says he’s always had an entrepreneurial spirit, has held lead roles at Novartis, GSK, Bristol Myers Squibb and Merck. He’s worked on blockbuster drugs like Humira, Gardasil, Varubi and Zolinza. And now, he’s channeling that spirit as CEO.