Bing Yao, ArriVent CEO

For­mer Viela CEO Bing Yao finds his next gig — bring­ing Chi­nese R&D in­no­va­tion state­side

When Hori­zon Ther­a­peu­tics bought out Viela Bio for $53 a share, every­one won­dered what then-CEO Bing Yao would do next — in­clud­ing him­self. Three months af­ter the sale was com­plet­ed, we have an an­swer.

Yao launched Ar­riVent Bio­phar­ma on Wednes­day with up to $150 mil­lion in fund­ing and an EGFR-tar­get­ed ty­ro­sine ki­nase in­hibitor in-li­censed from Shang­hai-based Al­list Phar­ma­ceu­ti­cals. His goal? To bring in­no­va­tions from Chi­na and oth­er emerg­ing biotech hubs to the US, EU and be­yond.

“We iden­ti­fied an op­por­tu­ni­ty to glob­al­ize med­i­cines in that area,” Yao told End­points News. “We found that we can build a very strong de­vel­op­ment team to de­vel­op those com­pounds and bring them to the US.”

The move rep­re­sents the grow­ing role of Chi­na as a leader in in­no­va­tion in phar­ma R&D. Back in Jan­u­ary, No­var­tis dropped $650 mil­lion up­front to bring BeiGene’s PD-1 an­ti­body state­side. And af­ter step­ping away from his post at Mer­ck, Roger Perl­mut­ter re­cent­ly signed on as a sci­ence ad­vi­sor to the Shang­hai-based CBC Group, a promi­nent in­vest­ment group that’s been fos­ter­ing some of the big new biotech star­tups in Asia.

“We are try­ing to bring ex­ter­nal in­no­va­tions in and al­so bring our in­no­va­tions out to oth­er ge­o­graph­i­cal re­gions,” BeiGene’s SVP of ex­ter­nal in­no­va­tions Lu­song Luo told End­points a few months ago.  

Ar­riVent is plan­ning to file an IND by the end of the year for its lead can­di­date, fur­mon­er­tinib, in EGFR-mu­tat­ed non-small cell lung can­cer. The drug has al­ready been ap­proved in Chi­na for EGFR T790M mu­ta­tion-pos­i­tive lo­cal­ly ad­vanced or metasta­t­ic NSCLC, and Yao be­lieves it has the po­ten­tial to be best-in-class.

Fur­mon­er­tinib’s go­ing up against a slew of oth­ers in the red-hot EGFR-mu­tat­ed NSCLC mar­ket, in­clud­ing EQRx and Han­soh Phar­ma’s au­mol­er­tinib, which has al­so been ap­proved in Chi­na. That drug best­ed As­traZeneca’s TKI in­hibitor Ires­sa on pro­gres­sion-free sur­vival in a head-to-head tri­al, ac­cord­ing to da­ta pre­sent­ed at this year’s AS­CO, and the part­ners said they planned to pur­sue dis­cus­sions with reg­u­la­tors in “mul­ti­ple coun­tries” im­me­di­ate­ly.

While Ar­riVent’s ini­tial fo­cus will be on­col­o­gy, Yao says he’s open to lever­ag­ing can­di­dates across a broad range of de­vel­op­ment stages, from late re­search to late-stage tri­als to ap­proval.

“We have an ex­ten­sive net­work,” he added.

The Se­ries A round — led by Hill­house Cap­i­tal Group — in­cludes $90 mil­lion up­front, with an­oth­er $60 mil­lion lined up if the com­pa­ny reach­es cer­tain mile­stones. Lil­ly Asia Ven­tures, Or­biMed, Oc­ta­gon Cap­i­tal Ad­vi­sors, Boyu/Zoo Cap­i­tal, and Lyra Cap­i­tal al­so chipped in on the round.

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.

Marianne De Backer (L) and Jeff Hatfield

Bay­er nabs star biotech Vi­vid­ion with a $2B buy­out and an ‘arms-length’ pact, pulling a part­ner out of the IPO con­ga line

Vividion is canceling that IPO it filed. Instead of following the industry-wide migration to Nasdaq, the biotech that has captured considerable attention for its still-preclinical work finding cryptic pockets to bind to on proteins is going to work for Bayer now.

The pharma giant is putting out word today that it has bought out Vividion for $1.5 billion in cash and another half-billion dollars in milestones.

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Tadataka Yamada (Photographer: Kiyoshi Ota/Bloomberg via Getty Images)

Sci­ence pi­o­neer, phar­ma re­search chief, glob­al health ad­vo­cate and biotech en­tre­pre­neur Tadata­ka ‘Tachi’ Ya­ma­da has died

Tadataka Yamada, a towering physician-scientist who made his name in academia before transforming drug development at GlaxoSmithKline and developing vaccines for malaria and meningitis at the Gates Foundation, died unexpectedly of natural causes at his home in Seattle Wednesday morning.

He was 76. Frazier Healthcare Partners’ David Socks confirmed his death.

Known widely by the mononym “Tachi,” Yamada had a globetrotting career and arrived in industry relatively late in life. A 2004 Independent article noted GSK had asked Yamada to stay on beyond his approaching 60th birthday, the company’s usual retirement age. Yamada would continue working for the next 17 years, steering the Gates Foundation’s global health division for 6 years, funding Jim Wilson’s gene therapy work when few would touch it, launching Takeda Vaccines and co-founding a series of high-profile biotechs.

UK re-in­ves­ti­gates Pfiz­er's eye-pop­ping price goug­ing on an epilep­sy drug

When a drugmaker raises the price of a drug in the US by more than 2,000% overnight, and without any particular reason for that increase, nothing typically happens to the company. No fines, no court orders, just business as usual.

Martin Shkreli’s decades-old anti-parasitic drug Daraprim was the perfect example — massive price spike on an old drug, lots of media attention, public outcry, Congressional committees dragging his former company through multiple hearings, and at the end of it? Nothing happened to the price or the company (until generic competition came).

Thomas Lingelbach, Valneva CEO

A small vac­cine de­vel­op­er fa­vored by the UK gov­ern­ment in Covid-19 touts a PhI­II first in chikun­gun­ya

Before Valneva garnered the favor of the UK government as a potential supplier of Covid-19 vaccines, the French biotech prided itself on being the first company to bring a chikungunya vaccine into Phase III.

It now has positive pivotal results to back up the breakthrough therapy designation the FDA granted just weeks ago.

There are currently no approved jabs to prevent chikungunya virus infection despite decades of R&D efforts, a fact that underscores just how arduous traditional vaccine development can be, particularly for neglected tropical disease. In a absence of a major commercial market, the US government and NGOs such as CEPI have deployed various grants and incentives to spur on a small crew of academics and industry players, with Merck, via its acquisition of Themis, claiming a spot in that race.

Josh Hoffman, outgoing Zymergen CEO (Zymergen)

UP­DAT­ED: Syn­bio uni­corn Zymer­gen jet­ti­sons found­ing CEO, cuts guid­ance as cus­tomers re­port lead prod­uct does­n't work

Zymergen, just months off a $500 million IPO that put the synthetic bio firm in rarified air, has now ejected its founding CEO and downgraded its revenue forecasts after customers reported its lead film product doesn’t work as advertised, the company said Tuesday afternoon.

CEO Josh Hoffman will leave his role and sacrifice his board seat immediately in favor of Jay Flatley, the former CEO of Illumina who will take the lead role on an interim basis as the company conducts a search for its next leader.

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Jeffrey Bluestone, Sonoma CEO (Photo credit: Steve Babuljak)

Jeff Blue­stone just raised $265M to de­vel­op cu­ra­tive cell ther­a­pies. We asked him how

Jeff Bluestone had some big goals in mind when he decided to make a switch from a decades-long career in academia and non-profit research to a biotech startup CEO. And now — 18 months after the $40 million launch party — he has a whole lot more money on hand to pay for the considerable amount of work ahead at Sonoma Biotherapeutics.

This morning Bluestone is taking the wraps off a $265 million B round after boosting the core syndicate of A-list investors he started with. Even by today’s standards, that sum dwarfs the kind of $100 million-plus megarounds that have become standard fare in biotech over the last 2 years.

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Zymergen co-founders Zach Serber, Josh Hoffman, and Jed Dean (Zymergen via website)

Zymer­gen's sud­den im­plo­sion shocked biotech. A lin­ger­ing loan could make things even worse

As former synbio unicorn Zymergen picks up the pieces from its spectacular implosion Tuesday, an outstanding loan from Perceptive Advisors — the only blue-chip biotech crossover investor to touch Zymergen’s fundraising efforts — could make the situation worse, according to public documents.

In December 2019, more than a year before Zymergen filed for what would eventually become a $500 million IPO, the “biofacturing” firm signed a $100 million credit facility with Perceptive to help supplement the nearly $700 million the company had raised across four VC rounds.

Bio­gen, Ei­sai are push­ing for an­oth­er ac­cel­er­at­ed Alzheimer's OK — this time for BAN2401

Now that the door at the FDA has been opened wide for Alzheimer’s drugs that can demonstrate a reduction in amyloid, Biogen and its partners at Eisai are pushing for a quick OK on the next drug to follow in the controversial path of aducanumab.

In a presentation to analysts, Eisai neurology chief Ivan Cheung outlined some bullish expectations for their newly-approved treatment and set the stage for what he believes will be a fast follow for BAN2401 (lecanemab) — after a dry spell in new drug development that’s lasted close to 20 years.

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