Carsten Lu, Adlai Nortye CEO

A No­var­tis castoff with a trou­bled past head­lines Chi­nese biotech's Hong Kong IPO quest

Tak­ing on a failed drug from one of bio­phar­ma’s biggest play­ers and spin­ning it in­to a win­ner is nev­er an easy task. But in the go-go world of Chi­nese on­col­o­gy, any risk is a risk worth tak­ing — and one biotech’s gam­ble could soon pay off.

Ad­lai Nortye, a Hangzhou, Chi­na-based biotech with op­er­a­tions in North Brunswick, NJ, has ap­plied to trade on the Hong Kong Ex­change just days af­ter scor­ing a fundrais­ing round to pur­sue its li­cense-heavy busi­ness mod­el, ac­cord­ing to a Tues­day fil­ing.

Last week, the biotech scored a $100 mil­lion D se­ries to ad­vance its clin­i­cal pipeline, in­clud­ing lead PI3K in­hibitor bu­parlis­ib (AN2025), a for­mer No­var­tis drug that Ad­lai Nortye ex­clu­sive­ly li­censed af­ter the Swiss drug­mak­er kicked it to the curb back in mid-2018.

Now, Ad­lai will look to score a big pub­lic of­fer­ing on the HKEX, which has been par­tic­u­lar­ly kind to on­col­o­gy star­tups in re­cent months, with up­starts like Zai Lab and Hutchmed earn­ing ma­jor rais­es and sky-high val­u­a­tions.

Bu­parlis­ib is the lead drug on the com­pa­ny’s dock­et, with Ad­lai Nortye kick­ing off a glob­al Phase III reg­is­tra­tional study in squa­mous cell car­ci­no­ma of the head and neck (HN­SCC) in April that will look to en­roll around 490 pa­tients in 150 tri­al sites. The move in­to HN­SCC could prove fruit­ful af­ter bu­parlis­ib no­to­ri­ous­ly flopped its late-stage test in lung can­cer, leav­ing No­var­tis few op­tions but to of­fload de­vel­op­ment.

In its fil­ing, Ad­lai Nortye tout­ed the drug’s ear­ly- and mid-stage da­ta and its mar­ket po­ten­tial in metasta­t­ic or re­frac­to­ry pa­tients who fail or don’t re­spond to PD-(L)1 ther­a­py, which is quick­ly be­com­ing stan­dard of care in ad­vanced HN­SCC pa­tients. There are five PI3Ks cur­rent­ly ap­proved around the globe, Ad­lai said, but none on the mar­ket for HN­SCC.

An even­tu­al ap­proval for bu­parlis­ib could kick­start what Ad­lai views as its drug cock­tail-fo­cused R&D strat­e­gy. The biotech has three oth­er mol­e­cules in its clin­i­cal pipeline, in­clud­ing a nov­el EP4 in-li­censed from Ei­sai and an HER2-, HR+ on­colyt­ic virus from On­colyt­ics Biotech. Mean­while, the com­pa­ny is al­so de­vel­op­ing an in-house, small mol­e­cule an­ti-PD-L1 dubbed AN4005 that re­cent­ly earned an IND in sol­id tu­mors.

The even­tu­al strat­e­gy is to cre­ate mul­ti-drug cock­tails mixed be­tween those can­di­dates and the sev­en pre­clin­i­cal drugs swim­ming around Ad­lai’s pipeline, the biotech said — with a cock­tail de­fined as an an­ti-PD-(L)1 added to one or more oth­er can­cer ther­a­pies.

Lars Birg­er­son

The biotech’s 68-mem­ber team is led by US af­fil­i­ate CEO Lars Birg­er­son, a Big Phar­ma vet­er­an and clin­i­cal pro­gram spe­cial­ist who has made the rounds at Bris­tol My­ers Squibb, Pfiz­er and oth­ers, and Nan­hei He, the biotech’s glob­al head of drug dis­cov­ery, who was a post­doc at the Salk In­sti­tute be­fore he helped kick­start the com­pa­ny in 2016. The biotech’s largest share­hold­er with 51% of vot­ing rights is Yang “Carsten” Lu, the com­pa­ny’s found­ing CEO and board chair­man.

Ad­lai Nortye is hit­ting the HKEX at an aus­pi­cious time for on­col­o­gy R&D in Chi­na, which has seen boom­ing in­ter­na­tion­al in­ter­est and both di­rect and in­di­rect par­tic­i­pa­tion from West­ern phar­ma.

Ear­li­er this week, an­oth­er Chi­nese start­up, Bei­jing Mab­works Biotech, ap­plied for its own list­ing on the ex­change with a lead “third-gen­er­a­tion” CD20 an­ti­body look­ing to chal­lenge a mar­ket dom­i­nat­ed by Roche’s Rit­ux­an and its biosim­i­lars. Both biotechs fit the mold of the cur­rent state of Chi­nese on­col­o­gy work, which has fo­cused on dri­ving key “me-too” drugs in­to glob­al mar­kets with nov­el mol­e­cules fol­low­ing fur­ther down the pipeline.

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.

Tien Lee, Aardvark Therapeutics CEO

Emerg­ing from stealth mode, Aard­vark rounds up enough cash to put its lead drug through Prad­er-Willi PhII

When Aardvark Therapeutics CEO Tien Lee started his work on the biotech’s lead candidate, appetite suppression was the goal for the small molecule.  Soon after, his team started to see added benefits with lower blood glucose levels and anti-inflammatory activity. On the tail end of that, the company has emerged from stealth mode and announced today that they’ve raised enough cash in the B round to cover mid-stage development work.

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.

Covid-19 roundup: Pfiz­er im­pos­es vac­cine man­date for US work­ers; WHO calls for mora­to­ri­um on boost­ers, while some coun­tries make plans any­way — re­port

As the US struggles to keep pace with the fast-spreading Delta variant, big companies like Walmart and Disney are imposing vaccine mandates for some workers. It may come as no surprise that Pfizer — the Big Pharma behind the US’ first authorized Covid-19 vaccine — is joining them.

Pfizer will start requiring all US employees and contractors to get vaccinated, or participate in weekly Covid-19 testing, spokesperson Pamela Eisele told Reuters. Workers outside the US are strongly urged to get a vaccine if they can, according to the report. And those with medical conditions or religious objections can seek accommodations.

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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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.

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.