Zhi Hong, Brii Bio CEO (file photo)

Bap­tized by Covid-19 fire, Brii Bio reaps $320M Hong Kong IPO to car­ry on with pipeline for in­fec­tious dis­eases and be­yond

Zhi Hong start­ed Brii Bio three years ago with the clear vi­sion that his trans-Pa­cif­ic start­up should have the best of both worlds — top-notch in­no­va­tion from the US, vast pa­tient pool and mar­ket in Chi­na — teth­ered by his years of ex­pe­ri­ence work­ing at Glax­o­SmithK­line’s in­fec­tious dis­ease team.

Ankang Li

In a sense, the strat­e­gy was ex­em­pli­fied (even if slight­ly re­versed) as the biotech de­cid­ed to join the hunt for a Covid-19 an­ti­body ear­ly last year: Its drug, which was de­vel­oped to­geth­er with Chi­nese sci­en­tists based on mon­o­clon­al an­ti­bod­ies iso­lat­ed from re­cov­ered pa­tients in Chi­na, was se­lect­ed by the NIH for large-scale plat­form tri­als in the US.

But when it came to launch­ing an IPO, Brii Bio had to choose: US or Chi­na first?

The biotech ul­ti­mate­ly went with the Hong Kong ex­change, where it’s now raised $320 mil­lion to steer a di­verse slate of pro­grams through the clin­ic with a fo­cus on pub­lic health. A to­tal of 11 cor­ner­stone in­vestors backed the list­ing, which saw the com­pa­ny price at the top of its range.

“I think Hong Kong stock mar­ket has be­come one of the most ac­tive fundrais­ing mar­kets for biotech com­pa­nies in the past two years,” CFO Ankang Li told End­points News.

Be­sides, out­side of Covid-19, Brii’s most ad­vanced can­di­dates are the two he­pati­tis B pro­grams in-li­censed from Vir and VBI, which are be­ing test­ed as a com­bo in a Phase IIb tri­al. Asian in­vestors, the com­pa­ny be­lieves, are more fa­mil­iar with the Chi­nese mar­ket that it’s try­ing to tap.

“So for HBV mar­ket in gen­er­al, I think Chi­na is def­i­nite­ly the largest mar­ket glob­al­ly,” Li said. “We have more than 78 mil­lion pa­tients in­fect­ed by HBV. So this is a huge mar­ket, and the cur­rent stan­dard of care, which in­cludes an­tivi­ral and in­ter­fer­on, they are not re­al­ly sat­is­fy­ing treat­ments be­cause they de­liv­er very low cure rate, be­low 7%.”

Even with big­ger play­ers like Roche pur­su­ing the same goal, Brii is con­fi­dent about its chances of lead­ing the field on its home turf, with the aim of get­ting a mar­ket­ed drug around 2024.

Be­hind that is a once-week­ly, long-act­ing oral HIV drug that Brii hopes will give GSK’s Vi­iV and Gilead a run for their mon­ey. Li not­ed that Hong, the CEO, ac­tu­al­ly start­ed the re­search on the first long-act­ing HIV reg­i­mens while at GSK, and there’s po­ten­tial to go even longer once they prove their tech­nol­o­gy works.

That spe­cif­ic knowl­edge on long-act­ing for­mu­la­tions al­so ex­plains why Brii has de­cid­ed to tag two CNS pro­grams — one for post­par­tum de­pres­sion and the oth­er for ma­jor de­pres­sive dis­or­der — to the oth­er­wise strict­ly in­fec­tious dis­ease-fo­cused pipeline.

On top of these in-house pro­grams, Brii li­censed Chi­na rights to mul­tidrug re­sis­tant an­tibi­otics from Qpex and an ex­per­i­men­tal treat­ment for mul­ti-drug re­sis­tant TB from AN2. It al­so has a part­ner­ship in place with mi­cro­bio­me spe­cial­ist Ar­ti­zan.

As the HBV pro­gram ad­vances and the an­tibi­otics tri­als start, Li ex­pects the clin­i­cal team to grow in Chi­na — where the strat­e­gy is to fo­cus on “very large in­di­ca­tions” with enough vol­ume to over­come pric­ing bar­ri­ers. The de­vel­op­ment of Brii’s HIV and CNS drugs, on the oth­er hand, will be cen­tered around the US. They cur­rent­ly have about 60 staffers in Chi­na while the US head­count is around 40.

Thanks to Covid-19, Brii has had an crash course on clin­i­cal de­vel­op­ment, speed­ing from pre­clin­i­cal work in­to Phase III with­in a year or so and lever­ag­ing NIH re­sources so that they can keep enough mon­ey for their oth­er pro­grams. Al­though the an­ti­body, like oth­ers from Eli Lil­ly and Glax­o­SmithK­line/Vir, failed to help hos­pi­tal­ized pa­tients, Brii said it seems to re­tain neu­tral­iz­ing ac­tiv­i­ty against mul­ti­ple vari­ants. Re­sults from the Phase III AC­TIV-2 study, tar­get­ed at the out­pa­tient set­ting, are due to read out soon.

Brii al­so has Phase II tri­als un­der­way in Chi­na to ad­dress a re­cent surge and plans to make the drug avail­able to pa­tients if it works, Li said — al­though he im­plies that it won’t be the biggest pri­or­i­ty mov­ing for­ward.

“We are still com­mit­ted to fur­ther de­vel­op our dis­cov­ery and ear­ly R&D team in the US, so in that area I think the US team will al­so grow,” Li said. “So I think we will take a very bal­anced ap­proach and both sides will prob­a­bly see a sig­nif­i­cant growth in the next one or two years.”

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.