Join­ing hunt for hep B cure, Brii Bio inks maid­en deals fea­tur­ing VBI, Vir, WuXi with a big ap­petite for more

This May, Zhi Hong de­buted the ul­tra-con­nect­ed trans-Pa­cif­ic up­start Brii Bio to bridge a gap in in­no­va­tion be­tween the US and Chi­na. Sev­en months in, he’s us­ing some of those con­nec­tions to in-li­cense two po­ten­tial cures for he­pati­tis B, en­ter an­oth­er dis­cov­ery col­lab­o­ra­tion and build a new glob­al head­quar­ters, kick­start­ing a quest to “cre­ate a new ground for in­fec­tious dis­eases.”

And with plen­ty of his $260 mil­lion launch fund still in the bank, the CEO al­ready has his eyes set on more part­ner­ships — all co­or­di­nat­ed from a new R&D hub be­ing built in Bei­jing, which will even­tu­al­ly be able to house up to 200 em­ploy­ees, as well as small­er out­posts across Shang­hai, San Fran­cis­co and Hong’s home base of Durham, North Car­oli­na.

“We are spread out in­to US and Chi­na and we have to call one place home, in a sense,” he tells me. “I’m hop­ing by the end of next year we will have about 50 peo­ple in Chi­na,” up from the cur­rent 20 split be­tween both sides of the Pa­cif­ic.

Lever­ag­ing in­sti­tu­tion­al sup­port for the Bei­jing fa­cil­i­ty and be­ing “very fru­gal” has al­lowed Brii to con­cen­trate its cash on deals, which will like­ly re­main mod­est in size: For Chi­na rights to VBI Vac­cines’ re­com­bi­nant pro­tein-based im­munother­a­peu­tic, Brii is pay­ing an up­front of $11 mil­lion, $7 mil­lion of which is an eq­ui­ty in­vest­ment. Ad­di­tion­al mile­stones add up to $117.5 mil­lion.

The RNAi ther­a­py from Vir, on the oth­er hand, is part of an ex­ist­ing li­cens­ing pact Hong struck with George Scan­gos when he left Glax­o­SmithK­line to start Brii. Orig­i­nat­ing from Al­ny­lam, VIR-2218 is de­signed to re­store pa­tients’ own im­mune re­sponse to HBV by knock­ing down sur­face anti­gens.

“But we can­not as­sume all the pa­tients will have suf­fi­cient amount of in­trin­sic im­mu­ni­ty,” he says. “This is where the VBI 2601 come in where we’re ac­tu­al­ly go­ing to for­mu­late this in such that will stim­u­late, in­duce a broad­er T cell as well as B cell re­sponse.”

There’s more than a hint of a com­bi­na­tion ap­proach here, though it will have to wait un­til the as­sets go past ear­ly-stage test­ing as monother­a­pies.

At the same time, Brii re­searchers will be work­ing on some in-house an­ti­body dis­cov­ery with WuXi Bi­o­log­ics via an ex­clu­sive col­lab­o­ra­tion, uti­liz­ing the CRO pow­er­house’s bis­pe­cif­ic plat­form to tack­le a cou­ple of nov­el im­munomod­u­la­to­ry tar­gets that Hong is stay­ing mum about. The pres­ti­gious Ts­inghua Uni­ver­si­ty, right next door to Brii’s Bei­jing site, will lend a hand on the bi­o­log­ics test­ing.

While ef­forts to tam­per with B cells, T cells and NK cells have in­spired con­sid­er­able in­ter­est in on­col­o­gy, it will rep­re­sent a new par­a­digm for in­fec­tious dis­ease, Hong says.

Hav­ing met with about 80 po­ten­tial part­ners, Hong is ready to ex­e­cute on a rapid suc­ces­sion of deals through 2020 — un­less a big deal comes along that ne­ces­si­tates an­oth­er round of fundrais­ing, he adds. “You nev­er know.”


Im­age: Zhi Hong. BRII BIO

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

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA buck­les un­der the strain of a pan­dem­ic work­load, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

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President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

President Donald Trump and FDA Commissioner Stephen Hahn (AP Images)

FDA is­sues fi­nal rule al­low­ing im­por­ta­tion of drugs from Cana­da — but al­so keeps the pow­er to re­voke it

Just over a month away from the presidential election, the FDA has issued a final regulation fulfilling President Trump’s promise to let states import certain prescription drugs from Canada.

On Thursday, Trump told a crowd in North Carolina that the new rule goes into effect “today.” But the published regulation states that it won’t take effect for 60 days. And even then, it could be a while before cheaper drugs make it across the border.

The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

Sil­ver­back dish­es out two pro­mo­tions in C-suite; Leg­end CEO post changes hands again

→ Accompanying the news that they just scored an $85 million Series C round, Laura Shawver-led Silverback Therapeutics has promoted two execs, with Valerie Odegard adding president to her CSO duties and Naomi Hunder moving to CMO. A Novo Nordisk alum, Odegard has been with the Seattle-based biotech since 2016 and the CSO the last 2 years. Before Silverback, she was VP of research at Juno Therapeutics.