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

Nick Galakatos, Blackstone global head of life sciences

Nick Galakatos and the Black­stone team now have a record $4.6B to in­vest in bio­phar­ma, with a big fo­cus on push­ing com­pa­nies over the top

Nick Galakatos and his team at Blackstone Life Sciences have seen their biggest opportunities swell up in mostly established players who don’t have all the money they need to accomplish everything on the to-do list. And right now, with the industry booming, that’s a long list with some hefty needs.

The Blackstone team has neatly tied up the largest private fund ever raised in life sciences for making big dreams come true in biopharma. Late Thursday, Blackstone put out word that they had closed their highly anticipated fund with the projected $4.6 billion all in.

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Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Top biotech an­a­lyst projects a gloomy out­look for Pfiz­er's JAK port­fo­lio

Many in the pharma world are hoping — better yet, expecting — JAK inhibitors to provide one of the next big boons for the industry. Few have invested as heavily in this area as Pfizer, which boasts a portfolio including Xeljanz and at least five mid-to-late stage candidates in the pipeline.

But a top Wall Street analyst is pumping the brakes on just how much good fortune is in store for the Big Pharma.

Oph­thalmic drugs, can­cer cell ther­a­pies at­tract $340M+ on two HKEX biotech de­buts

Nasdaq may be running the main biotech IPO show, but the Hong Kong stock exchange has some stellar performance on display even as the city confronts a third wave of Covid-19.

Ocumension Therapeutics and Immunotech Biopharm both traded up after making their public debuts on the HKEX’s busiest IPO day of the year so far, with seven stocks getting listed. The former raised close to $200 million while the latter took home $141 million.

Gilead boasts of pos­i­tive remde­sivir da­ta on mor­tal­i­ty — but their analy­sis pro­vokes the skep­tics

Gilead is surging again off data that suggest its antiviral remdesivir might improve survival.

The new data come from an analysis Gilead conducted comparing the death rate and recovery time of patients in one of its remdesivir trials to a group of 800 patients “with similar baseline characteristics and disease severity” who received only standard-of-care around the same time. The result, they said, suggested that patients who received remdesivir had a 62% better chance at surviving than those who did not.

Hal Barron, GSK

Win or lose on the mar­ket­ing OK, the FDA just gunned down GSK’s bright hopes for their BC­MA ther­a­py

The FDA’s ODAC — the Oncologic Drugs Advisory Committee — has a well-known bias in favor of adding new cancer drugs to the market, even if efficacy is at best marginal and serious safety issues demand careful management.

Doctors want as many arrows in their quiver as they can get. And when patients are dying after failing multiple drugs, why not give it a go one more time?

GlaxoSmithKline, though, is about to test out how their new BCMA antibody drug conjugate belantamab mafodotin can do after being mauled in an in-house FDA review, ahead of the Tuesday expert panel discussion. Even if the agency goes ahead with an expected green light, this drug will likely be constrained to a small niche — icing any plans they may have for making waves in oncology anytime soon.

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Covid-19 roundup: BioN­Tech go­ing head-to-head with Mod­er­na as PhI­II mR­NA launch looms; Tri­al on Shin­zo Abe’s once-fa­vorite an­tivi­ral is in­con­clu­sive

It’s a race to the Phase III finish line now for the 2 leading mRNA vaccines in the pipeline for Covid-19.

BioNTech chief Ugur Sahin told the Wall Street Journal that his company will start Phase III testing of their vaccine later this month, setting them up to lateral the data to regulators before the end of this year.

That puts them essentially on the exact same schedule as Moderna is dedicated to. The Massachusetts rival to BioNTech also expects to launch Phase III this month. Lots of rumors have circulated about delays and conflict among the scientists advancing the Moderna jab, but the biotech has consistently stuck to its plan to start a late-stage pivotal this month.

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Andrew Kruegel, Kures president and co-founder (Columbia Tech Ventures via Vimeo)

Af­ter psilo­cy­bin and ke­t­a­mine, a new biotech comes along de­vel­op­ing a drug Scott Got­tlieb fought

Andrew Kruegel was six years into his chemistry work at Columbia University, when, one day in August 2016, he learned he might have only 30 days before the government made him destroy his research.

Kruegel had been studying kratom, a leaf long used in Southeast Asia as a stimulant or for pain. It had opioid-like properties, he found, but seemed to offer pain relief without the addictive potential or respiratory side effects of traditional opioids — a riddle that might help illuminate how human opioid receptors work.

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