Brii Bio backs in­fec­tious dis­ease start­up while ink­ing deal for its lead TB drug, dou­bling down on an­tibi­otics

Zhi Hong

Al­most two years af­ter leav­ing GSK to launch Brii Bio with a whop­ping $260 mil­lion in fund­ing, Zhi Hong is see­ing the trans-Pa­cif­ic in­fec­tious dis­ease spe­cial­ist he set out to build take shape.

“Our pipeline is com­ing to­geth­er,” he told End­points News, with 12 part­nered as­sets plus some in­ter­nal pro­grams.

As its lat­est part­ner, AN2 Ther­a­peu­tics, comes in­to the lime­light for the first time with a $12 mil­lion seed round, so is Brii’s plans in the an­tibi­otics space. Brii has ob­tained Chi­na rights to AN2’s an­tibac­te­r­i­al tar­get­ing my­cobac­teri­um tu­ber­cu­lo­sis for mul­ti-drug re­sis­tant TB, which it says is in the clin­i­cal stage.

Brii has al­so joined the syn­di­cate along­side Moun­tain Group Part­ners, Ad­ju­vant Cap­i­tal and BioRock Ven­tures — an in­vest-and-li­cense ap­proach that was al­so seen in pre­vi­ous­ly an­nounced deals with Qpex Bio­phar­ma and Ar­ti­zan Bio­sciences.

“The trio of part­ner­ships has al­most ze­ro over­lap­ping when it comes to the use of an­tibi­otics,” Hong not­ed.

While Qpex’s port­fo­lio of an­tibi­otics is en­gi­neered to fight high­ly re­sis­tant, gram-neg­a­tive pathogens with “crit­i­cal needs” for treat­ment ac­cord­ing to the WHO, Ar­ti­zan boasts of a unique mech­a­nism by which it iden­ti­fies harm­ful bac­te­ria — then specif­i­cal­ly takes them out with­out the “col­lat­er­al dam­age of typ­i­cal an­tibi­otics,” Hong said.

While Brii waits for — and aids — its col­lab­o­ra­tors to pro­duce proof-of-con­cept da­ta, the biotech’s clin­i­cal team is fo­cused on ad­vanc­ing a po­ten­tial he­pati­tis B cure. Both came from deals an­nounced late last year.

Hav­ing re­cent­ly be­gun a Phase Ib/IIa study for the im­munother­a­py from VBI Vac­cines, they ex­pect to gar­ner ini­tial re­sults by the end of next year. Be­fore that they should hear back from Vir, George Scan­gos’ new­ly pub­lic start­up, on its own Phase I/II of the RNAi as­set.

Bei­jing R&D Cen­ter, Brii Bio

Click on the im­age to see the full-sized ver­sion

That gives them about a year be­fore switch­ing fo­cus to an­tibi­otics and dou­ble the head­count to around 80 — 60 in Bei­jing, where it has built an R&D cen­ter, and 20 in Hong’s home base of Durham, North Car­oli­na.

“You’re not go­ing to go to Chi­na overnight,” he said. “Chi­na’s reg­u­la­to­ry process­es, though it’s im­proved, can take six to nine months. So that gives you some time to build up a team.”

In tar­get­ing in­fec­tious dis­ease, and es­sen­tial­ly swear­ing off on­col­o­gy, Hong is clear about eye­ing a field where vol­ume mat­ters, which can be huge in a coun­try like Chi­na. And there is at least one more dis­ease area — one as­so­ci­at­ed with an ex­pand­ing mid­dle class, ur­ban­iza­tion and an ag­ing pop­u­la­tion — that he says Brii will soon ink an­oth­er pact in.

“So we are mov­ing in­to one non-in­fec­tious dis­ease area, and that’s prob­a­bly it,” he said. “We don’t want to be too frag­ment­ed.”

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Af­ter 4 years of furor, the FTC and New York state ac­cuse Mar­tin Shkre­li of run­ning a drug mo­nop­oly. And this time they plan to squash it

Pharma bro Martin Shkreli was jailed, publicly pilloried and forced to confront some lawmakers in Washington riled by his move to take an old generic and move the price from $17.50 per pill to $750. But through 4 years of controversy and public revulsion, his company never backed away from the price — left uncontrolled by a laissez faire federal policy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fingers off the drug once and for all and open it up to some cheap competition.

Patrik Jonsson, the president of Lilly Bio-Medicines

Who knew? Der­mi­ra’s board kept watch as its stock price tracked Eli Lil­ly’s se­cret bid­ding on a $1.1B buy­out

In just 8 days, from December 6 to December 14, the stock jumped from $7.88 to $12.70 — just under the initial $13 bid. There was no hard news about the company that would explain a rise like that tracking closely to the bid offer, raising the obvious question of whether insider info has leaked out to traders.

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Short at­tack­er Sahm Ad­ran­gi draws crosshairs over a fa­vorite of Sanofi’s new CEO — with PhII da­ta loom­ing

Sahm Adrang Kerrisdale

Kerrisdale chief Sahm Adrangi took a lengthy break from his series of biotech short attacks after his chief analyst in the field pulled up stakes and went solo. But he’s making a return to drug development this morning, drawing crosshairs over a company that’s one of new Sanofi CEO Paul Hudson’s favorite collaborators.

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UP­DAT­ED: Ac­celeron of­fers thumbs up on a PhII suc­cess for would-be block­buster drug — and shares rock­et up

There’s no public data yet, but Acceleron $XLRN says that its first major trial readout of 2020 is a success.

In a Phase II study of 106 patients with pulmonary arterial hypertension (PAH), Acceleron’s experimental drug sotatercept hit its primary endpoint: a significant reduction in pulmonary vascular resistance. The drug also met three different secondary endpoints, including the 6-minute walking test.

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Civi­ca and Blue Cross Blue Shield launch new ven­ture to low­er gener­ic prices

Five years after Martin Shkreli put a smug face to the volatile prices companies can charge even for generic drugs, payers and governments are coming up with outside-the-box solutions.

The latest fix is a new venture from the Blue Cross Blue Shield Association, 18 of its members and Civica, the generics company founded in 2018 by hospitals fed up with high prices for drugs that had long-since lost patent protection. While Civica focused on drugs that hospitals purchased, the new company will aim to lower prices on drugs that, like Shkreli’s Daraprim, are purchased by individuals.

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Merck Invests in State-Of-The-Art Biotech Development Facility in Switzerland

Mer­ck KGaA match­es lofty R&D goals with €250M in­vest­ment in­to a new clin­i­cal man­u­fac­tur­ing site in Switzer­land

As Merck KGaA strives to prove itself as a capable biopharma R&D player, it has begun construction on a €250 million facility dedicated to developing and manufacturing drugs for use in clinical trials.

The German drugmaker chose a location at Corsier-sur-Vevey, Switzerland, where it already has a commercial manufacturing site, in order to “bridge together research and manufacturing.”

“This investment in the Merck Biotech Development Center reflects our commitment to speed up the availability of new medicines for patients in need, and confirms the importance of Switzerland as our prime hub for the manufacturing of biotech medicines,” CEO Stefan Oschmann said at the groundbreaking ceremony, according to a statement.

Breast can­cer ap­proval in tow, As­traZeneca, Dai­ichi armed an­ti­body scores in key gas­tric can­cer study

AstraZeneca kicked off Monday with a flurry of good news. Apart from unveiling positive results on its stroke trial testing its clot-fighter Brilinta, and welcoming its experimental IL-23 inhibitor brazikumab back from Allergan — the British drugmaker also disclosed some upbeat gastric cancer data on its HER2-positive oncology therapy it is collaborating on with Daiichi Sankyo.

Buoyed by the performance of its oncology drugs, last March AstraZeneca chief Pascal Soriot bet big to partner with Daiichi on the cancer drug, with $1.35 billion upfront in a deal worth up to roughly $7 billion. Roughly 8 months later, as 2019 drew to a close, the FDA swiftly approved the drug — trastuzumab deruxtecan — for use in breast cancer, months ahead of the expected decision date.

Sor­ren­to shrugs off an anony­mous pri­vate eq­ui­ty group’s $1B of­fer to buy the com­pa­ny

San Diego-based Sorrento Therapeutics isn’t going the M&A route — at least not today.

The biotech caused quite a stir when it put out word a few weeks ago that an unidentified private equity group was bidding a billion dollars-plus for the company. The news drove a quick spike in the company’s share price as investors hooked up for the ride — that didn’t happen.

The update sparked a 5% drop in the share price $SRNE ahead of the bell. It’s now trading just above $4, without any evidence that the $7 price looked like it was firm.