Liang Schweizer. HiFiBiO

Kite part­ner Hi­FiBiO clos­es $67M round for pre­clin­i­cal an­ti­body can­di­dates churned out of sin­gle-cell an­a­lyt­ics plat­form

A fledg­ling biotech with op­er­a­tions span­ning (the Amer­i­can) Cam­bridge, Paris and Shang­hai has just bagged $67 mil­lion to bring its pipeline of can­cer and au­toim­mune dis­ease-fight­ing an­ti­bod­ies in­to the clin­ic.

De­spite its rel­a­tive­ly low pro­file, Hi­FiBiO boasts of part­ner­ships with well-known play­ers, from pi­lot projects with Pfiz­er and J&J in its ear­ly days to more re­cent col­lab­o­ra­tions with Take­da and Gilead’s Kite sub­sidiary.

While the five pro­fes­sors who launched the com­pa­ny in 2013 — David Weitz, Robert Nicol and Bradley Bern­stein at Har­vard plus An­drew Grif­fiths and Jérôme Bi­bette in France — had de­signed their foun­da­tion­al, “ul­tra-high­through­put” sin­gle-cell screen­ing tech plat­form around B cell an­ti­bod­ies, it can ac­tu­al­ly be ap­plied broad­ly to mine the im­mune reper­toire from pa­tient sam­ples, pick­ing out bio­mark­ers and strat­i­fy­ing pa­tients quick­ly but com­pre­hen­sive­ly, CEO Liang Schweiz­er said in an in­ter­view. That in­cludes sniff­ing out anti­gen and neoanti­gen TCRs — the pre­cise ap­pli­ca­tion that CAR-T pi­o­neer Kite was hooked on. And there are oth­er undis­closed pacts, too.

The Se­ries C, though, will be ded­i­cat­ed to its in­ter­nal pipeline. Hi­FiBiO cur­rent­ly has 10 can­di­dates in its pipeline and ex­pects to ad­vance mul­ti­ple drug can­di­dates to the clin­i­cal tri­al phase. But since they are tread­ing on first-in-class wa­ters, Schweiz­er prefers to stay mum about the pre­cise path­ways and dis­eases they are tar­get­ing.

Jeff He Hi­FiBiO

In gen­er­al, their im­mune-mod­u­lat­ing pro­grams would cen­ter around reg­u­la­to­ry T cells and myeloid-de­rived sup­pres­sor cells, ac­cord­ing to the com­pa­ny web­site.

Schweiz­er, who’s dou­bling as CSO, joined the com­pa­ny around 2017 as the sci­en­tif­ic founders were look­ing for some­one to shape the com­pa­ny up for drug de­vel­op­ment. Hav­ing lead Asian can­cer re­search for Sanofi and lat­er co-found­ed the plat­form start­up Har­bour Bio­med, Schweiz­er was brought in along­side long­time col­league Jeff He, now Hi­FiBiO’s COO.

The founders had long kept Chi­na in mind as both a big mar­ket and a source of in­no­va­tion, she added.

“To make a busi­ness suc­cess­ful, you po­si­tion your­self open­ly,” said Schweiz­er, who’s based in the US but trav­els reg­u­lar­ly to the oth­er two sites.

Tiger Hu CA­BA

Kite jumped in­to the fi­nanc­ing along­side a group of Chi­na-fo­cused in­vestors led by IDG Cap­i­tal. The rest in­cludes Se­quoia Cap­i­tal Chi­na, Delian Cap­i­tal, Hanne Cap­i­tal, VI Ven­tures, Leg­end Star Cap­i­tal and LYFE Cap­i­tal, many of whom al­so par­tic­i­pat­ed in the $37.5 mil­lion Se­ries B in May 2018.

Tiger Hu of IDG — a large gen­er­al­ist VC that lists health­care as a fo­cus — is join­ing the board of di­rec­tors.

In ad­di­tion to build­ing up the clin­i­cal and reg­u­la­to­ry team, Hi­FiBiO has al­so signed con­tracts with top clin­i­cians to ob­tain pa­tient sam­ples that will en­able its on­go­ing trans­la­tion­al re­search ef­fort. The team, now at rough­ly 70, is grow­ing by the week, Schweiz­er said.

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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Deborah Dunsire. Lundbeck

UP­DAT­ED: Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

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Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.

San Diego cou­ple charged with steal­ing trade se­crets, open­ing Chi­nese biotech as DOJ crack­down con­tin­ues

A San Diego couple has been charged with stealing trade secrets from a US hospital and opening a business based off those secrets in China as the controversial industry-wide crackdown on alleged corporate espionage continues. On the same day, the Department of Justice announced they had arrested Beijing representative Zhongsan Liu for allegedly trying to obtain research visas for government recruiters.

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UP­DAT­ED: Bio­gen pulls the plug on prized IPF drug from $562M+ Stromedix buy­out

One of Biogen’s attempts to branch out has flopped as the biotech scraps a mid-stage program for idiopathic pulmonary fibrosis.

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Warts for the win: Aclar­is' lead drug clears piv­otal study

Aclaris Therapeutics has found a way to get rid of the warts and all.

The company — which earlier this month decided to focus on its arsenal of kinase inhibitors — on Monday unveiled positive data from a pivotal study testing its lead experimental drug for use in common warts.

The drug, A-101, was tested in a 502-patient study called THWART-2 — patients enrolled had one to six warts before qualifying for the trial. Patients either self-administered A-101 topical solution or a vehicle twice a week over a two-month period. A higher proportion of patients on the drug (a potent hydrogen peroxide topical solution) saw their warts disappear at day 60, versus the vehicle (p<0.0001) — meeting the main goal of the study.  Each secondary endpoint also emerged in favor of A-101, the company said.

Charles Nichols, LSU School of Medicine

Could psy­che­delics tack­le the obe­si­ty cri­sis? A long­time re­searcher in the field says his lat­est mouse study sug­gests po­ten­tial

Psychedelics have experienced a renaissance in recent years amid a torrent of preclinical and clinical research suggesting it might provide a path to treat mood disorders conventional remedies have only scraped at. Now a preclinical trial from a young biotech suggests at least one psychedelic compound has effects beyond the mind, and — if you believe the still very, very early hype — could provide the first single remedy for some of the main complications of obesity.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Ac­celeron drops a de­vel­op­ment pro­gram as #2 drug fails to spark func­tion­al ben­e­fits in pa­tients with a rare neu­ro­mus­cu­lar ail­ment

Acceleron is scrapping a muscular dystrophy development program underway for its number 2 drug in the pipeline after pouring over some failed mid-stage secondary data.

Gone is the ACE-083 project in patients with facioscapulohumeral muscular dystrophy. Their drug hit the primary endpoint on building muscle but flopped on key secondaries for functional improvements in patients, which execs felt was vital to the drug’s success.