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.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Xuefeng Yu in Hong Kong, 2019 (Imaginechina via AP Images)

CanSi­no reaps $748M wind­fall from Shang­hai IPO — as it warns Covid-19 vac­cine won't be a huge mon­ey mak­er

CanSino began the year with a clear goal to secure a secondary listing on Shanghai’s STAR market. Then something more urgent came along: As a rising vaccine developer on a mission to bring global standard immunizations to China, it heeded the call to make a vaccine to protect against a virus that would paralyze the whole world.

Xuefeng Yu and his team managed to keep doing both.

More than a month after CanSino’s Covid-19 vaccine candidate is authorized for military use in China, the Hong Kong-listed company has made a roaring debut in Shanghai. It fetched $748 million (RMB$5.2 billion) by floating 24.8 million shares, and soared 88% on its first trading day.

Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,500+ biopharma pros reading Endpoints daily — and it's free.

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

(This piece was last updated on August 13. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,500+ biopharma pros reading Endpoints daily — and it's free.

James Wilson, WuXi Global Forum at JPM20

FDA puts up a red light for Pas­sage Bio’s first gene ther­a­py pro­gram, de­lay­ing a pro­gram from James Wilson's group at Penn

Gene therapy pioneer James Wilson spearheaded animal studies demonstrating the potential of new treatments injected directly into the brain, looking to jumpstart a once-and-done fix for an extraordinarily rare disease called GM1 gangliosidosis in infants. His team at the University of Pennsylvania published their work on monkeys and handed it over to Passage Bio, a Wilson-inspired startup building a pipeline of gene therapies — with an IND for PBGM01 to lead the way.

Qi­a­gen in­vestors spurn Ther­mo Fish­er’s takeover of­fer, de­rail­ing a $12B+ deal

Thermo Fisher Scientific had announced an $11.5 billion takeover of Dutch diagnostics company Qiagen back in March, but the deal apparently did not sit well with Qiagen investors.

After getting hammered by critics who contended that Qiagen $QGEN was worth a lot more than what Thermo Fisher wanted to spend, investors turned thumbs down on the offer — derailing the buyout even after Thermo Fisher increased its offer to $12.6 billion in July. Qiagen’s share price has been boosted considerably by Covid-19 as demand for its testing kits surged.

Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,500+ biopharma pros reading Endpoints daily — and it's free.

How much has pre­ci­sion med­i­cine helped? A new NCI study of­fers clues

Does precision medicine work?

The approach, based on finding a drug to target a patient’s specific genes, has undoubtedly saved individual lives, spurring Lazarus-like reversals in health in once-terminally ill patients. But critics have pointed out that its pursuit has meant drug companies spending hundreds of millions of dollars to target mutations that affect narrow slices of the populations, and that many of the gains researchers thought it would bring have eroded as cancers evolve resistance.

Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

UP­DAT­ED: Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,500+ biopharma pros reading Endpoints daily — and it's free.