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.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

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Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Leen Kawas, Athira CEO

Biotech founder placed on leave as $400M Alzheimer's start­up idea comes un­der scruti­ny

Athira Pharma, the Alzheimer’s biotech that emerged out of obscurity last year and raised nearly $400 million for a dark-horse approach to treating neurodegeneration, has found itself in sudden turmoil.

On Tuesday evening, the company released a terse statement announcing that CEO and founder Leen Kawas had been placed on administrative leave while an independent review board investigated “actions stemming” from her doctoral research at Washington State University. Mark Litton, who joined the company as COO two years ago, will take over day-to-day operations, they said.

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Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

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Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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Christian Hogg, Hutchmed CEO

Hutchmed files for $600M+ IPO in Hong Kong as lead on­col­o­gy drug su­r­u­fa­tinib awaits FDA's good graces

In oncology, a flush of Chinese-developed drugs has the biopharma industry rethinking the poles of power in R&D as the blossoming nation continues to make a name for itself and pick up bundles of cash in the process. Now, as its lead drug faces a pivotal FDA review, the company formerly known as Chi-Med is planting its flag on home soil with a massive public offering.

Hutchmed — recently renamed from Chi-Med, or Hutchison China MediTech — will look to raise $603 million as part of a Hong Kong IPO that serves as a homecoming of sorts for the Chinese-based oncology player, which has listed on Nasdaq since 2016.

FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

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Spring reg­u­la­to­ry agen­da: What’s com­ing soon-ish from the FDA

The FDA’s lack of a permanent commissioner does not seem to be halting its progress to propose and finalize dozens of new regulations, with the latest batch covering everything from adverse event reporting to supplemental application submissions to annual reports for INDs.

Overall, FDA expects to release more than 40 new proposed regulations and finalize another 24 in the coming months and years.

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