CEO Jeff Hatfield (Vividion)

Jeff Hat­field as­sem­bles a syn­di­cate with some A-list pub­lic in­vestors in the mix as Vi­vid­ion adds $135M raise

Bioreg­num Opin­ion Col­umn by John Car­roll

Back when Vi­vid­ion put to­geth­er its $82 mil­lion B round more than a year ago, I spec­u­lat­ed that the start­up was prob­a­bly gear­ing up for an IPO. That still hasn’t hap­pened, but they may be a lot clos­er af­ter to­day.

The ARCH- and Ver­sant-backed com­pa­ny just nailed down a $135 mil­lion raise from a dream team of crossover in­vestors, with Lo­gos Cap­i­tal and Box­er Cap­i­tal lead­ing as Soft­Bank jumps in with Avoro Cap­i­tal Ad­vi­sors, Black­Rock, RA Cap­i­tal Man­age­ment, T. Rowe Price As­so­ci­ates, Sur­vey­or Cap­i­tal (a Citadel com­pa­ny), Wood­line Part­ners LP, Acu­ta Cap­i­tal and Driehaus Cap­i­tal Man­age­ment. Ex­ist­ing in­vestors ARCH Ven­ture Part­ners, BVF Part­ners L.P., Cas­din Cap­i­tal, Mubadala Cap­i­tal, Nex­tech In­vest and Ver­sant Ven­tures all came back to chip in.

“There was a lot of en­thu­si­asm for this raise,” CEO Jeff Hat­field tells me about the pipeline-build­ing raise for a com­pa­ny that has big am­bi­tions in on­col­o­gy as well as im­munol­o­gy. “It came to­geth­er very quick­ly and we bumped it up a cou­ple of times.”

Hat­field isn’t ready to flag an IPO, though — “Who knows what the fu­ture holds?” — but he’s a lot more forth­com­ing about the pre­clin­i­cal work they have un­der­way.

In-house work in­cludes a fo­cus on the KEAP1-NRF2 ax­is, with work un­der­way on NRF2 mu­tant and ad­dict­ed can­cers. NRF2 mod­u­lates stress in cells, ex­plains Hat­field, and once “mu­tat­ed it leads to a form of can­cer that is cur­rent­ly” un­ad­dressed by any ex­ist­ing ther­a­peu­tics. That gets to the com­pa­ny’s fo­cus on the broad range of dis­ease tar­gets still in un­chart­ed drug ter­ri­to­ry.

The com­pa­ny has spe­cial­ized in iden­ti­fy­ing lig­ands for unique pock­ets, al­low­ing them to drug pre­vi­ous­ly un­drug­gable pro­teins. The chair­man is Rich Hey­man, who built and sold Aragon and Ser­agon.

There is al­so a tran­scrip­tion fac­tor pro­gram they’re work­ing on with Bris­tol My­ers that Hat­field de­scribes as “one of a hand­ful of Holy Grail tar­gets in on­col­o­gy and im­munol­o­gy.” But that’s as far as he’s will­ing to go at this stage.

James Sabry

So how about that IPO?

Just this morn­ing we wrote up a sto­ry about Soft­Bank’s plan to in­ject bil­lions more in pub­lic biotechs, help­ing to push the stock boom that’s dri­ven up the Nas­daq biotech in­dex by 35% over the past year — and adding more cash to crossovers would ap­pear to fit in neat­ly with that strat­e­gy.

Since that B round Vi­vid­ion has struck a deal with Roche — the Big Phar­ma every­one likes to have on their R&D side — that de­liv­ered $135 mil­lion in cash plus mul­ti­ple bil­lions on the back end. That gave Roche a shot at E3 lig­as­es — which plays a role in pro­tein degra­da­tion, one of BD chief James Sabry’s fa­vorite sub­jects — as well as new on­col­o­gy and im­munol­o­gy pro­grams.

That all adds up to some promi­nent play­ers, world-class part­ners, a lot of cash on hand and the first snap­shot of the pre­clin­i­cal strat­e­gy — all key in­gre­di­ents fu­el­ing the IPO boom of the past year.

So we’ll see.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

An­oth­er Cipla site lands a Form 483 over clean­ing is­sues and QC con­trols

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

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FDA ad­comm takes down Se­cu­ra Bio's leukemia drug af­ter fi­nal tri­al re­sults show po­ten­tial OS detri­ment

The FDA’s Oncologic Drugs Advisory Committee on Friday voted 8-4 against the benefit-risk profile of Secura Bio’s PI3K inhibitor Copiktra (duvelisib), which won approval in September 2018 as a third-line treatment for relapsed or refractory CLL or SLL, but updated pivotal trial results raised safety questions.

In addition to the serious and fatal toxicities of duvelisib, FDA speakers at the ODAC meeting pointed to an evolved treatment landscape for CLL and SLL, with targeted BTK or BCL2 inhibitors (front-line or second-line), and data pointing to a “potential detriment” in overall survival for duvelisib. But some ODAC members noted that the detriment was likely small and that there is some efficacy even as the data are difficult to interpret.

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