Len Post and Sofie Qiao (Vivace)

Vi­vace Ther­a­peu­tics scores $30M Se­ries C to take on­col­o­gy can­di­date for 'Hip­po' path­way to hu­man tri­al next year

Named for the Ital­ian term in­di­cat­ing a piece of mu­sic should be played at an up­beat and live­ly tem­po, Cal­i­for­nia-based Vi­vace Ther­a­peu­tics seems to have lived up to its name­sake.

In the mere five years the small-mol­e­cule drug dis­cov­ery and de­vel­op­ment com­pa­ny has been in busi­ness, its sci­en­tists and re­searchers have de­vot­ed sig­nif­i­cant amounts of time and mon­ey to­ward ther­a­peu­tics that tar­get a path­way in the body that can cause can­cer­ous tu­mors to de­vel­op if cer­tain pro­teins are ac­ti­vat­ed. Now, with $30 mil­lion in Se­ries C fi­nanc­ing, Vi­vace is aim­ing to test one of its can­di­dates against that path­way start­ing in ear­ly 2021.

The pro­teins, called YAP, in­vade cells through what’s called the Hip­po path­way — a sig­nal­ing sys­tem in the body that con­trols tis­sue re­gen­er­a­tion and tells or­gans when it’s time to stop grow­ing. If ac­ti­vat­ed, YAP can dis­rupt the path­way in a way that caus­es the can­cer­ous tu­mors to form.

CEO Sofie Qiao told End­points News that ex­am­in­ing the re­la­tion­ship be­tween YAP and the Hip­po path­way was the rea­son she found­ed Vi­vace in 2015 — it’s a nov­el re­la­tion­ship, es­pe­cial­ly in terms of its con­nec­tion to can­cer. For the first two years, Qiao said, the com­pa­ny op­er­at­ed in stealth mode, but in May 2017, Vi­vace raised a $25 mil­lion Se­ries B to be­come a com­mer­cial-fo­cused on­col­o­gy com­pa­ny.

Now, the work to un­der­stand and po­ten­tial­ly treat a pro­tein mu­ta­tion that may cause lung, gas­tric, colon, cer­vi­cal, ovar­i­an, breast, melanoma, he­pa­to­cel­lu­lar car­ci­no­ma and squa­mous cell car­ci­no­ma can­cers has paid off in the biggest way yet for Qiao and Vi­vace with the lat­est $30 mil­lion round.

“Most of the on­col­o­gy play­ers in our in­dus­try have been watch­ing this path­way for quite a few years, and many of them have proac­tive­ly ap­proached us for dis­cus­sion since we do have a pub­lic pres­ence,” Qiao said. “To the best of our knowl­edge, no one has sent any mol­e­cule to the clin­ic, so we are po­si­tioned to be the first com­pa­ny to test a mol­e­cule tar­get­ing this path­way in hu­man set­ting.”

No­table in­vestors for this round in­clude: Canaan Part­ners, WuXi Health­care Ven­tures, Cen­o­va Cap­i­tal, Se­quoia Cap­i­tal Chi­na, Box­er Cap­i­tal and RA Cap­i­tal Man­age­ment.

Qiao said near­ly all of the $30 mil­lion would be put in­to the hu­man clin­i­cal de­vel­op­ment process of Vi­vace’s drug can­di­date. The ini­tial process­es will tar­get tu­mors that are known to be en­tire­ly de­pen­dent on ac­ti­vat­ed YAP, and Vi­vace said in a news re­lease that pre-clin­i­cal R&D showed that its clin­i­cal can­di­date is ac­tive as a monother­a­py and in com­bi­na­tion with oth­er an­ti-can­cer ther­a­pies against tu­mors that re­ly up­on dys­func­tion of the Hip­po path­way.

Len Post, Vi­vace’s chief sci­en­tif­ic of­fi­cer, said in an in­ter­view that un­til now, no sci­en­tif­ic progress had re­al­ly been made on how to dis­rupt the Hip­po path­way if YAP pro­teins were ac­ti­vat­ed. Vi­vace’s work, he said, dis­cov­ered how cer­tain com­pounds work in the con­text of the path­way and what has to hap­pen to in­hib­it the path­way from form­ing can­cer­ous tu­mors.

For YAP pro­teins to ac­ti­vate, they have to find an­oth­er pro­tein called a tran­scrip­tion­al en­hanced as­so­ciate do­main. Vi­vace’s com­pounds block those TEAD pro­teins by pre­vent­ing the ad­di­tion of a fat­ty acid that would al­low the two pro­teins to bond.

The $30 mil­lion round brings Vi­vace’s to­tal in­vest­ment haul just since 2017 to rough­ly $70 mil­lion. Qiao said that those fig­ures in­di­cate a clear in­ter­est from the biotech in­vest­ment com­mu­ni­ty in the Hip­po path­way and its po­ten­tial im­pact on the field of on­col­o­gy.

“That shows how much en­thu­si­asm and in­ter­est the in­vestor com­mu­ni­ty has for this path­way,” she said. “I think they re­al­ly like our da­ta and our team and the po­ten­tial of our mol­e­cule re­al­ly gen­er­at­ing clin­i­cal ef­fi­ca­cy.”

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

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Or­biMed, bio­phar­ma's biggest in­vestor, clos­es $3.5B in three new pri­vate funds

One of the world’s leading biopharma investors has pulled in its next rounds of cash, with the funds planned to go to dozens of companies around the world.

OrbiMed raised $3.5 billion across three private investment funds, it announced Monday, as it continues building on its long track record in healthcare and biopharma. All in all, the firm expects to invest in at least 60 companies across the US, Asia and Europe.

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CEO James Rosen (Artizan)

Pre­ci­sion in­flam­ma­tion drugs? Yale spin­out Ar­ti­zan clinch­es $11M and Bio­haven deal to sin­gle out bad bac­te­ria

As a Yale spinout based in New Haven, Artizan Biosciences was pretty familiar with Biohaven — a successful neuro-focused drug developer and “shining star,” as Artizan CEO James Rosen puts it, in the burgeoning biotech community there.

But when a board director and an investor tried connecting the two, they were in for a surprise.

“Unbeknownst to Artizan, Biohaven had been doing a landscaping exercise surveying microbiome companies with whom to partner for CNS disorders,” Rosen told Endpoints News, “and lo and behold, they found Artizan right in their backyard.”

Four IPOs and a SPAC pitch a new slate of mi­cro­bio­me, can­cer and in­flam­ma­to­ry drugs to Wall Street

Biotech IPOs are still coming in all sorts of flavors these days.

Just look at what’s on the menu from Friday: There’s Finch Therapeutics, which needs the money to complete a second pivotal trial and start plotting commercialization of its microbiome-based products; Connect Biopharma, a Chinese outfit going through mid-stage studies in T cell-driven inflammatory diseases; Instil Bio, whose team is trying to ride a compassionate use program with their autologous tumor infiltrating lymphocytes straight into Phase II; Transcode Therapeutics, an under-the-radar cancer therapy developer leveraging multiple RNA modalities; and then there’s a SPAC — Foresite Capital’s third.

Gregory Verdine

Har­vard's Gre­go­ry Ver­dine has big am­bi­tions for his minipro­tein 'braces' — and now $107M to guide them to the clin­ic

Harvard scientist Gregory Verdine’s mission has always been clear: drug the undruggable. He’s now one step closer, with $107 million in the bank to bring a new class of drugs to the clinic — and he isn’t ruling out an IPO.

Since launching FogPharma in 2016, Verdine and his crew have been hard at work on a new kind of therapeutic class that combines the cell-penetrating capacity of small molecules with the target-engaging tenacity of biologics. The result is what he calls CPMPs, or cell-penetrating miniproteins.

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With new $106M crossover round, Tenaya preps heart fail­ure pro­grams for the clin­ic — and maybe an IPO

Less than a year and a half since pulling in its last round of funding, Tenaya Therapeutics is back with a crossover round that could set it up for an IPO down the road.

Private and public investors have now jumped aboard the Tenaya train to the tune of a $106 million Series C, the company announced Monday morning, with the hopes of advancing its lead gene therapy program for heart failure into the clinic. Tenaya also aims to fund its other heart failure platforms, having made much progress in cellular regeneration and precision medicine as well, CEO Faraz Ali told Endpoints News.

UP­DAT­ED: Biotech's shares rout­ed af­ter the FDA de­mands new tri­al, rais­es safe­ty and end­point is­sues in sur­prise CRL

A small biotech that’s been laboring long and hard on an oral chemo program for metastatic breast cancer was slammed hard on Monday morning, losing more than half of its market cap after revealing that the FDA had issued a surprise CRL with some harsh new hurdles in place.

Athenex $ATNX says that regulators stiff-armed its application for oral paclitaxel and encequidar — a marked setback after winning a priority review earlier that should have signified a more positive regulatory frame of mind. And Athenex was clear that any comeback for this program is going to face a high bar at the FDA.

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CEO Ray Tabibiazar (SalioGen)

Look­ing to take ad­van­tage of 'si­lenced' en­zymes, Sali­o­Gen emerges from stealth with eyes set on gene ther­a­py 3.0

Gene therapy has made big strides over the years, from the first generation AAV-based therapies to the CRISPR/Cas9 technology that has now taken the scientific world — and Nobel Prize committee — by storm. But where exactly does the future, or gene therapy 3.0, lie?

That’s the question a new biotech is aiming to answer, as SalioGen Therapeutics emerges from stealth Monday morning with a $20 million Series A. And they believe they’ve found a new delivery system that can more precisely deliver genes in vivo than the relatively large adeno-associated virus or CRISPR system: mammalian-derived enzymes.