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.”

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Gold­man Sachs jumps aboard Bain-backed 503(b) com­pound­ing phar­ma­cy with a $275M debt loan to sup­ply hos­pi­tals

Long the bane of the FDA’s existence, compounding pharmacies have seen a minor resurgence in the past year as short-term saviors for hospital drug shortages. Now, a 503(b) company specializing in hospital meds has earned a big backer to keep expanding its 200-drug strong portfolio.

Goldman Sachs and Owl Rock Capital Partners have doled out a $275 million debt loan to QuVa Pharma, a 503(b)-certified outsourcing facility providing compounded drugs to hospitals, the company said Thursday.

Bill Lis, Jasper Therapeutics

Jasper and its stem cell con­di­tion­ing an­ti­body earn a tick­et to Nas­daq in lat­est SPAC re­verse merg­er

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

Another biotech SPAC deal has landed as the glut of blank-check companies continues to make waves in the industry.

Thursday’s winner is Jasper Therapeutics, joining forces with Amplitude Healthcare Acquisition Corp. in a $100 million reverse-merger, Jasper announced. The deal also comes with a PIPE financing of an additional $100 million, setting Jasper up with a $490 million market cap once the merger closes in the third quarter.

Brent Saunders (Richard Drew, AP Images)

OcuWho? Star deal­mak­er turned aes­thet­ics czar Brent Saun­ders flips back in­to biotech. But who’s he team­ing up with now?

Brent Saunders went on a tear of headline-blazing deals building Allergan, merging and rearranging a variety of big companies into one before an M&A pact with Pfizer blew up and sent him on a bout of biotech drug deals. That didn’t work so well, so under pressure, he got his buyout at AbbVie — which needed a big franchise like Botox. And it was no big surprise to see him riding the SPAC wave into a recent $1 billion-plus deal that left him in the executive chairman’s seat at an aesthetics outfit — now redubbed The Beauty Health Company — holding a big chunk of the equity.

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Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?

Their answer: At most $8,290 per year — and perhaps as little as $2,560.

Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.