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.”

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

New Charles River Laboratories High Quality (HQ) Plasmid DNA Centre of Excellence at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. (Charles River)

Charles Riv­er Lab­o­ra­to­ries to start cell and gene ther­a­py man­u­fac­tur­ing at UK site in Sep­tem­ber

While Massachusetts-based Charles River Laboratories has been on an acquisition spree, they are not against planting their flag. The latest move by the company sees them crossing the pond to establish a manufacturing site in the UK.

The company on Tuesday opened its cell and gene therapy manufacturing center at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. The expansion follows Charles River’s acquisition of Cognate BioServices and Cobra Biologics in 2021 for $875 million. Cognate is a plasmid DNA, viral vector and cell therapy CDMO.

Bristol Myers Squibb (Alamy)

CVS re­sumes cov­er­age of block­buster blood thin­ner af­ter price drop fol­lows Jan­u­ary ex­clu­sion

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”

#Can­nes­Lions2022: Con­sumer health ex­ecs call on agen­cies to in­volve pa­tients in cre­ative process

CANNES — When Tamara Rogers joined GSK back in 2018, “science was king and R&D were the gods.” Now the global chief marketing officer of consumer healthcare wants to make room for another supreme being: the consumer.

As health and wellness becomes more relevant to consumers amid the pandemic, four health-focused executives called on marketers to involve patients in their creative process in a panel discussion at the Cannes Lions advertising creativity festival.

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