Vow­ing to spark a rev­o­lu­tion in small mol­e­cule R&D, Vi­vid­ion equips it­self with an ex­tra $82M for the fi­nal stretch to the clin­ic

Vi­vid­ion Ther­a­peu­tics has come a long way in the lit­tle more than 2 years since the com­pa­ny of­fi­cial­ly launched with a $45 mil­lion A round in ear­ly 2017. CEO Diego Mi­ralles has been build­ing his San Diego-based team and bank­ing cash along the way, adding a $101 mil­lion deal with Cel­gene — in­clud­ing a $97 mil­lion up­front — for a soon-to-be-ac­quired biotech play­er with a big ap­petite for ex­ter­nal dis­cov­ery al­liances.

Last fall they brought in a pair of ex­pe­ri­enced biotech vets — Fred Aslan as pres­i­dent and head busi­ness guy and Lar­ry Burgess to run chem­istry — and to­day they’re tak­ing the wraps off a meaty $82 mil­lion B round that takes their to­tal raise to $228 mil­lion. 

They just don’t have any drugs in the clin­ic. But they do have plans to rec­ti­fy that in the not-too-dis­tant fu­ture.


Im­age: Diego Mi­ralles. VI­VID­ION

There are 3 pro­grams in the lead op­ti­miza­tion stage right now fo­cused on an adap­tor pro­tein, a tran­scrip­tion fac­tor and an E3 lig­ase which are cen­tered on im­munol­o­gy and on­col­o­gy. Mi­ralles is still keep­ing a lot of the de­tails about time­lines and such to him­self, but he sug­gests that any­one fa­mil­iar with small mol­e­cule R&D work should fig­ure that one out fair­ly re­li­ably.

I’ll leave that one to our read­ers. I’ve seen too much vari­abil­i­ty to think there’s a uni­ver­sal av­er­age here. But I could be wrong.

Vi­vid­ion’s claim to biotech fame rests on a broad and bold boast:

They say they can screen every pro­tein in a cell in ways that re­veal pre­vi­ous­ly un­known pock­ets of op­por­tu­ni­ty. These tar­gets can be used to in­hib­it pro­teins, de­grade them, and more with small mol­e­cules spot­light­ed by their tech, li­censed from the lab of Scripps’ Ben Cra­vatt. And they’re not talk­ing about nar­row win­dows of op­por­tu­ni­ty, but in­stead plan to open up a broad swath of R&D ter­ri­to­ry that can ex­pand small mol­e­cules’ reach far be­yond the rel­a­tive­ly nar­row scope they’ve been lim­it­ed to.

“The com­pa­ny was spun out as a rev­o­lu­tion­ary tech­nol­o­gy idea,” says the CEO, and they’ve been gain­ing speed fast, grow­ing from a hand­ful of staffers to a group of 70 now in­tent on noth­ing less than spark­ing a re­nais­sance in small mol­e­cule drug de­vel­op­ment. 

Fred Aslan

Aslan and Mi­ralles both give Cel­gene top marks for step­ping up as col­lab­o­ra­tors, and they’re ready to make the shift to Bris­tol-My­ers af­ter that ac­qui­si­tion deal comes through. Aslan is an ex­pe­ri­enced start­up ex­ec, with a stint as co-founder at Re­cep­tos. And he says that the biotech will like­ly bide its time in com­ing up with new col­lab­o­ra­tions. 

They have the mon­ey to wait for the right ones.

What about an IPO? Mi­ralles de­clined to com­ment on that one, but he says there’s am­ple cash to get at least one of the 3 to the proof-of-con­cept stage, which is the next stage they want to hit on the way to the rev­o­lu­tion. And they have a glob­al syn­di­cate at their back.

The on­col­o­gy spe­cial­ists at Nex­tech In­vest — which likes to get in ahead of an IPO — led the round, with new in­vestors BVF Part­ners, Cas­din Cap­i­tal, Mubadala Ven­tures, Trini­tas Cap­i­tal, Mi­rae As­set Cap­i­tal, Al­ti­tude Life Sci­ence Ven­tures and Alexan­dria Ven­ture In­vest­ments jump­ing on board. Ex­ist­ing in­vestors ARCH Ven­ture Part­ners, Ver­sant Ven­tures, Car­di­nal Part­ners and Cel­gene all came back for the ride as well.

Lessons for biotech and phar­ma from a doc­tor who chased his own cure

After being struck by a rare disease as a healthy third year medical student, David Fajgenbaum began an arduous journey chasing his own cure. Amidst the hustle of this year’s JP Morgan conference, the digital trials platform Medable partnered with Endpoints Studio to share Dr. Fajgenbaum’s story with the drug development industry.

What follows is an edited transcript of the conversation between Medable CEO Dr. Michelle Longmire and Dr. Fajgenbaum, and it is full of lessons for biotech executives charged with bringing the next generation of medicines to patients.

Kathy High (file photo)

Gene ther­a­py pi­o­neer Kathy High has left Spark af­ter com­plet­ing $4.3B union with Roche

Kathy High dedicated the past seven years of her life shepherding experimental gene therapies she’s developed at Children’s Hospital of Philadelphia toward the market as president and head of R&D at Spark Therapeutics. Now that the biotech startup is fully absorbed into Roche — with an FDA approval, a $4.3 billion buyout and a promising hemophilia program to boast — she’s ready to move on.

Roche confirmed her departure with Endpoints News and noted “she will take some well-deserved time off and then will begin a new chapter in a sabbatical at a university.”

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Jim Scholefield via PR Newswire

Mer­ck los­es its chief dig­i­tal of­fi­cer, spot­light­ing tal­ent hunt for the hottest ti­tle in Big Phar­ma

Over the last few years we’ve seen the chief digital officer title become one of the hottest commodities in Big Pharma as global organizations hunt the best talent to sharpen the cutting edge of their tech platforms.

But Merck just discovered how hard it may be to keep them focused on pharma.

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Say good­bye to Toca­gen, strug­gling brain can­cer biotech to re­verse merge with Forte Bio­sciences

Five months after a huge Phase III failure triggered mass layoffs at the company, Tocagen will sign itself out of existence.

The biotech, once focused on brain cancer, announced it has signed a reverse merger agreement with Forte Biosciences, a biotech tackling atopic dermatitis and other inflammatory skin diseases. Tocagen’s stock shot up 85% on the news, although that only translated to a 41-cent bump for a company that saw the last of its value go poof in September. The new company will trade under the ticker $FBRX.

JJ Bienaimé (BioMarin via YouTube)

Speedy re­view and no ad­comm for Bio­Mar­in's pi­o­neer­ing he­mo­phil­ia gene ther­a­py

BioMarin’s keenly anticipated hemophilia A gene therapy — which CEO JJ Bienaimé envisions pricing at an eye-watering $2 million to $3 million a shot — has secured red carpet treatment at the FDA.

The therapy, fondly called valrox, has won priority review — and there the agency has indicated there are no plans for an advisory committee meeting. The US regulator’s final decision is expected by August 21. If approved, it will be the pioneering gene therapy for hemophilia.

“While the company…indicated that FDA does not currently plan on convening an advisory committee meeting to discuss the merits of the application, we caution that the possibility of such still remains as the agency digs into its review, which could be interpreted negatively by the Street,” BMO Capital Market’s George Farmer wrote.

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Tal Zaks (Moderna via YouTube)

For two decades, a new vac­cine tech­nol­o­gy has been slow­ly ap­proach­ing prime time. Now, can it stop a pan­dem­ic?

Two months before the outbreak, Moderna CMO Tal Zaks traveled from Cambridge, MA to Washington DC to meet with Anthony Fauci and the leaders of the National Institutes of Health.

For two years, Moderna had worked closely with NIH researchers to build a new kind of vaccine for MERS, one of the deadliest new viruses to emerge in the 21st century. The program was one test for a new technology designed to be faster, cheaper and more precise than the ways vaccines had been made for over a century. They had gathered evidence the technology could work in principle, and Fauci, the longtime head of the National Institute of Allergy and Infectious Diseases and a longtime advocate for better epidemic preparedness, wanted to see if it, along with a couple of other approaches, could work in a worst-case scenario: A pandemic.

“[We were] trying to find a test case for how to demonstrate if our technology could rapidly prepare,” Zaks told Endpoints News.

Zaks and Fauci, of course, wouldn’t have to wait to develop a new test. By year’s end, an outbreak in China would short circuit the need for one and throw them into 24/7 work on a real-world emergency. They also weren’t the only ones with new technology who saw a chance to help in a crisis.

An ocean away, Lidia Oostvogels was still on vacation and relaxing at her mother’s house in Belgium when her Facebook started changing. It was days after Christmas and on most people’s feeds, the news that China had reported a novel virus to the World Health Organization blurred into the stream of holiday sweaters and fir trees. But on Oostvogels’s feed, full of vaccine researchers and virus experts, speculation boiled: There was a virus in China, something contained to the country, but “exotic,” “weird,” and maybe having to do with animals. Maybe a coronavirus.

Lidia Oostvogels

“I was immediately thinking like, ‘Hey, this is something that if needed, we can play a role,'” Oostvogels told Endpoints.

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Phar­ma­co­ge­net­ics: FDA re­leas­es ta­ble of gene-drug in­ter­ac­tions

The FDA on Thursday published a table identifying more than 50 gene-drug interactions that the agency says are supported by scientific evidence and announced it is considering new approaches to evaluating pharmacogenetic associations.

“Consistent with our mission to protect and promote public health, we believe it is important to take steps now to help ensure that claims being made for pharmacogenetic tests offered today are grounded in sound science to avoid inappropriate management of patients’ medications,” said Center for Devices and Radiological Health Director Jeff Shuren and Center for Drug Evaluation and Research Director Janet Woodcock.

Christos Kyratsous (via LinkedIn)

He built a MERS treat­ment in 6 months and then the best Ebo­la drug. Now Chris­tos Kyrat­sous turns his sights on Covid-19

TARRYTOWN, NY — In 2015, as the Ebola epidemic raged through swaths of West Africa, Kristen Pascal’s roommates sat her down on their couch and staged an intervention.

“Are you sure this is what you want to be doing with your life?” she recalls them asking her.

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Pascal, a research associate for Regeneron, had been coming home at 2 am and leaving at 6 am. At one point, she didn’t see her roommate for a week. For months, that was life in Christos Kyratsous’ lab as the pair led a company-wide race to develop the first drug that could effectively treat Ebola before the outbreak ended. For Pascal, that was worth it.

“I’m ok, I don’t have Ebola,” Pascal told them. “I see that death toll rising and I can’t not do something about it.”

Last August, Regeneron learned they had succeeded: In a large trial across West Africa, their drug, REGN-EB3, was vastly more effective than the standard treatments. It was surprise news for the company, coming just 10 months into a trial they thought would take several years and a major victory in the global fight against a deadly virus that killed over 2,000 in 2019 and can carry a mortality rate of up to 90%.

For Kyratsous and Pascal, though, it brought only fleeting reprieve. Just four months after the NIH informed them REGN-EB3 worked, Kyratsous was back in his office reading the New York Times for updates on a new outbreak on another continent, and wondering alongside Pascal and senior management whether it was time to pull the trigger again.

In late January, as the death toll swelled and the first confirmed cases outside China broke double digits, they made a decision. Soon they were back on the phone with the multiple government agencies and their coronavirus partners at the University of Maryland’s Level 3 bio lab. The question was simple: Can Kyratsous and his team use a process honed over two previous outbreaks, and create a treatment before the newest epidemic ends? Or worse, if, as world health experts fear, it doesn’t vanish but becomes a recurrent virus like the flu?

“Christos likes things immediately,” Matt Frieman, Regeneron’s coronavirus collaborator at the University of Maryland, told Endpoints. “That’s what makes us good collaborators: We push each other to develop things faster and faster.”

Kristen Pascal (Regeneron)

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The first time Regeneron tried to respond to a global outbreak, it was something of a systems test, Kyratsous explains from his office at Regeneron’s Tarrytown headquarters. Kyratsous, newly promoted, has crammed it with photos of his family, sketches of viral vectors and a shark he drew for his 3-year-old son. He speaks rapidly – an idiosyncrasy his press person says has only been aggravated this afternoon by the contents of his “Regeneron Infectious Diseases”-minted espresso glass – and he gesticulates with similar fluidity, tumbling through antibodies, MERS, the novel coronavirus, Ebola-infected monkeys.

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Don't let Ab­b­Vie fool FTC with an easy di­vesti­ture, plead crit­ics in lat­est at­tack on $63B Al­ler­gan buy­out

If the FTC must let AbbVie and Allergan go ahead with their merger, at least make them divest their latest blockbuster on the market, a chorus of unions, consumer groups and public interest organizations plead in a new attempt to rein in the megamerger.

There’s a second part to their argument: If the antitrust watchdog does greenlight the divestiture AbbVie wants, then at least ensure the pharma giant cannot corner its future rivals with its exclusionary tactics.

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