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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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Sergio Traversa, Relmada Therapeutics CEO

Rel­ma­da makes 'crit­i­cal changes' to PhI­II tri­al to try and save de­pres­sion drug

Relmada Therapeutics is making changes to its Phase III study of its lead drug for major depressive disorder, in an attempt to avoid problems with a prior trial that showed little difference between the drug and a placebo.

That failure in October wiped 80% from Relmada’s stock price, and was followed by another negative readout a few months later. In both cases, the company said that there had been trial sites that were associated with what it called surprising placebo effects that skewed the results compared with the drug, REL-1017.

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Paul Song, NKGen Biotech CEO

NK cell ther­a­py-fo­cused biotech eyes SPAC deal

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

In­cyte hit by CRL on ex­tend­ed-re­lease JAK tablets, mud­dy­ing plans for Jakafi fran­chise ex­pan­sion

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Steven James, Pionyr Immunotherapeutics CEO

Gilead pass­es on ful­ly ac­quir­ing Pi­o­nyr, as eyes now turn to Tizona, a fel­low sum­mer 2020 buy­out op­tion

Gilead and Pionyr Immunotherapeutics, a biotech trying to follow up on the first generation of checkpoint inhibitors, have “mutually agreed” on a rewrite to their 2020 terms, with Gilead deciding not to buy out the company.

The California biopharma waived its option to acquire the remaining 50.1% of Pionyr, which would have triggered a $315 million upfront payment and up to $1.15 billion down the road. Had Gilead waited to decide, the drugmaker would have had a potential payment to make in the near term under their agreement, a spokesperson said in an email to Endpoints News.

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Peter Hecht, Cyclerion Therapeutics CEO

Hard pressed for cash, Cy­cle­ri­on looks for help fund­ing rare dis­ease drug

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.