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.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA have vowed not to let politics get in the way of science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped health agencies under his purview — including the FDA — of their rulemaking ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Eli Lilly CSO Dan Skovronsky (file photo)

#ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

#ES­MO20: As­traZeneca aims to spur PRO­found shift in prostate can­cer treat­ment with Lyn­parza OS da­ta

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

Dan Skovronsky, Eli Lilly CSO

An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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#ES­MO20: It’s not just Keytru­da any­more — Mer­ck spot­lights 3 top ear­ly-stage can­cer drugs

Any $12 billion megablockbuster in the portfolio tends to overshadow everything else in the pipeline. Which is something Merck can tell you a little bit about.

Keytruda not only dominates the PD-(L)1 field, it looms over everything Merck does, to the point some analysts wonder if Merck is a one-trick pony.

There’s no shortage of Keytruda data on display at ESMO this weekend, but now the focus is shifting to the future role of new drugs and combos in maintaining that lead position for years to come. And the pharma giant has a special focus for 3 early-stage efforts where Roger Perlmutter’s oncology team is placing some big bets.

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