Alex Zhavoronkov (Insilico)

In­sil­i­co preps first can­di­date for IND stud­ies, hop­ing to launch tri­al in IPF by end of 2021

Over the last sev­er­al years, Alex Zha­voronkov has turned In­sil­i­co in­to one of the most well-con­nect­ed AI biotechs out there. Now, the Hong Kong-based com­pa­ny is one step clos­er to reach­ing the clin­ic.

In­sil­i­co is bring­ing its first can­di­date in­to IND-en­abling stud­ies, Zha­voronkov an­nounced Wednes­day, with the goal of launch­ing an in-hu­man tri­al at some point lat­er this year. The move marks what he says is a first in AI drug dis­cov­ery, as both the tar­get and small-mol­e­cule in­hibitor in­volved in the pro­gram are com­plete­ly new and AI-gen­er­at­ed.

Zha­voronkov, who told End­points News he builds self-dri­ving ro­bots in his spare time, isn’t ready just yet to say what the tar­get or ex­per­i­men­tal drug are, but he not­ed that the fo­cus will be id­io­path­ic pul­monary fi­bro­sis. The tar­get it­self plays a key role in fi­brot­ic and in­flam­ma­to­ry path­ways, sit­ting on the in­ter­sec­tion of profi­brot­ic path­ways, he said.

More im­por­tant to In­sil­i­co is the process by which they dis­cov­ered the com­pound — de­spite us­ing more than 60 dif­fer­ent ap­proach­es, the main method was through its pro­pri­etary AI plat­form’s neur­al net­works. In­sil­i­co re­searchers start­ed by look­ing at how dif­fer­ent tis­sues sus­cep­ti­ble to fi­bro­sis can change over the course of pa­tients’ lives, but that op­er­a­tion is too dif­fi­cult for hu­mans to do on their own, as the req­ui­site datasets are mas­sive.

“We train on age, af­ter that we re-train on fi­bro­sis, get the first list of pri­or­i­tized like­ly tar­gets, and then we put them in­to bi­o­log­i­cal path­ways,” Zha­voronkov told End­points.

Af­ter that, In­sil­i­co ap­plied a sep­a­rate neur­al net­work to comb through data­bas­es over where gov­ern­ments were is­su­ing grant re­search and com­pa­nies were tak­ing clin­i­cal tri­als. That helped Zha­voronkov de­ter­mine whether the tar­get is ac­tu­al­ly new or if oth­er com­pa­nies had al­ready tried to make some­thing work with it.

Last­ly, Zha­voronkov want­ed to be able to trust the an­swers his neur­al net­works were spit­ting out. So he es­sen­tial­ly asked his AI to find po­ten­tial hid­den links be­tween the da­ta to in­crease their con­fi­dence that a drug would work, while al­so look­ing at how cer­tain key opin­ion lead­ers viewed the bi­ol­o­gy they were try­ing to crack.

In­sil­i­co de­vel­oped its plat­form in col­lab­o­ra­tion with Big Phar­mas to in­cor­po­rate how the “best of the best” hu­man re­searchers think about tar­get se­lec­tion, Zha­voronkov said, adding that in lots of cas­es, how­ev­er, tar­gets are cho­sen for busi­ness rea­sons rather than sci­ence. He wants to try to change that with his plat­form and Wednes­day’s an­nounce­ment.

“We need to find this ul­ti­mate bal­ance be­cause you re­al­ize that more than one tar­get can be im­pli­cat­ed in this dis­ease,” Zha­voronkov said. “So it is pos­si­ble there is not just one mag­ic bul­let, there could be sev­er­al bul­lets.”

When this new pro­gram ul­ti­mate­ly reach­es the clin­ic, by the end of this year at the ear­li­est, it will be a typ­i­cal Phase I study. But Zha­voronkov said he has the “lux­u­ry” of ex­per­i­ment­ing with every step of the tri­al giv­en oth­er phar­ma com­pa­nies haven’t yet en­tered this space in this fash­ion.

The im­me­di­ate next steps are to con­tin­ue push­ing out the plat­form to oth­er play­ers. In­sil­i­co has made the core of its AI open source in the hopes of bring­ing down drug dis­cov­ery costs across the in­dus­try. Zha­voronkov said val­i­dat­ing this tar­get in IPF cost In­sil­i­co on­ly $1.8 mil­lion.

“If I do not in­vent, I do not live,” Zha­voronkov said. “We will nev­er stop and we al­so have a huge pipeline of projects in AI.”

How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Ryan Watts, Denali CEO

De­nali slips as a snap­shot of ear­ly da­ta rais­es some trou­bling ques­tions on its pi­o­neer­ing blood-brain bar­ri­er neu­ro work

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Andrea Pfeifer, AC Immune CEO (AC Immune)

Look­ing to repli­cate Covid-19 suc­cess in neu­ro, BioN­Tech back­ers bet on AC Im­mune and its new­ly-ac­quired Parkin­son's vac­cine

The German billionaires behind BioNTech have found a new vaccine project to back.

Through their family office Athos Service, twin brothers Thomas and Andreas Strüngmann are leading a $25 million private placement into Switzerland’s AC Immune — which concurrently announced that it’s shelling out $58.7 million worth of stock to acquire Affiris’ portfolio of therapies targeting alpha-synuclein, including a vaccine candidate, for Parkinson’s disease.