Jo Varshney, VeriSIM Life CEO

Biosim­u­la­tion out­fit nets $15M Se­ries A in push to make pre­clin­i­cal R&D more pre­dictable

VeriSIM Life has been work­ing on cre­at­ing a biosim­u­la­tion plat­form since its found­ing in 2017 — and af­ter more than four years and a pre-seed and seed round, the Cal­i­for­nia soft­ware firm now has a Se­ries A un­der its belt.

The $15 mil­lion round, led by Mor­pheus Ven­tures and sup­port­ed by new in­vestors De­bio­pharm In­no­va­tion Fund and Col­or­con Ven­tures, in­cludes ex­ist­ing in­vestors OCA Ven­tures, In­tel Cap­i­tal, Ser­ra Ven­tures and Susa Ven­tures. The round will fund VeriSIM Life for the next 2 to 2½ years.

The R&D com­pa­ny, found­ed and led by first-time CEO Jo Varsh­ney and lo­cat­ed in San Fran­cis­co, has about 15 full-time em­ploy­ees, Varsh­ney told End­points News. With the Se­ries A, Varsh­ney said, the com­pa­ny can dou­ble its em­ploy­ees over the next 18 months and in­crease its in­fra­struc­ture, ex­pand­ing cur­rent part­ner­ships and po­ten­tial­ly open­ing the door to new ones.

The firm’s plat­form, called BIOiSIM, tries to com­bine AI and ma­chine learn­ing to more ac­cu­rate­ly pre­dict which drug can­di­dates are most like­ly to suc­ceed in an­i­mals and ul­ti­mate­ly hu­mans.

Varsh­ney — orig­i­nal­ly a vet­eri­nar­i­an by train­ing be­fore get­ting her PhD in com­par­a­tive on­col­o­gy and ge­nomics — said that close to 90% of drugs that pass an­i­mal test­ing do not pass test­ing in clin­i­cal tri­als in hu­mans. And in her mind, that num­ber can be changed.

“And we want to re­duce that num­ber. Even 20 to 30% in­creas­es and im­proves the chances of bet­ter R&D de­ci­sions, as well as bet­ter clin­i­cal pa­tient en­roll­ment pro­to­cols,” Varsh­ney said.

What makes VeriSIM’s plat­form unique, ac­cord­ing to Varsh­ney, is that its plat­form in­te­grates ma­chine learn­ing and deep learn­ing meth­ods in physics-based mod­el­ing, which she says al­lows VeriSIM Life to sim­u­late and more ac­cu­rate­ly pre­dict po­ten­tial clin­i­cal out­comes. That plays in­to trans­lata­bil­i­ty and in her words, “de-risk­ing R&D.”

“So for ex­am­ple, we want to de-risk the ef­fi­ca­cy end­points, we want to de-risk what the best route of ad­min­is­tra­tion would look like, what the dos­ing could look like,” Varsh­ney said. “And we’ve in­cor­po­rat­ed all that in a uni­fied or cen­tral­ized ar­chi­tec­ture that en­ables a cen­tral­ized learn­ing of our sys­tem to print to have bet­ter ac­cu­ra­cy pre­dic­tions, but al­so over­all learn­ing about a sys­tem.”

Be­yond VeriSIM Life, it has a sub­sidiary: Pul­moSIM Ther­a­peu­tics, which from Varsh­ney’s view, is val­i­da­tion of VeriSIM Life’s plat­form. So far, the biotech has two can­di­dates in its pipeline: one is for pul­monary ar­te­r­i­al hy­per­ten­sion, which al­ready has or­phan drug des­ig­na­tion, and the sec­ond is for id­io­path­ic pul­monary fi­bro­sis.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Yong Dai, Frontera Therapeutics CEO

Scoop: Lit­tle-known Or­biMed-backed biotech clos­es $160M round to start gene ther­a­py tri­al

Frontera Therapeutics, a China and US biotech, has closed a $160 million Series B and received regulatory clearance to test its first gene therapy stateside, Endpoints News has learned.

Led by the largest shareholder, OrbiMed, the biotech has secured $195 million total since its September 2019 founding, according to an email reviewed by Endpoints. The lead AAV gene therapy program is for an undisclosed rare eye disease, according to the source.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Kelly Martin, Radius Health CEO

VC firms take os­teo­poro­sis drug­mak­er Ra­dius Health pri­vate for al­most $900M

After attacks from activist investors and disappointing returns on share prices, Radius Health has now agreed to new ownership, a direction resulting in leaving the Nasdaq.

Radius Health, a biotech out of Massachusetts with one approved product in its arsenal, announced Thursday morning that it agreed to be acquired by two VC firms: Gurnet Point Capital and Patient Square Capital. The deal, worth around $890 million, will include debt assumption and the payout of $1 CVR per share for investors. And on top of that, OrbiMed is providing debt financing.

DEM BioPharma CEO David Donabedian (L) and executive chair Jan Skvarka

Long­wood sets an­oth­er 'don't eat me' biotech in­to gear with help of for­mer Tril­li­um CEO Jan Skvar­ka

Jonathan Weissman and team are out with a cancer-fighting biotech riding the appetite for those so-called “don’t eat me” and “eat me” signals.

The scientific co-founder — alongside fellow Whitehead Institute colleague Kipp Weiskopf and Stanford biologist Michael Bassik — has launched DEM BioPharma with incubator Longwood Fund and a crop of other investors.

In all, the nascent, 10-employee biotech has $70 million to bankroll hematology- and solid tumor-based programs, including a lead asset that could enter human trials in two to three years, CEO David Donabedian told Endpoints News.

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