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.

Clin­i­cal tri­al di­ver­si­ty da­ta show mis­match be­tween en­roll­ment and dis­ease preva­lence, GSK says

A lack of diversity in clinical trials has persisted despite decades of initiatives to try to turn the tide.

In a recent review of 17 years of clinical trials, drugmaker GSK found that there were some mismatches between the demographics of its US-based trials and how prevalent diseases were in those populations.

The results, the company says, will help GSK and others design studies that better represent epidemiological rates within races and ethnicities.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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Giovanni Caforio, Bristol Myers Squibb CEO (Nicolas Messyasz/Sipa via AP Images)

Bris­tol My­ers turns at­ten­tion to new prod­ucts in wake of Revlim­id patent loss

Bristol Myers Squibb CEO Giovanni Caforio is shifting his focus to newer products as generic sales continue to gnaw at the company’s blockbuster myeloma drug Revlimid.

Both Revlimid and Abraxane sales took a dive last year thanks to generic rivals, BMS reported in its Q4 and full-year results on Thursday. As a result, Q4 sales dipped 5% and full-year sales remained flat. However, Caforio sees a silver lining — or rather, two of them.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP)

FTC makes an ex­am­ple of GoodRx, bans dis­counter from shar­ing pri­vate health da­ta with ad­ver­tis­ers

Prescription drug discount provider GoodRx will no longer be allowed to share its users’ sensitive health data with advertisers after the Federal Trade Commission charged the online coupon provider with failing to notify consumers of such disclosures to Facebook, Google, and other companies.

GoodRx agreed to pay a $1.5 million civil penalty for violating the FTC’s Health Breach Notification Rule after the FTC said it repeatedly violated a 2017 promise to not share sensitive personal health information. The FTC alleged that the company shared users’ prescription medications and personal health conditions with third party advertisers and platforms like Facebook, Google, Criteo, Branch and Twilio.