Bernat Olle, Vedanta Biosciences CEO (Vedanta)

Build­ing off Pfiz­er in­vest­ment, mi­cro­bio­me-fo­cused Vedan­ta ex­pands new fundraise to launch 2 stud­ies

A lit­tle more than six months af­ter win­ning an en­dorse­ment from Pfiz­er for its IBD mi­cro­bio­me pro­gram, Vedan­ta Bio­sciences is ready to step on the gas.

Vedan­ta wrapped up a $68 mil­lion Se­ries D raise Wednes­day morn­ing, which in­clud­ed the $25 mil­lion eq­ui­ty in­vest­ment Pfiz­er plunked down back in Jan­u­ary. With the biotech con­tent with its ear­ly-stage re­sults and man­u­fac­tur­ing ca­pa­bil­i­ties, Vedan­ta is get­ting ready to po­ten­tial­ly launch mul­ti­ple mid- to late-stage stud­ies and need­ed the ex­tra cash, CEO Bernat Olle tells End­points News.

“With the last fi­nanc­ing, we al­ready start­ed to delve in­to our first pa­tient stud­ies, in­clud­ing our lead pro­gram in­to Clostrid­ioides dif­fi­cile in­fec­tion, which is in Phase II,” Olle said. “Now that we’re look­ing at the end of that study, in an­tic­i­pa­tion of the re­sults we’re start­ing to pre­pare for the late-stage study.”

The Phase II study is ex­pect­ed to read out da­ta by the end of Sep­tem­ber, and Vedan­ta plans to have its Phase III man­u­fac­tur­ing fa­cil­i­ty up and run­ning at the end of 2021. Should every­thing pro­ceed ac­cord­ing to plan, the Phase III tri­al will be­gin in mid-2022.

On top of this lead can­di­date, known as VE303, Vedan­ta is an­tic­i­pat­ing ad­vanc­ing a sec­ond pro­gram for IBD with Wednes­day’s funds. That’s Pfiz­er’s fo­cus, and the biotech ex­pects to launch the Phase II study for the can­di­date, known as VE202, in the sec­ond half of this year.

Vedan­ta is aim­ing to shake up the field of mi­cro­bio­me treat­ments, which thus far has typ­i­cal­ly seen com­pa­nies de­vel­op ther­a­peu­tics based on fe­cal trans­plants to re­store bal­ance of healthy mi­crobes in the gut. The Cam­bridge, MA-based biotech is tak­ing a dif­fer­ent ap­proach, how­ev­er, uti­liz­ing clon­al cell banks to make their ex­per­i­men­tal drugs rather than re­ly on donor sam­ples.

It’s a method Olle says is sim­i­lar to how the biotech in­dus­try evolved over the years from mak­ing drugs based on plas­ma do­na­tions to fo­cus­ing more on mon­o­clon­al an­ti­bod­ies. The old ap­proach be­came a par­tic­u­lar thorn in biotech’s side sev­er­al decades ago, Olle said, when the rise of HIV and he­pati­tis C — which could be passed through trans­fu­sions — made the treat­ments high­ly risky.

Look­ing out at the rest of the mi­cro­bio­me field, Olle thinks sim­i­lar is­sues are pop­ping up again. Vedan­ta hopes to elim­i­nate the vari­abil­i­ty seen among donor sam­ples and de­vel­op­ing ther­a­pies that are all the same.

With their cell banks, Vedan­ta can “cre­ate a cell line, store it in a freez­er and es­sen­tial­ly have un­lim­it­ed sup­ply in the fu­ture,” Olle said. “We can go back to the freez­er stock and start the fer­men­ta­tion process where every cap­sule has the ex­act same com­po­si­tion every time, in con­trast to those based on trans­plants.”

In­vestors large­ly fled the mi­cro­bio­me treat­ment space af­ter a key late-stage flop in 2016 from Seres Ther­a­peu­tics sent VCs run­ning. But cash has slow­ly start­ed to trick­le back in as new suc­cess­es emerge. In May 2020, Re­bi­otix pre­sent­ed pos­i­tive da­ta from a place­bo-con­trolled study for its own C. diff trans­plant ther­a­py, and ear­li­er this month, af­ter Seres found promis­ing re­sults with a new tack, Nestlé dropped $525 mil­lion to fund de­vel­op­ment for their lead mi­cro­bio­me treat­ment.

The round al­so marks an­oth­er win this week for PureTech, which found­ed Vedan­ta in 2010. On Mon­day, the PureTech-backed en­ti­ty Gele­sis, de­vel­op­ing a weight man­age­ment cap­sule that makes pa­tients feel fuller, shuf­fled to Nas­daq through a SPAC merg­er.

Wednes­day’s fi­nanc­ing was led by af­fil­i­ates of Mag­ne­tar Cap­i­tal. Oth­er par­tic­i­pants in­clud­ed new and ear­li­er in­vestors such as Veri­tion Fund Man­age­ment, Fo­s­un Health Cap­i­tal, co-founder PureTech Health, Rock Springs Cap­i­tal, Skyviews Life Sci­ence, JSR Cor­po­ra­tion, Sym­Bio­sis LLC, Shumway Cap­i­tal and Health for Life Cap­i­tal, among oth­ers.

Illustration: Assistant Editor Kathy Wong for Endpoints News

How Pur­due's $272M ad­dic­tion pay­out fund­ed a new home for its dis­card­ed non-opi­oid re­search

Don Kyle spent more than 20 years working for Purdue Pharma, right through the US opioid epidemic that led to the company’s rise and eventual infamy. But contrary to Purdue’s focus on OxyContin, Kyle was researching non-opioid painkillers — that is, until the company shelved his research.

As the company’s legal troubles mounted, Kyle found an unlikely way to reboot the project. In 2019, he took his work to an Oklahoma State University center that’s slated to receive more than two-thirds of the state’s $272 million settlement with Purdue over claims that the drugmaker’s behavior ignited the epidemic of opioid use and abuse.

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President Joe Biden at the State of the Union address with Vice President Kamala Harris and House Speaker Kevin McCarthy (Patrick Semansky/AP Images)

The drug pric­ing pres­i­dent: Biden warns of ve­to for any IRA re­peal at­tempts

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Rupert Vessey, Bristol Myers Squibb head of research and early development

Up­dat­ed: R&D tur­bu­lence at Bris­tol My­ers now in­cludes the end of a $650M al­liance and the de­par­ture of a top re­search cham­pi­on

This morning biotech Dragonfly put out word that Bristol Myers Squibb has handed back all rights to its IL-12 clinical-stage drug after spending $650 million to advance it into the clinic.

The news arrives amid a turbulent R&D stage for the pharma giant, which late last week highlighted Rupert Vessey’s decision to depart this summer as head of early-stage R&D following a crucial three-year stretch after he jumped to Bristol Myers in the big Celgene buyout. During that time he struck a series of deals for Bristol Myers, and also shepherded a number of Celgene programs down the pipeline, playing a major role for a lineup of biotechs which depended on him to champion their drugs.

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Bill Haney, Dragonfly CEO (Dave Pedley/Getty Images for SXSW)

Drag­on­fly chief: Bris­tol My­ers shouldn’t blame IL-12’s clin­i­cal per­for­mance for de­ci­sion to scrap the deal — eco­nom­ics played a key role

Bristol Myers Squibb says the IL-12 drug they were developing out of Dragonfly Therapeutics was scrubbed from the pipeline for a simple reason: It didn’t measure up on clinical performance.

But Bill Haney, the CEO of Dragonfly, is taking issue with that.

The early-stage drug, still in Phase I development, has passed muster with Bristol Myers’ general clinical expectations, advancing successfully while still in Phase I, he says.

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Utpal Koppikar, new Verily CFO

Ex­clu­sive: Ver­i­ly wel­comes Atara Bio­ther­a­peu­tics vet­er­an as new CFO

Verily, Alphabet’s life sciences outfit, has plucked a new CFO from the ranks of Atara Biotherapeutics, the company announced on Wednesday.

Utpal Koppikar joins Verily after a nearly five-year stint as CFO and senior VP at Atara, though his résumé also boasts roles at Gilead and Amgen.

The news follows a major reshuffling at Verily, including several senior departures earlier this year and a round of layoffs.

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Singer Nick Jonas is back at work for Dexcom, this time for its new G7 glucose monitor.

Dex­com's spokescelebri­ty Nick Jonas re­turns to Su­per Bowl in new glu­cose mon­i­tor com­mer­cial

Dexcom is going back to the Super Bowl with its pop singer and patient spokesperson Nick Jonas. Jonas takes center stage as the lone figure in the 30-second commercial showcasing Dexcom’s next-generation G7 continuous glucose monitoring (CGM) device.

Jonas’ sleight-of-hand tricks populate the commercial — he pinches his empty fingers together and pops them open to reveal the small CGM — even as he ends the ad, saying, “It’s not magic. It just feels that way.” Jonas then disappears in a puff of smoke.

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Richard Francis, newly-appointed Teva CEO (Novartis via Facebook)

New Te­va CEO Richard Fran­cis repri­or­i­tizes to 'get back to growth'

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

FDA Commissioner Robert Califf on Capitol Hill, Feb. 8, 2023 (Drew Angerer/Getty Images)

FDA com­mis­sion­er floats ideas on how to bet­ter han­dle the pan­dem­ic

FDA Commissioner Rob Califf joined the heads of the CDC and NIH in the hot seat today before a key House subcommittee, explaining that there needs to be a much faster, more coordinated way to oversee vaccine safety, and that foreign biopharma inspections, halted for years due to the pandemic, are slowly ramping up again.

Califf, who stressed to the House Energy and Commerce’s Subcommittee on Health that the CDC also needs better data, made clear that the FDA’s ability to monitor the safety of vaccines “would also benefit greatly by a coordinated federal public health data reporting authority.”

Sanofi is renewing its #VaccinesForDreams campaign with more stories, such as Juan's in Argentina (Sanofi)

Sanofi re­news so­cial cam­paign to re­mind that vac­cines let peo­ple ‘Dream Big’

Sanofi is highlighting people’s dreams — both big and small — to make the point that vaccines make them possible.

The renewed “Dream Big” global social media campaign’s newest dreamer is Juan, a teacher in the Misiones rainforest in Argentina whose story is told through videos on Instagram and Sanofi’s website with the hashtag #VaccinesForDreams.

The campaign ties to Sanofi’s broader umbrella initiative “Vaccine Stories” to promote the value of vaccines and drive awareness of the need for improved vaccination coverage.

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