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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Time for round 2: Il­lu­mi­na-backed VC snags $325M for its next fund

Illumina Ventures closed off its second investment fund with a total commitment of $325 million, offering fresh fuel to back a slate of startups that have already included a smorgasbord of companies, covering everything from diagnostics to biotech drug development and genomics.

Fund II brings the total investment under Illumina Ventures’ oversight to $560 million, which has been focused on early-stage companies. And it has a transatlantic portfolio that includes SQZ, Twist and Encoded Therapeutics.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Raju Mohan, Ventyx Biosciences CEO

Months af­ter a mam­moth raise, Ven­tyx Bio­sciences dips back in­to ven­ture well

Several months after emerging from what CEO Raju Mohan called “quiet mode” with a mammoth $114 million raise, Ventyx Biosciences is now making its plans for the clinic loud and clear.

The California-based immune modulation player kicked the week off with a $51 million Series B, while also naming some key hires ahead of its big clinical push.

The CMO slot is going to Jörn Drappa, former CMO at Viela Bio before it was bought out by Horizon Therapeutics earlier this year. The AstraZeneca vet stayed on at Horizon for a while as executive VP of R&D before making the jump to Ventyx.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.