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.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

An­oth­er Cipla site lands a Form 483 over clean­ing is­sues and QC con­trols

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

FDA ad­comm takes down Se­cu­ra Bio's leukemia drug af­ter fi­nal tri­al re­sults show po­ten­tial OS detri­ment

The FDA’s Oncologic Drugs Advisory Committee on Friday voted 8-4 against the benefit-risk profile of Secura Bio’s PI3K inhibitor Copiktra (duvelisib), which won approval in September 2018 as a third-line treatment for relapsed or refractory CLL or SLL, but updated pivotal trial results raised safety questions.

In addition to the serious and fatal toxicities of duvelisib, FDA speakers at the ODAC meeting pointed to an evolved treatment landscape for CLL and SLL, with targeted BTK or BCL2 inhibitors (front-line or second-line), and data pointing to a “potential detriment” in overall survival for duvelisib. But some ODAC members noted that the detriment was likely small and that there is some efficacy even as the data are difficult to interpret.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.