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 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.

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.

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.