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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Yong Dai, Frontera Therapeutics CEO

Scoop: Lit­tle-known Or­biMed-backed biotech clos­es $160M round to start gene ther­a­py tri­al

Frontera Therapeutics, a China and US biotech, has closed a $160 million Series B and received regulatory clearance to test its first gene therapy stateside, Endpoints News has learned.

Led by the largest shareholder, OrbiMed, the biotech has secured $195 million total since its September 2019 founding, according to an email reviewed by Endpoints. The lead AAV gene therapy program is for an undisclosed rare eye disease, according to the source.

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Spanish Prime Minister Pédro Sanchez and European Commission President Ursula von der Leyen (AP Photo/Geert Vanden Wijngaert)

EU to launch vac­cine de­vel­op­ment and man­u­fac­tur­ing part­ner­ship with Latin Amer­i­can and Caribbean coun­tries

While European companies, including BioNTech, are focused on increasing vaccine access to African countries by setting up vaccine manufacturing facilities, the European Union is looking westward to Latin America and the Caribbean.

Speaking at a press conference with Spanish Prime Minister Pédro Sanchez, EU Commission president Ursula von der Leyen said that the EU is launching a new initiative for vaccines and medicines manufacturing in Latin America, to get drugs to Latin America and the Caribbean faster.

DEM BioPharma CEO David Donabedian (L) and executive chair Jan Skvarka

Long­wood sets an­oth­er 'don't eat me' biotech in­to gear with help of for­mer Tril­li­um CEO Jan Skvar­ka

Jonathan Weissman and team are out with a cancer-fighting biotech riding the appetite for those so-called “don’t eat me” and “eat me” signals.

The scientific co-founder — alongside fellow Whitehead Institute colleague Kipp Weiskopf and Stanford biologist Michael Bassik — has launched DEM BioPharma with incubator Longwood Fund and a crop of other investors.

In all, the nascent, 10-employee biotech has $70 million to bankroll hematology- and solid tumor-based programs, including a lead asset that could enter human trials in two to three years, CEO David Donabedian told Endpoints News.

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GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.