French can­cer-fo­cused mi­cro­bio­me play­er is flush with €18M Se­ries B in­jec­tion

Last year, the death of an im­muno-com­pro­mised el­der­ly pa­tient in a fe­cal mi­cro­bio­ta trans­plan­ta­tion tri­al — due to a do­na­tion that con­tained a rare type of E. coli bac­te­ria — sent shiv­ers across the field. The in­ci­dent marred an oth­er­wise ex­plod­ing field of drug de­vel­op­ment that backed re­plen­ish­ing the gut with good bac­te­ria as a safe and ef­fec­tive means to for­ti­fy the im­mune sys­tem to fight dis­ease.

Hervé Affa­gard

For France’s MaaT Phar­ma, an on­col­o­gy-fo­cused mi­cro­bio­me com­pa­ny, the set­back was al­most re­as­sur­ing.

“Bot­tom line is if they would have used our prod­uct, this pa­tient would not have died,” chief Hervé Affa­gard said in an in­ter­view with End­points News, sug­gest­ing that MaaT’s rig­or­ous test­ing stan­dards in­clude the screen­ing of drug-re­sis­tant bac­te­ria that would have pre­clud­ed the use of the rogue do­na­tion.

On Wednes­day the com­pa­ny — whose lead ex­per­i­men­tal prod­uct is an en­e­ma for­mu­la­tion de­signed to help pa­tients with acute graft-ver­sus-host dis­ease that have un­der­gone stem cell trans­plan­ta­tion — scored €18 mil­lion in Se­ries B fi­nanc­ing as it works on prov­ing its met­tle in a field crowd­ed with com­peti­tors fo­cused on a raft of dis­eases.

Mi­cro­bio­me-based ther­a­peu­tics to­day is a fe­cund field for drug de­vel­op­ers — big and small — cap­i­tal­iz­ing on sci­ence that sug­gests flush­ing ‘good’ gut bac­te­ria in­to the sys­tem can treat a pletho­ra of con­di­tions — from C. diff in­fec­tions to obe­si­ty — us­ing dif­fer­ent ther­a­peu­tic modal­i­ties, some of which are de­signed to side­step the “ick” fac­tor as­so­ci­at­ed with tra­di­tion­al stool trans­fer or fe­cal mi­cro­bio­ta trans­plan­ta­tion (FMT).

The con­cept of FMT was orig­i­nal­ly doc­u­ment­ed in Chi­na and has been used in the Unit­ed States since the 1950s with lit­tle reg­u­la­to­ry scruti­ny. In the last decade, the FDA sanc­tioned the use of FMT as a last re­sort mea­sure for re­cur­rent C. diff, but the agency con­tin­ues to con­sid­er it an in­ves­ti­ga­tion­al treat­ment. Glob­al­ly, hun­dreds of tri­als are now un­der­way test­ing the po­ten­tial of FMT for pa­tients suf­fer­ing from var­i­ous ill­ness­es, from autism to can­cer.

A few years ago, the spec­tac­u­lar fail­ure of Seres Ther­a­peu­tics’ sem­i­nal ef­fort in­to de­vel­op­ing a “crap­sule” — donor-de­rived processed fe­cal ma­te­r­i­al en­cap­su­lat­ed in a pill — de­railed an emerg­ing field work­ing to har­ness the in­sights gained from gut mi­cro­bio­ta to de­vel­op drugs. How­ev­er, the suc­cess of fe­cal trans­plant ther­a­pies to treat stub­born­ly re­cur­rent C. diff in­fec­tions has gained trac­tion, at­tract­ing a buck­et of biobucks and even in­spir­ing the takeover of a key play­er, Re­bi­otix.

MaaT Phar­ma prides it­self on its metic­u­lous process of donor screen­ing, qual­i­ty con­trol and di­ver­si­ty of bac­te­ria in its prod­uct — which like many oth­ers is for­mu­lat­ed us­ing fe­ces from healthy donors.

The Ly­on-based com­pa­ny’s lead for­mu­la­tion — MaaT013 — is cur­rent­ly in a mid-stage study in GvHD pa­tients. Da­ta from this tri­al are ex­pect­ed by the end of the year.

“It’s a kind of an im­muno-restora­tion, in­stead of im­muno­sup­pres­sion,” Affa­gard said of MaaT013, not­ing that all the drugs that have been de­vel­oped so far for GvHD pa­tients are im­muno­sup­pres­sive.

Late last year, MaaT re­port­ed en­cour­ag­ing MaaT013 da­ta from 8 pa­tients whose GvHD per­sist­ed de­spite up to five pre­vi­ous sys­temic treat­ments as part of a com­pas­sion­ate use pro­gram in hos­pi­tals. Each pa­tient ex­pe­ri­enced at least a par­tial re­sponse af­ter re­ceiv­ing MaaT013, while 3 out of 8 pa­tients at­tained a com­plete re­sponse, the com­pa­ny said.

“So we know our project is work­ing,” Affa­gard said. “Those pa­tients they’re re­ceiv­ing chemother­a­py, stem cell trans­plan­ta­tion…their mi­cro­bio­me was de­stroyed many times dur­ing their jour­ney.”

Next-gen­er­a­tion se­quenc­ing plat­forms and ad­vanced bioin­for­mat­ics ap­proach­es have stim­u­lat­ed re­search eval­u­at­ing the role of the gut mi­cro­bio­me in can­cer. In 2019, a con­sor­tium of ex­perts con­vened to dis­cuss the ev­i­dence un­der­ly­ing the as­so­ci­a­tion and found that while there are plau­si­ble mech­a­nisms and sup­port­ive ev­i­dence from in vit­ro, murine and cross-sec­tion­al hu­man stud­ies —di­rect ev­i­dence from large lon­gi­tu­di­nal co­hort stud­ies is lack­ing. In ef­fect, the role of the hu­man mi­cro­bio­me in the cause and sub­se­quent de­vel­op­ment of can­cer re­mains un­proven, the pan­el con­clud­ed, al­though a ma­jor­i­ty of pan­elists nev­er­the­less agreed with the hy­poth­e­sis.

MaaT is go­ing to use the fresh in­jec­tion of funds to prove its bet on the as­so­ci­a­tion. The mon­ey will be used for the on­go­ing Phase II en­e­ma study, as well as a cap­sule for­mu­la­tion that is set to be test­ed in a tri­al this year. The com­pa­ny is al­so ex­plor­ing the po­ten­tial of “restor­ing a bal­anced mi­cro­bio­me” to im­prove the clin­i­cal out­comes of check­point in­hibitors, with plans for a com­bi­na­tion tri­al in sol­id tu­mors.

The Se­ries B round in­clud­ed the par­tic­i­pa­tion of US in­vestor Sym­Bio­sis as well as sup­port from MaaT’s ex­ist­ing in­vestors Sev­en­ture Part­ners, Crédit Mutuel In­no­va­tion and Biocodex.

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.

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.”

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

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.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Kelly Martin, Radius Health CEO

VC firms take os­teo­poro­sis drug­mak­er Ra­dius Health pri­vate for al­most $900M

After attacks from activist investors and disappointing returns on share prices, Radius Health has now agreed to new ownership, a direction resulting in leaving the Nasdaq.

Radius Health, a biotech out of Massachusetts with one approved product in its arsenal, announced Thursday morning that it agreed to be acquired by two VC firms: Gurnet Point Capital and Patient Square Capital. The deal, worth around $890 million, will include debt assumption and the payout of $1 CVR per share for investors. And on top of that, OrbiMed is providing debt financing.