Mer­ck en­lists 4D Phar­ma's mi­cro­bio­me plat­form in a bid to build a new class of vac­cines

Mer­ck has signed a re­search deal with 4D Phar­ma to use its Mi­croRX plat­form to turn liv­ing bac­te­ria in­to vac­cines.

The col­lab­o­ra­tion comes in the nascent field of “live bio­ther­a­peu­tics” – a term the FDA us­es to de­scribe liv­ing or­gan­isms, gen­er­al­ly bac­te­ria, used as med­i­cine. 4D Phar­ma, a small biotech based in Leeds, UK, builds its LBP by ex­tract­ing bac­te­ria from a healthy donor and putting it in a cap­sule pa­tients swal­low.

The deal al­lows 4D Phar­ma to cause New Jer­sey-based Mer­ck to pur­chase $5 mil­lion of or­di­nary 4D Phar­ma shares dur­ing the first year. There’s an undis­closed cash pay­ment to 4D, along with $347.5 mil­lion in op­tions hing­ing on de­vel­op­ment and reg­u­la­to­ry mile­stones, and roy­al­ties.

But there’s no word yet on what those in­di­ca­tions are. Or what pre­cise­ly these vac­cines are. 

Al­though 4D Phar­ma talks about de­vel­op­ing  “live bio­ther­a­peu­tic vac­cines” with Mer­ck, the FDA’s 2016 guid­ance on LBP clin­i­cal tri­als specif­i­cal­ly de­fines LBPs as some­thing that con­tains liv­ing or­gan­isms, is used to pre­vent or cure hu­man ail­ments, and “is not a vac­cine.”  

It ap­pears, though, that this is a new de­vel­op­ment and not an at­tempt by ei­ther com­pa­ny to re­brand the more es­tab­lished pre­ven­ta­tive LBP tar­gets. To its long list of pipeline tar­gets, the com­pa­ny very re­cent­ly – the Way­back Ma­chine on­ly lets us check as re­cent­ly as Ju­ly 15, when it was not yet there – added “MRx Vac­cines.” It ap­pears with the short­est line, and links to the mes­sage: “We have en­tered a re­search col­lab­o­ra­tion and op­tion agree­ment with MSD, util­is­ing the Mi­croRx plat­form to dis­cov­er and de­vel­op LBPs as nov­el vac­cines.”

The “Plat­form” por­tion of 4D’s pipeline

Click on the im­age to see the full-sized ver­sion

LBPs are cur­rent­ly be­ing in­ves­ti­gat­ed as a pre­ven­ta­tive treat­ment for bac­te­r­i­al vagi­nosis, necro­tiz­ing en­te­ro­col­i­tis, and al­ler­gic rhini­tis. 4D is cur­rent­ly in­volved in four clin­i­cal tri­als, study­ing Blau­tix in IBS, MRx0518 in com­bi­na­tion with Mer­ck’s Keytru­da on sol­id tu­mors and MRx0518 in a neoad­ju­vant set­ting for sol­id tu­mors, and MRx-4DP0004 for asth­ma.

Daria Hazu­da, Mer­ck’s VP of in­fec­tious dis­eases and vac­cines dis­cov­ery re­search added, “we hope to gain mean­ing­ful in­sights in­to the role for the host mi­cro­bio­me in mod­u­lat­ing the im­mune re­sponse and ul­ti­mate­ly pro­tec­tion con­ferred by vac­cines.”

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

The fu­ture of mR­NA, J&J's vac­cine ad­comm, Mer­ck­'s $1.85B au­toim­mune bet and more

Welcome to the third installment of 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.

If this report was helpful in recapping it all for you, please do share it with your colleagues.

Get ready for FDA’s third Covid-19 vaccine

On the heels of a ringing endorsement from FDA reviewers earlier in the week, J&J‘s single-dose vaccine — which proved 66% effective at preventing symptomatic Covid-19, and 85% effective at stopping severe disease 28 days after administration — the advisory committee convened by the agency voted unanimously to recommend its emergency use authorization. It was “a relatively easy call,” according to one of the committee members — although that doesn’t mean they didn’t have questions. Jason Mast has the highlights from the discussion, including new information from the company, on this live blog.

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Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Roche and Genen­tech re­searchers plot $53M dis­cov­ery quest aimed at spark­ing a 'Holy moly' piv­ot in neu­ro R&D

Roche and Genentech have committed $53 million to back a 10-year quest aimed at going back to the drawing board to use new technology and fresh scientific insights to generate a pipeline of drugs for neurological diseases.

Researchers from both Roche and its big South San Francisco hub — mixing teams from gRED and pRED this time — will mix it up with the scientists drawn together for the Weill Neurohub — formed in 2019 as a joint research partnership involving UCSF, Berkeley and the University of Washington — in an exploration of the field to develop new therapies for some of the toughest diseases in drug R&D: Alzheimer’s, Parkinson’s, Huntington’s, ALS and autism.

With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

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Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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