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.”

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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Roger Perlmutter, Merck

#ASH19: Here’s why Mer­ck is pay­ing $2.7B to­day to grab Ar­Qule and its next-gen BTK drug, lin­ing up Eli Lil­ly ri­val­ry

Just a few months after making a splash at the European Hematology Association scientific confab with an early snapshot of positive data for their BTK inhibitor ARQ 531, ArQule has won a $2.7 billion buyout deal from Merck.

Merck is scooping up a next-gen BTK drug — which is making a splash at ASH today — from ArQule in an M&A pact set at $20 a share $ARQL. That’s more than twice Friday’s $9.66 close. And Merck R&D chief Roger Perlmutter heralded a deal that nets “multiple clinical-stage oral kinase inhibitors.”

This is the second biotech buyout pact today, marking a brisk tempo of M&A deals in the lead-up to the big JP Morgan gathering in mid-January. It’s no surprise the acquisitions are both for cancer drugs, where Sanofi will try to make its mark while Merck beefs up a stellar oncology franchise. And bolt-ons are all the rage at the major pharma players, which you could also see in Novartis’ recent $9.7 billion MedCo buyout.

ArQule — which comes out on top after their original lead drug foundered in Phase III — highlighted early data on ‘531 at EHA from a group of 6 chronic lymphocytic leukemia patients who got the 65 mg dose. Four of them experienced a partial response — a big advance for a company that failed with earlier attempts.

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Left top to right: Mark Timney, Alex Denner, Vas Narasimhan. (The Medicines Company, Getty, AP/Endpoints News)

In a play-by-play of the $9.7B Med­Co buy­out, No­var­tis ad­mits it over­paid while of­fer­ing a huge wind­fall to ex­ecs

A month into his tenure at The Medicines Company, new CEO Mark Timney reached out to then-Novartis pharma chief Paul Hudson: Any interest in a partnership?

No, Hudson told him. Not now, at least.

Ten months later, Hudson had left to run Sanofi and Novartis CEO Vas Narasimhan was paying $9.7 billion for the one-drug biotech – the largest in the string of acquisitions Narasimhan has signed since his 2017 appointment.

The deal was the product of an activist investor and his controversial partner working through nearly a year of cat-and-mouse negotiations to secure a deal with Big Pharma’s most expansionist executive. It represented a huge bet in a cardiovascular field that already saw two major busts in recent years and brought massive returns for two of the industry’s most eye-raising names.

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Paul Hudson. Sanofi

New Sanofi CEO Hud­son adds next-gen can­cer drug tech to the R&D quest, buy­ing Syn­thorx for $2.5B

When Paul Hudson lays out his R&D vision for Sanofi tomorrow, he will have a new slate of interleukin therapies and a synthetic biology platform to boast about.

The French pharma giant announced early Monday that it is snagging San Diego biotech Synthorx in a $2.5 billion deal. That marks an affordable bolt-on for Sanofi but a considerable return for Synthorx backers, including Avalon, RA Capital and OrbiMed: At $68 per share, the price represents a 172% premium to Friday’s closing.

Synthorx’s take on alternative IL-2 drugs for both cancer and autoimmune disorders — enabled by a synthetic DNA base pair pioneered by Scripps professor Floyd Romesberg — “fits perfectly” with the kind of innovation that he wants at Sanofi, Hudson said.

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Jake Van Naarden, Josh Bilenker, Nisha Nanda (Credit: Loxo, Aisling Capital)

Josh Bilenker and his Loxo crew are tak­ing the reins on on­col­o­gy R&D at Eli Lil­ly, culling the weak and map­ping a new path

Josh Bilenker, Jake Van Naarden and Nisha Nanda came out of Eli Lilly’s $8 billion Loxo Oncology buyout with a bundle of cash and plenty of choices on what they could do next. Start a new company, go public. Live on the beach in 5-star luxury. Contemplate the stars — in their own observatory.

So what are they doing?

They formed a new executive team that is taking over the management of Eli Lilly’s hundreds-strong oncology R&D group — essentially using Loxo as a base for a bold new experiment in Big Pharma R&D in an attempt to create a true biotech environment with the deep pockets of a top-15 industry player. They’ve recruited David Hyman from Memorial Sloan Kettering to join the team as chief medical officer. And the mandate includes culling out the oncology pipeline, highlighting their star prospects and going after new programs wherever they can find the best prospects.

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Game on: Re­gen­eron's BC­MA bis­pe­cif­ic makes clin­i­cal da­ta de­but, kick­ing off mul­ti­ple myelo­ma matchup with Bris­tol-My­ers

As J&J attempts to jostle past Bristol-Myers Squibb and bluebird for a landmark approval of its anti-BCMA CAR-T — and while GlaxoSmithKline maps a quick path to the FDA riding on its own BCMA-targeting antibody-drug conjugates — the bispecifics are arriving on the scene to stake a claim for a market that could cross $10 billion per year.

The main rivalry in multiple myeloma is shaping up to be one between Regeneron and Bristol-Myers, which picked up a bispecific antibody to BCMA through its recently closed $74 billion takeover of Celgene. Both presented promising first-in-human data at the ASH 2019 meeting.

FDA lifts hold on Abeon­a's but­ter­fly dis­ease ther­a­py, paving way for piv­otal study

It’s been a difficult few years for gene and cell therapy startup Abeona Therapeutics. Its newly crowned chief Carsten Thiel was forced out last year following accusations of unspecified “personal misconduct,” and this September, the FDA imposed a clinical hold on its therapy for a form of “butterfly” disease. But things are beginning to perk up. On Monday, the company said the regulator had lifted its hold and the experimental therapy is now set to be evaluated in a late-stage study.

Roche. File photo

Roche faces an­oth­er de­lay in strug­gle to nav­i­gate Spark deal past reg­u­la­tors — but this one is very short

Roche today issued the latest in a long string of delays of its $4.3 billion buyout of Philadelphia-based Spark Therapeutics. The delay comes as little surprise — it is their 10th in as many months — as their most recent delay was scheduled to expire before a key regulatory deadline.

But it is notable for its length: 6 days.

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