Katie Fanning, Mozart Therapeutics CEO

Mozart Ther­a­peu­tics makes its of­fi­cial de­but, jump­ing in­to the hot Treg R&D field with some big-name in­vestors back­ing it

Treg cells have been get­ting more and more at­ten­tion re­cent­ly among au­toim­mune spe­cial­ists. There’s been Jeff Blue­stone’s Sono­ma, the $157 mil­lion launch of Gen­tiBio this sum­mer and Egle Ther­a­peu­tics — which launched just last week — to name a few.

Now, there’s a new Treg play­er jump­ing in that wants to dis­tin­guish it­self in the mar­ket: Mozart Ther­a­peu­tics. To­day, the biotech is emerg­ing from stealth in its of­fi­cial de­but with a $55 mil­lion Se­ries A — with a bunch of A-list Big Phar­ma names on board a syn­di­cate co-led by ARCH and Sofinno­va Part­ners.

Play­ing the com­pa­ny’s name off as a metaphor to how the biotech wants to “or­ches­trate” reg­u­la­to­ry T cell net­works — as CEO Katie Fan­ning put it — Mozart is look­ing to branch it­self out in the world of Treg cells by look­ing at CD8+ Tregs, she told End­points News in an in­ter­view.

In her words, most of the ex­ist­ing biotechs look­ing at Treg cells for au­toim­mune dis­eases are look­ing at the CD4 type of cells.

“We’re cap­i­tal­iz­ing on the work that came out of Mark Davis’ lab at Stan­ford, where he iden­ti­fied this nov­el path­way or crosstalk be­tween CD8 reg­u­la­to­ry T cells and CD4 cells,” Fan­ning said. “And he found that when those CD8 Treg cells are mo­bi­lized, that they had a cy­tolyt­ic and spe­cif­ic killing to path­o­gen­ic CD4 cells.”

Davis’ work on CD4+ and CD8+ T cells was pub­lished in Na­ture in 2019.

That tech­nol­o­gy was then li­censed to Mozart, which qui­et­ly start­ed in Ju­ly 2020 — and stayed in stealth un­til now.

What are they fo­cus­ing on? As a com­pa­ny, they say au­toim­mune and in­flam­ma­to­ry dis­eases — and their first pro­gram will fo­cus on Celi­ac dis­ease. And while that pro­gram is still in lead op­ti­miza­tion, Fan­ning told us that based on their own time­line, it will most like­ly be ear­ly 2024 un­til we see the can­di­date in the clin­ic.

The back­ers Mozart has are well-known — and well-fund­ed. Those names in­clude Bay­er through its ven­ture di­vi­sion Leaps, Eli Lil­ly, ARCH Cap­i­tal Ven­tures and Mer­ck’s ear­ly-stage fund MRL Ven­tures Fund.

One of these key in­vestors has worked be­fore with Fan­ning, a biotech vet­er­an who had been a part of Ven­tiRx. That in­vestor had made the same kind of deal for the now-de­funct Nohla: gath­er uni­ver­si­ty re­search, make it in­to a com­pa­ny, or­ga­nize a syn­di­cate of in­vestors to back it, and then re­peat. That would be the hand­i­work of Steven Gillis, man­ag­ing di­rec­tor of Arch Ven­ture Part­ners, who is now chair­man of the board at Mozart.

Be­fore Mozart, Arch helped raise $43.5 mil­lion in a Se­ries A for Nohla in 2016. The biotech then qui­et­ly sold its as­sets in 2019 af­ter its lead can­di­date, di­lanu­bi­cel, failed to meet pri­ma­ry end­points in clin­i­cal tri­als.

Lu­cio Ian­none

Lu­cio Ian­none — a new mem­ber of Mozart’s board of di­rec­tors and a vice pres­i­dent of Leaps — has worked with Fan­ning be­fore; both are board mem­bers for MIT-based biotech eGe­n­e­sis.

From Ian­none’s per­spec­tive, Mozart’s po­ten­tial tech­nol­o­gy goes hand-in-hand with one of Leaps’ main in­vest­ment goals — to “re­verse au­toim­mune dis­eases and chron­ic in­flam­ma­tion.”

“The idea is that Leaps is al­ways in­vest­ed in trans­for­ma­tive tech­nolo­gies and what­ev­er helps to switch … from treat­ment to cure is some­thing we look at,” Ian­none said. “And Mozart came up as a new way to reg­u­late CD8 reg­u­la­to­ry T cell net­works.”

The biotech will use the new funds to progress its lead CD8 Treg mod­u­la­tor — the Celi­ac pro­gram — in­to the clin­ic while al­so ad­vanc­ing ad­di­tion­al pro­grams gen­er­at­ed from its plat­form.

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Brian Thomas, Metagenomi CEO

Gen 2: Berke­ley spin­out lands $175M megaround to keep it on the cut­ting edge of the boom­ing gene-edit­ing field

The big bucks keep pumping into the gene-editing field.

This morning Metagenomi, allied with one of the biggest names in the mRNA field with a company DNA that includes the ubiquitous Jennifer Doudna, is showing off a $175 million B round that will pay for a rapid swelling of its staff in pursuit of some of the cutting-edge tech that keeps this field in the spotlight. And they’re aligning themselves with some major industry players with an eye on the clinic while getting behind some startups to help expand the work into new fields.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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