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.

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Róbert Wessman, Alvotech chairman and founder

Ice­landic bil­lionare's biosim­i­lar com­pa­ny rais­es $450M, preps for Nas­daq launch with SPAC merg­er

As Icelandic billionaire Róbert Wessman tries to take down AbbVie’s megablockbuster Humira in court, he’s also taking his biosimilar upstart to the big time with a $2.25 billion SPAC merger, Nasdaq launch and $450 million raise announced early Tuesday.

While Wessman’s Alvotech has not won FDA approval for any of its biosimilar candidates yet, the company was the first to file with the FDA for approval of its high-concentration Humira biosimilar and to have successfully conducted a switching study in support of a highly-coveted interchangeability designation. But other companies like Amgen, Boehringer Ingelheim and Pfizer have since caught up ahead of the launches of their own Humira biosimilar competitors in 2023.

Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Gary Glick, Odyssey Therapeutics founder

Al­ways busy, Gary Glick re­cruits Or­biMed in a mas­sive $218M Se­ries A for enig­mat­ic da­ta sci­ence biotech

Gary Glick is back at it again, founding yet another biotech company. And by the sheer size of its first raise, this may be the biggest one yet.

Glick has assembled what he calls an all-star roster and recruited one of the biggest healthcare investors in OrbiMed to put together a massive $218 million Series A for his newest venture, Odyssey Therapeutics. The launch, announced Tuesday morning and co-led by SR One Capital Management, comes not three months after Glick sold First Wave Bio to AzurRx for $229 million.

Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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Mer­ck pumps the brakes on two more PhI­II tri­als for its lead an­ti-HIV drug

After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since.

On Monday, the biopharma company announced it’s pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir.

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