Dilanubicel

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. 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 — 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.