Merida Biosciences Launches with Novel Precision Immunology Approach

April 16, 2025

Dario Gutierrez, PhD, was shocked by the lack of medical treatment for a family member suffering from immune thrombocytopenic purpura (ITP), an autoimmune disease in which autoantibodies bind to a platelet receptor and target them for destruction.

“I saw how she went to treatment, and it was high-dose steroids for a while—pretty much, many people don’t respond to it, and then they remove the spleen, which is where they think a lot of the degradation of the platelets is happening,” Gutierrez told Inside Precision Medicine. “As I saw the treatment, I thought that this has got to be a joke—is this really the standard care?”

Building off the atomic-level understanding of how autoantibodies bind to target receptors (revealed by cryoEM and other structural tools) to drive the pathogenesis of autoimmune diseases, Gutierrez began to explore the idea of a precision immunology company to develop a new generation of immunotherapies as an Entrepreneur-in-Residence at Third Rock Ventures. The result was Merida Biosciences, where Gutierrez and a team had been working in stealth since 2022 on biotherapeutics using the fragment crystallizable (Fc) region of antibodies located at the base of the Y-shaped structure to neutralize pathogenic autoantibodies

Merida Biosciences has now decloaked and has revealed a lead program based on pioneering a novel approach to treating Graves’ disease, a rare disease that affects about 3% of women and 0.5% of men. Their approach began with an in-depth exploration of how diverse autoantibodies interact with the thyroid-stimulating hormone receptor (TSHR) at the atomic level. Leveraging advanced techniques like structural characterization, polyclonal mapping, and computational protein design, the team is developing a biotherapeutic capable of selectively neutralizing these harmful autoantibodies. Crucially, their approach seeks to leave normal thyroid hormone signaling and protective immunoglobulin levels untouched, offering a highly targeted solution to this autoimmune disorder.

In preparation for the launch, the company recently brought on CEO Adam Townsend and CMO Matthew Leoni, MD, to join Gutierrez and COO Dodzie Sogah, PhD. “This is week six for me, and we became a public company a couple of days ago,” Townsaid told Inside Precision Medicine. “Chasing after the root cause of some of these debilitating autoimmune disorders is precisely the type of thing I think we all want to do. We’re going to go and chase big diseases with a small, lean team, and the word that seems to resonate now is a scrappy team. It’s Dario’s brainchild that we are all responsible for driving forward.”

In 2020, Georg Schett, MD, treated a patient with severe lupus with CAR-T cells, which sent shockwaves through the autoimmune disease community as a bedridden, treatment-resistant patient made a hasty full recovery in a matter of weeks. Since then, pharma giants and startups have been racing to be the first to get FDA approvals for CAR-T cell therapies in several major autoimmune diseases.

While CAR-T cell therapy results in autoimmune diseases (and oncology) have been remarkable—indeed, I remember being shocked a year and a half ago seeing a presentation from Kyverna Therapeutics with a video of a myasthenia gravis patient going from incapacitated in a hospital bed to riding a bicycle in a few months—there are some significant drawbacks. The complicated manufacturing logistics, slow turnaround time, and high costs are substantial concerns. As Gutierrez put it, “You always want to find the simplest solution to any problem—you don’t need to build a rocket ship to go from Boston to New York.” Sogah added, “It’s hard for me to see how CAR-T cell therapy would have a path toward having a reasonable product profile indication like Graves’ disease versus a subcutaneous therapeutic that could be used once every couple of years.”

While manufacturing, logistics, and costs can be cut with time, the significant risk imbued by using CAR-T therapy that targets B cells remains: taking down the entire B-cell population and not just a specific subset. “With CAR-T cell therapy for autoimmune diseases, you’re basically burning an entire field just to kill a couple of weeds,” Leoni told Inside Precision Medicine. “You’re wiping out the entire B cell population when all you want to get at is the autoantibodies that are there and the cells producing them.”

Wiping out B-cell populations leaves a patient utterly vulnerable to infection. To this end, the first adult patient treated with CAR-T cell therapy was William Ludwig. He was treated at the University of Pennsylvania’s Abramson Cancer Center and remained cancer-free for 11 years before dying from COVID-19 complications in early 2021. “If you get infected with COVID-19 tomorrow or if you’re going to get vaccinated for tetanus again, you’d wish you had those cells because they are protective,” said Gutierrez. “Most of your B cells are there for a reason—they’re very protective.”

In this regard, CAR-T cell therapy is in some ways not very different mechanistically from the preceding generation of treatments like rituximab or another anti-CD20. “You’re still wiping stuff out,” said Leoni. “For autoimmune diseases, such as ITP, broad-spectrum steroids are used to wipe out all the B cell components, and steroids can have an effect on every cell in your body, which is why they can cause so much damage.”

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