GC Therapeutics Appoints Stem Cell Therapy Leader Stefan Irion, MD, as Chief Scientific Officer

GC Therapeutics (GCTx), a pioneering biotechnology company advancing the next generation of cell-based medicines through its TFome™ (Transcription-Factor-ome) induced pluripotent stem cell (iPSC) programming platform that enables expansion into in vivo rejuvenation and reprogramming, today announced the appointment of Stefan Irion, MD, as chief scientific officer. Dr. Irion brings more than two decades of experience translating stem cell science into clinical stage therapeutics. In his role at GCTx, Dr. Irion will lead and direct the company’s research strategy as it advances its differentiated cell therapy pipeline toward the clinic. His appointment follows the recent addition of Ms. Kate Haviland as Board Chair, further strengthening GCTx’s leadership team and positioning the company for its next phase of growth. Concurrently, co-founder Alex Ng, PhD, will assume the role of chief innovation officer, where he will support the continued evolution and innovation of the company’s TFome™ platform, which powers the company’s Cell State Cookbook™ and virtual cell models.

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Dr. Irion joins GCTx from BlueRock Therapeutics (a wholly-owned, independently operated subsidiary of Bayer AG ), where he served as chief scientific officer and a member of the Executive Committee. At BlueRock, he built and led a research organization of approximately 60 scientists developing cell & gene therapies across multiple therapeutic areas. Earlier, at Memorial Sloan Kettering Cancer Center, Dr. Irion played a central role in developing MSK-DA01 (bemdaneprocel), a first human pluripotent stem cell-derived dopaminergic neuron therapy for Parkinson’s Disease. He served as lead author on the IND package and was instrumental in the program’s out-licensing to BlueRock, where he subsequently guided the program through IND clearance. MSK-DA01 has since completed a Phase 1 clinical trial, received both RMAT and Fast Track designations from the FDA, and has started enrollment for its registrational Phase III study. Prior to BlueRock, Dr. Irion led discovery efforts at iPierian that produced the anti-tau antibody IPN0007, contributing to Bristol-Myers Squibb’s $725 million acquisition of the company in 2014.

“We are thrilled to welcome Stefan to our leadership team,” said Parastoo Khoshakhlagh, PhD, CEO and Co-founder of GCTx. “Stefan brings deep expertise in developing novel therapeutics, along with exceptional leadership and an innovative perspective. His strong commitment to patients makes him uniquely suited to help drive GCTx’s next phase of growth. We are confident he will have a meaningful impact on our mission to make cell therapy accessible to patients around the world and to unlock the TFome™ platform capabilities into rejuvenation and in vivo reprogramming.”

Dr. Irion is a named inventor on multiple patents in stem cell engineering and cell therapy, and his research has been published in leading journals including Nature, Nature Biotechnology, Cell Stem Cell, and Nature Communications. He received his medical degree summa cum laude from the University of Tübingen, Germany, and completed postdoctoral training at the Mount Sinai School of Medicine in New York, and the University Health Network in Toronto.

“Having spent my career working to bring cell therapies from bench to bedside, I’ve seen how much is still possible; and how many patients are still waiting,” said Dr. Irion. “TFome™ opens a new chapter in how we control cell fate and design therapies, giving us a level of precision, scale and flexibility that simply wasn’t available before. The Cell State Cookbook™ and virtual cell models not only accelerate what we already know how to do; they expand what’s imaginable, from next-generation cell therapies to in vivo reprogramming and rejuvenation approaches that could address diseases we’ve barely been able to touch. I’m thrilled to join a team that is turning that potential into treatments, and to help make sure more patients benefit sooner.”

Dr. Irion’s appointment underscores GCTx’s commitment to advancing innovative cell therapies and making them more accessible to patients in need.

About TFome™, the world’s first “plug-and-play” cellular programming platform

Induced pluripotent stem cell (iPSC) differentiation into distinct cell types depends on various signaling pathways that ultimately converge onto transcription factors (TFs), which control the sets of genes that are active in a cell. Cell fate is determined by specific TFs acting in concert.

GCTx has built the world’s first complete collection of human TFs. Through sophisticated multidimensional screening modalities that integrate genome-scale experimental testing and powerful next-generation predictive AI foundation models informed by GCTx’s proprietary data, TFome™ has been proven to identify fully optimized TF combinations to differentiate iPSCs into virtually any functional cell type. This allows for a single-step, four-day stem cell differentiation process with >90% efficiency with no requirement for cell type-specific optimization for microenvironmental factors. This has not been achieved previously via conventional small-scale testing. TFome™ also enabled the construction of the Cell State Cookbook™ (CSC™) to build the epigenomic transition matrix which is positioned to precisely engineer any cell state for in vivo reprogramming.

Through TF-based cell fate programming, TFome is designed to yield first-in-class and best-in-class off-the-shelf cell therapy products up to 100 times more rapidly than conventional methods of cell differentiation with improved potency, efficiency, quality and cost (SuperCells™). GCTx is positioned to be the first company in the iPSC-based cell therapy space to pursue multiple cell products from one starting point using a similar manufacturing strategy for more accelerated development and timelines. GCTx has built the largest empirical map of TF-driven cell state transitions, the CSC™, based on data from over two million tested TF combinations. The CSC™ powers compounding predictive AI foundation models that capture key features of cell state control and enable rapid identification of optimized TF programs, significantly streamlines discovery for cell therapy development and in vivo reprogramming.

TFome™ was invented and developed by a world-class team of scientists in the lab of professor George Church, Ph.D., at Harvard Medical School and the Wyss Institute.

About GC Therapeutics

GC Therapeutics (GCTx) is a biopharmaceutical company created to scale and unlock the next generation of cell therapy-based medicines. GCTx’s induced pluripotent stem cell (iPSC) programming platform, TFome™, integrates the latest advancements in synthetic biology, gene editing, cell engineering and machine learning to overcome the therapeutic development and scaling complexities associated with cell therapy and improve patient access across a broad range of disease areas. GCTx’s initial focus is on developing first-in-class and best-in-class cell therapies for neurological and metabolic diseases with potential for expansion into other therapeutic modalities. Founded in 2019, GCTx is based in Cambridge, MA and has raised $75 million to date from leading life sciences investors. For more information, please visit us at www.gc-tx.com and follow us on LinkedIn and X.

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