Cell Therapies and Small Molecules
Revolutionizing cell therapy manufacturing for faster and broader patient access
CAR-T treatments have life-saving potential but despite continued progress, only 25%-30%* of eligible patients currently receive it. Long lead times, costly central manufacturing and complex logistics continue to be limiting factors for large-scale capacity and broad patient access.
CAR-T treatments have life-saving potential
But only 25%-30%* of eligible patients currently receive it
At Galapagos, our scientists are dedicated to addressing the urgent needs of cancer patients who cannot wait for treatment.
To accelerate and expand access to cell therapies, we are pioneering a decentralized manufacturing approach that brings production closer to patients. Our innovative cell therapy manufacturing platform has the potential to dramatically reduce vein-to-vein time, the time between leukapheresis to infusion, from months or weeks to just seven days, thereby enabling the rapid delivery of potential life-saving treatments.
Beyond speed, a fundamental goal of cell therapy manufacturing is to deliver fit T-cells with strong self-renewal capacity and long-term functionality.1 In practice, T-cells often lose self-renewal capacity during culture and transduction, where they differentiate and become exhausted.2
To meet these objectives, we are implementing a globally scalable, innovative, and decentralized cell therapy manufacturing platform. This platform is designed to deliver fresh, fit, stem-like early memory T-cells with a median vein-to-vein time of seven days, while also enhancing physician oversight and improving the patient experience.
Pioneering the Future of Cell Therapy
Encouragingly, our platform has shown higher proportions of early T-cell phenotypes—including naïve/stem cell memory (TN/SCM) and central memory (TCM) cells—in the final therapeutic product for our first-generation CD19 CAR-T product candidates, GLPG5101 and GLPG5201 (see Portfolio section), compared to the starting material available after initial leukapheresis. These findings reinforce the potential of our approach to redefine cell therapy manufacturing and improve patient outcomes.
Flexible Decentralized Manufacturing Model:
Agile, reliable, scalable and consistent decentralized production near the clinic
- Consistency by design
- GMP production at a compliant facility
- Centrally supplied equipment / material kits
- Globally scalable
- 24/7 technical support
Galapagos’ innovative and differentiating decentralized cell therapy platform consists of an end-to-end xCellit® workflow management and monitoring software system, a decentralized, functionally closed, automated manufacturing platform for cell therapies (using Lonza’s Cocoon®) and a proprietary quality control testing and release strategy.
Galapagos’ Decentralized Manufacturing Model
We are preparing to initiate pivotal development of our lead CD19 CAR-T candidate, GLPG5101, in 2026, with the goal of obtaining the first approval in 2028, using our decentralized manufacturing approach. At the same time, we are committed to leveraging our platform as broadly as possible with new modes-of-action and indications to further enhance patient care. This includes advancing next-generation cell therapy programs, such as armored, multi-targeting constructs in both hematological and solid tumors, to maximize impact.
To achieve these goals, and supported by our strong collaborations with Lonza (for the Cocoon® platform) and Thermo Fisher Scientific (for the development of an ultra-rapid PCR sterility test together with miDiagnostics), we are scaling up manufacturing capacity at our existing DMUs in the U.S., including Landmark Bio (Boston area), Excellos (San Diego area), and Catalent (New Jersey, New York, and surrounding areas), as well as at multiple DMUs in key European markets. Additional DMUs will be integrated into Galapagos’ network to ensure sufficient capacity to support future pivotal studies in key regions.
Innovation engine to develop next-generation cell therapies
With the 2022 acquisition of U.S.-based AboundBio, we have significantly expanded our capabilities in next-generation cell therapy discovery and development. Our innovation engine is built on the ability to generate vast and diverse human antibody libraries in multiple formats, including antigen-binding fragments (Fab), single-chain variable fragments (scFv), and unique variable heavy (VH) domains. These libraries enable the rapid discovery of high-affinity binders, within days to weeks, that can be optimized for development and adapted for various applications, such as multi-targeting CARs.
Our next-generation cell therapy pipeline provides a strong foundation for sustainable value-creation. It comprises multi-targeting, armored cell therapy constructs designed to improve potency, prevent resistance, and improve persistence of CAR-Ts in hematological and solid tumors.
We are preparing to initiate clinical development of our first armored, bi-specific CAR-T candidate in 2025, and our goal is to expand our clinical pipeline with at least one new program per year starting in 2026.
By leveraging proprietary methodologies, we enhance binder diversity, affinity, and specificity, increasing the potential for next-generation, multi-targeting, armored cell therapies. These innovations aim to address key limitations of existing treatments by improving potency, preventing resistance, and enhancing therapy persistence, even in cases of relapse.
By combining our existing clinical pipeline with our next-generation portfolio and innovative manufacturing approach, Galapagos is committed to reshaping the future of oncology care and making a meaningful impact on patients' lives.
Small Molecule Platform
In small molecule drug discovery, an assay designed to assess target activity is exposed to large collections of small chemical molecules, allowing the identification of chemical structures that interact with the target to block or activate its activity, resulting in the target’s modulation in the cells and prevention of disease-causing effects.
We have built extensive expertise in small molecule research and development. Our in-house capabilities include chemical library development, high throughput screening, pharmacology, and preclinical development with the goal of accelerating the time from target identification to first-in-human clinical development.
On January 8, 2025, we announced a plan to separate into two publicly traded entities. As part of the planned strategic reorganization, we are seeking partners to take over our small molecule portfolio.
Competitive environment
We operate in a highly innovative industry characterized by pioneering advances in the understanding of disease biology, rapidly changing technologies, strong intellectual property barriers to entry, and many companies involved in the discovery, development and commercialization of novel medicines. We compete with a broad range of biopharmaceutical companies that focus their research and development activities on oncology and immunology, including drug modalities that compete with our focus areas of small molecules, CAR-T cell therapies and biologics.
For more information on industry trends and risks, we refer to the Risk Management section of this report.
1 1Arcangeli S, Bove C, Mezzanotte C, Camisa B, Falcone L, Manfredi F, et al. CAR T cell manufacturing from naive/stem memory T lymphocytes enhances antitumor responses while curtailing cytokine release syndrome. J Clin Invest. 2022;132(12):e150807. doi: 10.1172/JCI150807.
2 2Watanabe N, Mo F, McKenna MK. Impact of manufacturing procedures on CAR T cell functionality. Front Immunol. 2022;13:876339. doi: 10.3389/fimmu.2022.876339.