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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

CAR-T treatments have life-saving potential (graphic)
* Ref: Kourelis T, Bansal R, Patel KK, et al: Ethical challenges with CAR-T slot allocation with idecabtagene vicleucel manufacturing access. J Clin Oncol 40, 2022 (16_suppl; abstr e20021); Hoffman MS, Hunter BD, Cobb PW, Varela JC, Munoz J. Overcoming barriers to referral for chimeric antigen receptor T- cell therapy in patients with relapsed/refractory diffuse large B-cell lymphoma. Transplant Cell Ther. 2023;29(7):440-448. Mikhael J, Fowler J, and Shah N Chimeric Antigen Receptor T-Cell Therapies: Barriers and Solutions to Access. JCO Oncology Practice Vol 18, No 1

At Galapagos, our scientists are dedicated to addressing the urgent needs of cancer patients who cannot wait for treatment.

Our WHY, our HOW (graphic)

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

Pioneering the Future of Cell Therapy (graphic)

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

Flexible Decentralized Manufacturing Model (graphic)
  • 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

Galapagos’ Decentralized Manufacturing Model (graphic)

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.

Antibody
A blood protein produced in response to and counteracting a specific antigen. Antibodies combine chemically with substances which the body recognizes as alien, such as bacteria, viruses, and foreign substances
Biologics
Biologics, also referred to as Biologicals, are those class of medicines which are grown and then purified from large-scale cell cultures of bacteria or yeast, or plant or animal cells. Biologicals are a diverse group of medicines which includes vaccines, growth factors, immune modulators, monoclonal antibodies, as well as products derived from human blood and plasma. What distinguishes biologics from other medicines is that these are generally proteins purified from living culture systems or from blood, whereas other medicines are considered as 'small molecules' and are either made synthetically or purified from plants
CAR-T
Chimeric antigen receptor T cells (also known as CAR-T cells) are T cells that have been genetically engineered to produce an artificial T cell receptor for use in immunotherapy
CD19
CD19 is a protein found on the surface of B-cells, a type of white blood cell. Since CD19 is a hallmark of B-cells, the protein has been used to diagnose cancers that arise from this type of cell, notably B-cell lymphomas
Cell therapy
Cell therapy aims to treat diseases by restoring or altering certain sets of cells or by using cells to carry a therapy through the body. With cell therapy, cells are cultivated or modified outside the body before being injected into the patient. The cells may originate from the patient (autologous cells) or a donor (allogeneic cells)
Discovery
Process by which new medicines are discovered and/or designed. At Galapagos, this is the department that oversees target and drug discovery research through to nomination of preclinical candidates
End-to-end
A process that takes a system or service from beginning to end and delivers a complete functional solution, usually without strong reliance on third parties
GLPG5101
A second generation anti-CD19/4-1BB CAR-T product candidate currently in Phase 1/2 study in multiple aggressive B-cell malignancies
GLPG5201
A second generation anti-CD19/4-1BB CAR-T product candidate in Phase 1/2 study in R/R CLL/SLL and RT
Immunology
The study of the immune system and is a very important branch of the medical and biological sciences. The immune system protects humans from infection through various lines of defence. If the immune system is not functioning as it should, it can result in disease, such as autoimmunity, allergy, and cancer
Intellectual property
Creations of the mind that have commercial value and are protected or protectable, including by patents, trademarks or copyrights
Leukapheresis
Laboratory procedure in which white blood cells are separated from a sample of blood
Oncology
Field of medicine that deal with the diagnosis, treatment, prevention, and early detection of cancer
Pivotal studies
Registrational clinical studies
Preclinical
Stage of drug research development, undertaken prior to the administration of the drug to humans. Consists of in vitro and in vivo screening, pharmacokinetics, toxicology, and chemical upscaling
Product candidate
Substance that has satisfied the requirements of early preclinical testing and has been selected for development, starting with formal preclinical safety evaluation followed by clinical testing for the treatment of a certain disorder in humans

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.