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Our Forward, Faster Strategy

Our goal is to bring transformational medicines to patients across the globe for more years of life and quality of life. Our focus is on conditions with high unmet medical need. 

To achieve this, we are working to synergize compelling science, technology, and approaches to develop a deep pipeline of potentially best-in-class small molecules, CAR-T therapies and biologics in oncology and immunology

We continue to take steps to transform into an innovative pure-play biotech company by sharpening our focus on our key priority areas. Following the transfer of our entire Jyseleca® (filgotinib) business, we are moving forward with greater focus and flexibility to invest in our key technology platforms and strategic therapeutic areas. 

We are committed to challenging the status quo and delivering results for patients, employees, and shareholders. 

Realizing turnaround to drive value

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We are committed to bringing transformational medicines to patients across the globe

Delivering best-in-disease medicines with transformational impact (graphic)

We have a clear path to value creation:

  • Pioneering for patients through our targeted R&D approach. At Galapagos, we are focusing on discovering and developing best-in-class medicines in oncology and immunology.
    • We are advancing our current clinical programs.
    • We are developing our unique decentralized CAR-T manufactured programs in hemato-oncology.
    • We are continuing to pursue strategic investments and partnerships to support and expand our pipeline. We are focused on validated targets and next-generation cell therapies and biologics in oncology and immunology.
  • Diversifying our pipeline and making clear portfolio decisions to achieve our vision. We believe we have a greater chance of success by working with multiple drug modalities and combinations across our core therapeutic areas. By 2028, we aim to have:
    • A first medicine available to patients.
    • A robust late-stage pipeline with several programs in pivotal trials.
    • A solid early-stage pipeline of small molecules, next-generation cell therapies and biologics in our core therapeutic areas.
  • Accelerating and building our pipeline through strategic partnerships and M&A. To achieve our ambitious goals, we evaluate and access external innovation. We are scouting for the best science, products, and people to complement our internal assets and capabilities, with the aim of building a balanced portfolio of best-in-class medicines across modalities and development stages in our core therapeutic areas. We are open to finding the best possible deal structure or collaboration model that benefits Galapagos and our stakeholders, with a key focus on expanding and accelerating our pipeline and bringing differentiated medicines to patients.  
  • Fostering a strong culture of innovation. Our success is made possible by our incredible teams. Our employees’ relentless drive for innovation, teamwork, and a quality mindset focused on efficiency is what drives our progress. We are committed to creating a purpose-driven, inclusive workplace where our people feel safe and empowered, have opportunities to learn and grow, are recognized for their contributions, and perform at their best as individuals and as a team.

Life-changing science and innovation

We combine deep disease expertise and multiple drug modalities to accelerate time-to-patients through our internal efforts and focused business development.

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CAR-T cell therapy

In 2022, we entered the field of CAR-T and antibody-therapy research and development through the acquisitions of CellPoint (in the Netherlands) and Abound Bio (in the U.S). The transactions provide us with end-to-end capabilities in CAR-T therapy development and offer the potential for a paradigm shift in the space through the implementation of a breakthrough, decentralized manufacturing model and cutting-edge fully human antibody-based capabilities to design next-generation CAR-Ts.

CAR-T cell therapy near the point-of-care

Galapagos is committed to manufacturing personalized cell therapies at or near the point-of-care (PoC). Our ambition is to reduce the manufacturing turnaround time significantly from months or weeks to days, ensuring that patients can receive their therapy in a timely manner.

Our aspiration in cell therapy

Our aspiration in cell therapy (graphic)

Although current CAR-T cancer therapies have made continued progress, long lead times, costly central manufacturing and complex logistics continue to be limiting factors for large-scale capacity and broad patient access globally.

Limitations of current CAR-Ts

Limitations of current CAR-Ts (graphic)
* Evidence-Based Oncology, October 2023, Volume 29, Issue 8

To address these challenges, we are implementing a differentiated, decentralized, point-of-care CAR-T manufacturing platform that has the potential to deliver fresh, fit cells with a seven day vein-to-vein time, enabling greater physician control and a significantly improved patient experience.

This innovative platform consists of an end-to-end xCellit® workflow management and monitoring software system, a decentralized, functionally closed, automated cell therapy manufacturing platform (using Lonza’s Cocoon®) and a proprietary quality control testing and release strategy. 

Increase access with manufacturing near the point-of-care

Increase patient access with point of care delivery (graphic)
*vein-to-vein time: time between leukapheresis and infusion delivery at the hospital

CAR-T therapy in 7 days vein-to-vein: video

Streamlining CAR-T Therapy (graphic)
*GMP production at a compliant manufacturing facility located at the clinic premises or in close proximity to the clinic. The Cocoon® Platform is a registered trademark of Lonza Group AG.

Next-generation CAR-Ts and biologics

Galapagos is developing very large, diverse human antibody libraries in standard fragments of antigen-binding fragment (Fab), single-chain variable fragments (scFv), and unique variable (VH) domain formats. These libraries enable our team to discover novel high affinity binders in multiple formats rapidly (days to weeks), to optimize them for development, and to convert them for multiple applications, including multi-specific CAR-Ts, and fusion proteins.

Our proprietary methodologies have the potential to increase binder diversity, affinity and specificity, and increase the probability of identifying a lead therapeutic antibody candidate.

These unique capabilities enable us to develop next-generation CAR-T therapies that have the potential to transform patient outcomes through potentially more effective and longer-lasting treatment options, even in the event of relapse after prior CAR-T therapy. Together with the decentralized CAR-T manufacturing model, at or near the point-of-care, we aim to expand patient access and ultimately transform patient outcomes.

Scientific capabilities

Scientific capabilities (graphic)
scFV, single-chain fragment variable; Fab, fragment antigen-binding; VH, heavy chain variable domain

Small molecule research and precision medicine

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.

Since our founding, we have built extensive expertise in small molecule research and development, and we are applying our small molecule approach to the discovery and development of potentially best-in-class precision medicines in our core therapeutic areas of oncology and immunology.

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. In addition, we have access to the innovative research and drug discovery capabilities and expertise of NovAliX (France) through a five-year collaboration. We are actively building a deep, early-stage small molecule pipeline addressing multiple targets across a range of indications in our two therapeutic areas. 

Our aspiration in small molecules

Our aspiration in small molecules (graphic)

Competitive environment

We operate in a highly innovative industry characterized by rapid 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 Galapagos’ focus areas of small molecules, CAR-T cell therapies and biologics.

For more information on industry trends and risks, we refer to the Risk Factors 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
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
Filgotinib
Formerly known as GLPG0634, commercial name is Jyseleca®. Small molecule preferential JAK1 inhibitor, approved in RA and UC in the European Union, Great-Britain and Japan. Phase 4 studies in both RA and UC are ongoing
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
Jyseleca®
Jyseleca® is the brand name for filgotinib
Oncology
Field of medicine that deal with the diagnosis, treatment, prevention, and early detection of cancer
Point-of-care
Drug treatment is provided close to or near the patient
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