Seven biotechs in Belgium making leaps in the clinic 

Belgium, the land of chocolate, beer, and waffles, has a thriving biotech and life science sector, with more than 300 biopharmaceutical companies operating in the country.  

The country is positioned as Europe’s second-largest biotech industry, according to a report by Belga News Agency. It is renowned for its expertise in pharmaceuticals, diagnostics, and medical technology. Cancer and immunotherapy company Galapagos, originally based in Mechelen in Belgium, now has sites across Europe and the U.S., and is a big part of the biotech scene, both in the country and the European continent.  

In this article, we look at seven biotech companies in Belgium that are climbing the ladder in the clinic. 

AgomAb Therapeutics  

• Founded: 2017
• Focus area: Fibrotic disease therapies
• Lead candidate: AGMB-129 (ALK5 inhibitor for Crohn’s disease)

Based in the port city of Ghent in Belgium, AgomAb develops antibody treatments for fibrosis using technology licensed from the Dutch biotech company ArgenX. Fibrosis is a condition that can damage several organs, including the lungs, liver, kidneys, and heart. AgomAb’s antibodies can bind to a specific receptor found on epithelial and endothelial cells and trigger a cascade of processes that stimulate the regeneration of fibrotic tissue.  

Most advanced in the pipeline is its Crohn’s disease candidate, AGMB-129. Crohn’s disease causes inflammation in the gut and intestines. AgomAb’s drug inhibits the protein ALK5, which is a regulator of fibrosis. Interim results of a phase 2 study showed promise in March. The candidate hit the primary endpoints as well as showed changes in mRNA gene expression based on biopsies taken from the small intestine.  

Its other clinical candidate AGMB-447 is being investigated for idiopathic pulmonary fibrosis, a condition in which the air sacs in the lungs become damaged, making it hard for oxygen to enter the blood. The drug, which targets the ALK5 protein, is in phase 1 trials. The therapeutic candidate was awarded orphan drug designation by the U.S. Food and Drug Administration (FDA) in June last year.  

In October 2024, it secured $89 million in a series D financing to boost R&D in fibrosis. This was following a $100 million investment in a series C funding round back in 2023. 

Augustine Therapeutics 

• Founded: 2019
• Focus area: Small molecules
• Lead candidate: AGT-100216 (HDAC6 inhibitor for Charcot-Marie-Tooth)

The protein HDAC6 plays a key role in maintaining the health of axons – the long slender, portion of neurons – to regulate pathways in the nervous system and transport organelles. When HDAC6 becomes dysfunctional, it disrupts the movement of the organelles, causing cellular stress. Belgian biotech Augustine Therapeutics wants to inhibit HDAC6 to treat certain diseases, so it has created a pipeline of small molecules focused on targeting HDAC6. 

The most advanced candidate in the lineup is AGT-100216, which just entered the clinic in May to treat patients with Charcot-Marie-Tooth disease, a group of genetic nerve disorders that are characterized by progressive muscle weakness and sensory loss. By stopping HDAC6, AGT-100216 aims to reverse or prevent the underlying cellular damage. As no current curative treatments exist for Charcot-Marie-Tooth, HDAC6 inhibitors like AGT-100216 offers hope, as it has been shown to reverse disease progression in preclinical models. 

Meanwhile, HDAC6 inhibitors have also preclinically been found to produce curative and preventive effect for chemotherapy-induced peripheral neuropathy – nerve damage caused by chemotherapy drugs – without impairing the anticancer activity of the chemotherapy. 

In March, Augustine Therapeutics raised €78 million ($85 million) in a series A financing round. This was following its €17 million ($19.9 million) series A1 financing round last year that was funded by pharma giant Lilly and the U.S.-based Charcot-Marie-Tooth Research Foundation. 

Confo Therapeutics  

• Founded: 2015
• Focus area: Endocrine and metabolic disease therapeutics
• Lead candidate: CFTX-1554 (angiotensin II receptor for peripheral pain)

Also located in Ghent in Belgium, is Confo Therapeutics, a biotech company that develops drugs that target G protein-coupled receptors (GPCRs), which are a large family of proteins that play a role in numerous diseases but are difficult to drug.   

GPCRs are often hard to screen in the lab because they are unstable in vitro. Confo has developed a technology that keeps GPCRs stable, enabling the mass screening and identification of GPCRs in different diseases. This way, researchers can identify formerly undruggable targets and develop medicines accordingly.   

With the help of this technology, it is developing its pipeline, which includes its phase 1c candidate CFTX-1554 for peripheral pain. This is a condition where the nerves outside the spinal cord and brain malfunction. CFTX-1554 inhibits angiotensin II type 2 receptor (AT2R), a target for the relief of peripheral pain. Unlike painkillers like opioids, which are currently given to patients, Confo’s drug is designed to avoid side effects like addiction and sedation. The drug is being evaluated in a phase 1 trial in a collaboration with pharma giant Lilly. 

According to the licensing deal with Lilly, Confo received $40 million upfront and is eligible to secure up to $590 million in milestone payments. Confo has also partnered with Japanese top pharma Daiichi Sankyo to discover medicines for diseases that affect the central nervous system (CNS). Last year in July, it nabbed €60 million ($70.14 million) in a series B funding round to further advance its GPCR pipeline. 

Galapagos 

• Founded: 1999
• Focus area: Cell therapies and small molecules
• Lead candidate: GLPG5101 (CAR-T therapy for B-cell malignancies)

Specializing in cell therapies and small molecules, Belgium-based Galapagos has been around since 1999, and has since set up shop in Leiden, Romainville, Basel, Milan, Madrid, Boston, and Zagreb. 

Its cell therapy platform consists of a xCellit workflow management and monitoring software system. In its pipeline, the lead candidate is GLPG5101, a CAR-T therapy that targets B cell blood cancers. The drug GLPG5101 is an anti-CD19/4-1BB cell therapy that is administered as a single fixed intravenous dose. It is currently in phase 2 studies. A year ago, it snagged investigational new drug (IND) clearance from the FDA for non-Hodgkin lymphoma, a type of cancer that originates in the lymphatic system. 

Data from the ongoing study found that all eight patients with mantle cell lymphoma responded to treatment. In 20 out of 21 patients with marginal zone lymphoma and follicular lymphoma, objective and complete responses were observed. And nine out of 13 people with diffuse large B-cell lymphoma (DLBCL) responded to treatment, and seven achieved a complete response. 

Meanwhile, at the top of its small molecule pipeline is its tyrosine kinase 2 inhibitor GLPG3667 for systemic lupus erythematosus, which is also in phase 2 trials. 

In May, it revealed that it was rethinking plans to split into two companies, which was initially going to separate cell therapies from other medicines. 

Galapagos teamed up with the Blood Centers of America, the largest blood supply network in the U.S., to provide decentralized manufacturing services for Galapagos’ CAR-T product candidates close to cancer treatment centers last year. 

Hyloris Pharmaceuticals 

• Founded: 2012
• Focus area: Cardiovascular diseases

Liege-based biotech Hyloris Pharmaceuticals is developing therapeutic candidates across several indications. One of the most clinically advanced in its heart disease pipeline is an intravenous form of aspirin to treat acute coronary syndrome, a condition where blood flow to the heart gets blocked, causing damage to the heart muscle.  

Hyloris bought the licensing rights to develop and commercialize intravenous aspirin from American company Rhoshan Pharmaceuticals back in 2021, and now it plans to potentially sell it in the U.S. if it bags approval.  

Recently, it announced positive clinical results for atomoxetine, which is a norepinephrine reuptake inhibitor for attention deficit hyperactivity disorder (ADHD). This patent-pending liquid formulation of atomoxetine is designed to offer an alternative to the oral form of the drug, Strattera, for those with ADHD who have difficulty swallowing solid oral dosage forms. The company is currently outlining the new drug application (NDA) to send to the FDA. 

This year has been a busy one for Hyloris. It partnered with Kuvatris Therapeutics to advance the intravenous formulation of the small molecule suramin for sleeping sickness, a parasitic disease. To propel development of the program, which is currently in phase 3 studies, the Belgian biotech company is forking out $2 million in milestone-based funding over the 12-18 months to Kuvatris. 

It also penned a licensing agreement with New Zealand-based AFT Pharmaceuticals so that the latter could get a hold of Hyloris’ tranexamic acid oral rinse, Xtraza, a medicine that controls bleeding. AFT is looking to commercialize Xtraza in Canada, Australia, New Zealand, Singapore, and Hong Kong, in exchange for Hyloris pocketing up to 50% of the profits reaped.  

MRM Health  

• Founded: 2020
• Focus area: Microbiome-based therapeutics
• Lead candidate: MH002 for ulcerative colitis

The gut microbiome not only plays a key role in digestion but also assists with many body functions. Belgium-based biotech company MRM Health aims to harness the gut microbiome to develop therapies for inflammatory, CNS, and metabolic diseases.  

Its clinical candidate MH002 is being studied in phase 1b/2a trials for ulcerative colitis and pouchitis. Ulcerative colitis occurs when the colon and rectum – present in the lower end of the digestive system – become inflamed, resulting in diarrhea, tummy aches, and fatigue. MH002 is a biotherapeutic that consists of six safe commensal strains – microbes that are present in the body that don’t harm human health – that showed positive results in its phase 2a trial two years ago.  

The drug had a 12% improvement in the Mayo Endoscopic Severity score – a measure of inflammation in ulcerative colitis – while the score worsened by 5% with placebo. Significant improvement in stool consistency was also observed after two weeks.  

Last year, results from the pouchitis trial came back positive as well. Pouchitis is inflammation that happens in the ileal pouch. This pouch is typically created by doctors in the ileum – the end region of the small intestine – often during large intestine-removal surgery. This pouch allows patients to control their bowel movements, however, when this area becomes inflamed, it can lead to diarrhea, tummy ache, and cramping. MH002 was found to have a 46% clinical remission rate – a decrease in disease symptoms – and reduced inflammation. The study met its safety endpoint.  

The biopharma is also engaged in the discovery of drugs for Parkinson’s disease, type 1 diabetes, and an autoimmune disease called spondyloarthritis that affects the spine and the joints. 

Precirix  

• Founded: 2014
• Focus area: Radiopharmaceuticals
• Lead candidate: CAM-H2 (HER2-directed radioligand for solid tumors)

Situated in the capital city of Brussels, Precirix is keen on advancing its radiopharmaceuticals portfolio as more and more biotechs across the world make strides in this space.  

Radiopharmaceuticals are drugs that contain radioisotopes that bind to biological molecules in order to target specific cells and tissues. Its phase 1 candidate CAM-H2 targets HER-2, a protein that promotes the growth of cancer cells in cancers like breast cancer.  

Research has shown the uptake of CAM-H2 in the brain lesions of patients whose breast cancer has spread to the brain. The phase 1/2 study will look at the drug’s impact on the spread of cancer. A dose escalation trial is also in the cards to ensure the safety of the drug.  

Besides, the CAM-H2 study has enrolled patients with stomach cancer and gastro-esophageal junction cancer, a type of cancer that begins at the region where the food pipe joins the stomach. 

Recently, it submitted an investigational new drug (IND) application to the FDA for its radiopharmaceutical candidate CAM-FAP-Ac-225, which targets fibroblast activation protein.  

Life science clusters and R&D in Belgium   

Belgium’s burgeoning healthcare sector is largely thanks to the various clusters that the country houses. The major life science clusters in the country are BioVille, the Brussels South Charleroi Biopark, and the Ghent Bio-Energy Valley.    

BioVille in the city of Hasselt, is a hotspot for the healthcare sector, with a focus on medical technology as well as digital technology. BioVille’s DigiHub is for the advancement of e-health, with research and development in artificial intelligence and wearables.   

The Brussels South Charleroi Biopark hosts 90 companies and three academic research centers, and employs more than 3200 people. The biopark has an incubation program that helps young biotech companies create development and business plans to eventually be able to secure investors. The cluster is mainly involved in cell and gene therapies, immunology, neurology, and cancer research. The Ghent Bio-Energy Valley is an initiative founded by Ghent University to boost biofuel and bio-enzyme production in a bid to create a bio-based economy.   

As life science clusters fuel R&D in the region, Belgium has also become a spot for young startups to set up shop. Some of these include immunotherapeutics company Amyl Therapeutics founded in 2020, cancer and autoimmune disease-focused ATB Therapeutics established in 2018, and antimicrobial resistance startup Santero Therapeutics founded in 2021.  

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