LISCO to partner with Swedish Beactica Therapeutics to support first-in-human readiness in glioblastoma

The KU Leuven Institute for Single Cell Omics (LISCO)

The KU Leuven Institute for Single Cell Omics (LISCO) will support the preparation of an Investigational New Drug (IND) package and first-in-human (FIH) trial strategy for Swedish precision medicine company Beactica Therapeutics AB. The collaboration follows the award of a €2.5 million European Innovation Council (EIC) Transition grant, one of only 40 projects selected from 611 applications.

The three-year project, starting this spring, aims to complete IND-enabling studies and position Beactica’s first-in-class immune-epigenetic therapy for glioblastoma (GBM) for regulatory submission and early clinical trials.

While Beactica leads compound development, toxicology and regulatory filing, LISCO will provide the mechanistic validation and biomarker framework needed to support a stratified first-in-human approach and to generate the evidence base for future companion diagnostic (CDx) development.

Embedding IND preparation in Leuven’s glioblastoma ecosystem

LISCO’s contribution is embedded within Leuven’s broader glioblastoma research ecosystem, where disease expertise, advanced in vivo models and spatial multi-omics technologies are closely connected.

“The company was attracted by our integrated approach, combining deep glioblastoma expertise, advanced in vivo models and spatial multi-omics technologies,” explained Prof. Frederik De Smet who bridges LISCO’s technology platform and KU Leuven’s glioblastoma research community.

Prof. An Coosemans of the Leuven Cancer Institute provides advanced glioblastoma mouse models that serve as the biological testing ground for the compound. Within this framework, different LISCO teams contribute complementary layers of spatial analysis. 

Prof. Frederik De Smet’s team applies spatial proteomics to assess target presence and pathway modulation in vivo. Prof. Thierry Voet’s group contributes spatial transcriptomics to characterize cellular states and pathway activity at high resolution, as well as spatial epigenomics.

“By characterizing Prof. Coosemans’ GBM mouse models with these complementary spatial technologies, we can test whether the biological mechanism is truly active in vivo,” explains Prof. De Smet.

This integration of disease models and multi-layered spatial profiling creates a translational bridge between nonclinical validation and early clinical development.

From mechanism to molecular validation

The drug candidate targets LSD1, a regulator of histone modifications that influence how DNA is packaged and accessed. By modulating these epigenetic mechanisms, the compound aims to reprogram both tumour cells and immune cells within the tumour microenvironment.

Evaluating whether this epigenetic reprogramming truly occurs in vivo is central to IND readiness. Through integrated spatial proteomics, transcriptomics and epigenomics, LISCO can determine whether LSD1 modulation leads to measurable molecular and cellular shifts in relevant tumour contexts.

“The epigenetic layer is critical to understanding whether the compound truly reprograms tumour and immune cells,” says Prof. De Smet. 

By linking spatial molecular validation to disease-specific in vivo systems, LISCO strengthens the mechanistic foundation required for regulatory documentation and supports a more informed transition toward first-in-human development.

Addressing heterogeneity in glioblastoma

In glioblastoma, however, validating mechanism alone is not enough. The disease is highly heterogeneous, a major risk factor in early-phase trials.

“Glioblastoma is very difficult to treat. One of the main reasons is that there are a lot of variations between patients. If you would just include the next 20 patients in your trial, the chance is very high that there are only one or two patients who would react effectively.”

Without a stratification strategy, promising compounds risk failing for biological rather than pharmacological reasons.

“You need a companion diagnostic that you can already use for pre-selection. Because if you just give it to a random patient, there is a very high chance that it will fail.”

Biomarker strategy and IND readiness

For that reason, LISCO’s work extends beyond confirming target engagement. By identifying biomarker hypotheses that can be tracked from preclinical systems into patient-derived datasets, the team helps define which biological subgroups are most likely to benefit, laying the groundwork for companion diagnostic development and more precise inclusion criteria in first-in-human studies.

“Validation of the target, validation of the mechanism, and then actually the first suggestion around a biomarker, that is the output.”

By linking mechanism, biomarker development and patient stratification, LISCO strengthens both the scientific rationale of the IND package and the design of a more targeted FIH trial.

“The company develops the compound and manages the IND preparation, but they turned to us for the mechanistic validation and biomarker strategy that strengthen the biological foundation of the IND.”

“We actually help to improve that direction of selection. That can really make the difference between a failed trial or a successful trial.”

This collaboration illustrates how LISCO can support life sciences companies at key moments in drug research and development.

“We are a catalyst in a way to collect the necessary knowledge to get your IND package approved, at least the biological and mechanistic part of it.”

Read the full press release here.