Development roadmap Preclinical to first-in-human
A brighter future in cancer care

Building the evidence to move light-controlled oncology forward.

GenLumina is developing a light-activated intracellular payload for targeted cancer therapies. Our roadmap builds the platform evidence required for pharmaceutical partner programmes first, followed by regulatory and clinical translation. In the clinical phase, the same spatial-control principle can also create opportunities for integration with hospital imaging technology.

GenLumina development roadmap
01 · Development path

From platform proof to clinical readiness.

Each stage adds formulation, conjugation, safety, efficacy, manufacturing and regulatory evidence. The objective is not simply to advance one internal product, but to progressively de-risk a payload platform that can support multiple partner-specific oncology programmes.

2025–2026 · Now

Platform proof & in-vivo evidence

  • Formulation and conjugation development
  • In-vitro targeted and conjugated proof-of-concept
  • 3D tumor model validation
  • In-vivo safety and biodistribution work
  • In-vivo efficacy validation
2027–2028

Preclinical development

  • Partner-specific PoC programmes
  • GLP and CMC development
  • Dose-range finding
  • Pharmacokinetics and pharmacodynamics
  • Manufacturing and reproducibility
2028–2030

IND-ready preparation

  • Regulatory safety package
  • Efficacy and dose optimization
  • Clinical-grade manufacturing preparation
  • Regulatory pre-submission
  • Clinical protocol preparation
From 2030

First-in-human & clinical translation

  • Initial safety evaluation in patients
  • Clinical activation workflow
  • Image-guided treatment integration opportunities
  • Clinical partner and medtech co-development
02 · Partnering & commercialization path

Scientific evidence creates commercial options.

Partnering does not need to wait until clinical development. Pharma and biotech collaborations can start during preclinical development with a partner-owned targeting molecule. Medtech integration becomes relevant later, when clinical imaging and activation workflows are being established.

Now

Build platform evidence

GenLumina establishes the scientific foundation: payload behavior, conjugation, uptake, controlled activation, safety and tumor-cell killing.

Platform de-risking
Partner entry

Partner-specific PoC

A pharma or biotech partner brings an antibody, peptide or ligand from its own pipeline. GenLumina conjugates the molecule and evaluates the combination against jointly agreed criteria.

Partner-funded validation
Successful PoC

Option & licence

If the programme meets predefined criteria, the partner can progress an agreed option toward separately negotiated development rights for a defined indication and territory.

Programme-specific licensing
Clinical stage

Medtech co-development

Hospital imaging can identify and localize the tumor. GenLumina can work with medtech partners to explore an additional light-activation channel that connects imaging with local payload activation.

Image-guided treatment
The platform can create multiple programmes without transferring the entire technology to one partner.

Pharma determines what recognizes the tumor. GenLumina provides the controllable payload. In the clinical phase, medtech can contribute where and how the activation is delivered.

03 · Current evidence focus

Build evidence in CRC. Keep the platform open.

Colorectal cancer provides an internal starting point for building efficacy and delivery evidence. It does not define the commercial limits of the platform. Partner programmes can use other targets, indications and targeting molecules where the biology and light-delivery strategy are appropriate.

Colorectal cancer research
Internal evidence programme

Colorectal cancer

CRC is being used to generate evidence around conjugation, delivery, activation, safety and efficacy and to strengthen the scientific package needed for partner discussions.

GenLumina platform expansion to other tumor types
Partner-driven expansion

Other targets and tumor types

The payload platform is intended to support additional antibodies, peptides or ligands and separately agreed indications selected around partner pipelines.

04 · Collaborate with us

Different partners enter at different stages.

Pharma & biotech

Partner-specific PoC

Bring an antibody, peptide or ligand and evaluate it with the GenLumina payload in a focused preclinical programme.

Clinical specialists

Clinical translation

Help define the treatment setting, activation workflow, patient selection and early clinical-development requirements.

Medtech

Image-guided activation

At the clinical stage, explore how existing imaging platforms can support tumor localization and an additional light-activation channel for treatment.

05 · Clinical perspective

Why selective local control matters.

Clinical collaborators highlight the potential value of more selective, less toxic treatment approaches across several cancer settings.

“Given the potential of GenLumina’s light-activated therapy to target tumors effectively, improve surgical precision, and minimize collateral tissue damage, I believe this technology holds great promise for advancing cancer treatment, particularly for colorectal, ovarian, and pancreatic cancers.”

Dr. Alexander Vahrmeijer LUMC · Surgical Oncologist

“A more effective photodynamic treatment would make tens of thousands of surgical procedures with complications, disturbing scars, and multiple hospital visits unnecessary every year.”

Remco van Doorn LUMC · Dermatologist

“A better, more tumor-selective and less toxic treatment for skin cancers is eagerly awaited. The light-activated DNA-silver constructs provide a new opportunity to explore highly selective treatment of superficial cancers.”

Dr. Wouter Vogel NKI · Nuclear Dermatologist
06 · Shape the next programme

Bring your targeting biology.

Pharma and biotech partners can start with a focused partner-specific PoC today. Together we can define the scientific criteria and the commercial option that determines how a successful programme can advance.

Explore partnering →