Decoding in vivo immune reprogramming driven by MDC-735
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MISAME PROJECT
The MISAME Project is designed to unlock and clinically validate the immune reprogramming potential of MDC-735, a first-in-class bifunctional immunotherapy for glioblastoma. The project establishes mechanism-anchored biomarkers of response that capture immune activation, tumor microenvironment remodeling, and immune memory induction: critical elements for value creation in early-phase clinical development.
Rather than focusing solely on safety readouts typical for First-in-Human trials, MISAME enables early biological proof of efficacy, significantly enhancing the clinical, translational, and commercial attractiveness of MDC-735 for Phase I/II programs and strategic partners.
Why MISAME Matters
MISAME is delivering pharmacodynamic and immune response markers that:
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Demonstrate in vivo immune activation and reprogramming
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Provide early evidence of anti-tumor immune engagement
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Enable dose–response optimization
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Increase asset valuation well before late-stage efficacy trials
This approach transforms Phase I/II trials from risk-mitigation exercises into value-inflection milestones.
Glioblastoma: Reprogramming the Immune-Cold TME
Glioblastoma (GBM) is among the most immunosuppressive and lethal solid tumors, characterized by a deeply hostile tumor microenvironment (TME). MDC-735 is engineered to convert this immune-cold environment into an immune-active state.
Our therapy not only eliminates tumor cells but also:
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Activates innate and adaptive immunity
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Triggers immunogenic cell death
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Reprograms the TME
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Induces durable immune memory
Preclinical data demonstrate complete tumor eradication in GBM-bearing mice and long-term protection against tumor re-challenge, positioning MDC-735 as a potential disease-modifying therapy, not merely a cytotoxic agent.
The results have been published in 2025 in Science Translational Medicine:
The MDC Platform: First-in-Class Macrophage Drug Conjugates
Developed under ERC funding, the MDC platform represents a first-in-class therapeutic modality. MDC-735 utilizes macrophages loaded with a drug conjugate to deliver payloads directly to tumor cells while simultaneously orchestrating immune activation.
Key differentiators:
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Targeted intracellular drug delivery
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Antigen presentation to T and NK cells
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In situ immune system education
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Systemic immune engagement beyond the tumor site
MISAME is the first project to comprehensively map these effects in vivo and in patients.
Project Objectives
The MISAME Project aims to:
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Characterize immune activation and reprogramming induced by MDC-735
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Identify and validate pharmacodynamic and immune biomarkers of response
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Establish biomarkers suitable for Phase I and II clinical trials
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Support dose selection and therapeutic window optimization
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Provide early clinical evidence of biological activity and immune engagement
Special emphasis is placed on circulating and TME-derived cytokine signatures, enabling:
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Non-invasive monitoring
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Longitudinal assessment
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Cost-effective clinical implementation
Strategic Impact
MISAME positions MDC-735 as:
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A mechanism-driven immuno-oncology asset
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A platform validated through immune reprogramming
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A high-value candidate for strategic partnerships
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A de-risked clinical program with early biological proof
By translating immune activation into measurable clinical signals, MISAME fundamentally reshapes how early-phase MDC therapy is evaluated, valued, and advanced.
BENEFICIARIES
PCO: Cellis Sp. z o.o.
PCP: University Hospital of Zurich (USZ)
Beneficiaries: glioblastoma patients, clinicians and researchers in oncology and immunotherapy, and the biotech/pharma sector through improved therapeutic strategies and validated biomarkers
PROJECT VALUE
Total eligible cost (consortium):
PLN 4,474,466.41 (CHF 997,695.86)
Requested funding (total):
PLN 3,650,188.62 (CHF 813,902.20)
PLANNED AND ACHIEVED RESULTS
CONTACT
Contact PCO: office@cellis.eu
Contact PCP: TBA
SPCP WEBSITE
For more information on the SPCP, please visit the official website of the Swiss–Polish Cooperation Programme:
FUNDING
This project is funded by the Swiss–Polish Cooperation Programme. The project started on June 1st, 2025.
