Loading SynMiR experience
Restoring therapeutic sensitivity.
SynMiR is developing synthetic microRNA-based therapeutics designed to address drug resistance in melanoma.
Cancer rarely escapes through one pathway.
Resistance is multi-factorial. Syn-miRs are designed to modulate multiple resistance-associated genes at once.
Local delivery. Sustained exposure.
A PLGA-based locoregional delivery strategy is being developed to concentrate activity where residual disease may emerge.
From academic discovery to biotech asset.
SynMiR is building the preclinical data package required for investor, regulatory and pharma-partner readiness.
A synthetic microRNA approach to multi-pathway resistance.
SynMiR designs proprietary Syn-miRs: synthetic RNA sequences engineered to act on networks of genes associated with tumour survival and therapeutic escape.
Multi-target design
Unlike single-target approaches, Syn-miRs are designed to engage multiple molecular nodes involved in resistance.
Bioinformatic generation
The platform uses proprietary computational logic to generate miRNA-like sequences tailored to disease-relevant gene networks.
Pipeline scalability
The same design logic can support future oncology indications beyond the first melanoma candidate.
Current development is preclinical. Further validation is required before clinical use.
Melanoma relapse is driven by resistance.
Targeted therapies have improved outcomes, but acquired resistance remains a major clinical and strategic challenge.
Initial response
BRAF/MEK targeted therapies can produce meaningful initial responses in selected melanoma patients.
Acquired resistance
Over time, tumour cells may activate alternative pathways and bypass single-axis inhibition.
Unmet need
Reducing recurrence and delaying resistance remain key goals in melanoma treatment innovation.
Designed for local control, not systemic exposure.
SynMiR is pursuing locoregional delivery using PLGA-based controlled release to improve local exposure while limiting systemic distribution.
Systemic RNA delivery challenges
- Rapid degradation
- Potential immune activation
- Off-target exposure
- Narrow therapeutic window
Locoregional PLGA strategy in Melanoma
- Delivery at or near the surgical site
- Controlled release over weeks
- Reduced systemic exposure by design
- Potential fit with surgically accessible melanoma settings
Early evidence supports continued development.
SynMiR has generated preliminary molecular and preclinical evidence. The next milestone is to validate the optimized delivery system in vivo.
Target engagement rationale
Initial molecular studies support the mechanism-of-action hypothesis and target-network engagement.
Activity in resistant melanoma models
Syn-mel-10-8 showed strong phenotypic activity in resistant melanoma cell models during internal preclinical testing.
Initial in vivo signal
A first in vivo study using a standard delivery system showed tumour-size reduction during treatment exposure, highlighting the need for sustained delivery.
Optimized PLGA delivery
A second in vivo study is focused on PLGA-based sustained local release and improved exposure at the target site.
All results are preclinical and investigational. SynMiR has not been evaluated in humans and is not approved for clinical use.
18 months to a value-inflecting preclinical package.
The current plan focuses capital on milestone-driven de-risking rather than broad exploratory research.
IP & asset control
Exclusive license execution and IP/FTO workstream consolidation.
Delivery validation
PLGA manufacturing, QC and in vivo efficacy validation with optimized delivery.
Safety package
Early toxicology, dose range and tolerability workstreams with external partners.
Investor-ready data room
Data package assembly, indication strategy, regulatory pre-submission preparation and pharma BD outreach.
A focused entry market with expansion potential.
SynMiR’s initial strategy is designed around a surgically accessible melanoma setting, with potential expansion into broader adjuvant and combination opportunities after de-risking.
Focused entry
Injectable or locoregional melanoma settings where delivery feasibility and unmet need are clearest.
Adjuvant expansion
Potential future use in post-surgical, high-risk BRAF-mutated melanoma populations, subject to clinical validation.
Platform optionality
Longer-term potential to expand into combination strategies or additional oncology indications after delivery and safety validation.
* Market estimates and indication prioritization are under validation through KOL interviews, clinical input and investor due diligence.
Built for pharma partnership.
SynMiR is not building a commercial salesforce. The business model is based on asset de-risking, partnership, licensing and co-development.
Discover
Design synthetic microRNA candidates against disease-relevant gene networks.
Validate
Generate preclinical efficacy, delivery, safety and manufacturability evidence.
Partner
Create the data package required for licensing, co-development or strategic pharma discussions.
We create value by reducing scientific, delivery, regulatory and IP risk.
Science-strong founders. Building commercial execution.
Alessandro De Santis
Co-inventor of Syn-mel-10-8 and 100% committed to SynMiR, Alessandro holds a doctorate in Molecular Biology and RNA Therapeutics from Sapienza University of Rome. As CEO, he leads the company's transition from academic research to investment-ready biotech — driving preclinical execution, fundraising strategy, and CRO management toward first clinical milestone.
Carlo Presutti
Associate Professor at Sapienza University of Rome and Principal Investigator of the laboratory where SynMiR's core technology was discovered, Carlo brings over two decades of expertise in RNA biology, non-coding RNAs, and cancer mechanisms. As Chairman, he provides scientific leadership, institutional anchoring, and access to a global KOL network essential for clinical validation and partnership development.
Filippo Grossi
A Management Engineer by training, Filippo leads SynMiR's commercial and strategic development. He is responsible for investor readiness, financial modelling, indication prioritisation, and go-to-market positioning — translating the company's scientific value into a fundable business case and driving KOL engagement and strategic partnerships.
Scientific Advisors
- Fabiana Quaglia — Drug Delivery / PLGA Nanoparticle Formulation
- Claudia Conte — Drug Delivery / PLGA Formulation
- Livia Perfetto — Bioinformatics / Multi-Omics & Target Validation
- Clinical Oncologist (Melanoma KOL) — recruitment in progress, post-M3 indication confirmation
Interested in the next inflection point?
SynMiR is preparing its preclinical de-risking roadmap and investor materials for selected advisors, investors and strategic partners.
For investor, advisory and strategic partnership discussions only.