Redefining the standard of care for solid tumors

Pipeline & Assets

For every cancer patient who responds to today’s treatment options, countless don’t. Our goal with AAV immuno-gene therapy is for robust treatment response to be the rule, not the exception. And we’re starting with brain cancers.

Our Pipeline

Built on a universal platform, our therapeutic pipeline is advancing rapidly across multiple solid tumor cancers.

SRN-101

Indication

High-Grade Glioma

Discovery

Proof of Concept

IND-Enabling

Clinical

Indication

Undisclosed solid tumor

Discovery

Proof of Concept

IND-Enabling

Clinical

Indication

Undisclosed solid tumor

Discovery

Proof of Concept

IND-Enabling

Clinical

Indication

Undisclosed solid tumor

Discovery

Proof of Concept

IND-Enabling

Clinical

Undisclosed

Indication

Multiple

Discovery

Proof of Concept

IND-Enabling

Clinical

Asset	Indication	Discovery Proof of Concept IND-Enabling Clinical
SRN-101	High-Grade Glioma	Middle of IND-Enabling phase
	Undisclosed solid tumor	end of Proof of Concept phase
	Undisclosed solid tumor	Middle of Proof of Concept phase
	Undisclosed solid tumor	Beginning of Proof of Concept phase
Undisclosed	Multiple	middle of Discovery phase

Introducing SRN-101, a universal AAV immuno-gene therapy

Our first clinical program with SRN-101 will target high-grade gliomas, aggressive brain cancers with limited therapeutic options

Validated Payload

SRN-101 is a recombinant adeno-associated virus vector expressing an engineered cytokine payload with clinically validated immunomodulatory and antineoplastic effects

Regulatory Designations

The FDA has granted SRN-101 designations for Orphan Drug (ODD), Rare Pediatric Disease (RPD), and Fast Track (FT) for treating high-grade gliomas.

Leading the Way

High-grade gliomas are just the start; SRN-101’s promise extends to numerous solid tumor cancers

Why start with brain cancers?

These are notoriously difficult-to-treat cancers and often carry a devastating prognosis. The unmet need for patients with these cancers is dire.

The opportunity for Siren to help is massive.

Attempts to effectively treat brain cancers with systemic drugs have largely failed. Systemic drugs can’t cross the blood brain barrier and get to the tumor site. They are too toxic, and they are generally ineffective against these tumors.

The brain’s immune-privileged status allows us to locally deliver AAV without excluding patients based on neutralizing antibodies. AAV has already proven it can deliver transformative clinical results in the brain, underscoring its potential for treating brain tumors.

Our combination of AAV cytokine vectorization and direct tumor-targeting makes our approach ideally suited for brain cancers.

Expanded Access Policy – SRN-101

SRN-101 is an investigational therapy in development by Siren Biotechnology. SRN-101 has not been approved by the U.S. Food and Drug Administration (FDA). At this time, Siren Biotechnology does not offer an expanded access (compassionate use) program for SRN-101. Because SRN-101 is in early-stage development, it is not available outside of future FDA-authorized clinical trials.

If expanded access becomes available in the future, requests would be evaluated based on factors including available safety data, stage of clinical development, manufacturing capacity, and potential impact on ongoing or planned clinical trials. We anticipate acknowledging receipt of inquiries within approximately 5-10 business days. SRN-101 is not currently listed on ClinicalTrials.gov.

For general inquiries, please contact: regulatory@sirenbiotechnology.com. This policy may be updated as development progresses.