Last updated: 25 February 2026

Here at Dren Bio, our patient-centric approach is at the core of everything we do. We are committed to the discovery and development of new therapies that have the potential to meaningfully improve the lives of patients suffering from cancer and other serious diseases.

At present, all Dren Bio therapies are considered investigational, which means that they have not been approved as safe and effective by regulatory health authorities.

Our investigational therapies are studied in clinical trials designed to rigorously evaluate safety and potential benefit. Therefore, the most appropriate and preferred way to access a Dren Bio investigational therapy is through participation in one of our ongoing clinical trials. To find out more about participating, patients should consult with their treating physician based on the up-to-date information listed on clinicaltrials.gov (current studies include NCT05475925; NCT06602232; NCT06999187).

Outside of clinical trials, access to Dren Bio investigational products may be considered in limited circumstances and subject to applicable local laws and regulations. Dren Bio does not currently support expanded access for investigational therapies in Phase 1 development.

Physician-requested expanded access will be considered for patients being treated at existing Dren Bio clinical trials sites provided that:

1. The patient is not otherwise eligible for an ongoing clinical study sponsored by Dren Bio;
2. The patient has a serious disease and has exhausted available, suitable therapy options;
3. The therapeutic target has a plausible biologic mechanism in the patient’s disease;
4. The potential benefits of treatment with the investigational therapy are thought to outweigh the potential risks;

Additional Considerations:

In addition, we consider whether there is adequate supply of the investigational product, whether an appropriate regulatory mechanism exists in the applicable country or region to support expanded access, and whether providing the investigational product would interfere with investigational trials that could support the investigational product’s development or marketing approval.

Requests must be submitted by the patient’s treating, licensed physician via email to

expanded.access.inquiry@drenbio.com.

Dren Bio anticipates acknowledging receipt of complete requests within five (5) business days.

Dren Bio retains sole discretion to determine whether expanded access will be granted in each case based on the above criteria and the potential impact on our clinical development programs. We may update this policy from time to time to reflect changes in clinical data, operations, regulatory or legal requirements, or investigational product availability.

For questions on Dren Bio’s Expanded Access Policy, please contact us via email (expanded.access.inquiry@drenbio.com).