PIPELINE
PIPELINE
Expanded Access Policy

Duality Biologics (“DualityBio”) is a clinical-stage biotech company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers and autoimmune diseases.

On January 13th, 2023, the U.S. Food and Drug Administration (FDA) granted DB-1303 Fast Track Designation for the Treatment of Advanced, Recurrent or Metastatic Endometrial Carcinoma with HER2 Overexpression that has progressed on or after standard systemic treatment. DB-1303 is a novel antibody-drug conjugate comprised of anti-HER2 monoclonal antibody, enzymatically cleavable peptide-linker, and a proprietary topoisomerase I inhibitor P1003. It is designed to have high plasma stability, low free payload in circulation and wide therapeutic index.

 

Patients facing serious illnesses who have exhausted all available treatment options often want to know if and how they can receive early access to investigational drugs that have not yet been approved by government regulatory agencies. The information below explains options that may be available to patients in these circumstances.

 

1. Clinical Trials

For new medicines to be legally approved for use, companies like DualityBio are required to evaluate their safety and effectiveness in clinical trials and submit trial results to regulatory agencies. To participate in a trial, you must meet certain criteria. For those who meet the criteria to join a clinical trial, participation offers the chance to contribute to medical research that may benefit many others. Participation in a clinical trial comes with certain risks; that is why patient “informed consent” is a required step in the process of enrolling.

 

2. Expanded Access or Compassionate Use

In cases where a clinical trial is not an option, and the patient has exhausted all available treatment options, regulators/health authorities may grant permission for us to provide a treating physician with an investigational drug pre-approval. Such individual use of an investigational drug pre-approval is often called “expanded access” or “compassionate use” but may go by other names. DualityBio refers to these requests as expanded access.

Additional information on Expanded Access may be obtained by visiting the U.S. Food and Drug Administration at: Expanded Access: Information for Physicians.

 

DualityBio is not currently making its investigational products available on an expanded access basis anywhere in the world, as we believe that our clinical trials are the most appropriate way to access our investigational products. We encourage patients who are interested in accessing therapies in our pipeline to talk to their doctor about participating in a clinical trial. Information about all of our trials, including enrollment status, eligibility criteria, and locations, is available at https://www.clinicaltrials.gov/.

 

DualityBio currently is enrolling patients on the DB-1303 trial.

 

To the extent we determine that expanded access to any of our investigational therapies becomes appropriate in the future, this website and policy will be updated to include information regarding the criteria to be used to evaluate these requests, among other information. If you have further questions, please feel free to contact us at info@dualitybiologics.com with any questions.





GLOBALLY COMPETITIVE PRODUCT PIPELINE


Focusing on the field of oncology and autoimmune diseases, DualityBio has developed a pipeline of more than 10 best-in-class and/or first-in-class Antibody-Drug Conjugate (ADC) drugs, to address the unmet medical needs of patients worldwide. 

Expanded Access Policy
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