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Antibody Drug Conjugate (ADC) Franchise Main Article

Antibody Drug Conjugate (ADC) Franchise

ADCs are a type of targeted cancer medicine that deliver chemotherapy (“payload”) directly to cancer cells via a linker attached to a monoclonal antibody.

Using expertise in both protein engineering and medicinal chemistry, our team of exceptional scientists has methodically addressed seven critical limitations of current ADC technology, which may more fully realize the potential of ADCs for cancer treatment. Our proprietary ADC technology, which has broad application across multiple types of cancer, is designed to deliver enhanced cancer cell destruction with less systemic exposure to chemotherapy. The highly stable linker helps minimize the risk that the payload is released before the monoclonal antibody reaches the cancer cell. It also allows a higher drug-to-antibody ratio (DAR), enabling more payload to be attached.

The cornerstone of our ADC Franchise is a proprietary payload and linker-payload technology, which consists of:

  • Payload: DXd, a novel derivative of exatecan (DX-8951f), a topoisomerase I inhibitor
  • Linker: A unique and proprietary tetrapeptide that joins the antibody and payload together, and is designed to be broken down by lysosomal enzymes such as cathepsins, which are highly expressed in tumor cells

Our linker-payload combination allows for a Drug-Antibody Ratio (DAR) of about 8, meaning nearly eight molecules of DXd are conjugated per antibody.

Our ADC Franchise currently consists of six novel ADCs including DS-8201 for HER2-expressing tumors and U3-1402 for HER3-expressing tumors in phase 1 clinical development as well as DS-7300, DS-1062, and two other ADCs with undisclosed targets in preclinical development. We also are open to partnership opportunities with external companies to combine our linker-payload technology with other monoclonal antibodies as well as collaborations with immuno-oncology assets to study in combination with our ADC assets.

These are investigational agents and are not approved by the FDA or any other worldwide regulatory agency as a treatment for any indication. Efficacy and safety have not been established. There is no guarantee that these investigational agents will become commercially available.

Antibody Drug Conjugate (ADC) Franchise

DS-8201

HER2 ADC

DS-8201 is an investigational ADC currently in phase 1 clinical development for HER2-positive advanced or metastatic breast cancer and gastric cancer, HER2 low expressing breast cancer, and other HER2-expressing solid cancers.

DS-8201 has been granted Fast Track designation by the FDA for the treatment of HER2 positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2-targeted therapies including ado-trastuzumab emtansine (T-DM1).

For more information about the phase 1 study, visit ClinicalTrials.gov.

U3-1402

HER3 ADC

U3-1402 is an investigational and potential first-in-class ADC currently in phase 1 clinical development for HER3-expressing metastatic or unresectable breast cancer that is refractory or intolerant to standard treatment or for which no standard treatment is available.

For more information about this phase 1 study, visit ClinicalTrials.gov.

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