LEAD CANDIDATE

Loncastuximab Tesirine (Lonca)

Lonca is an ADC composed of a humanized monoclonal antibody that binds to human CD19 and conjugated through a linker to a PBD-dimer toxin. Once bound to a CD19-expressing cell, Lonca is internalized into the cell where enzymes release the PBD-based warhead.

CD19 is an ideal target for an ADC approach

CD19 is highly expressed in a range of B-cell hematological tumors, including certain types of lymphoma and leukemia, while its expression in healthy tissue is restricted.

Lonca is the focus of the LOTIS Clinical Development Program

In clinical trials, lead candidate Lonca has demonstrated significant single-agent clinical activity across a broad population of patients with relapsed or refractory diffuse large B-cell, mantle cell, and follicular lymphomas.

The clinical development of this product is ongoing. Loncastuximab Tesirine (ADCT0402) is an investigational agent. Safety and efficacy has not yet been established.

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[402-101] – A Phase 1 Dose-escalation Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of ADCT-402 in Patients With Relapsed or Refractory B-cell Lineage Non Hodgkin Lymphoma (B-NHL)

NCT02669017
COMPLETE

[402-201] – A Phase 2 Open-Label Single-Arm Study to Evaluate the Efficacy and Saftey of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

NCT03589469
ACTIVE/CLOSED TO RECRUITING

[402-103] – A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of Loncastuximab Tesirine and Ibrutinib in Patients With Advanced Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma

NCT03684694
ACTIVE/RECRUITING

[402-104] – A Phase 1 Open-Label Study to Evaluate the Safety and Antitumor Activity of Loncastuximab Tesirine and Durvalumab in Patients With Advanced Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma

NCT03685344
ACTIVE/CLOSED TO RECRUITING

[402-311] – A Phase 3 Randomized Study of Loncastuximab Tesirine Combined With Rituximab Versus Immunochemotherapy in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

NCT04384484
NOT YET RECRUITING