On June 12, 2019 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of antibody drug conjugates (ADCs), reported that data on ADCT-402 (loncastuximab tesirine) and ADCT-301 (camidanlumab tesirine) have been selected for four presentations at the 15th International Conference on Malignant Lymphoma (15-ICML), which is being held June 18-22, 2019, in Lugano, Switzerland (Press release, ADC Therapeutics, JUN 12, 2019, View Source [SID1234596062]).
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Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President of Clinical Development at ADC Therapeutics, said, "We are pleased to be presenting compelling data at 15-ICML from our 183-patient Phase I clinical trial of ADCT-402 in relapsed or refractory B-cell lymphoma (including 139 patients with diffuse large B-cell lymphoma), as well as our 128-patient Phase I clinical trial of ADCT-301 in relapsed or refractory Hodgkin and non-Hodgkin lymphoma (including 77 patients with Hodgkin lymphoma). Based on these data, ADCT-402 is now in an ongoing pivotal Phase II trial and we plan to commence a pivotal Phase II trial of ADCT-301 later this summer. In addition, new preclinical studies highlight the potential of these novel ADCs for the treatment of lymphomas as both single agents and in combination with other targeted drugs. The data reinforce our position as a leader in the development of next generation PBD-based ADCs and the strength of our hematology franchise, which now also includes ADCT-602 in a Phase I clinical trial for acute lymphoblastic leukemia."
Oral Presentations
Title: Analysis of Efficacy and Safety of Loncastuximab Tesirine (ADCT-402) by Demographic and Clinical Characteristics in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Abstract Number: 054
Session: Session 4 – Treatment with Novel Antibodies
Date/Time: Thursday, June 20, 16:25 CEST
Location: Room A, Cinema Corso Auditorium and Aula Magna
Presenter: John Radford MD, FRCP, Department of Medical Oncology, The University of Manchester and The Christie NHS Foundation Trust, Manchester, UK
Title: Analysis of Clinical Determinants Driving Safety and Efficacy of Camidanlumab Tesirine (ADCT-301, Cami) in Relapsed/Refractory (R/R) Classical Hodgkin Lymphoma (cHL)
Abstract Number: 055
Session: Session 4 – Treatment with Novel Antibodies
Date/Time: Thursday, June 20, 16:40 CEST
Location: Room A, Cinema Corso Auditorium and Aula Magna
Presenter: Graham Collins, MB, BS, DPhil, Department of Clinical Haematology, Oxford University Hospitals, NHS Foundation Trust, Oxford, UK
Title: The Antibody-Drug Conjugate (ADC) Loncastuximab Tesirine (ADCT-402) Targeting CD19 Shows Strong In Vitro Anti-Lymphoma Activity Both as Single Agents and In Combination
Abstract Number: 084
Session: Focus On Non-Clinical New Drugs
Date/Time: Thursday, June 20, 17:55 CEST
Location: Auditorium (USI Universitá)
Presenter: Chiara Tarantelli, PhD, Università della Svizzera italiana, Institute of Oncology Research
Poster Presentation
Title: The Anti-CD25 Antibody-Drug Conjugate Camidanlumab Tesirine (ADCT-301) Presents a Strong Preclinical Activity Both as Single Agent and In Combination in Lymphoma Cell Lines
Poster Number: 270
Session: Poster Session
Date/Time: Wednesday, June 19, 12:00-17:00 CEST; Thursday, June 20, 9:00-17:00 CEST; Friday, June 21, 9:00-18:30 CEST
Location: Marquee
Presenter: Filippo Spriano, PhD, Institute of Oncology Research
Abstracts are available on the 15-ICML web site: www.lymphcon.ch.
About ADCT-402
ADCT-402 (loncastuximab tesirine) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody that binds to human CD19, conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer toxin. Once bound to a CD19-expressing cell, ADCT-402 is internalized into the cell where enzymes release the PBD-based warhead. CD19 is a clinically validated target for the treatment of B-cell malignancies. The PBD-based warhead has the ability to form highly cytotoxic DNA interstrand cross-links, blocking cell division and resulting in cell death. ADCT-402 is being evaluated in a pivotal Phase II clinical trial in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) (NCT03589469), a Phase Ib trial in combination with ibrutinib in patients with R/R DLBCL or mantle cell lymphoma (MCL) (NCT03684694) and a Phase Ib trial in combination with durvalumab in patients with R/R DLBCL, MCL or follicular lymphoma (NCT03685344). The U.S. Food and Drug Administration granted orphan drug designation to ADCT-402 for the treatment of relapsed or refractory DLBCL and MCL.
About ADCT-301
ADCT-301 (camidanlumab tesirine) is an antibody drug conjugate (ADC) composed of a monoclonal antibody that binds to CD25 (HuMax-TAC, licensed from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload tesirine. Once bound to a CD25-expressing cell, ADCT-301 is internalized into the cell where enzymes release the PBD-based warhead. The intra-tumor release of its PBD warhead may cause bystander killing of neighboring tumor cells. In addition, the PBD warhead will trigger immunogenic cell death, which in turn will strengthen the immune response against tumor cells. ADCT-301 is being evaluated in ongoing Phase Ia/Ib clinical trials in patients with relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma (NCT02432235), as well as a Phase Ib clinical trial in solid tumors (NCT03621982).