On July 6, 2020 ADC Therapeutics SA (NYSE:ADCT), a clinical-stage oncology-focused biotechnology company leading the development and commercialization of next-generation antibody drug conjugates (ADCs) with highly potent and targeted pyrrolobenzodiazepine (PBD) dimer technology, reported that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the pivotal Phase 2 clinical trial of camidanlumab tesirine (Cami, formerly ADCT-301) in patients with relapsed or refractory Hodgkin lymphoma (HL) (Press release, ADC Therapeutics, JUL 6, 2020, View Source [SID1234561688]).
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"The ADC Therapeutics team worked diligently to provide a thorough and prompt response to the FDA following its request for information about our pivotal Phase 2 clinical trial of Cami," said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. "During the partial clinical hold we continued to treat patients benefiting from Cami, and now look forward to resuming the enrollment of new patients in the trial as soon as possible."
The 100-patient Phase 2, multi-center, open-label, single-arm clinical trial is evaluating the safety and efficacy of Cami in patients with relapsed or refractory HL. Patients with pathologically confirmed relapsed or refractory HL who have failed three prior lines of therapy, including brentuximab vedotin and a checkpoint inhibitor approved for HL such as nivolumab or pembrolizumab, are eligible for enrollment in the clinical trial. The trial is intended to support the submission of a Biologics License Application to the FDA.
About Camidanlumab Tesirine (Cami)
Camidanlumab tesirine (Cami, formerly ADCT-301) is an antibody drug conjugate (ADC) comprised 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 killing the cell with an immunogenic cell death. The intra-tumoral release of its PBD warhead may also cause bystander killing of neighboring tumor cells. The ADC also depletes CD25-positive regulatory T cells in the tumor environment. All of these properties of Cami may enhance immune-mediated anti-tumor activity. Cami is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma (HL), as well as in a Phase 1a/1b clinical trial in patients with relapsed or refractory HL and non-Hodgkin lymphoma and a Phase 1b clinical trial in solid tumors.