On September 17, 2020 ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, reported the presentation of an on-demand e-poster titled "First-in-Human Study of Camidanlumab Tesirine (ADCT-301, Cami), an anti-CD25 Targeted Therapy in Patients with Advanced Solid Tumors: Pharmacokinetics (PK) and Biomarker Evaluation" (abstract #1030P) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 (Press release, ADC Therapeutics, SEP 17, 2020, View Source [SID1234565280]).
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The ongoing, multicenter, open-label Phase 1b clinical trial of camidanlumab tesirine (Cami, formerly ADCT-301) is enrolling patients with selected locally advanced or metastatic solid tumors. The primary objective of the trial is to characterize the safety and tolerability of Cami and identify recommended dose(s) and schedule(s) for future studies.
"The early PK and biomarker data from our ongoing first-in-human trial of Cami as a single agent in solid tumors support the continued evaluation of its immune-mediated anti-tumor activity through the depletion of CD25-positive regulatory T cells in the tumor microenvironment," said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. "What we have observed thus far in the Phase 1b trial, as well as in a preclinical study that was recently published in the Journal for ImmunoTherapy of Cancer, also indicates that the exploration of Cami in combination with other immuno-modulating therapies is warranted. We look forward to advancing Cami as a novel immuno-oncology approach for the treatment of solid tumors while we also continue to evaluate Cami in our pivotal Phase 2 trial in patients with relapsed or refractory Hodgkin lymphoma."
Preliminary Data from Phase 1b Trial of Cami in Advanced Solid Tumors at ESMO (Free ESMO Whitepaper)
As of July 31, 2020, 41 patients were enrolled and treated every three weeks at doses of: 20 (n=3), 30 (n=5), 45 (n=5), 60 (n=5), 80 (n=8), 100 (n=7), 125 (n=6), and 150 µg/kg (n=2). The two most common tumor types were colorectal and pancreatic (both n=14).
Preliminary findings indicate that treatment with Cami is associated with clinically relevant modulation of immune cells, both in the circulation and in tumor tissue, with mild to moderate inter-patient variability in tumor tissue. Increases in soluble CD25 and cytokines in serum post-dosing followed a similar pattern to increases in CD4-positive and CD8-positive T cells, suggesting an increase in activated lymphocytes. Changes in lymphocyte subpopulations in the blood resulted in a dose-related increase in the effector T cell (Teff) to regulatory T cell (Treg) ratio.
The e-poster became available on the ESMO (Free ESMO Whitepaper) Congress platform today and will be available until 20:00 CEST / 2 p.m. EDT on Monday, September 21, 2020. Thereafter, the e-poster will be available on ADC Therapeutics’ website, www.adctherapeutics.com.
For more information about the company’s Phase 1b clinical trial of Cami in solid tumors, visit www.clinicaltrials.gov (identifier NCT03621982).
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. This applies to CD25-expressing tumor cells, and also to CD25-expressing Tregs. The intra-tumoral release of its PBD warhead may also cause bystander killing of neighboring tumor cells and PBDs have also been shown to induce immunogenic cell death. 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.