ADC Therapeutics announced it partnered with Freenome to identify biomarkers that can help to predict which diffuse large B-cell lymphoma (DLBCL) patients are most likely to respond to ADCT-402 (loncastuximab tesirine), its investigational antibody-drug conjugate now in a Phase 2 trial.
Freenome has developed a platform that detects cell-free biomarkers, including DNA, RNA and proteins, using a routine blood sample. ADC Therapeutics will use the platform to spot biomarkers of use in decisions concerning ADCT-402, the company said in a press release.
ADCT-402 belongs to a class of compounds known as antibody-drug conjugates, consisting of a cancer-targeting antibody bound to a toxic molecule. The investigational therapy binds to CD19, a protein found on the surface of many types of blood cancer cells, and carries a toxin called pyrrolobenzodiazepine (PBD) dimer. Binding to CD19 releases the toxin, killing the cancer cell once it is taken up.
“Our partnership with ADC Therapeutics validates our unique … platform and its potential to help biopharmaceutical companies develop innovative cancer therapies for patients in need,” said Gabe Otte, chief executive officer of Freenome.
“Our platform can help biopharma partners refine biomarker development and potentially de-risk and accelerate drug development by characterizing patients likely to respond to therapy,” Otte added.
The safety and efficacy of ADCT-402 in treating relapsed or refractory DLBCL is being assessed in an open-label, Phase 2 clinical trial (NCT03589469). This pivotal study is now enrolling up to 140 people, who failed to respond to two or more prior therapies, at clinical sites in the U.S., the U.K., Italy and Switzerland.
Its main goal is to determine the response rate. Secondary measures include duration of response, complete response rate, the time patients live without disease progression, and overall survival, as well as safety and quality of life.
“We are excited to leverage Freenome’s unique platform to potentially enhance our identification and understanding of the patients who are most likely to benefit from treatment with ADCT-402, which has been demonstrating significant single-agent clinical activity in … patients with relapsed or refractory diffuse large B-cell lymphoma,” said Patrick van Berkel, senior vice president of research and development at ADC Therapeutics.
The company announced in August that positive trial results will be used to support a Biologics License Application to the U.S. Food and Drug Administration (FDA) requesting ADCT-402’s approval for these patients.