On August 6, 2019 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of antibody drug conjugates (ADCs), and SOPHiA GENETICS, a leader in Data-Driven Medicine, reported they have entered into a collaboration to identify genomic markers associated with clinical response to ADCT-402 (loncastuximab tesirine) (Press release, ADC Therapeutics, AUG 6, 2019, View Source [SID1234596057]). ADC Therapeutics is currently evaluating ADCT-402 in a pivotal Phase II clinical trial in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
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SOPHiA GENETICS will conduct somatic mutation analysis of more than 4,000 genes in cell-free DNA (cfDNA) samples extracted from blood of DLBCL patients participating in ADC Therapeutics’ Phase II trial. SOPHiA technology will match detected genomic markers with clinical response to ADCT-402. The analytical power of SOPHiA for the detection of cancer mutations is key for this new development phase and illustrates the benefits of adopting Data-Driven Medicine applications for clinical trials.
"Our collaboration with SOPHiA GENETICS has the potential to uncover genomic mutations that correlate with clinical response to ADCT-402," stated Patrick van Berkel, Senior Vice President of Research and Development at ADC Therapeutics. "We have observed significant single-agent clinical activity in our pivotal Phase II trial of ADCT-402 in a broad population of patients with relapsed or refractory diffuse large B-cell lymphoma. The insights from this collaboration will allow us to better identify and understand the characteristics of patients who respond best to treatment. We look forward to the results of this research enabled by SOPHiA’s unique platform."
"We are pleased to partner with ADC Therapeutics, a leader in antibody drug conjugate development, to provide advanced biomarker analysis and turn the results into actionable insights that can improve clinical outcomes for patients and pave the way towards a new era in drug development," said Esteban Czwan, Senior Vice President BioPharma at SOPHiA GENETICS.
Financial terms of the collaboration were not disclosed.
About ADCT-402
ADCT-402 (loncastuximab tesirine) is an antibody drug conjugate (ADC) comprised 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.