ADC Therapeutics and SOPHiA GENETICS Partner for Biomarker Discovery in Pivotal Phase II Clinical Trial
Study to identify genomic markers associated with clinical response to ADCT-402 (loncastuximab tesirine) in relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
Lausanne, Switzerland, 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, today announced they have entered into a collaboration to identify genomic markers associated with clinical response to ADCT-402 (loncastuximab tesirine). 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).
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.
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.
About ADC Therapeutics
ADC Therapeutics SA is an oncology drug discovery and development company that specializes in the development of highly targeted antibody drug conjugates (ADCs) armed with highly potent pyrrolobenzodiazepine (PBD)-based warheads. Strategic target selection suitable for PBD-based ADCs and substantial investment in early clinical development have enabled ADC Therapeutics to build a deep clinical and research pipeline of therapies for the treatment of hematological and solid tumor cancers with significant unmet need. The Company has multiple PBD-based ADCs in ongoing clinical trials, ranging from first in human to pivotal Phase II clinical trials, in the USA and Europe, and numerous preclinical ADCs in development. ADCT-402, the Company's lead product candidate, has demonstrated significant single-agent clinical activity across a broad population of patients with relapsed or refractory diffuse large B-cell lymphoma, including difficult-to-treat patients. ADCT-301, the Company's second lead product candidate, has demonstrated clinical activity in heavily pretreated patients with Hodgkin lymphoma and, based on its mechanism of action, also has potential for the treatment of solid tumors. ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. For more information, visit www.adctherapeutics.com.
About SOPHiA GENETICS
SOPHiA GENETICS is a health tech company that developed SOPHiA, an advanced AI technology helping healthcare professionals make sense of the large amount of clinical data. SOPHiA GENETICS is democratizing Data-Driven Medicine by enabling the rapid adoption of genomic and radiomic analysis worldwide, turning data into actionable insights, and sharing knowledge through its community of 980 healthcare institutions in 81 countries in a sustainable and inclusive way. The company's achievements and innovative approach is recognized by the MIT Technology Review "50 Smartest Companies."
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