New drug for lymphoma! CD19 Targeted Antibody Drug Couple (ADC) loncastuximab tesirine (Lonca) is on the market in the U.S.!

September 23, 2020 // -- ADC Therapeutics SA is a Late Clinical Swiss biotechnology company dedicated to the development and commercialization of highly effective targeted antibody drug couples (ADCs) for the treatment of blood malignancies and solid tumors.
recently, the company announced that it had filed a bio-product licensing application (BLA) with the U.S. Food and Drug Administration (FDA) for Loncastuximab tesirine (Lonca, formerly known as ADCT-402), a drug used to treat recurring or recurring diffuse large B-cell lymphoma (DLBCL).
Loncastuximab tesirine (Lonca) is an ADC therapy targeted at CD19, made up of an human-based anti-human CD19 monoclonal antibody coupled with pyrrolobenzodiazepine (PBD) diazocular toxin through a connector.
Once it binds to cells that express CD19, Lonca is internalized by the cells and then releases a cytotoxin that irreversibly binds to DNA, creating strong interclocking that prevents DNA chain separation, disrupting the necessary DNA metabolic processes such as replication, which eventually leads to cell death.
CD19 is a well-established target for the treatment of B-cell malignancies.
Lonca BLA, an antibody drug association-PBD djumer technology, based on data from the key Phase 2 LOTIS 2 study.
this is a multi-center, open-label, one-arm clinical trial that evaluates the efficacy and safety of Lonca's treatment of patients with relapsed or incurable DLBCL who have previously received at least 2 system therapies.
In June 2020, the company presented mature data from LOTIS 2 at the 25th European Society of Hematology (EHA) Virtual Conference: as of April 6, 2020, 145 patients had been admitted to the group, with a median of three previous system therapies.
results showed that Lonca's objective mitigation rate (ORR) was 48.3% (70/145 cases) and its full mitigation rate (CR) was 24.1% (35/145 cases).
study, Lonca's tolerance was generally controllable, and the most common adverse events (TEAE) that occurred during treatment at level 3 in 10% of patients were neural granulocyte reduction (25.5%). fever-neutral granulocyte reduction (3.4%), platet board reduction (17.9%), elevated GGT (16.6%) and anemia (10.3%).
the company also launched LOTIS 5, a validated Phase 3 clinical trial of Lonca's combination with lysoxi monoantigen, to support a complementary BLA that uses Lonca as a second-line therapy for relapsed or refractic DLBCL.
origin: ADC Therapeutics Submits Biologics License application to the U.S. Food and Drug Administration for Loncastuximab Tesirine for Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma.