FDA approves the first CD19-targeted ADC drug, Linglu Pharmaceuticals owns Chinese rights | Yimai Meng broke the news

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Big coffee gathered2021 Nucleic Acid Drug Development Forum Announcement Schedule ★ Nanjing in May2021 Nucleic Acid Drug Development Forum is about to open April 25, 2021 / Yimaike News eMedClub News/--A few days ago, ADC Therapeutics' CD19 ADC drug loncastuximab tesirine (Lonca, trade name Zynlonta) received accelerated approval from the US FDA for the treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).

Zynlonta became the 11th ADC drug approved by the US FDA and the first ADC drug that was approved by the US FDA to target CD19.

Lonca is an ADC that targets the CD19 antigen.
It is composed of a humanized monoclonal antibody that binds to CD19 coupled with a pyrrobenzodiazepine (PBD) dimer toxin.

Once combined with CD19 expressing cells, loncastuximab tesirine will be internalized into the cells and release PBD-based warheads.

The US FDA has granted Lonca the orphan drug designation for the treatment of r/r DLBCL and mantle cell lymphoma (MCL) patients.

CD19 is a clinically effective target for the treatment of B-cell malignant tumors; Lonca's warhead is designed to irreversibly bind to DNA and can form highly cytotoxic DNA inter-strand cross-links, thereby destroying the necessary DNA metabolic process and blocking cell division , Which eventually leads to cell death.

▲ Schematic diagram of lonca's structure (picture source: adctherapeutics) Zynlonta's approval is based on data from Lonca's key phase 2 clinical trial LOTIS 2, which was published in EHA 2020.

LOTIS 2 is a multi-center, open-label, single-arm clinical study designed to evaluate the effectiveness and safety of Lonca in the treatment of r/r DLBCL in ≥2 lines.

Data from the LOTIS 2 trial showed that the overall response rate (ORR) reached 48.
3% (70/145), and the complete response rate (CR) was 24.
1% (35/145).

The median response time of the patients was 1.
3 months, and the median duration of response (mDoR) of 70 remission patients was 10.
3 months.

In terms of safety: Lonca shows manageable toxicity; ≥10% of patients have treatment emergent adverse events of grade ≥3, and the most common treatment emergent adverse events of grade ≥3 are neutropenia and hyperthermic neutrophils Cytopenia, thrombocytopenia, increased GGT, and anemia.

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In December 2020, Overland Pharmaceuticals and ADC Therapeutics announced the formation of a new company, Overland ADCT BioPharma (CY).
Limited, responsible for the development and commercialization of four ADC drugs of ADC Therapeutics in Greater China and Singapore, including Lonca, ADCT-602, ADCT-601 and ADCT-901.

In March 2021, the clinical trial application of "Loncastuximab Tesirine for Injection" declared by Linglu Pharmaceutical was granted the implied license of the State Food and Drug Administration.

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The CD19 ADC introduced by Linglu Pharmaceuticals obtained clinical implied permission.
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The nucleic acid drug development forum will kick off in Nanjing from May 7th to 8th, 2021, to welcome the "new era of super drugs".