ADC Therapeutics SA (ADCT)
First Day Turnover6.69%
We are a late clinical-stage oncology-focused biotechnology company evolving into a commercial-stage company as we prepare for the launch of our lead product candidate, if approved. We are a pioneer in the development of highly potent and targeted ADCs for patients suffering from hematological malignancies and solid tumors. We develop our ADCs by applying our decades of experience in this field and using next-generation PBD technology to which we have proprietary rights for our targets. We are leveraging our R&D strengths, our disciplined approach to target selection and our preclinical and clinical development strategy to generate a diverse and balanced portfolio and research pipeline.
Our hematology franchise comprises three clinical-stage product candidates, loncastuximab tesirine (“Lonca” and previously known as ADCT-402), camidanlumab tesirine (“Cami” and previously known as ADCT-301) and ADCT-602. Our solid tumor franchise comprises two clinical-stage product candidates, Cami and ADCT-601, and two preclinical product candidates, ADCT-901 and ADCT-701. We retain exclusive worldwide development and commercialization rights to all of our product candidates, other than Cami for which we have a collaboration and license agreement with Genmab. Our commercial organization has initiated pre-launch market activities and is leveraging our team’s deep industry experience to maximize the commercial potential of any approved products.
Our two lead product candidates, Lonca and Cami, have demonstrated significant clinical activity across a broad population of heavily pre-treated patients, while maintaining manageable tolerability profiles. We have evaluated Lonca in a 145-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory DLBCL that showed a 45.5% interim ORR as of October 2019. This interim ORR exceeded our target primary endpoint and the 41.4% ORR observed for DLBCL patients in our 183-patient Phase 1 clinical trial who were treated at the initial dose used in our pivotal Phase 2 clinical trial.
We intend to submit a BLA to the FDA in the second half of 2020 for Lonca for the treatment of relapsed or refractory DLBCL. We are also conducting a Phase 1/2 clinical trial of Lonca in combination with ibrutinib for the treatment of relapsed or refractory DLBCL and MCL that showed a 76.9% ORR and a 61.5% complete response rate in DLBCL patients as of April 21, 2020 at the dose that will be used in the pivotal Phase 2 part of the clinical trial. We also intend to have an end-of-Phase 1 meeting with the FDA in the second quarter of 2020 to discuss a potential pivotal Phase 2 clinical trial of Lonca for the treatment of relapsed or refractory FL that we expect to commence in the fourth quarter of 2020.
In addition, we are evaluating Cami in a 100-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory HL and have enrolled 47 patients as of April 15, 2020. We have completed enrollment of a 133-patient Phase 1 clinical trial of Cami for the treatment of relapsed or refractory HL and NHL that has shown an 86.5% ORR in patients with HL at the initial dose for our pivotal Phase 2 clinical trial and a 44.0% ORR in a subset of NHL patients with T-cell lymphomas as of April 2019. We believe that our pivotal Phase 2 clinical trial of Cami for the treatment of HL, if successful, will support a BLA submission. We are also evaluating Cami in a Phase 1b clinical trial as a novel immuno-oncology approach for the treatment of various advanced solid tumors.
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