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ADC Therapeutics Administers First Patient Dose in Phase 1b Clinical Trial of ADCT-601 Targeting AXL as Monotherapy and in Combination with Gemcitabine in Advanced Solid Tumors


ADCT-601 binds to AXL, a cancer antigen expressed in solid tumors such as sarcomas and associated with resistance to chemotherapy

ADCT-601 has been observed to exhibit a manageable safety profile as monotherapy in Phase 1a

Preclinical studies demonstrate antitumor activity and synergy with gemcitabine

ADC Therapeutics SA (NYSE:ADCT) today announced that the first patient has received a dose in the Phase 1b clinical trial evaluating ADCT-601 (mipasetamab uzoptirine) targeting AXL as monotherapy and combined with gemcitabine in patients with certain advanced solid tumours.

“We look forward to further evaluating ADCT-601, our AXL-targeting CAM, in advanced solid tumors after establishing a manageable safety profile in our dose-escalating Phase 1a trial,” said Joseph Camardo, MD, Medical Director of ADC Therapeutics. “AXL is an ideal target for a CAM approach because it is expressed in many solid tumors. Furthermore, the combination of ADCT-601 with gemcitabine has demonstrated its synergistic ability in preclinical solid tumor models”.

The Phase 1b, open-label, dose-escalation and dose-extension clinical trial is evaluating the safety and tolerability of ADCT-601 as monotherapy and in combination with gemcitabine in patients with certain advanced solid tumors. The first group of the trial will include approximately 18 patients with sarcoma, a tumor resistant to currently available cancer treatments and in which AXL is overexpressed. For more information on the Phase 1b trial, please visit www.clinicaltrials.gov (ID NCT05389462).

About the ADCT-601

ADCT-601 is composed of a humanized monoclonal antibody that binds to human AXL (under license from BerGenBio), and conjugated using GlycoConnect™ technology (under license from Synaffix BV) to a linker with a toxin, pyrrolobenzodiazepine dimer (PBD). Once bound to an AXL-expressing cell, ADCT-601 is internalized into the cell, where enzymes release the PBD-based warhead. In preclinical human cancer models, ADCT-601 demonstrated potent and long-lasting antitumor activity upon administration of an AXL-mediated PBD dimer warhead.

About ADC Therapeutics

ADC Therapeutics (NYSE:ADCT) is a commercial-stage biotechnology company improving the quality of life of people with cancer through its next-generation targeted antibody-drug conjugates (ADCTs). The Company is leveraging its proprietary CAM technology, based on PBDs, to transform the therapeutic paradigm for patients with hematological malignancies and solid tumors.

ZYNLONTA (loncastuximab tesirin-lpyl), ADC Therapeutics’ CD19-targeting CAM, is FDA-approved for the treatment of relapsed or refractory diffuse large b-cell lymphoma after at least two lines of systemic therapy. ZYNLONTA is also being developed in combination with other agents. Cami (camidanlumab tesirine) is in a pivotal Phase 2 trial for relapsed or refractory Hodgkin’s lymphoma and a Phase 1b clinical trial for the treatment of various advanced solid tumors. In addition to ZYNLONTA and Cami, ADC Therapeutics has several CAMs in clinical and preclinical development.

ADC Therapeutics is based in Lausanne (Biopôle), Switzerland, with offices in London, San Francisco Bay and New Jersey. For more information, please visit https://adctherapeutics.com/ and follow the Company at Twitter and LinkedIn.

ZYNLONTA® is a registered trademark of ADC Therapeutics SA.

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