ADC Therapeutics Doses First Patient in Phase 1b Clinical Trial of ADCT-601 Targeting AXL as a Single Agent and in Combination with Gemcitabine in Advanced Solid Tumors

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

ADCT-601 was observed to have a manageable tolerability profile as monotherapy in Phase 1a

Pre-clinical studies demonstrate anti-tumor activity and synergy with gemcitabine

ADC Therapeutics SA (NYSE: ADCT) today announced the first patient has been dosed in the Phase 1b clinical trial evaluating ADCT-601 (mipasetamab uzoptirine) targeting AXL as a single agent and in combination with gemcitabine in patients with selected advanced solid tumors.

“We look forward to the continued evaluation of ADCT-601, our AXL-targeting ADC, in advanced solid tumors after having established a manageable tolerability profile in our Phase 1a dose escalation trial,” said Joseph Camardo, MD, Chief Medical Officer of ADC Therapeutics. “AXL is an ideal target for an ADC approach because it is expressed in many solid tumors. In addition, the combination of ADCT-601 with gemcitabine is demonstrated to be synergistic in preclinical models of solid tumors.”

The Phase 1b open-label, dose-escalation and dose-expansion clinical trial evaluates the safety and tolerability of ADCT-601 as a single agent and in combination with gemcitabine in patients with selected advanced solid tumors. The first arm of the trial will enroll approximately 18 patients with sarcoma, a tumor resistant to current available cancer treatments in which AXL is overexpressed. For more information about the Phase 1b trial, please visit www.clinicaltrials.gov (identifier NCT05389462).

About ADCT-601

ADCT-601 is composed of a humanized monoclonal antibody that binds to human AXL (licensed from BerGenBio), conjugated using GlycoConnect™ technology (licensed from Synaffix BV) to a linker with a pyrrolobenzodiazepine (PBD)-dimer toxin. 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 via AXL-mediated delivery of a PBD dimer warhead, ADCT-601 demonstrated potent and durable antitumor activity.

About ADC Therapeutics

ADC Therapeutics (NYSE: ADCT) is a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs). The Company is advancing its proprietary PBD-based ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors.

ADC Therapeutics’ CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) is approved by the FDA for the treatment of relapsed or refractory diffuse large b-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents. Cami (camidanlumab tesirine) is being evaluated in a pivotal Phase 2 trial for relapsed or refractory Hodgkin lymphoma and in a Phase 1b clinical trial for various advanced solid tumors. In addition to ZYNLONTA and Cami, ADC Therapeutics has multiple ADCs in ongoing clinical and preclinical development.

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

ZYNLONTA® is a registered trademark of ADC Therapeutics SA.

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