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

Rhea-AI Summary

ADC Therapeutics announced the initiation of a Phase 1b clinical trial for ADCT-601 (mipasetamab uzoptirine), targeting AXL in patients with advanced solid tumors. The trial aims to assess ADCT-601's safety as a standalone and in combination with gemcitabine, particularly in sarcoma, a tumor resistant to current treatments. ADCT-601 has shown a manageable tolerability profile and promising preclinical synergy with gemcitabine. This advancement continues ADC Therapeutics' focus on improving cancer treatment through targeted antibody-drug conjugates.

Positive

• Phase 1b trial of ADCT-601 initiated, targeting AXL in advanced solid tumors.
• ADCT-601 shows manageable tolerability profile as a monotherapy.
• Preclinical studies indicate synergy with gemcitabine.

Negative

• None.

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

LAUSANNE, Switzerland--(BUSINESS WIRE)-- 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.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations and financial position, business and commercialization strategy, market opportunities, products and product candidates, research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, projected revenues and expenses and the timing of revenues and expenses, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

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Investors

Eugenia Litz

ADC Therapeutics

Eugenia.Litz@adctherapeutics.com

+44 7879 627205

Amanda Hamilton

ADC Therapeutics

amanda.hamilton@adctherapeutics.com

+1 917-288-7023

Media

Mary Ann Ondish

ADC Therapeutics

maryann.ondish@adctherapeutics.com

+1 914-552-4625

Source: ADC Therapeutics SA

FAQ

What is ADCT-601 and its clinical trial status?

ADCT-601 is an antibody-drug conjugate targeting AXL, currently in a Phase 1b clinical trial.

What tumors are being targeted in the ADCT-601 trial?

The trial focuses on advanced solid tumors, specifically sarcoma.

What are the expected outcomes of the Phase 1b trial for ADCT-601?

The trial aims to evaluate the safety and tolerability of ADCT-601 alone and with gemcitabine.

What is the significance of targeting AXL with ADCT-601?

AXL is linked to chemotherapy resistance in solid tumors, making it a critical target.

How does ADCT-601 demonstrate synergy with gemcitabine?

Preclinical studies have shown that ADCT-601 enhances the efficacy of gemcitabine in cancer treatment.