ADC Therapeutics Doses First Patient in Phase 1 Clinical Trial of ADCT-901 in Advanced Solid Tumors

Rhea-AI Summary

ADC Therapeutics (NYSE: ADCT) has initiated a Phase 1 clinical trial for ADCT-901, targeting KAAG1, a novel tumor antigen in advanced solid tumors with high unmet needs. The trial, focused on safety, tolerability, pharmacokinetics, and antitumor activity, follows FDA's clearance of the IND application. KAAG1 is significantly expressed in tumors like ovarian and triple-negative breast cancer, presenting a potential therapeutic opportunity.

Positive

• Initiation of Phase 1 clinical trial for ADCT-901 targeting KAAG1.
• FDA clearance for ADCT-901's IND application.
• Targeting tumors with high unmet medical needs, including ovarian and triple-negative breast cancers.

Negative

• None.

ADCT-901 targets KAAG1, a novel tumor target for ADC development

LAUSANNE, Switzerland--(BUSINESS WIRE)-- ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, today announced the first patient has been dosed in the Phase 1 clinical trial evaluating ADCT-901, targeting kidney associated antigen 1 (KAAG1), in patients with selected advanced solid tumors with high unmet medical needs.

“With the FDA’s clearance of the IND application for ADCT-901, we are pleased to quickly move this promising new antibody drug conjugate into clinical development,” said Joseph Camardo, MD, Chief Medical Officer of ADC Therapeutics. “There is high expression of KAAG1 in tumors that have few new medicines, such as ovarian and triple negative breast cancer. We look forward to further evaluating the safety, antitumor activity and optimal dosing for ADCT-901 in this Phase 1 trial.”

ADCT-901 is composed of a humanized monoclonal antibody (3A4) directed against human KAAG1 conjugated through a cathepsin-cleavable linker to the PBD dimer SG3199, the same cytotoxin used in ADC Therapeutics’ lead product, ZYNLONTA®. KAAG1 is an attractive, novel tumor target for ADCs expressed on the membrane of tumor cells, while its expression on healthy tissue is very limited.

The open-label, dose-escalation and dose-expansion clinical trial will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ADCT-901 as monotherapy in patients with selected advanced solid tumors. For more information about the Phase 1 trial, please visit www.clinicaltrials.gov (identifier NCT04972981).

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 late-stage clinical 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210927005086/en/

Investors

Eugenia Litz

ADC Therapeutics

Eugenia.Litz@adctherapeutics.com

+44 7879 627205

Amanda Hamilton

ADC Therapeutics

amanda.hamilton@adctherapeutics.com

+1 917-288-7023

EU Media

Alexandre Müller

Dynamics Group

amu@dynamicsgroup.ch

+41 (0) 43 268 3231

USA Media

Mary Ann Ondish

ADC Therapeutics

maryann.ondish@adctherapeutics.com

Tel.: +1 914-552-4625

Source: ADC Therapeutics SA

FAQ

What is the purpose of the Phase 1 clinical trial for ADCT-901?

The Phase 1 clinical trial aims to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ADCT-901 in patients with advanced solid tumors.

What tumor types are being targeted by ADCT-901?

ADCT-901 targets advanced solid tumors with high unmet medical needs, particularly ovarian and triple-negative breast cancer.

When was the IND application for ADCT-901 cleared by the FDA?

The IND application for ADCT-901 was cleared by the FDA prior to the initiation of the clinical trial.

What is KAAG1 and why is it significant?

KAAG1 is a novel tumor antigen that is highly expressed in certain tumors, making it an attractive target for antibody-drug conjugates like ADCT-901.

What is the expected outcome of the ADCT-901 trial?

The trial aims to establish the safety and optimal dosing of ADCT-901, with hopes of demonstrating its effectiveness against targeted tumors.