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Quantum Leap, Ambrx to include ADC in Phase II breast cancer trial

Quantum Leap Healthcare Collaborative and Ambrx Biopharma have selected the latters antibody drug conjugate ADC ARX788 for a new investigational treatment arm in the Phase II ISPY 2.2 TRIAL to treat HER2positive breast cancer in the neoadjuvant setting. An antiHER2 antibody drug conjugate ADC ARX788 is being analysed widely in breast cancer gastric gastroesophageal junction GEJ cancer and various other solid tumours. The adaptive trial is sponsored by Quantum Leap and assesses developing targeted agents to combine them with less toxic chemotherapeutic regimens or to completely replace cytotoxic chemotherapy. The company expects to commence subject enrolment in the ARX788 arms in May this year. In the trial ARX788 will be assessed as a single agent and along with the programmed cell death protein 1 PD1 targeting checkpoint inhibitor cemiplimab in subjects with HER2positive earlystage breast cancer in the neoadjuvant setting.

ISPY 2.2 follows the ISPY 2 TRIAL designed to quickly analyse encouraging experimental therapies and detect the most effective ones in specific patient subgroups depending on molecular characteristics. Ambrx Biopharma board chairman president and CEO Feng Tian said I am thrilled that Quantum Leap has selected Ambrxs antibody drug conjugate ARX788 to be evaluated in the ISPY 2.2 TRIAL. We are encouraged by the favourable antitumour activity and safety profile of ARX788 for the treatment of earlystage breast cancer. It may provide a less toxic treatment option for patients through the precision conjugation of cytotoxic payloads targeting HER2 receptors. In April last year Quantum Leap concluded subject enrolment in the icatibant arm of the ISPY COVID Trial analysing various agents to treat critically ill patients.

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