On April 25, 2022 Quantum Leap Healthcare Collaborative (Quantum Leap) and Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, reported the selection of Ambrx’s antibody drug conjugate (ADC) ARX788 for a new investigational treatment arm in the I-SPY 2.2 TRIAL for the treatment of HER2-positive breast cancer in the neoadjuvant setting (Press release, Ambrx, APR 25, 2022, View Source [SID1234612928]). Sponsored by Quantum Leap, the I-SPY 2.2 TRIAL is a continuation of the I-SPY 2 TRIAL that seeks to create personalized treatments by adapting therapies for each patient to optimize the clinical outcome.

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"We are particularly excited about this collaboration," stated Dr. Laura J. Esserman, MD, MBA, Director of the Breast Care Center at the UCSF Helen Diller Family Comprehensive Cancer Center, and Principal Investigator of I-SPY Family of Trials. "We hope this will usher in an era of more targeted, effective and less toxic therapies for people with HER2-positive breast cancers, leveraging decades of investment in science and drug development, and delivering better treatment to patients when they need it most. This is the right drug, for the right patient at the right time."

I-SPY 2.2 is an adaptive Phase 2 clinical trial that evaluates emerging targeted agents, allowing those agents to either be combined with less toxic chemotherapeutic regimens or to replace cytotoxic chemotherapy entirely. ARX788 will be evaluated as a monotherapy, and in combination with the PD-1 targeting checkpoint inhibitor cemiplimab, in HER2-positive early-stage breast cancer in the neoadjuvant setting. Ambrx anticipates the ARX788 arms to begin enrolling patients in May 2022.

Quantum Leap, sponsor of the I-SPY 2.2 TRIAL, leads a pre-competitive consortium that includes the U.S. Food & Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from more than 16 major U.S. cancer research centers.

"I am thrilled that Quantum Leap has selected Ambrx’s antibody drug conjugate, ARX788, to be evaluated in the I-SPY 2.2 TRIAL," said Feng Tian, Ph.D., Chairman of the Board, President, and CEO of Ambrx. "We are encouraged by the favorable anti-tumor activity and safety profile of ARX788 for the treatment of early-stage breast cancer. It may provide a less toxic treatment option for patients through the precision conjugation of cytotoxic payloads targeting HER2 receptors. I look forward to collaborating with Quantum Leap and exploring the potential of our antibody drug conjugate in enabling effective chemo-free therapeutic treatments to patients."

ARX788 is an anti-HER2 antibody drug conjugate (ADC) that is being studied broadly in breast cancer, gastric/GEJ cancer and other solid tumors. ARX788 is a homogeneous and highly stable ADC that maximizes potential anti-tumor activity by optimizing the number and position of its payloads and the chemical bonds that conjugate the payloads to the antibody. The United States Food and Drug Administration (FDA) has granted ARX788 the Fast Track Designation for the treatment of HER2-positive metastatic breast cancer.