Therapy Areas: Cardiovascular
ARX788 Included in the I-SPY 2.2 Phase 2 Adaptive Clinical Trial for Breast Cancer
25 April 2022 - - US-based biopharmaceutical company Ambrx Biopharma Inc's (NYSE: AMAM) antibody drug conjugate ARX788 has been selected 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, the company and US-based Quantum Leap Healthcare Collaborative said.

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.

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 US Food and Drug Administration, industry, patient advocates, philanthropic sponsors, and clinicians from more than 16 major US cancer research centers.

ARX788 is an anti-HER2 antibody drug conjugate 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 has granted ARX788 the Fast Track Designation for the treatment of HER2-positive metastatic breast cancer.

Ambrx is a clinical stage biopharmaceutical company using an expanded genetic code technology platform to discover and develop Engineered Precision Biologics.

These include next generation antibody drug conjugates, bispecifics, targeted immuno-oncology therapies, novel cytokines to modulate the immune system, and long-acting therapeutic peptides for metabolic and cardiovascular disease.

Ambrx is advancing a robust portfolio of clinical and preclinical programs designed to optimize efficacy, safety and ease of use, in multiple therapeutic areas, including its lead product candidate ARX788.

In addition, Ambrx has clinical collaborations with multiple partners, for drug candidates generated using Ambrx technology.

The I-SPY 2 TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis) was designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures).

The trial is a unique collaborative effort by a consortium that includes the Food and Drug Administration, industry, patient advocates, philanthropic sponsors, and clinicians from more than 20 major US cancer research centers.

Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations.

Quantum Leap Healthcare Collaborative is a 501(c) (3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs.


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