Avelas Receives FDA Breakthrough Therapy Designation for Pegloprastide (AVB-620) for Use During Breast Cancer Surgery

Avelas Biosciences, Inc., pioneering the field of intraoperative fluorescent cancer imaging, today announced that the company has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for pegloprastide (AVB-620) for the intraoperative detection and visualization of positive margins during breast cancer surgery. Pegloprastide is designed to deliver a fluorescent marker to cancer cells to aid surgeons in identifying positive margins in real time during surgery. Positive margins can be a sign that cancer may be left behind, requiring a second surgery.

“We now have clarity on the development path to make fluorescence image-guided surgery the new standard of care for breast cancer lumpectomies,” said Jay Lichter, Ph.D., Chairman, President, and Chief Executive Officer of Avelas. “Pegloprastide has the potential to greatly reduce the number of repeat surgeries, potentially improving outcomes for hundreds of thousands of women and saving thousands of lives.”

The presence of positive margins is a significant challenge in breast-conserving surgery. Positive surgical margins occur when post-operative pathology indicates cancer cells are present at or very close to the edge of removed tissue, indicating that there may be residual cancer left behind after an operation. It is estimated that each year in the United States more than 260,000 women undergo a lumpectomy, of which one-third (more than 80,000) are repeat surgeries with the goal of achieving negative margins.1 Beyond that, of the estimated 90,000 women who choose a mastectomy, many choose it for fear of incomplete initial lumpectomy or due to an initial attempt at a lumpectomy that resulted in positive margins.1

The FDA’s Breakthrough Therapy designation is intended to expedite the development and review of a drug candidate that is under investigation to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints. A Breakthrough Therapy designation provides more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review.

Previously reported positive top-line data from the company’s completed Phase 2/3 study, which evaluated the safety and efficacy of pegloprastide in women with primary, nonrecurrent breast cancer undergoing surgery, met its primary endpoint of detecting cancer in margin specimens in real time (p<0.001). The data showed use of pegloprastide during surgery correctly identified cancer in up to 75% of patients who would have otherwise been candidates for a repeat (re-excision) surgery. Observed re-excision rate in the study was 6% in patients whose surgeries included pegloprastide. Current re-excision rates are estimated at 20-40% among all patients receiving an initial lumpectomy. 2-7