SAN DIEGO--(BUSINESS WIRE)--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?

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?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

About Pegloprastide (AVB-620) and QUEST SPECTRUM? Fluorescent Imaging Device

Pegloprastide (AVB-620) is based on the science of activatable cell-penetrating peptides and is the only fluorescence-based clinical cancer detection product that uses the ratio of two fluorophores within the same molecule (ratiometric imaging) to provide more accurate and actionable information. Pegloprastide?s ratiometric readout attenuates common artifacts of fluorescent imaging, including differences in drug concentration and distance of the camera from the tissue area of interest. Pegloprastide is used during surgery with a specialized fluorescent imaging device manufactured for Avelas by?Quest Medical Imaging, based on its?QUEST SPECTRUM? platform?technology. QUEST SPECTRUM? device has a wide field of view and provides a rapid assessment of tissue. Beyond breast cancer, Avelas has plans to explore the use of pegloprastide during surgery for other types of cancer, including ovarian, colorectal, head and neck, melanoma, and sarcoma.

About Quest

Quest Photonic Devices is a group of companies that is developing high-end multispectral imaging cameras and light sources for medical and industrial use. Through its subsidiary companies, Quest Medical Imaging B.V. and Quest Medical Imaging Inc., Quest focuses specifically on the medical market of fluorescence image-guided surgery and is committed to improving patient care and surgical outcomes.

About Avelas Biosciences

Avelas Biosciences is a biotechnology company focused on developing pegloprastide (AVB-620), a novel drug-device combination product for use during cancer surgery. Pegloprastide is designed to improve surgery by detecting cancer in real time and has the potential to become part of standard-of-care treatment for a variety of cancer surgeries. Avelas was founded on technology from Roger Y. Tsien, Ph.D., co-winner of the Nobel Prize in Chemistry 2008. Avelas is headquartered in San Diego. For more information, visit?www.avelasbio.com?or email?info@avelasbio.com.

References

1. MedInsight (2014-2017); JAMA (2009-2017); L.E.K. Consulting Market Research Analysis (2019) 2. Chagpar AB, Killelea BK, Tsangaris TN, et al. A Randomized, Controlled Trial of Cavity Shave Margins in Breast Cancer. N Engl J Med. 2015;373(6):503-510. 3. Metcalfe LN, Zysk AM, Yemul KS, et al. Beyond the Margins-Economic Costs and Complications Associated with Repeated Breast-Conserving Surgeries. JAMA Surg. 2017;152(11):1084-1086. 4. Fitzgerald S, Romanoff A, Cohen A, et al. Close and Positive Lumpectomy Margins Are Associated with Similar Rates of Residual Disease with Additional Surgery. Ann Surg Oncol. 2016;23(13):4270-4276. 5. Chagpar AB, et al. Abstract PD8-07: Does resection of cavity shave margins result in lower positive margin and re-excision rates in patients with stage 0-III breast cancer? Results from a prospective multicenter randomized controlled trial. San Antonio Breast Cancer Symposium Abstract: 2018. 6. Singer L, Brown E, Lanni T Jr. Margins in breast conserving surgery: The financial cost and potential savings associated with the new margin guidelines. Breast. 2016;28:1-4. 7. Kuritzky A, et al. Re-excision and Recurrence in a 5-year Follow-up of a BCS Cohort. Moffit Cancer Center. Poster Presentation: 2017.