Avelas Biosciences Initiates Period 2 of Phase 2 Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery

August 2, 2018

SAN DIEGO, August 2, 2018 – Avelas Biosciences, Inc., a clinical stage oncology-focused company that is developing products to advance a new standard-of-care for cancer surgery and therapeutic intervention, today announced that the first patient has been dosed in Period 2 of its Phase 2 clinical trial of AVB-620 in women with primary, nonrecurrent breast cancer undergoing surgery.

“We are excited to have initiated the second period of our Phase 2 study of AVB-620 in women with breast cancer undergoing surgery,” said Carmine Stengone, President and Chief Executive Officer of Avelas Biosciences. “This second portion of our Phase 2 study should enable us to further demonstrate the accuracy of AVB-620 in distinguishing between malignant and nonmalignant tissues.”

“A technology like AVB-620 has the potential to revolutionize cancer surgery by enabling surgeons to visualize cancer while still in the operating room, and make informed, real-time decisions to improve surgical treatment,” said Steven Chen, M.D., Chief Medical Officer of Avelas Biosciences. “We believe that AVB-620 has the potential to significantly reduce the number of breast cancer re-operations, which would result in better outcomes for patients and substantial cost savings for healthcare payers.”

About the Phase 2 Study

The Phase 2 study of AVB-620 is a multi-center, open-label, single-arm study designed to evaluate patients during two separate trial periods. Period 1, which was completed in December 2017, enrolled 31 patients to evaluate optimal conditions to achieve differentiation between malignant and nonmalignant tissue using fluorescent signals. Period 2 of the Phase 2 study will enroll approximately 108 additional patients to assess the ability of AVB-620 to identify malignant tissue at or close to the surface of excised tissue and of tissue that would otherwise have been left behind. Additional information about this clinical trial is available at www.clinicaltrials.gov using the identifier: NCT03113825.

About Avelas Biosciences

Avelas Biosciences is a San Diego-based drug-device company focused on developing products to advance a new standard-of-care for cancer surgery and therapeutic intervention. The company’s lead candidate, AVB-620, has completed a Phase 1b clinical trial assessing safety, pharmacokinetics and fluorescence properties using tissue image analysis. A Phase 2 clinical trial for AVB-620 in breast cancer is ongoing. In addition, the company is advancing a therapeutic program, which utilizes the same technology platform. Avelas was founded on technology from Roger Y. Tsien, Ph.D., co-winner of the 2008 Nobel Prize in chemistry.

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