Avelas Biosciences Initiates Phase 1b Trial of AVB-620 in Breast Cancer Patients

April 16, 2015

Avelas Biosciences Initiates Phase 1b Trial of AVB-620 in Breast
Cancer Patients

Company Appoints Breast Cancer Surgeon Steven Chen, M.D., as Vice President of Clinical Affairs

SAN DIEGO, April 16, 2015 — Avelas Biosciences, an in vivo cancer diagnostic company dedicated to improving cancer surgeries, announced today that it has initiated a Phase 1b study of its lead fluorescent cancer illuminator, AVB-620, in women with primary, non-recurrent breast cancer undergoing surgery. In commencing the clinical trial, the company also welcomed the addition of Steven Chen, M.D., as vice president of clinical affairs.

The open label, dose escalation study will enroll up to 39 women with stage I-III breast cancer undergoing lumpectomy or mastectomy and lymph node assessment. The study will evaluate AVB-620 safety and tolerability, pharmacokinetics, and determine the dose needed to generate fluorescence signals in tumor and lymph node tissues to enable recordings and image analysis. Additionally, the study will evaluate the effect of timing of AVB-620 administration, relative to surgery, on fluorescence characteristics.

“While there has been tremendous progress in the development of new cancer therapeutics, there has been very little progress on helping surgeons visualize the boundary between healthy and cancerous tissue during surgery,” said Dr. Chen. “Without better techniques, surgeons are forced to rely on pathology results that take days to determine whether all of the cancer has been successfully removed, forcing too many women to undergo a second surgery to remove cancerous tissue left behind. I’m very hopeful about the potential of AVB-620 to enable surgeons to visualize and completely excise all of the cancerous tissue during the first surgery. Addressing this gap in the
current surgical paradigm is a key reason why I’m joining Avelas Biosciences to help drive the clinical development of this promising new diagnostic.”

Prior to joining Avelas Biosciences, Dr. Chen was an associate professor of surgery and the associate program director of the surgical oncology training program at City of Hope National Medical Center. Before that he served as the chief of breast surgery at UC Davis Medical Center. Dr. Chen maintains a practice in San Diego as director of surgical oncology at OasisMD.

Dr. Chen serves as a director on the board of the American Society of Breast Surgeons and the Frederick A. Coller Surgical Society. He also serves on the training committee of the Society of Surgical Oncology which accredits breast surgical oncology training programs, as well as serving on a number of committees for other national professional societies including the American Medical  Association and the American College of Surgeons, as well being an active member of the American Society of Clinical Oncology and the Society of University Surgeons.

“That an eminent practicing surgical oncologist such as Dr. Chen would leave a successful clinical practice to join our leadership team underscores the urgent need for agents such as AVB-620,” said Carmine Stengone, president and CEO of Avelas Biosciences. “His experience being immersed in the challenges of the current standards of care can be directly applied to the development of AVB-620, which may prevent many of the 40,000 or more unnecessary secondary breast surgeries each year in the U.S., save the health system millions of dollars annually, and most importantly, drastically improve patient care and recovery.”

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