Avelas Biosciences Announces Positive Interim Phase 1b Results and Advances to Dose Expansion Stage

May 9, 2016

Initiates Stanford Cancer Center as Third Clinical Trial Site alongside UCSD Moores Cancer Center and UCSF Helen Diller Cancer Center

SAN DIEGO, May 9, 2016 — Avelas Biosciences, Inc., a clinical stage oncology-focused company dedicated to improving cancer patient care from diagnosis through treatment, today announced positive interim results from a Phase 1b trial of its AVB-620 surgical marker in women with primary, non-recurrent breast cancer undergoing surgery.

Fifteen patients were enrolled at UCSD Moores Cancer Center in the initial dose escalation part of the Phase 1b trial, the purpose of which was to evaluate safety and pharmacokinetics and to determine the dose for additional imaging analysis in the next stage of the study. Interim analysis showed no toxicity issues, differentiated fluorescence between cancerous and non-cancerous tissue and identified a preferred dose to take forward into the expansion phase of the trial.

“I’m delighted to announce that our Phase 1b trial is proceeding as planned,” said Carmine N. Stengone, president and chief executive officer of Avelas Biosciences. “We are seeing a clearly differentiated signal from cancerous versus non-cancerous tissue with no safety concerns and a selected dosage, based on fluorescence performance, with which we can proceed. Given these results, we look forward to presenting data from the completed study later this year.”

“Fluorescent surgical markers like AVB-620 have the potential to transform cancer surgery by finally enabling surgeons to see cancer and make real-time decisions to improve surgical treatment,” said Anne Wallace, M.D., Director of the Comprehensive Breast Health Center at Moores Cancer Center at UC San Diego Health. “Long term, this technology could lead to decreased surgical time and a reduction in the number of re-operations, both of which could result in better outcomes for patients and substantial cost savings.”

Avelas is now advancing the dose-expansion stage of the Phase 1b trial, for which several patients have already been enrolled, where the focus remains on safety, pharmacokinetics, and the timing of imaging after AVB-620 administration. The company expects to announce data from its completed Phase 1b trial later this year, by which time a total of 27 patients is expected to have been enrolled. Coincident with advancing to the dose-expansion stage, a third clinical site for the trial has been initiated, the Stanford Cancer Center Palo Alto, with Irene Wapnir, M.D., Professor of Surgery at the Stanford University Medical Center, serving as the site’s principal investigator.

About AVB-620

AVB-620 is an intravenously administered in vivo fluorescent protease-activatable peptide that detects, labels, and visualizes cancer. The initial indication is intraoperative identification of primary tumor extent and metastatic lymph nodes in breast cancer patients. AVB-620 displayed outstanding preclinical data with sensitivity of >95% in preclinical breast cancer models and 100% in ex vivo analysis of human breast cancer tissue. AVB-620 is currently being evaluated in a phase 1b clinical study in breast cancer patients.

About Avelas Biosciences

Avelas Biosciences is a San Diego-based biotechnology company focused on developing technologies that advance a new standard-of-care for cancer surgery and therapeutic intervention. The company’s lead candidate, AVB-620, is in a Phase 1b trial planned for enrollment of 27 breast cancer patients, assessing safety, pharmacokinetics and fluorescence properties using tissue image analysis. Avelas was founded by Avalon Ventures on technology from Nobel laureate Roger Y. Tsien, Ph.D.


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