Investigators are assessing AVB-001 as a treatment for those with high-grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube in a phase 1/2 trial.
The FDA has granted fast track designation to the investigational AVB-001 as a therapy for patients with platinum-resistant relapsed/refractory ovarian cancer, according to a press release from Avenge Bio, Inc.1
AVB-001 is currently under assessment as part of an open-label, first-in-human, phase 1/2 multi-center study (NCT05538624) in patients with refractory ovarian cancer. It was noted that investigators completed the first dose cohort in April 2023.2 In this cohort, investigators reported that there were no dose-limiting toxicities and that treatment with AVB-001 was well tolerated.
“We are extremely pleased to receive the FDA fast track designation for AVB-001 based on [the] FDA’s review of our preclinical and emerging clinical data,” Michael Heffernan, chief executive officer at Avenge Bio, said in the press release.1 “The fast track designation has been provided for platinum-resistant, refractory ovarian cancer, and acknowledges the potential for AVB-001 to treat this significant unmet medical need.”
Developers designed AVB-001 as an encapsulated cell product for producing native IL-2 via intraperitoneal administration. The agent is also being manufactured for managing other peritoneal malignancies and pleural cancers.
Investigators of the phase 1/2 trial evaluated AVB-001 at escalating single doses between 0.6 and 3.6 ug human IL-2/kg per day as part of the dose escalation phase. In the dose expansion phase, AVB-001 will continue to be administered at the maximum-tolerated dose or recommended phase 2 dose. Additional expansion cohorts in part 2 may assess AVB-001 on its own or as part of exploratory combination strategies.
The trial’s primary end points include dose-limiting toxicities, treatment-emergent adverse effects (TEAEs) and serious AEs, and investigator-assessed objective response rate (ORR) based on RECIST v1.1 criteria. Secondary end points include duration of response, progression-free survival, and overall survival.
Patients 18 years and older with histologically confirmed, metastatic or unresectable, platinum-resistant, high-grade, serous adenocarcinoma of the ovary, peritoneum or fallopian tube who have received no more than 5 prior lines of therapy are able to enroll on the trial. Additional eligibility criteria include having an ECOG performance status of 0 or 1 at screening; adequate absolute neutrophil counts, hemoglobin levels, platelet counts, and creatinine clearance; and evidence of measurable disease per RECIST v1.1 criteria.
Those with low-grade serous, mucinous, clear cell, or endometrioid adenocarcinoma of the ovary, primary peritoneum, or fallopian tube are unable to enroll. Additional exclusion criteria include having another malignancy 3 years prior to beginning study treatment, or a known or suspected allergy to AVB-001.
“We are pleased to complete the first dose cohort in this phase 1/2 clinical trial,” Claudio Dansky Ullmann, MD, chief medical officer at Avenge Bio, said in a press release at the time of the first dose cohort completion.2 “Although early, we are encouraged by the initial observations in this first dose level indicating the potential for this allogeneic cell-based immunotherapy. We look forward to announcing additional data on this program in the second half of 2023.”