AVB-001 Receives FDA FTD in Platinum-Resistant Ovarian Cancer

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.

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.”

References

1. Avenge Bio receives FDA fast track designation for AVB-001, a novel cell therapy leveraging the LOCOcyte™ immunotherapy platform. News release. Avenge Bio, Inc. October 2, 2023. Accessed October 3, 2023. https://bit.ly/3rAwOq7
2. Avenge Bio announces successful completion of first dose level cohort in phase 1/2 clinical trial of AVB-001 for the treatment of ovarian cancer. News release. Avenge Bio, Inc. April 26, 2023. Accessed October 3, 2023. https://bit.ly/3LLuDHo