Avenge Bio has completed the first dose level cohort in its Phase I/II clinical trial of AVB-001, designed for the treatment of patients with refractory ovarian cancer.
The safety, tolerability, pharmacokinetics and pharmacodynamics properties of AVB-001 are evaluated in the single-arm, open-label, first-in-human, dose-escalation and expansion study.
The study will also evaluate preliminary efficacy of AVB-001 when delivered intraperitoneally (IP) to patients with high grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube.
AVB-001 has been well tolerated in the first cohort with no dose-limiting toxicities, on-target or off-target toxicities, or other unexpected events.
Avenge Bio chief medical officer Claudio Dansky Ullmann said: “We are pleased to complete the first dose cohort in this Phase I/II clinical trial. 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 programme in the second half of 2023.”
The company noted that investigators have commenced second dose level cohort dosing.
Claimed to be Avenge’s advanced product candidate, AVB-001 produces native IL-2 immunotherapy. Initially, it is being studied in metastatic peritoneal cancers including ovarian cancer.
In addition to ovarian cancer, Avenge is developing programmes for other peritoneal malignancies and pleural cancers such as malignant pleural mesothelioma.
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