First Patient Dosed in Immunotherapy Trial for Relapsed Refractory Ovarian Cancer

Avenge Bio announced the dosing of the first patient in a First-in-Human Phase 1/2 clinical trial evaluating AVB-001 in relapsed refractory ovarian cancer. The company has developed the LOCOcyte Immunotherapy platform for the precision administration of potent immune effector molecules to treat solid tumors.

AVB-001, developed in the LOCOcyte platform, consists of proprietary engineered allogeneic human cells. The cells are encapsulated in a pro-inflammatory biomaterial that are delivered to the local tumor environment and generate high, sustained concentrations of native IL-2. The product initiates a robust and durable, local and systemic immune response while avoiding toxicities associated with systemic immunotherapies.

This first-in-human, single-arm, open-label, dose-escalation and expansion study (NCT05538624) is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of AVB-001 delivered intraperitoneally (IP) to patients with high grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube.

"The initiation of our first clinical trial of AVB-001 is a significant milestone for Avenge and the first candidate leveraging our LOCOcyte immunotherapy platform to enter the clinic. We are excited to advance AVB-001 as a potential treatment for patients with relapsed refractory ovarian cancer which has limited treatment options," said Michael Heffernan, Chief Executive Officer of Avenge.  

"Ovarian cancer is one of the most difficult cancers to treat. It is typically not detected until later stages, and about 70 percent of patients will have recurrence after an initial treatment, which is often fatal. Immune checkpoint inhibitors have limited activity in this disease and there is a critical need for novel and effective therapies. Patients with ovarian cancer and other peritoneal malignancies are uniquely positioned to benefit from this novel cellular therapy," added Dr. Claudio Dansky Ullmann, Avenge's Chief Medical Officer.

The LOCOcyte allogeneic cell-based immunotherapy platform enables potent localized modulation of the immune system which also precipitates a systemic immune response, allowing for the treatment of previously intractable cancers.