Monday, October 02, 2023
Avenge Bio, Inc. ("Avenge"), a biotechnology company specializing in the development of the LOCOcyte™ Immunotherapy platform for precise delivery of potent immune effector molecules to treat solid tumors, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for AVB-001 in the treatment of patients with relapsed resistant/refractory ovarian cancer.
Michael Heffernan, CEO of Avenge Bio, expressed their satisfaction with receiving FDA Fast Track designation for AVB-001, citing the substantial unmet medical need in platinum-resistant, refractory ovarian cancer.
The FDA's Fast Track program expedites the development and review of drug candidates for serious conditions with unmet medical needs. This designation applies not only when there are no existing treatments but also for drugs that may offer advantages over currently available therapies. Fast Track designation leads to increased FDA meetings to discuss development, trial design, clinical data, and the submission of a Biologics License Application (BLA).
In January 2023, Avenge announced the initiation of an open-label, First-in-Human, Phase 1/2, multicenter study (NCT05538624) designed to evaluate the safety and efficacy of AVB-001. AVB-001 is an encapsulated cell product engineered to produce native human interleukin-2 (hIL-2) and is administered intraperitoneally (IP) to patients.
In addition to advancing the lead clinical trial for ovarian cancer, Avenge is exploring the potential of AVB-001 in addressing other high unmet medical needs in peritoneal malignancies and pleural cancers.
Avenge Bio's LOCOcyte™ allogeneic cell-based immunotherapy platform enables potent localized modulation of the immune system, eliciting a systemic immune response to treat previously challenging cancers. This technology offers three significant advantages .Generation of potent immune effector molecules through synthetic engineering of allogeneic cells, creating a therapy that is readily deployable.Localization of the therapy near the primary tumor site, stimulating both innate and adaptive immune responses.Training the patient's immune system to generate a robust response that targets and eliminates distant metastases without causing systemic toxicity.