On October 2, 2023 Avenge Bio, Inc. ("Avenge" or the "Company"), a biotechnology company developing the LOCOcyte Immunotherapy platform for the precision administration of potent immune effector molecules to treat solid tumors, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for AVB-001 for treatment of patients with relapsed resistant/refractory ovarian cancer (Press release, Avenge Bio, OCT 2, 2023, View Source [SID1234635577]).
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"We are extremely pleased to receive the FDA Fast Track designation for AVB-001 based on FDA’s review of our preclinical and emerging clinical data. 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," said Michael Heffernan, CEO at Avenge Bio.
FDA Fast Track program is designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fulfill an unmet medical need. The Fast Track designation is available not only where treatments do not exist, but also for drugs that demonstrate a potential advantage over available therapies. Once granted Fast Track designation, the FDA increases the frequency of meetings to discuss the development, trial design, clinical data, and submission of the 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 delivered intraperitoneally (IP) to patients.
In addition to advancing the lead clinical trial in ovarian cancer, Avenge is also developing AVB-001 for additional conditions of high unmet needs in other peritoneal malignancies and pleural cancers.
About LOCOcyte Platform
Our LOCOcyte allogeneic cell-based immunotherapy platform enables potent localized modulation of the immune system which also precipitates a systemic immune response, allowing us to treat previously intractable cancers. The technology leverages three unique advantages:
Potent immune effector molecules are generated by synthetically engineering allogeneic cells creating a ready-to-use therapy,
Therapy is localized in proximity to the primary tumor site and generates innate and adaptive immune response, and
The immunomodulator trains the patient’s immune system generating a robust immune response that seeks and eradicates distal metastasis without systemic toxicity.