2022-08-03| Trials & Approvals

LOCOcyte – Avenge Bio’s Potential Treatment for Ovarian Cancer gets FDA Clearance

by Max Heirich
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On August 3, Avenge Bio announced that the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) application for AVB-001 in peritoneal malignancies. Avenge Bio expects to start the Phase 1 clinical trial in the latter half of 2022. 

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Avenge Bio’s LOCOcyte™ platform and Ovarian Cancer

The LOCOcyte platform is Avenge Bio’s immunotherapy platform which administers potent immune effector molecules for the treatment of solid tumors. The platform achieves this by creating a controlled cell therapy leveraged by immunomodulators and biomaterials.

LOCOcyte possesses a few unique advantages over its competitors. First, it generates potent immune effector molecules by synthetically engineering allogeneic cells, creating a ready-to-use therapy. Then, the treatment develops an innate and adaptive immune response after localization to the primary tumor site. Finally, the platform engineers the patient’s immune system to destroy metastasized cells without raising toxicity levels. 

This platform’s first-in-human clinical trial centers around AVB-001, a treatment that produces the Proleukin Interleukin-2 (IL-2). IL-2 is a cytokine signaling molecule in the immune system which activates white blood cells. The line of thinking is that administering this protein will produce an enhanced immune response against solid tumors, specifically those in the ovaries. 

Dr. Claudio Dansky Ullmann, Avenge Bio’s Chief Medical Officer said, “Ovarian cancer is one of the most difficult cancers to treat. It is typically not detected until later stages, and most patients will recur after an initial treatment, which is often fatal. As a clinician, I am looking forward to the potential impact for these patients. Patients with metastatic peritoneal cancer are uniquely positioned to benefit from this novel cellular therapy.”

FDA Allows The Clinical Trial to be Conducted

The subjects for the upcoming clinical trial will be patients with platinum-resistant ovarian cancer. This is a condition with very few treatment options at this time. 

Michael Heffernan, Chief Executive Officer of Avenge Bio, said, “We are very pleased to be advancing AVB-001 into the upcoming clinical trial as a potential treatment for patients with metastatic ovarian cancer, a life-threatening disease. The FDA’s clearance of our IND represents a significant milestone for Avenge and the first to be cleared leveraging the LOCOcyte™ technology platform.”

With the FDA having granted clearance, the Phase 1 multi-center clinical trial begins in the second half of 2022. This trial has three goals: to evaluate the tolerability of AVB-001 in patients, determine a dose amount for a Phase 2 trial, and assess the treatment’s anti-tumor activity. 

Should the results of the coming trial prove to meet the expected endpoints positively, there could very likely be a new treatment for ovarian cancer in the coming years. 

Related Article: First Patient Dosed in Anti-tumor Clinical Trial

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