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Developing a More Precise Allogeneic Cell Therapy for Ovarian Cancer

Michael Heffernan, chairman and chief executive officer, Avenge Bio, discussed the IND clearance of AVB-001 and the soon-to-initiate phase 1 trial.

“It'll be a first-in-human trial in ovarian cancer patients who have failed prior treatments of standard of care, platinum therapy, and so on. Those patients who are enrolled will get a single administration in the peritoneal cavity of the product AVB-001 and we will be looking at all of the safety parameters.”

Avenge Bio will soon be initiating a first-in-human phase 1 trial of AVB-001, an allogeneic cell therapy for the potential treatment of metastatic peritoneal cancer after the FDA cleared its investigational new drug application. The trial, expected to initiate in the second half of 2022, will evaluate the tolerability of an intraperitoneal administration of the therapy, determine the recommended phase 2 dose, assess antitumor activity, and measure immunological changes in the blood and peritoneal environment inparticipants with platinum resistant ovarian cancer.

AVB-001 is developed using Avenge’sLOCOcyte platform and consists of IL-2-secreting cells encapsulated in immune-activating alginate capsules. The platform is designed to produce a controlled, allogeneic cell therapy with the use of immunomodulators and biomaterials and offers advantages in generating a robust immune response that should be effective in metastases as well without systemic toxicity.

CGTLive spoke with Michael Heffernan, chairman and chief executive officer, Avenge Bio, to learn more about the trial, its goals and endpoints. He also discussed the advantages that the LOCOcyte platform offers in developing allogeneic cell therapies.

Avenge Bio announces FDA clearance of the AVB-001 IND for the treatment of ovarian cancer, a novel cellular therapy leveraging the LOCOcyte™ immunotherapy platform. News release. Avenge Bio. AUgust 3, 2022. https://www.prnewswire.com/news-releases/avenge-bio-announces-fda-clearance-of-the-avb-001-ind-for-the-treatment-of-ovarian-cancer-a-novel-cellular-therapy-leveraging-the-lococyte-immunotherapy-platform-301598446.html