Avenge Bio previously presented positive preclinical data at the ASGCT 2022 meeting.
The FDA has cleared Avenge Bio’s investigational new drug application (IND) for AVB-001, an allogeneic cell therapy, for the potential treatment of metastatic peritoneal cancers.1
"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," Michael Heffernan, chief executive officer, Avenge Bio, said in a statement.1
The phase 1 trial is expected in initiate in the second half of 2022 and will evaluate the tolerability of the therapy, determine the recommended phase 2 dose, assess antitumor activity, and measure immunological changes in the blood and peritoneal environment. Participants with platinum resistant ovarian cancer will be treated with an intraperitoneal administration of AVB-001 in the trial.
AVB-001 consists of IL-2-secreting cells encapsulated in immune-activating alginate capsules.It is developed using Avenge’s LOCOcyte platform designed to produce a controlled, allogeneic cell therapy with the use of immunomodulators and biomaterials. The platform offers advantages in producing potent, localized therapies that generate a robust immune response that should be effective in metastases as well without systemic toxicity.
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"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," Claudio Dansky Ullmann, MD, chief medical officer, Avenge Bio, added to the statement.1
Avenge previously presented positive preclinical data on AVB-001 at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting, May 16-19, in Washington DC.2 These data demonstrated the therapy’s ability to eradicate solid tumors with a tolerable safety profile.
“We are excited to present additional preclinical data that support our lead development program, AVB-001, as we advance towards filing an IND in Q2 2022 and a Phase 1 clinical trial in ovarian cancer in 2H 2022,” Douglas Carlson, chief operating and financial officer, had said in a previous statement.2 “In addition, we continue to build a robust data set for AVB-001, a novel immunotherapy, in malignant pleural mesothelioma. All of our development programs leverage Avenge’s LOCOcyte platform to deliver proprietary encapsulated engineered human cells to the local tumor environment.