Ernexa’s stem cell therapy could soon enter ovarian cancer trials
Company says FDA in alignment on development approach
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Ernexa Therapeutics is making headway on plans to start clinical testing of ERNA-101, its stem cell therapy designed to treat ovarian cancer.
The U.S. Food and Drug Administration (FDA) at a recent meeting “provided strong regulatory alignment on Ernexa’s development approach” and outlined a clear pathway for what will be needed for the agency to approve an investigational new drug application (IND) asking for permission to start testing the therapy in people, according to a company press release.
“We are very pleased with the outcome of our engagement with the FDA,” said Sanjeev Luther, president and CEO of Ernexa. “The Agency’s feedback validates our development strategy and gives us the green light to move forward with urgency.”
With feedback from the FDA in hand, Ernexa is accelerating its plans to develop ERNA-101 and expects to initiate a clinical trial in the second half of this year. Tech transfer — the process by which the company transfers information needed to manufacture the therapy to the sites where manufacturing will take place — is in progress, the company said.
‘Transformative’ therapy
“We are operating at full speed to bring our first-in-human studies online in 2026,” Luther said. “This is a major step toward delivering transformative cell therapies to patients with serious and underserved diseases.”
Ovarian cancer is a form of gynecological cancer that develops due to the uncontrolled growth of cells around the ovaries. Available treatments, such as chemotherapy, are limited, with cancers often recurring following therapy.
ERNA-101 contains mesenchymal stem cells (MSCs). These specialized stem cells are able to grow into certain types of bodily tissue as well as secrete signaling molecules to coordinate the activity of other cells in the body. ERNA-101 uses MSCs engineered from cells collected from healthy donors. The cells are modified to target and travel to the sites of ovarian tumors, secreting signaling molecules that activate immune cells to attack and destroy the tumors.
Ernexa is also developing ERNA-201, an MSC-based therapy designed to suppress immune activity, to treat autoimmune diseases.
