Combination therapy completely clears ovarian cancer in lab mice
Immunotherapy-cell therapy combo wipes out disease in 2/3 of animals in study
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Combining immunotherapy with an experimental cell therapy from Ernexa Therapeutics completely eliminated ovarian cancer in two-thirds of mice in laboratory experiments.
The new data, from experiments conducted by an independent group, bolster evidence for the drug, ERNA-101, as the company seeks regulatory approval to begin clinical testing in people. Ernexa plans to submit an application to the U.S. Food and Drug Administration (FDA) in the third quarter, with the goal of starting a clinical trial before the end of the year.
“This independent study represents an important milestone as we transition from a preclinical company to a clinical-stage oncology company,” Sanjeev Luther, president and CEO of Ernexa, said in a company press release. “Independent reproduction of [earlier] findings in a larger, statistically robust study substantially increases our confidence in ERNA-101 and meaningfully strengthens the scientific foundation supporting our upcoming [application to the FDA].”
Finding hidden tumor cells
Ovarian cancer is a form of gynecological cancer caused by the uncontrolled growth of cells around the ovaries. Available treatments, such as chemotherapy, are often not effective at fully controlling the cancer or preventing it from growing back.
One reason ovarian cancer can be difficult to treat is that ovarian tumors tend to be immunologically cold: In other words, the tumor cells deploy molecular mechanisms that help them hide from the body’s immune system, which can normally kill cancer cells. A class of immunotherapies called PD1 inhibitors, which block signals that cancer cells use to evade the immune system, has shown powerful anticancer activity in many forms of cancer. But in immunologically cold ovarian tumors, PD1 inhibitors alone usually aren’t sufficient to trigger a cancer-killing immune response.
ERNA-101 uses stem cells collected from healthy donors and engineered to travel to ovarian tumors and secrete signaling molecules that prompt the immune system to more effectively target cancer cells. The goal is to turn the immunologically cold tumor hot, allowing other treatments, such as PD-1 inhibitors, to act more potently.
“One of the greatest challenges in immuno-oncology is that many solid tumors remain effectively invisible to the immune system,” said Robert H. Pierce, MD, Ernexa’s chief scientific officer. “We believe ERNA-101 has the potential to become an important combination immunotherapy platform for ovarian cancer and potentially numerous other immunologically ‘cold’ solid tumors where today’s checkpoint inhibitors have produced limited clinical benefit.”
Some of the mice in the experiments were treated with ERNA-101 or PD1 inhibitors alone, while others received both ERNA-101 and PD1 inhibitors in combination.
When used alone, neither ERNA-101 nor PD1 inhibitors completely cleared tumors in any of the mice tested. But when both treatments were combined, tumors were completely eradicated in 10 of 15 treated mice.
“Complete tumor eradication and long-term survival were observed only with the ERNA-101 combination therapy, reinforcing our belief that ERNA-101 has the potential to unlock the full therapeutic benefit of checkpoint inhibitors in ovarian cancer and potentially many other immunologically ‘cold’ solid tumors,” Luther said.
Pierce said the results “provide compelling validation that ERNA-101 may successfully remodel the tumor microenvironment, recruit and activate [cancer-killing immune] cells, and dramatically enhance the activity of PD-1 checkpoint inhibitors.”
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