Trial Okayed for Engineered Cell Cancer Therapy

Tumor infiltrating lymphocyte illustration (M.D. Anderson Cancer Center)

21 July 2022. A clinical trial is set to begin testing engineered immune-system cells designed to precisely target and infiltrate cancerous tumors without other potentially toxic proteins. Obsidian Therapeutics Inc. in Cambridge, Massachusetts and M.D. Anderson Cancer Center in Houston say the Food and Drug Administration cleared their investigational new drug application, in effect a request to begin clinical trials, of an experimental treatment for solid-tumor cancers.

Obsidian Therapeutics is a seven year-old company developing synthetic cell and gene therapies to treat cancer and other diseases. The company’s technology is based on research by its scientific founder Thomas Wandless, a biochemistry professor at Stanford University. Obsidian creates fusion proteins as therapies, expressed from what the company calls gene cassettes, that join together genetic components for proteins with ligands or binding molecules for stability, with a drug-responsive domain protein. On their own, drug-responsive domain proteins are unstable, but Obsidian says its fusion proteins correct for this instability, making it possible for its cancer treatments to work without adding more immune support from interleukin-2 or IL2 therapy that can be toxic for some patients.

The company’s lead therapy candidate, code-named OBX-115, is designed as a treatment for solid-tumor cancers, beginning with melanoma, an aggressive form of skin cancer. American Cancer Society expects nearly 100,000 new cases of melanoma to be diagnosed in the U.S. this year, leading to 7,650 deaths.

Study OBX-115 safety and efficacy

Obsidian Therapeutics is developing OBX-115 with M.D. Anderson, part of the University of Texas system, in a collaboration begun in Nov. 2020 to create engineered tumor-infiltrating lymphocytes or TILs, white blood cells in the immune system, to treat solid tumor cancers. The new clinical trial is expected to be an early-stage study of OBX-115 safety in patients with metastatic melanoma, who have relapsed or not responded to other treatments, but is also expected to generate early indicators of efficacy. CTMC, short for Cell Therapy Manufacturing Center and a joint venture between M.D. Anderson and biotechnology manufacturing company National Resilience, will produce doses of OBX-115 for the trial.

“We believe OBX-115 therapy has the potential to significantly transform the treatment landscape for patients,” says Paul Wooten, Obsidian Therapeutics CEO in a statement, “bringing broader access to TILs with the elimination of concomitant IL2 therapy, and the potential to achieve improved clinical outcomes.”

“Preclinical studies suggest OBX-115 has the potential to show efficacy in these patients,” adds Rodabe Amaria, professor of melanoma oncology at M.D. Anderson, “and OBX-115 does not require patients to receive concomitant IL2 therapy.” Amaria also notes, “There is a significant opportunity to improve the standard of care in melanoma, especially in later line patients and those who have not responded well to immune checkpoint therapies.”

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