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FDA Clears IND For Iovance's IOV-5001 In Treating Cancer; Phase 1/2 Enrollment Planned For H2 2026

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us

Iovance Biotherapeutics Inc. (IOVA), a commercial-stage biopharmaceutical company, on Monday announced FDA clearance of the investigational new drug (IND) submission for IOV-5001, a tumor-infiltrating lymphocyte (TIL) therapy.

IOV-5001 was engineered to express the interleukin IL-12 within the targeted tumor and tethers the IL-12 to the cell surface to prevent release into the bloodstream, thus delivering significantly higher doses to the cancer cell. In preclinical studies, IOV-5001 showed consistent anti-tumor activity and a more durable T cell profile compared to existing TIL therapies.

The company plans to initiate enrollment in a Phase 1/2 trial in the second half of 2026. The trial is expected to enroll patients with advanced colorectal, triple-negative, and estrogen receptor-low breast cancers, and other solid tumors.

IOVA closed Monday at $3.96, down 3.41%. In the pre-market, shares are trading at $3.97, down 0.03%.

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