The U.S. Food and Drug Administration recently greenlit a Phase 1 clinical trial for TGW101, a novel therapy designed to attack TAG-72 in advanced solid tumors, potentially including prostate cancer.
TAG-72 is a mucin-like protein often found on the surface of cancer cells, including those in the prostate. Studies show it appears in about 80-88% of primary prostate cancers, especially in tumors with higher Gleason scores, a measure of cancer aggressiveness. It’s also present in precancerous lesions, suggesting a role early in the disease. However, its expression drops sharply in metastatic cases, with only 17% of lymph node metastases and half of bone metastases showing significant levels. Hormonally treated tumors also lose much of this protein, complicating its use in advanced prostate cancer patients who need treatment most.
The new drug, TGW101, is an antibody-drug conjugate, a type of therapy that delivers a toxic payload directly to cancer cells. Unlike traditional drugs, TGW101 uses a unique “Click-to-Release” technology, allowing it to release its cancer-killing agent in the tumor’s surroundings without needing to enter the cell. This is a big deal for TAG-72, which doesn’t easily allow drugs inside cells. The FDA-approved trial, announced on April 22, 2025, will test TGW101’s safety and effectiveness in up to 50 patients with advanced solid tumors across U.S. medical centers. Early lab studies showed promising results, with TGW101 safely shrinking tumors in animal models, but it’s unclear if prostate cancer patients will be a major focus.

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