Metastatic Breast Cancer Advance
Zetagen Therapeutics Reports Promising Phase 2a Results for ZetaMetâ„¢ in Metastatic Breast Cancer
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A single injection into bone tumors left no fractures, no skeletal-related events, and halted tumor activity in every treated patient. That is the headline from Zetagen Therapeutics' Phase 2a results for ZetaMet™ (Zeta BC 003), presented at the American Society of Clinical Oncology Annual Meeting on June 2, 2026, in Chicago. Calgary Sun reported the open-label study targeted metastatic breast cancer patients with lytic bone lesions — small holes in weakened bones caused by cancer spread.
The results also showed an 87.9% mean decrease in lesion size by Day 180, along with reduced pain scores and lower opioid use, according to Fort McMurray Today. ZetaMetâ„¢ holds FDA Breakthrough Device Designation but remains investigational and has not been approved for general use.
One Injection, Zero Fractures in All Ten Patients
The Phase 2a trial enrolled ten patients with metastatic breast cancer who had lytic bone lesions — areas where cancer had eaten away bone tissue. Doctors delivered ZetaMet™ via a single intratumoral injection, using a technique called percutaneous vertebroplasty. According to Chatham Daily News, zero skeletal-related events or fractures were recorded across all patients in the study.
Every treated lesion met the threshold for complete response under both MD Anderson Criteria and RECIST v1.1 — two standard tools doctors use to measure tumor activity. That is a 100% complete response rate. CEO Joe C. Loy said the results show the team overcame "longstanding industry challenges in intratumoral administration" by building proprietary carriers that keep the compound exactly where it is injected, per Northern News.
Why Bone Metastases Have Been So Hard to Treat
About 70% of metastatic breast cancer patients develop lytic bone lesions, according to The Crag and Canyon. Around 330,000 people in the U.S. live with some form of bone metastases. Under current standard care, median survival after a new bone metastasis diagnosis is just nine months. Standard drugs like bisphosphonates slow bone loss — they do not rebuild bone.
ZetaMet™ takes a different approach. It uses a small molecule — originally FDA-approved for other uses in 1971 — that Zetagen later found activates the p21 molecular pathway. That pathway can both stop tumor growth and trigger new bone formation. The goal is not just to stabilize the lesion but to actively repair it, Ontario Farmer noted.
Early Case Report to ASCO Stage: A Four-Year Road
Zetagen's path to ASCO 2026 started with a single patient. In October 2023, a peer-reviewed case report in the journal Pain Management showed that one Stage 4 breast cancer patient had her lytic lesions resolve after ZetaMetâ„¢ treatment, with no fracture. The FDA granted Breakthrough Device Designation back in December 2021, signaling the agency saw real potential in the approach, per Trentonian.
Enrollment for the Phase 2a trial (NCT05280067) wrapped up in May 2025. By November 2025, a topline abstract was accepted at the San Antonio Breast Cancer Symposium showing the 87.9% lesion volume reduction figure. That same month, Zetagen closed a $12.9 million Series B1 financing round that was 100% oversubscribed, with JSTAR Capital Investments as lead, according to Montreal Gazette.
What Comes Next — and What Still Needs Proof
Zetagen is already building out the broader Zeta Platform. Parallel programs target prostate cancer bone metastases (ZetaMet-Pâ„¢) and liver metastases (ZetaMastâ„¢), suggesting the company sees this as a multi-cancer platform, not a single product. The $12.9 million raised is earmarked to move toward commercialization, per Fort McMurray Today.
Still, important caution applies. The Phase 2a trial was open-label with only ten patients and no control arm. Current ASCO and ESMO guidelines still classify treatment for lytic lesions as palliative — not curative. Larger, randomized Phase 3 trials comparing ZetaMet™ head-to-head against drugs like denosumab will be needed before the FDA could consider approving it for broad use, noted Calgary Sun.
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