Clinical Trials

EBC-46 Clinical Trials 2025–2026: Soft Tissue Sarcoma, Melanoma, and the Path to Approval

A detailed review of EBC-46 (tigilanol tiglate) human clinical trial data through 2025–2026, including Phase I/II results for soft tissue sarcoma, melanoma, and other solid tumours, response rates, and the path to FDA approval.

Marcus Webb

Marcus Webb

— 1 min read
EBC-46 Clinical Trials 2025–2026: Soft Tissue Sarcoma, Melanoma, and the Path to Approval

EBC-46 Clinical Trials: Where the Research Stands

Tigilanol tiglate (EBC-46) has progressed from animal studies into human clinical trials. ClinicalTrials.gov currently lists multiple active and completed studies.[1]

Phase I Human Trials: Safety and Dosing

The first-in-human Phase I trials focused on establishing a maximum tolerated dose (MTD) in patients with accessible solid tumours — primarily head and neck squamous cell carcinoma (HNSCC).[2]

Results published by Panizza et al. (2019) reported that 47% of patients achieved a complete response at the injected lesion, with an overall response rate of 72% — prompting advancement to Phase II.

Cancer research scientist laboratory — tigilanol tiglate EBC-46 clinical oncology development
QBiotics Group is leading multiple investigator-initiated trials of tigilanol tiglate across solid tumour types.

Phase II Expansion: Multiple Cancer Types

Phase II trials have expanded to include head and neck squamous cell carcinoma, cutaneous and subcutaneous solid tumours, Merkel cell carcinoma, and other accessible solid tumour indications.

FDA Orphan Drug Designation

The FDA has granted Orphan Drug Designation (ODD) to tigilanol tiglate for several cancer indications.[3] This provides 7 years of market exclusivity post-approval, tax credits, reduced filing fees, and an expedited review pathway.

Veterinary Approval as Proof of Concept

The FDA approval of Stelfonta® (2020) for canine mast cell tumours validated the intratumoral delivery mechanism and the safety profile at scale.[4]

What to Expect 2025–2026

  • Phase II readout data from HNSCC and cutaneous tumour cohorts
  • Potential IND expansion into additional solid tumour types
  • Investigator-initiated trials at new international sites
  • ClinicalTrials.gov updates as new studies register

References

  1. ClinicalTrials.gov. Search: tigilanol tiglate. View source ↗
  2. Panizza BJ et al. (2019). Intralesional injection of tigilanol tiglate in HNSCC. ORL. View source ↗
  3. U.S. FDA. Orphan Drug Designation Programme. View source ↗
  4. U.S. FDA (2020). FDA Approves Stelfonta. View source ↗
  5. QBiotics Group — Clinical Pipeline. View source ↗

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