Clinical trialsCompany release

Obsidian's amsoki-cel shows 67% response rate in resistant melanoma as registration cohort enrols

🇺🇸 Obsidian Therapeutics, Inc. (OBX) · Thu 12 Nov 2026

Obsidian Therapeutics reported Q3 2026 results alongside updated SITC data on its engineered TIL therapy, and said enrolment in the Agni-01 registration-enabling cohort should complete by end of Q1 2027.

Obsidian Therapeutics reported its third-quarter 2026 results on 12 November, pairing the financials with updated clinical data for amsoki-cel, its engineered tumour-infiltrating lymphocyte (TIL) therapy, presented at SITC.

In advanced melanoma resistant to immune checkpoint inhibitors, the company reported an objective response rate of 67% among 15 patients, with median progression-free survival of 8.3 months. The summary gives no further detail on the patient population or follow-up.

A pooled safety set of 37 patients showed no immune effector cell-associated neurotoxicity syndrome (ICANS), no dose-limiting toxicities and no treatment-related deaths, according to the company.

Obsidian expects to complete enrolment in the registration-enabling Agni-01 cohort by the end of the first quarter of 2027, with topline data due by the end of 2027.

On the financial side, the company reported cash of $324.4 million, which it says funds operations into the second half of 2028, and a net loss of $50.7 million for the quarter.

What it means for your team

  • Regulatory teams tracking cell therapy in solid tumours should note the Agni-01 timeline: enrolment completion by end Q1 2027 and topline data by end 2027, which sets the earliest window for any filing discussions.
  • Safety reviewers may watch how the absence of ICANS, dose-limiting toxicities and treatment-related deaths in 37 patients holds up as the registration cohort grows.
  • The efficacy figures come from a small sample of 15 patients and a company announcement, so market-access teams should treat them as early signals rather than confirmatory evidence.

Company's press release (SEC filing): Obsidian Therapeutics, Inc. ↗

Article written by VigiEye from the official source (Obsidian Therapeutics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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