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Obsidian Therapeutics Inc, a clinical-stage biopharmaceutical company harnessing novel protein-regulation technology to develop engineered tumour-infiltrating lymphocyte (TIL) cell therapies, announced the first patient has been enrolled in the registration-enabling cohort of the phase 1/2 Agni-01 multicenter study of amsokigene autoleucel (amsoki-cel, formerly OBX-115), an engineered TIL cell therapy armored with pharmacologically regulatable membrane-bound IL15 (mbIL15), in patients with immune checkpoint inhibitor (ICI)-resistant advanced or metastatic melanoma.
Following discussions with US Food and Drug Administration, the company has decided to pursue a single-arm trial design intended to support future BLA submission.
“We have obtained alignment with the US Food and Drug Administration across key trial design and manufacturing considerations, including drug potency assay, to proceed with the registration-enabling cohort in support of the single-arm accelerated approval pathway for amsoki-cel in advanced melanoma. Enrolling the first patient in this cohort is an important step toward bringing a patient-centric tumour-infiltrating lymphocyte treatment regimen to patients with difficult-to-treat ICI-resistant advanced melanoma,” said Parameswaran Hari, chief medical officer of Obsidian. “We believe amsoki-cel has the potential to serve a broad patient population given its IL2-free regimen, option for less-invasive core needle biopsy tumour tissue procurement, and exclusively low-dose lymphodepletion compatible with outpatient administration. We anticipate reporting topline data from the registration-enabling cohort by year-end 2027.”
The single-arm registration-enabling cohort is part of the ongoing Agni-01 study, which is a multicenter phase 1/2 study, and designed to further evaluate the safety and efficacy of amsoki-cel at the recommended phase 2 dose (RP2D) in patients with ICI-resistant advanced melanoma. The primary endpoint is objective response rate (ORR) as measured per Response Evaluation Criteria in Solid Tumours by blinded independent central radiologist review (BICR). Enrollment is anticipated to be completed by end of Q1 2027.
Initiation of the registration-enabling cohort follows positive phase 1/2 results from the Agni-01 study, where amsoki-cel demonstrated strong efficacy with a 67 per cent ORR at the RP2D (n=10/15), including two complete responses in a patient population with high unmet need, difficult-to-treat advanced melanoma. Amsoki-cel has also delivered a consistent, favourable safety profile with low-dose lymphodepletion and no IL2 in the treatment regimen. There were no reported dose-limiting toxicities, treatment-related mortality, immune effector cell-associated neurotoxicity syndrome or ICU transfers.
Obsidian is also investigating amsoki-cel in patients with non-small cell lung cancer (NSCLC) in the Agni-01 trial. NSCLC phase 1 data are expected in the first half of 2027.
Obsidian Therapeutics harnesses novel protein-regulation technology to develop engineered tumour-infiltrating lymphocyte cell therapies for the treatment of patients with solid tumours. Obsidian Therapeutics’ proprietary cytoDRiVE technology is designed to precisely regulate the timing and level of protein function by using US FDA-approved small-molecule drugs. Obsidian has offices in Cambridge and Bedford, MA.
Obsidian Therapeutics leverages its cytoDRiVE platform to develop engineered tumour-infiltrating lymphocyte cell therapies. Obsidian’s lead investigational TIL program, amsoki-cel, is a novel engineered tumour-derived autologous T cell immunotherapy (tumour-infiltrating lymphocyte cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15). Amsoki-cel has the potential, if approved, to become a meaningful therapeutic option for patients with advanced (unresectable or metastatic) melanoma and other solid tumours by leveraging the expected benefits of mbIL15 and Obsidian’s proprietary, differentiated manufacturing process designed to enhance persistence, antitumor activity, and clinical safety of tumour-infiltrating lymphocyte cell therapy. Obsidian is investigating amsoki-cel in the phase 1/2 Agni-01 multicenter trial in patients with advanced solid tumours.
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