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Recently reported results from the ongoing phase 1 TUNINTIL trial of the oncolytic virus TILT-123 show safety of this approach.
TILT-123, a dual cytokine armed oncolytic virus, achieved the primary end point of safety in patients with metastatic melanoma in the phase 1 TUNINTIL trial (NCT04217473), according to the developer of the therapy, TILT Biotherapeutics.
The open-label, dose-escalation study examined the immunotherapeutic as either monotherapy or in combination with tumor-infiltrating lymphocytes (TILs), with no serious adverse events noted in either therapeutic arm.
“We are delighted our first-in-human phase 1 trial in metastatic melanoma has successfully met its primary clinical end point of safety at the initial dose and is now progressing steadily to the next dose level,” Akseli Hemminki, CEO of TILT Biotherapeutics, said in a press release. “Overall, the trial has the potential to increase the efficacy of adoptive T-cell therapy, remove the need for pre- and post-conditioning regimens, and deliver the combined anti-tumor benefits of armed oncolytic viruses and T-cell therapy.”
Additionally, the company has received regulatory approval to open a second site at CHU Nantes in France and will proceed to the second of 5 total dose levels with interim data expected by the end of 2021.
The mechanism of action behind TILT-123 uses cytokines to boost the patient’s immune response against oncologic cells. The therapy codes for tumor necrosis factor α, or TNF-α, and interleukin 2.
The TUNITIL trial is evaluating safety and the therapy’s potential to increase adoptive T-cell therapy effectiveness, remove the need for conditioning regimens, and result in antitumor benefit.
Patients who are eligible for inclusion on the trial are those with pathologically confirmed previously treated refractory or recurrent stage III or IV melanoma without the availability of curative intent therapies. Patients must have experience with at least 1 prior systemic therapy, but multiple lines of prior therapy are allowed. Patient must have a WHO performance score of 1 or less and those with a life expectancy longer than 3 months.
Tumors measuring 9 mm in size or greater with no signs of necrosis must be available for biopsy to enable growth of TILs and at least 1 additional tumor 14 mm or larger must be available for injections and biopsies for correlative analysis. Disease burden must be measurable, although it does not need to full RECIST 1.1 criteria.
Those who are ineligible include patients using immunosuppressive medications, with the exception of replacement corticosteroids, pulmonal and topical treatments, and up to 20 mg of prednisone or prednisolone; history of other invasive cancers within 5 years; treatment with another anticancer therapy within 30 days; uncontrolled cardiac disease; and lactate dehydrogenase level of greater than 3 times the upper limit of normal, among others.
The company was granted permission in Denmark to extend the trial period up to 2 years for the purpose of determining long-term survival as well as response rate, progression-free survival, and immune response against tumor persistence and shedding.
TILT Biotherapeutics advances cancer immunotherapy clinical trial achieving primary end point in the first cohort. News release. March 15, 2021. Accessed March 17, 2021. https://bit.ly/3eOUQVF