TILT Biotherapeutics advances cancer immunotherapy clinical trial achieving primary end point in the first cohort
TILT Biotherapeutics, a clinical-stage biotechnology company developing cancer immunotherapeutics, announces that it has achieved the primary endpoint of safety in its phase I trial with the first dose of its dual cytokine armed oncolytic adenovirus, TILT-123, at Herlev hospital in Denmark. No serious adverse events (SAEs) were observed in the trial for TILT-123 as a monotherapy or in combination with tumour infiltrating lymphocytes (TILs). The company has received regulatory approval to open a second clinical trial site at CHU Nantes, France, with 15 patients in total to be enrolled across the two sites. The clinical trial will now proceed to the second (of five) dose levels and expects interim data by the end of this year.
The ‘TUNINTIL’ clinical trial(1) is a phase 1, open-label, dose-escalation study of the company’s oncolytic adenovirus coding for Tumor Necrosis Factor Alpha (TNF alpha) and Interleukin 2 (IL-2) known as TILT-123. Metastatic melanoma patients receive TILT-123 as an initial monotherapy over one month, followed by up to two administrations of tumor infiltrating lymphocytes (TILs) in the second month as well as ongoing consecutive doses of TILT-123.
TILT Biotherapeutics’ CEO, Akseli Hemminki, a biotech entrepreneur and cancer clinician who has personally treated almost 300 patients with ten different oncolytic viruses, said, “We are delighted our first-in-human phase 1 trial in metastatic melanoma has successfully met its primary clinical endpoint of safety at the initial dose and is now progressing steadily to the next dose level. I am grateful for the excellent work by the team at Denmark’s prestigious National Center for Cancer Immune Therapy and look forward to continuing this and also working with the team in Nantes. 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.”
The company has received approval in Denmark to extend this trial for up to two years to demonstrate long term survival benefit. As part of this, the company will be analyzing secondary end points for TILT-123 including response rate, overall survival, progression free survival, and immune response against the tumor, its persistence and shedding.
The heart of TILT’s approach revolves around the use of armed oncolytic adenoviruses, using cytokines to boost the patient’s immune response to better enable it to find and destroy cancer cells. The TUNINTIL trial’s primary objective is to evaluate the safety of TILT-123 and is designed to also deliver insights about the behavior of TILT-123 in humans, such as systemic tumor transduction following intravenous delivery and virus replication in the tumor, as well as immunological responses.
Adicet Bio Announces Initiation of its First-in-Human Phase 1 Trial of ADI-001 for the Treatment of B Cell Non-Hodgkin’s Lymphoma
Adicet Bio, Inc. (Nasdaq: ACET), a biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and other diseases, today announced that it has initiated its First-in-Human Phase I clinical trial evaluating ADI-001 for the treatment of B cell non-Hodgkin’s lymphoma (NHL). ADI-001 is an investigational first-in-class allogeneic gamma delta T cell therapy expressing a chimeric antigen receptor (CAR) targeting CD20, engineered to potentially enhance selective tumor targeting, facilitate innate and adaptive anti-tumor immune response, and improve persistence for durable activity in patients.
“Initiating the Phase 1 trial represents an important milestone in the development of our lead product candidate, ADI-001, for patients with NHL, and for Adicet’s emerging pipeline of “off-the-shelf” gamma delta T cell product candidates. Based on ADI-001’s encouraging preclinical data, we believe our novel CAR gamma delta T cell therapy has the potential to provide an attractive treatment option for NHL patients,” said Francesco Galimi, M.D., Ph.D., Senior Vice President and Chief Medical Officer of Adicet. “We are excited to bring ADI-001 into clinical development and look forward to advancing our product pipeline to address additional solid and hematologic tumors.”
Adicet’s Phase I trial is an open-label, multi-center study of ADI-001 enrolling adults diagnosed with B cell malignancies who have either relapsed, or are refractory to at least two prior regimens. The primary objectives of the trial are to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ADI-001, and to determine optimal dosing as a monotherapy. A combination of ADI-001 and interleukin 2 may also be evaluated in this trial. The trial is expected to enroll approximately 75 patients, with preliminary safety and tolerability data expected by the end of 2021, subject to the impact of COVID-19. For more information about the clinical trial design, please visit: www.clinicaltrials.gov (NCT04735471).