HONG KONG Singapore-based Tessa Therapeutics Pte. Ltd. released the results of two investigator-initiated phase I/II trials that found its autologous CD30 CAR T-cell therapy TT-11 showed a high rate of durable complete responses and a favorable safety profile in patients with relapsed/refractory Hodgkin lymphoma.
The studies, funded by Tessa, were led by researchers at the Baylor College of Medicine and the University of North Carolina (UNC) Lineberger Comprehensive Cancer Center.
The trials enrolled 41 adult patients who received CD30 CAR T-cell therapy following lymphodepletion with chemotherapy. The overall response rate in the 32 patients with active disease who received fludarabine-based lymphodepletion was 72%, including 19 patients (59%) with complete responses.
Among those who participated in the studies, 94% were still alive a year after treatment and 61% of those who had a complete response also reported no evidence of recurrence a year later.
None of the patients experienced complications that have been seen with several CD19 CAR T cell trials. The results have been published in the Journal of Clinical Oncology.
These data are significant, as they demonstrate that CAR T-cell therapy may be a safe and effective treatment option for patients with Hodgkin lymphoma and potentially other lymphomas expressing the CD30 antigen, said Natalie Grover, study co-first author, assistant professor in the UNC Department of Medicine and a UNC Lineberger member.
The highest dose treatment led to the complete disappearance of tumors in the majority of patients, and almost all subjects had clinical benefit. As such, we believe further study of this treatment approach is warranted, said Carlos Ramos, study co-first author, professor at the Center for Cell and Gene Therapy at Baylor College of Medicine, Houston Methodist Hospital and Texas Childrens Hospital.
Expanded testing to come
Ivan Horak, Tessas president of R&D, told BioWorld that the company plans to further explore the results in a Tessa-sponsored regulatory phase II trial, which it aims to initiate this year. The TT-11 trial would be conducted out of 22-plus sites in U.S. and Europe, he said.
The companys clinical trial partners include institutions in the U.S. such as MD Anderson, Baylor College of Medicine, Stanford Cancer Institute, City of Hope National Medical Center, UCSF Medical Center and Baylor Scott & White Health, as well as other centers in Massachusetts, Texas and California.
The University of North Carolina has granted Tessa an exclusive license to its patents, data and know-how, while Baylor College of Medicine has granted Tessa the rights to use its data and know-how, for the further development and commercialization of this therapy. Tessa declined to speak on the financial arrangements given confidentiality considerations.
Tessa's pipeline currently has four IND-approved clinical trials, covering the evaluation of TT-11 in Hodgkins lymphoma the companys lead program, which has a regenerative medicine advanced therapy designation and non-Hodgkin lymphomas, as well as trials for TT-11X and TT-16. It also has one preclinical program for a candidate known as TT-20X, which will explore allogeneic dual CAR Epstein-Bar virus-specific T cells in solid tumors. The company also plans to test TT-11 (HL) in pediatric patients, Horak said.
TT-11X, the companys allogeneic candidate, combines the properties of CD30-CAR and virus specific T-cells (VSTs) in an allogeneic setting. VSTs can be used for allogeneic application without T-cell antigen receptor (TCR) deletion or other genetic modifications, with a minimal risk of graft rejection, Horak said. CD30-CAR as a target has shown strong efficacy in Hodgkin lymphoma and further increases the persistence and expansion of VST cells, he said.
TT-16 is in an upcoming investigator-initiated phase I trial in HER2-positive solid tumors. The FDA has approved the trial to commence at Baylor College of Medicine.
Tessa also is building an in-house 90,000-square-foot GMP facility, which will be one of the companys commercial-scale cell therapy manufacturing facilities in Asia.
Recommendation and review posted by G. Smith
