On November 3, 2022 Tessa Therapeutics Ltd. (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, reported that three abstracts reporting data from clinical trials investigating the company’s autologous CD30.CAR-T therapy (TT11) and allogeneic CD30.CAR EBVST therapy (TT11X) have been accepted for presentation at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH 2022) taking place December 10-13, 2022, at the Ernest N. Morial Convention Center in New Orleans (Press release, Tessa Therapeutics, NOV 3, 2022, View Source [SID1234623203]).
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TT11, Tessa’s lead clinical asset, is an autologous CD30.CAR-T therapy currently being investigated as a potential treatment for relapsed or refractory classical Hodgkin lymphoma (r/r cHL) as both a monotherapy (Phase 2 CHARIOT) and combination therapy (Phase 1b). Two abstracts involving updated data from the CHARIOT clinical trial will be presented at ASH (Free ASH Whitepaper) 2022, including an oral podium presentation demonstrating that circulating tumor DNA (ctDNA) analysis with Foresight Diagnostics PhasED-Seq technology provides a viable biomarker to monitor responses, rapidly stratify risk, and predict outcomes of r/r cHL patients treated with TT11.
TT11X, Tessa’s allogeneic "off-the-shelf" cell therapy, is based on Tessa’s proprietary CD30.CAR-modified Epstein-Barr virus-specific T-cell (EBVST) platform. An abstract highlighting updated data from the ongoing Phase 1/2 study of TT11X (BESTA) in CD30-positive lymphomas will be featured in an oral podium presentation at ASH (Free ASH Whitepaper) 2022. The research demonstrates CD30.CAR EBVSTs (TT11X) to be a well-tolerated and preliminary efficacious treatment for CD30+ lymphomas.
"We are honored that ASH (Free ASH Whitepaper) has accepted three abstracts involving Tessa’s autologous and allogeneic CD30.CAR-T therapies, including two oral podium presentations, at its prestigious annual meeting," stated Thomas Willemsen, President and CEO of Tessa Therapeutics. "The data being presented at ASH (Free ASH Whitepaper) 2022 from the ongoing clinical trials of TT11 and TT11X demonstrate the potential of these therapies to safely and effectively treat CD30 positive lymphomas, including relapsed or refractory classical Hodgkin lymphoma. ASH (Free ASH Whitepaper) is an ideal venue for highlighting this important research, and we are grateful to the investigators at the College of Medicine, Stanford University and MD Anderson Cancer Center for leading their respective presentations."
Abstract Number: 167 (Podium)
Abstract Title: CD30.CAR-modified Epstein-Barr Virus-specific T-cells (CD30.CAR EBVST’s) Provide a Safe and Effective Off-The-Shelf Therapy for Patients with CD30-Positive Lymphoma (BESTA)
Presenting Author: David H. Quach, PhD, Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX
Session Date: Saturday, Dec. 10, 2022, at 1:00 PM CT; Ballroom AB
Abstract Summary:
Off-the-shelf allogeneic T-cell therapies face a major challenge of graft-versus-host disease (GVHD) and graft rejection mediated by host and recipient alloreactive T-cells, respectively. Epstein-Barr-specific T cells (EBVSTs), which are virus-specific rather than allo-specific, offer the potential to mitigate GVHD, and data thus far from more than 300 allogeneic recipients have not produced GVHD. An analysis from an ongoing Phase 1/2 clinical trial of CD30.CAR EBVSTs in patients with CD30-positive lymphoma has demonstrated the therapy to be a well-tolerated and preliminary efficacious treatment for CD30+ lymphomas and may avert GVHD and immediate rejection even after multiple infusions.
Early results from the pilot segment of a Phase 2 trial of autologous CD30.CAR-T in patients with relapsed/refractory (r/r) classic Hodgkin Lymphoma (cHL) demonstrated a favorable safety profile and excellent anti-tumor responses of CD30.CAR-T. In an updated clinical and exploratory biomarker analysis, the therapy is shown to be well tolerated with no unexpected safety signal. Additionally, data suggest strong anti-tumor efficacy with an overall response rate of 73.3% in heavily pretreated r/r cHL patients, as well as good expansion and persistence after infusion.
CHARIOT, a Phase 2 single-arm, multicenter study, is designed to investigate the safety and efficacy of CD30.CAR-T cells in cHL patients experiencing progression after at least 3 lines of therapy. In the pilot part of the study, ctDNA was analyzed as an exploratory biomarker using Foresight Diagnostics PhasED-Seq MRD assay at multiple time points, including at baseline (pre-treatment), Day 42 post-CD30.CAR-T infusion (D42), and upon progressive disease (PD). Based on ctDNA successfully genotyped directly from pre-treatment plasma in 12 patients, it was determined that ctDNA responses largely mirrored radiographic responses, suggesting that pre-treatment ctDNA levels could have predictive value on patient response to CAR-T therapy. From this, the researchers concluded that PhasED-Seq ctDNA analysis is a viable biomarker to monitor responses, rapidly risk stratify, and predict outcomes of patients with r/r cHL treated with CD30.CAR-T therapy.