TT11X / Tessa Therap - LARVOL DELTA

CABAL2: Constitutive IL7R (C7R) Modified Banked Allogeneic CD30.CAR EBVSTS for CD30-Positive Lymphomas (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: Baylor College of Medicine | Not yet recruiting ➔ Recruiting

Enrollment open • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Epstein-Barr Virus Infections • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Allogeneic CD30.CAR-EBVSTs in Patients With Relapsed or Refractory CD30-Positive Lymphomas (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Baylor College of Medicine | Trial primary completion date: Jun 2025 ➔ Jun 2026

Trial primary completion date • Classical Hodgkin Lymphoma • Epstein-Barr Virus Infections • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • ALK • TNFRSF8

Constitutive IL7R (C7R) Modified Banked Allogeneic CD30.CAR EBVSTS for CD30-Positive Lymphomas (clinicaltrials.gov) - P1 | N=90 | Not yet recruiting | Sponsor: Baylor College of Medicine | Initiation date: Jun 2024 ➔ Jan 2025

Trial initiation date • Virus specific T cells • Diffuse Large B Cell Lymphoma • Epstein-Barr Virus Infections • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Constitutive IL7R (C7R) Modified Banked Allogeneic CD30.CAR EBVSTS for CD30-Positive Lymphomas (clinicaltrials.gov) - P1 | N=90 | Not yet recruiting | Sponsor: Baylor College of Medicine

New P1 trial • Diffuse Large B Cell Lymphoma • Epstein-Barr Virus Infections • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes in Relapsed or Refractory CD30-Positive Lymphomas (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Baylor College of Medicine | N=18 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Epstein-Barr Virus Infections • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • ALK • TNFRSF8

Singapore’s Top-funded Biotech Start-up Announces Liquidation Following Failure of Fundraising (GeneOnline) - "Despite being backed by Singapore’s top investors including Temasek Holdings and the government-linked EDBI, Tessa Therapeutics Ltd. still failed to raise more capital to sustain operations and develop its cell therapies for cancers. As a result, this Singapore-based biotech start-up has announced to its shareholders the intent of initiating liquidation procedures in the near future...Last September, TT11X even won recognition in the 'Most Promising Off-the-Shelf Therapies' category at the Asia-Pacific Cell & Gene Therapy Excellence Awards 2022....Tessa’s other leading pipelines include TT11, an autologous CD30 CAR T-cell therapy for R/R Classical Hodgkin lymphoma, as well as TT16, a combination therapy utilizing HER2-specific autologous CAR VST and an oncolytic virus."

Financing • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Solid Tumor

Tessa Therapeutics’ ‘Off-the-Shelf’ CAR-T Therapy Shows Promising Results in Early-Stage Study of Hodgkin Lymphoma (GlobeNewswire) - P1 | N=18 | NCT04952584 | "Tessa Therapeutics...announced promising safety and efficacy data from a study of its off-the-shelf CD30.CAR EBVST therapy (TT11X) in patients with relapsed or refractory (R/R) Hodgkin lymphoma. The results were presented by Tessa collaborators at the Baylor College of Medicine in an oral podium presentation at the 17th International Conference on Malignant Lymphoma (ICML)....An overall response rate of 78% (14/18 patients) was observed across all four dose levels, including seven complete responses and seven partial responses, with higher doses producing improved clinical responses. Additionally, TT11X was demonstrated to be well tolerated with no dose-limiting toxicities observed, including no evidence of graft-versus-host disease (GVHD) or immune effector cell-associated neurotoxicity syndrome (ICANS)."

P1 data • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

Tessa Therapeutics’ Autologous and Allogeneic Cell Therapy Data to be Featured at the 17th International Conference on Malignant Lymphoma, Lugano (GlobeNewswire) - "Tessa Therapeutics Ltd...announced two presentations featuring clinical data from the company’s autologous CD30.CAR-T therapy TT11 and off-the-shelf CD30 CAR EBVST therapy (TT11X) will be featured at the 17th International Conference on Malignant Lymphoma taking place from June 13-17, 2023, at Lugano, Switzerland."

Clinical data • P1 data • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes in Relapsed or Refractory CD30-Positive Lymphomas (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Baylor College of Medicine | Trial completion date: Jun 2038 ➔ Jun 2040 | Trial primary completion date: Jun 2023 ➔ Jun 2025

Trial completion date • Trial primary completion date • Virus specific T cells • Epstein-Barr Virus Infections • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • ALK • TNFRSF8

Humanized CD30 chimeric antigen receptor T cells with a novel 4-1BB derived spacer have improved activity and safety against CD30-positive lymphomas​ (SITC 2022) - P1 | "Humanized CD30.CARs combined with the 4-1BB-derived spacer did not exhibit any nonspecific interactions with CD16+ immune cells, while displaying superior efficacy in vitro , better persistence in vivo in various humanized mouse models, and more importantly an improved safety profile in a leukemia model with high tumor burden. Conclusions Our re-engineered CD30.CAR construct, consisting of a humanized CD30.CAR and a 4-1BB-derived spacer, is likely to improve allogeneic CD30.CAR EBVST performance."

CAR T-Cell Therapy • Clinical • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lymphoma • Oncology • TNFRSF8

Tessa Therapeutics Enters into Cooperative Research and Development Agreement (CRADA) with the U.S. National Cancer Institute (GlobeNewswire) - "Tessa Therapeutics Ltd...announced entry into a Cooperative Research and Development Agreement (CRADA) with the U.S. National Cancer Institute (NCI), part of the National Institutes of Health (NIH), to investigate TT11X, Tessa’s allogeneic 'off-the-shelf' CD30.CAR-modified Epstein-Barr virus-specific T-cell (EBVST) therapy, in multiple subtypes of non-Hodgkin lymphoma. Under terms of the CRADA, Tessa will collaborate with the NCI’s Division of Cancer Treatment and Diagnosis (DCTD) to identify potential opportunities to expand the applicability of TT11X as a treatment of non-Hodgkin lymphoma. In this collaboration, NCI Cancer Therapy Evaluation Program (CTEP) will serve as the regulatory sponsor and conduct mutually approved clinical trials through NCI funded clinical network groups and using drug supply and other necessary support provided by Tessa."

Licensing / partnership • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Tessa Therapeutics Announces New Clinical Data from Phase 1 Allogeneic Study Presented at 2022 Annual Meeting of American Society of Hematology (ASH) (GlobeNewswire) - P1 | N=18 | NCT04288726 | "Tessa Therapeutics Ltd. (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, today announced enhanced clinical data from an ongoing Phase 1 study (NCT04288726) of TT11X, an allogeneic 'off the shelf'' CD30.CAR-modified Epstein-Barr virus-specific T-cell (EBVST) therapy being co-developed by Baylor College of Medicine and Tessa....An overall response rate of 79% (11/14 patients) was observed across all three dose levels, including six complete responses and six partial responses. The strongest responses were achieved in patients treated at the higher dose levels with additional infusions resulting in increasing effectiveness."

P1 data • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

Tessa Therapeutics, Baylor College of Medicine Execute Agreement For Global Commercial Rights to ‘Off-the-Shelf’ CAR-T Platform (GlobeNewswire) - "Tessa Therapeutics Ltd...announced the execution of an exclusive agreement with Baylor College of Medicine for worldwide commercial rights to the allogeneic Epstein-Barr virus specific T-cell (EBVST) technology platform developed jointly by Tessa’s Scientific Co-Founder, Malcolm Brenner, M.D., Ph.D., and his colleagues Cliona Rooney Ph.D. and Helen Heslop M.D., D.Sc. at Baylor College of Medicine. Tessa is currently advancing a pipeline of products that utilize CD30.CAR-modified EBVSTs, including its lead allogeneic cell therapy, TT11X, which is being co-developed for the treatment of relapsed or refractory CD30-positive lymphomas."

Licensing / partnership • Hematological Malignancies • Lymphoma • Oncology

Tessa Therapeutics Announces Three Abstracts Highlighting Data from Autologous and Allogeneic Cell Therapy Programs Accepted for Presentation at 64th ASH Annual Meeting and Exposition (GlobeNewswire) - "Two abstracts involving updated data from the CHARIOT clinical trial will be presented at ASH 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....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 2022. The research demonstrates CD30.CAR EBVSTs (TT11X) to be a well-tolerated and preliminary efficacious treatment for CD30+ lymphomas."

Biomarker • P1/2 data • P2 data • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

Tessa Therapeutics Recognized in “Most Promising Off-the-Shelf Therapies” Category at Asia-Pacific Cell & Gene Therapy Excellence Awards 2022 (GlobeNewswire) - P1 | N=18 | NCT04288726 | "Tessa Therapeutics Ltd....announced that TT11X, the company’s allogeneic 'off-the-shelf' CD30.CAR EBVST cell therapy, has been recognized in the 'Most Promising Off-the-Shelf Therapies category at the Asia-Pacific Cell & Gene Therapy Excellence Awards (ACGTEA) 2022. The ACGTEA 2022 Awards were held in conjunction with the 6th Cell & Gene Therapy World Asia 2022'...Clinical data from an ongoing Phase 1 study (NCT04288726) of TT11X in CD30-positive lymphomas demonstrated a favorable safety profile and encouraging signs of efficacy with clinical responses observed in seven of nine patients, including a complete disappearance of tumors reported in four patients."

Clinical • P1 data • Hematological Malignancies • Lymphoma • Oncology

Allogeneic CD30.CAR-EBVSTs in Patients With Relapsed or Refractory CD30-Positive Lymphomas (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Baylor College of Medicine | Trial primary completion date: Jun 2022 ➔ Jun 2025

Trial primary completion date • Epstein-Barr Virus Infections • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • ALK • TNFRSF8

Tessa Therapeutics to Host Scientific Session on CD30 CAR-T targeting of CD30+ Lymphomas at the SDCT-REMEDIS Cell Therapy Conference 2022 (GlobeNewswire) - "Tessa Therapeutics Ltd...announced that the company will host a scientific session during the SDCT-REMEDIS Cell Therapy Conference 2022 being held virtually from June 23-24, 2022. Tessa is currently advancing two clinical programs leveraging distinct CD30 CAR-T technologies for the treatment of CD30+ lymphomas. Tessa’s lead clinical program – TT11 – is an autologous CD30 targeting CAR-T therapy currently being investigated as a potential treatment for relapsed or refractory classical Hodgkin lymphoma. Additionally, Tessa is developing an allogenic 'off-the-shelf' CD30-CAR EBVST cell therapy – TT11X – targeting relapsed or refractory CD30-positive lymphomas....'We look forward to progressing clinical programs investigating our autologous (TT11) and allogenic (TT11X) CAR-T technologies during 2022, with several development milestones expected throughout the year'."

Clinical data • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

Tessa Therapeutics Showcases Positive Clinical Data from Phase 1 Study of “Off the Shelf” CD30 Cell Therapy at 2021 Annual Meeting of American Society of Hematology (ASH) (GlobeNewswire) - P1, N=18; NCT04288726; "Clinical response was observed in seven patients spanning all three dose levels, including four complete responses and three partial responses, with an overall response rate of 77.8 percent. The strongest responses were achieved in patients treated at the higher dose levels. All three patients treated with TT11X at the third and highest dose level (4 × 108 CD30.CAR EBVSTs) and one patient treated with a mid-level dose (1 × 108 CD30.CAR EBVSTs) showed a complete response four to six weeks after receiving treatment....A second poster presentation scheduled for Monday, December 13 at 6 p.m. ET will highlight data from the Phase 2 CHARIOT trial...in patients with relapsed or refractory classical Hodgkin lymphoma (cHL)."

P1 data • P2 data • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

Tessa Therapeutics Announces Presentation of Autologous and Allogeneic Cell Therapy Data at 2021 ASH Annual Meeting (BioSpace) - “Tessa Therapeutics Ltd....announced that data from its ongoing autologous and allogeneic cell therapy studies targeting lymphomas has been accepted for two separate poster presentations at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition being held from December 11-14, 2021. The presentations include clinical data from a Phase II multi-center study evaluating safety and efficacy of CD30 CAR-T therapy (TT11) in patients with relapsed / refractory classical Hodgkin Lymphoma (R/R cHL) and another Phase I investigator-initiated study testing allogeneic ‘off-the-shelf’ CD30 CAR EBVST therapy (TT11X) in patients with relapsed / refractory CD30+ lymphoma. Accepted abstracts will also be published online in the November supplemental issue of Blood, a publication of the American Society of Hematology.”

Clinical data • Hodgkin Lymphoma • Lymphoma • Oncology

Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes in Patients With Relapsed or Refractory CD30-Positive Lymphomas (clinicaltrials.gov) - P1; N=18; Not yet recruiting; Sponsor: Baylor College of Medicine

Clinical • New P1 trial • Epstein-Barr Virus Infections • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • ALK • TNFRSF8

Tessa Therapeutics Announces Positive, Topline Data from Ongoing Phase 1 Trial of Allogeneic, “Off-the-Shelf” Cell Therapy, in Patients with Relapsed or Refractory CD30-Positive Lymphoma (GlobeNewswire) - P1, N=18; NCT04288726; "Tessa Therapeutics Ltd...announced early clinical results for an allogeneic CD30-CAR EBVST therapy (TT11X)....The data is from an ongoing Phase 1 dose-escalation study (NCT04288726) testing TT11X in patients with CD30+ lymphomas. The results will be presented today at the 24th Annual Meeting of American Society of Gene and Cell Therapy (ASGCT 2021)....The results demonstrated a favorable safety profile with encouraging clinical activity even at lower dose levels in heavily pre-treated relapsed / refractory (R/R) CD30+ lymphoma patients."

P1 data • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

Tessa Therapeutics’ Allogeneic, “Off-the-Shelf” CD30 Cell Therapy to be Featured in Podium Presentation at the ASGCT 24th Annual Meeting (GlobeNewswire) - “Tessa Therapeutics Ltd… announced that early clinical data from a Phase 1 dose-escalation study of Tessa’s TT11X allogeneic CD30-CAR Epstein Barr Virus Specific T-cell (EBVST) therapy in patients with CD30-positive lymphoma will be featured in a podium presentation at the American Society for Gene and Cell Therapy (ASGCT) 24th Annual Meeting, held virtually from May 11 – 14, 2021.”

P1 data • Hematological Malignancies • Lymphoma • Oncology

Allogeneic CD30.CAR-EBVSTs in Patients With Relapsed or Refractory CD30-Positive Lymphomas (clinicaltrials.gov) - P1; N=18; Not yet recruiting; Sponsor: Baylor College of Medicine

Clinical • New P1 trial • Epstein-Barr Virus Infection • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • ALK • TNFRSF8

Allogeneic CD30.CAR-EBVSTs in Patients With Relapsed or Refractory CD30-Positive Lymphomas (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: Baylor College of Medicine; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Epstein-Barr Virus Infection • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • ALK • TNFRSF8

Tessa Therapeutics Announces Successful Dosing of First Patient Cohort in Phase I Allogeneic Cell Therapy Trial (PRNewswire) - "Tessa Therapeutics Ltd...today announced the successful completion of dosing of the first patient cohort (n=3) in a Phase I dose escalation study, evaluating the safety and efficacy of Tessa's TT11X – Allogeneic CD30-CAR Epstein Barr Virus Specific T-cell (EBVST) therapy."

Enrollment status • Hematological Malignancies • Lymphoma • Oncology