TAC01-CD19 / Triumvira - LARVOL DELTA

TACTIC-19: Autologous TAC T Cells Targeting CD19 in R/R Large B-Cell Lymphoma (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Triumvira Immunologics, Inc. | N=36 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6 • CD19

TACTIC-2: TAC T-cells for the Treatment of HER2-positive Solid Tumors (clinicaltrials.gov) - P1/2; N=70; Not yet recruiting; Sponsor: Triumvira Immunologics, Inc.

Clinical • New P1/2 trial • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

[VIRTUAL] Development of TAC-T Cells for Treatment of Solid Tumors (IOS 2020) - "TAC is designed to redirect T cells to tumor cells and to activate T cells by co-opting the endogenous T cell receptor complex independently of MHC, leading to safe and effective tumor rejection in mouse models. Triumvira previously cleared an IND/CTA submission for TAC01-CD19 in LBCL and proceeds with a second solid tumor program currently in preclinical development."

Oncology • Solid Tumor • CD19

Triumvira Immunologics announces Fast Track Designation for Its first TAC T-cell therapeutic product candidate: TAC01-CD19 (Businesswire) - “Triumvira Immunologics, Inc….announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track designation for its novel T-cell therapy product TAC01-CD19 in patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) after at least 2 prior systemic therapies. A Phase 1/2 study (TACTIC-19) conducted in patients with CD19-positive B-cell malignancies, including DLBCL, is expected to be initiated by the end of 2019.”

Fast track designation • New P1/2 trial

Triumvira Immunologics announces clearance of IND and CTA by U.S. FDA and Health Canada for Its first TAC T-cell therapeutic product candidate, TAC01-CD19 (Businesswire) - “Triumvira Immunologics, Inc….announced that both the U.S. Food & Drug Administration (FDA) and Health Canada have cleared Triumvira’s Investigational New Drug (IND) and Clinical Trial Applications (CTA) for its novel T cell therapy product TAC01-CD19 in patients with CD19-postive B-cell malignancies. The Phase 1/2 study (TACTIC-19) is expected to be initiated in the third quarter of 2019.”

Canadian regulatory • IND • Trial initiation date

Triumvira submits Investigational New Drug (IND) application to the FDA and Clinical Trial Application (CTA) to Health Canada to evaluate TAC01-CD19, a T cell antigen coupler therapy, in ph 1/2 TACTIC-19 trial (Businesswire) - "Triumvira Immunologics Inc...has simultaneously submitted an IND to the U.S. Food and Drug Administration and a CTA to Health Canada to initiate a Phase 1/2, first-in-human trial of TAC01-CD19, a TAC-T cell therapy product engineered to target CD-19 in patients with Relapsed/Refractory Large B-Cell Lymphoma (TACTIC-19)....'We look forward to opening our first of five prominent clinical trial sites in the early summer of 2019'"

Canadian regulatory • Clinical • IND

Newly added product (Businesswire) - P2, Non-Hodgkin’s Lymphoma, Diffuse Large B Cell Lymphoma

Pipeline update