Undisclosed allogeneic Vγ9Vδ2 HER2-TAC T / Triumvira - LARVOL DELTA

A phase I/II trial investigating safety and efficacy of autologous TAC01-HER2 in relapsed or refractory solid tumors. (ASCO-GI 2024) - P1/2 | "This patient had progressed on 4 prior lines of therapy including trastuzumab and trastuzumab deruxtecan... Treatment with TAC01-HER2 showed manageable safety and promising clinical activity in a heavily pre-treated cancer population. The recommended phase 2 dose was identified as dose level 4 (6-8 x 106 cells/kg). Clinical trial information: NCT04727151."

Clinical • IO biomarker • P1/2 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

A phase I/II trial investigating safety and efficacy of autologous TAC01-HER2 in relapsed or refractory solid tumors (SITC 2023) - P1/2 | "This patient had progressed on 4 prior lines of therapy including trastzumab and trastuzumab deruxtecan. Conclusions Treatment with TAC01-HER2 showed manageable safety and promising clinical activity in a heavily pre-treated cancer population. The recommended phase 2 dose was identified as dose level 4 (6–8 x 106 cells/kg)."

Clinical • P1/2 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

Preclinical characterization and modelling of allogeneic Vγ9Vδ2 TAC T cells for the treatment of solid tumors (SITC 2023) - "TAC01-HER2, a first-in-class, autologous TAC T cell product targeting HER2 (ERBB2), has entered a phase I/II clinical trial in patients with HER2-positive solid tumors...Conclusions HER2-targeted TAC γδ T cells display strong and specific activity against HER2-expressing tumor models in vitro and in vivo. This highlights the versatility of the TAC platform and its potential in the development of an allogeneic product for therapeutic applications in solid tumors."

Preclinical • Oncology • Solid Tumor • CD69 • HER-2 • IL15

Functional characterization of GUCY2C-TAC T cells for the treatment of colorectal cancer using preclinical models (SITC 2023) - "Conclusions In vitro and in vivo data confirm strong and specific activity of T cells engineered with humanized GUCY2C-TAC receptors. Taken together, these data support further development of GUCY2C-TAC T cells for therapeutic applications in colorectal cancer."

IO biomarker • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • GUCY2C • HER-2

A phase I/II trial investigating safety and efficacy of autologous TAC01-HER2 in relapsed or refractory solid tumors (ESMO 2023) - P1/2 | "This patient had progressed on 4 prior lines of therapy including trastzumab and trastuzumab deruxtecan. Conclusions Treatment with TAC01-HER2 showed manageable safety and promising clinical activity in a heavily pre-treated cancer population. Dose escalation is complete."

Clinical • P1/2 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

A phase I/II trial investigating safety and efficacy of autologous TAC01-HER2 in relapsed or refractory solid tumors (ESMO-GI 2023) - P1/2 | "This patient had progressed on 4 prior lines of therapy including trastzumab and trastuzumab deruxtecan... Treatment with the novel T cell therapy, TAC01-HER2 showed manageable safety and promising clinical activity in a heavily pre-treated cancer population, refractory to prior HER2 targeted treatments, including a complete reduction of target lesions in one patient. Dose escalation of TAC01-HER2 is ongoing."

Clinical • P1/2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

A phase I/II trial investigating safety and efficacy of autologous TAC01-HER2 in relapsed or refractory solid tumors. (ASCO 2023) - P1/2 | "Dose escalation of TAC01-HER2 is ongoing, with seven subjects treated and three more scheduled in Cohort 4. These results in a heavily pre-treated cancer population show manageable safety and promising clinical activity with a novel T cell therapy that may have broad clinical applicability in HER+ cancers. Clinical trial information: NCT04727151."

Clinical • P1/2 data • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Pneumonia • Solid Tumor • HER-2

A phase I/II trial investigating safety and efficacy of autologous TAC01-HER2 in relapsed or refractory solid tumors (AACR 2023) - P1/2 | "In phase I dose escalation, the primary objective is to evaluate the safety of TAC01-HER2 at increasing doses of 0.3, 0.8, 3, and 8 x 106 cells/kg in HER2+ solid tumors (1+, 2+ or 3+ as identified by immunohistochemistry) in adult subjects who have progressed after ≥2 lines of systemic therapy. Dose limiting toxicities (DLTs) are assessed up to 28 days from cell infusion. In Phase II, dose expansion groups will further evaluate the safety, efficacy, and pharmacokinetics of the optimal TAC01-HER2 dose in HER2+ breast and other solid tumor types."

Clinical • P1/2 data • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor • HER-2

Preclinical characterization of allogeneic Vγ9Vδ2 HER2-TAC T cells for the treatment of HER2-positive solid tumors (AACR 2023) - "TAC01-HER2, a first-in-class, autologous TAC T cell product targeting HER2 (ERBB2), has entered a phase I/II clinical trial in patients with HER2-positive solid tumors... The in vitro and in vivo data confirm strong and specific activity of HER2-targeted TAC γδ T cells against HER2-expressing tumor models and highlights the potential of the TAC platform in the development of an allogeneic product for therapeutic applications in solid tumors."

Preclinical • Oncology • Solid Tumor • CD69 • HER-2

Triumvira Immunologics Presents Promising Data on TAC T Cells for the Treatment of HER2-overexpressing Solid Tumors at the 2023 AACR Annual Meeting (PRNewswire) - "HER2-TAC γδ (gamma/delta) T cells selectively react to and kill HER2-expressing tumor cells in co-culture at low effector-to-target ratios, indicating strong functionality....Intravenous administration of γδ T cells results in effective tumor eradication in mouse models, similar to TAC01-HER2 (produced in αβ T cells) and without showing signs of toxicity."

Preclinical • Oncology • Solid Tumor

Triumvira Immunologics to Present New Data on its TAC T Cell Autologous and Allogeneic Products and the Ongoing Phase I/II Solid Tumor Trial at the 2023 AACR Annual Meeting (PRNewswire) - "Triumvira Immunologics...announced that the Company will be presenting preclinical and clinical data on its lead asset TAC01-HER2 for the treatment of human epidermal growth factor receptor 2 (HER2) positive solid tumors at the 2023 American Association for Cancer Research (AACR) Annual Meeting taking place in Orlando, April 14-19. The presentations will include updated clinical data and product characterization from the ongoing Phase I/II trial of autologous TAC01-HER2 (NCT04727151) in patients with solid tumors and preclinical data on an allogeneic HER2-TAC T cell product."

P1/2 data • Preclinical • Oncology • Solid Tumor

A phase I/II trial investigating the safety and efficacy of autologous TAC T cells targeting HER2 in relapsed or refractory solid tumors. (ASCO-GI 2023) - P1/2 | "Dose escalation of TAC01-HER2 is ongoing, with the first subject being treated at DL 3. These results in a heavily pre-treated gastrointestinal cancer population show manageable safety and promising efficacy with a novel T cell therapy that may have broad clinical applicability in HER+ cancers. Clinical trial information: NCT04727151."

Clinical • IO biomarker • P1/2 data • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gallbladder Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

A Phase I/II Trial Investigating Safety and Efficacy of Autologous TAC T Cells Targeting HER2 in Relapsed or Refractory Solid Tumors (SITC 2022) - P1/2 | "Continued dose escalation of TAC01-HER2 is ongoing. Following completion of each dose level, a Data Safety Monitoring Committee has met to review all AEs to approve or deny escalation to the next highest dose level"

Clinical • IO biomarker • P1/2 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • HER-2

Triumvira Immunologics Demonstrates Strength of Preclinical Research Pipeline for Gastric and Colorectal Cancers in Three Posters at SITC 2022 (Businesswire) - "Triumvira Immunologics...announced preclinical data for its investigational TAC-T cell therapies...at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting....In a third poster, Triumvira shares data supporting the durable anti-tumor responses by TAC-T cells in preclinical models of solid tumors....The data demonstrated that HER2-specific TAC-T cells elicit an effective anti-tumor activity in multiple preclinical models, consisting of activated TAC-T cells that do not become terminally exhausted but are dominated by an activated CD8 response and supported by the expansion of a memory population, indicative of a robust self-renewal capacity."

Preclinical • Oncology • Solid Tumor • HER-2