TAC100-HER2 / Triumvira, Lonza - LARVOL DELTA

TACTIC-2: TAC T-cells for the Treatment of HER2-positive Solid Tumors (clinicaltrials.gov) - P1/2 | N=30 | Terminated | Sponsor: Triumvira Immunologics, Inc. | N=110 ➔ 30 | Trial completion date: Jun 2027 ➔ Mar 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jun 2025 ➔ Dec 2023; Study terminated by Sponsor for commercial reasons

Combination therapy • Enrollment change • Monotherapy • Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • ALK • BRAF • BRCA • EGFR • HER-2 • PD-L1

TACTIC-2: TAC T-cells for the Treatment of HER2-positive Solid Tumors (clinicaltrials.gov) - P1/2 | N=110 | Active, not recruiting | Sponsor: Triumvira Immunologics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • ALK • BRAF • BRCA • EGFR • HER-2 • PD-L1

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

Triumvira Immunologics to Present Clinical Data at the 2024 ASCO Gastrointestinal Cancers Symposium (PRNewswire) - "Triumvira Immunologics...today announced that it will present two abstracts at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco, California, from January 18-20, 2024. The company will showcase clinical data from its ongoing Phase I/II studies investigating the safety and efficacy of autologous TAC-T cells targeting human epidermal growth factor receptor 2 (HER2) and Claudin 18.2 (CLDN 18.2), respectively, in relapsed or refractory solid tumors (TACTIC-2 /NCT04727151, TACTIC-3 /NCT05862324)."

P1/2 data • Oncology • Solid Tumor

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

Triumvira Immunologics Announces First Patient Dosed in Phase II of TACTIC-2 Cell Therapy Trial for the Treatment of HER2+ Gastric and GEJ Cancers (PRNewswire) - "Triumvira Immunologics...announced that the first patient has been dosed in Phase II of its Phase I/II study TACTIC-2...investigating the safety and efficacy of autologous TAC-T cell lead asset, TAC01-HER2, in targeting HER2 in relapsed or refractory gastric and gastroesophageal junction (GEJ) tumors....TACTIC-2 is an open-label, multicenter Phase I/II study that aims to establish safety, maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), pharmacokinetic profile and efficacy of TAC01-HER2 as a monotherapy, and in combination with pembrolizumab, in subjects with HER2 positive gastric and gastroesophageal adenocarcinoma."

Trial status • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Triumvira Immunologics to Present New Clinical and Preclinical Data on its TAC-T Cell Technology at SITC 2023 Annual Meeting (PRNewswire) - "Triumvira Immunologics...announced that it will participate with one oral presentation and four posters at the Society for Immunotherapy of Cancer (SITC) 2023 Annual Meeting in San Diego, California, from November 1-5. The company will showcase clinical and preclinical data across various programs, including its ongoing Phase I/II study investigating the safety and efficacy of autologous TAC-T cells targeting human epidermal growth factor receptor 2 (HER2) in relapsed or refractory solid tumors (TACTIC-2 /NCT04727151) and its CLDN18.2, GUCY2C and allogeneic TAC T cell technologies."

P1/2 data • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

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

Triumvira Immunologics to Present Clinical Data from TACTIC-2 Trial Investigating TAC01-HER2 at ESMO 2023 Congress and AACR-NCI-EORTC International Conference (PRNewswire) - "Triumvira Immunologics...announced that it will present clinical data from its ongoing Phase I/II study investigating the safety and efficacy of autologous TAC-T cells targeting HER2 in relapsed or refractory solid tumors (TACTIC-2 /NCT04727151) at two upcoming scientific conferences: the European Society for Medical Oncology (ESMO) Congress, being held October 20-24, 2023, in Madrid, Spain, and the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, being held October 11-15, 2023, in Boston."

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

A phase I/II trial investigating safety and efficacy of autologous TAC01-HER2 in relapsed or refractory solid tumors. (AACR-NCI-EORTC 2023) - No abstract available

Clinical • P1/2 data • Oncology • Solid Tumor • HER-2

TACTIC-2: TAC T-cells for the Treatment of HER2-positive Solid Tumors (clinicaltrials.gov) - P1/2 | N=110 | Recruiting | Sponsor: Triumvira Immunologics, Inc. | N=70 ➔ 110 | Trial completion date: Feb 2025 ➔ Jun 2027 | Trial primary completion date: Nov 2024 ➔ Jun 2025

Combination therapy • Enrollment change • Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • ALK • BRAF • BRCA • EGFR • HER-2 • PD-L1

Triumvira Immunologics to Showcase Clinical Findings from TACTIC-2 Clinical Trial Assessing TAC01-HER2 at 2023 ESMO World Congress on Gastrointestinal Cancer (PRNewswire) - "Triumvira Immunologics...today announced that it will be presenting 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 European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer taking place in Barcelona, Spain, June 28 - July 1, 2023. The upcoming presentation will feature the latest clinical findings obtained from the ongoing Phase I/II trial of TAC01-HER2 (NCT04727151) among patients with relapsed or refractory solid tumors."

P1/2 data • Oncology • Solid Tumor

TAC T-Cell Therapy Shows Promise in Treating HER2+ Solid Tumors (Targeted Oncology) - P1/2 | N=70 | TACTIC-2 (NCT04727151) | Sponsor: Triumvira Immunologics, Inc. | "The ongoing, phase 1/2 TACTIC‑02 trial (NCT04727151) exploring TAC01-HER2 has shown the agent to be well-tolerated with early signs of clinical activity in patients with HER2-positive solid tumors....In both dosing cohorts of the study, TAC01-HER2 led to encouraging safety data. No dose limiting toxicities, cytokine release syndrome, or immune effector cell-associated neurotoxicity were observed, and all serious adverse events were unrelated to TAC01-HER2."

P1/2 data • Oncology • Solid Tumor

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

Triumvira Immunologics Highlights Positive Phase 1 Clinical Data on TAC01-HER2 in Solid Tumors at ASCO 2023 Annual Meeting (PRNewswire) - P1/2 | N=70 | TACTIC-2 (NCT04727151) | Sponsor: Triumvira Immunologics, Inc. | "Triumvira Immunologics...today announced that positive data from its Phase I/II trial investigating the safety and efficacy of autologous TAC01-HER2 in refractory solid tumors...will be presented at the 2023 American Society Of Clinical Oncology (ASCO) Annual Meeting...Interim results from the Phase I TACTIC-02 study suggest a highly favorable safety profile for TAC-01 HER2 treatment with the potential of being an outpatient procedure. One DLT (dose limiting toxicities) of Grade 3 pneumonitis and one Grade 3 CRS were observed at the highest dose level, both resolved with standard of care measures, without the need for ICU admission. No neurotoxicities reported to date across all cohorts....In gastric/GEJ/esophageal cancer patients, the DCR is 83%, while the ORR is 33% across DL 2-4."

P1/2 data • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Triumvira Immunologics to Present Clinical Data from Phase I/II Trial TACTIC-2 Investigating TAC01-HER2 at the 2023 ASCO Annual Meeting (PRNewswire) - "Triumvira Immunologics...announced that the Company will be presenting 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 Society Of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, IL, June 2-6. The presentation...will highlight updated clinical data from the ongoing Phase I/II trial of TAC01-HER2 (NCT04727151) in patients with relapsed or refractory solid tumors."

P1/2 data • Oncology • Solid Tumor

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) - P1/2 | N=70 | TACTIC-2 (NCT04727151) | Sponsor: Triumvira Immunologics, Inc. | "The presentations will include updated clinical data from the ongoing TACTIC-2 trial of TAC01-HER2...in patients with solid tumors and preclinical data on an allogeneic HER2-TAC T cell product....TAC01-HER2 obtained a disease control rate of 67% in heavily pretreated patients with solid tumors in patients who failed all standard of care therapies....In gastric/GEJ/esophageal patients, the DCR is 83% at 3 months while the ORR is 33% across DL 2-4 which exceeds the current standard of care of 4% ORR."

P1/2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Triumvira Immunologics Presents Promising Data on TAC T Cells for the Treatment of HER2-overexpressing Solid Tumors at the 2023 AACR Annual Meeting (PRNewswire) - "Patient-derived TAC01-HER2 products consisted of a high percentage of memory T cells similar to products generated from healthy donors with significant proportions of CD4 and CD8 T cells. In a 5-day in vitro potency assay, patient-derived products showed effective tumor cell killing response similar to healthy-donor derived TAC T cells. Intravenous administration of patient-derived TAC01-HER2 in mice led to complete tumor clearance, indicating that patient-derived TAC01-HER2 products are highly functional."

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

Triumvira Immunologics Establishes Collaboration with Merck to Evaluate TAC01-HER2 Cell Therapy in Combination with KEYTRUDA (pembrolizumab) in Patients with HER2-positive Solid Tumors (PRNewswire) - "Triumvira Immunologics...announced a clinical trial collaboration and supply agreement with Merck (known as MSD outside the U.S. and Canada). Triumvira's ongoing TACTIC-2 trial will evaluate the use of its novel autologous cell therapy TAC01-HER2 as a monotherapy but also in combination with Merck's anti-PD-1 therapy KEYTRUDA^® (pembrolizumab) for the treatment of HER2-positive solid tumors...The expansion phase of the trial is expected to launch in 2023....Merck will supply Triumvira with KEYTRUDA for the trial and the two companies will form a Joint Development Committee to review the clinical trial results."

Licensing / partnership • Trial status • Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor