CCT303-406 / Sunterra Biotech, Exuma Biotech - LARVOL DELTA

EXUMA Biotech Announces Phase 1 Results for its Autologous HER2 Directed, Tumor Metabolism Regulated (TMR) CAR-T Product at ASCO GI 2025 (PRNewswire) - P1 | N=12 | NCT04511871 | Sponsor: Shanghai PerHum Therapeutics Co., Ltd. | "The single center, investigator-initiated, dose escalation trial enrolled 12 patients with HER2-positive Stage IV solid tumor malignancies, including three gastric, one esophageal, four colorectal, and four breast cancers....Key Findings: Safety: No dose limiting toxicities or investigational-product related serious adverse events. No adverse events leading to study discontinuation....Efficacy: A deep PR (100% reduction in SLD) was observed in a gastroesophageal cancer patient that was ongoing at 36 weeks of follow-up. Cohort 3's 12-month survival rate was 80%, compared to 45.5% for all three dose cohorts combined."

P1 data • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • HER2 Positive Breast Cancer

A Phase I Trial of CCT303-406 in Patients With Relapsed or Refractory HER2 Positive Solid Tumors (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Shanghai PerHum Therapeutics Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Mar 2024 ➔ Oct 2024

Enrollment closed • Trial primary completion date • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor • HER-2

A Phase I Trial of CCT303-406 in Patients With Relapsed or Refractory HER2 Positive Solid Tumors (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Shanghai PerHum Therapeutics Co., Ltd. | Trial completion date: Oct 2023 ➔ Mar 2025 | Trial primary completion date: Oct 2022 ➔ Mar 2024

Trial completion date • Trial primary completion date • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor

EXUMA Biotech Presents Early Clinical and Translational Findings from Solid Tumor Cell Therapy and In Vivo CAR Engineering Research at the AACR Annual Meeting 2023 (PRNewswire) - "EXUMA's presentation, 'Can cellular therapy provide another arrow in the quiver for HER2 positive malignancies?' reviewed the potential for novel modalities to continue targeting HER2 in late-stage HER2-positive cancers and provided translational and clinical insights from a novel HER2 targeted CAR-T product (CCT303-406) developed by the company in addition to next-generation technologies."

Preclinical • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor

A Phase I Trial of CCT303-406 in Patients With Relapsed or Refractory HER2 Positive Solid Tumors (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Shanghai PerHum Therapeutics Co., Ltd. | Trial completion date: Apr 2023 ➔ Oct 2023 | Trial primary completion date: Apr 2022 ➔ Oct 2022

Trial completion date • Trial primary completion date • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor • HER-2

A Phase I Trial of CCT303-406 in Patients With Relapsed or Refractory HER2 Positive Solid Tumors (clinicaltrials.gov) - P1; N=15; Recruiting; Sponsor: Shanghai PerHum Therapeutics Co., Ltd.

Clinical • New P1 trial • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor