CAN1012 / Canwell Biotech - LARVOL DELTA

Efficacy of the TLR7 agonist CAN1012 alone or combined with the anti-PD-1 antibody toripalimab (ESMO 2025) - P1, P1/2 | "Conclusions CAN 1012 induces rapid and deep clinical responses, with robust local and systemic immune activation and good tolerability, in immunotherapy pre-treated pts. CAN1012 in combination with toripalimab is a promising novel therapeutic option."

Clinical • IO biomarker • Breast Cancer • Liposarcoma • Melanoma • Oncology • Sarcoma • Solid Tumor • CD8 • IL6

Intratumoral CAN1012(selective TLR7 Agonist) in Subjects with Solid Tumors (clinicaltrials.gov) - P1 | N=27 | Active, not recruiting | Sponsor: Canwell Biotech Limited | Trial completion date: Dec 2024 ➔ Jun 2025 | Trial primary completion date: Dec 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Results from a phase I dose escalation trial of CAN1012 in patients with solid tumors (SITC 2024) - P1 | "Conclusions CAN1012 is tolerable and active in an advanced cancer population; further clinical and pharmacodynamic data will be presented. The Phase 1/2 studies of CAN1012 in combination with Toripalimab have been started, which would provide more clinical and pharmacodynamic data."

Clinical • IO biomarker • P1 data • Colon Cancer • Melanoma • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor • CD4 • CD8 • IFNA1 • IL6 • TGFB1 • TNFA

CAN1012 Combined With PD-1 in Patients With Solid Tumors (clinicaltrials.gov) - P1/2 | N=71 | Recruiting | Sponsor: Canwell Biotech Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

Intratumoral CAN1012(Selective TLR7 Agonist) in Subjects With Solid Tumors (clinicaltrials.gov) - P1 | N=27 | Active, not recruiting | Sponsor: Canwell Biotech Limited | Recruiting ➔ Active, not recruiting | N=96 ➔ 27

Enrollment change • Enrollment closed • Metastases • Oncology • Solid Tumor

CAN1012 Combined With PD-1 in Patients With Solid Tumors (clinicaltrials.gov) - P1/2 | N=71 | Not yet recruiting | Sponsor: Canwell Biotech Limited

Metastases • New P1/2 trial • Oncology • Solid Tumor

Intratumoral CAN1012(Selective TLR7 Agonist) in Subjects With Solid Tumors (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: CanWell Pharma Inc. | Trial completion date: Jun 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2022 ➔ Dec 2024

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Initial results from phase I dose escalation trial of CAN1012 in patients with solid tumor malignancies (SITC 2023) - P1 | "In addition, a favorable efficacy is observed in some of treated patients. Conclusions The trial is still undergoing according to the initial design and is expected to be completed by the end of this year."

Clinical • P1 data • Oncology • Solid Tumor • CD4 • CD8 • IFNA1

CAN1012: a Selective and Potent TLR7 Agonist with Strong Antitumoral Properties Mediated by Localized Innate Immune Activation (SITC 2022) - P1 | "A first-in-human Phase I clinical study in advanced cancer patients is ongoing in the US ( NCT04987112 ). Trial Registration NCT04987112 Ethics Approval Aniaml studies had been approved by the ethics review committee at the institution at which the studies were conducted"

Oncology • CD4 • CD8 • IFNA1 • TLR9 • TNFA

Intratumoral CAN1012 in Subjects With Solid Tumors (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: Canwell Biotech Limited

New P1 trial • Oncology • Solid Tumor