WTX212 / Westlake Therap - LARVOL DELTA

Reboot-107: A Phase I Study of WTX212A Monotherapy or in Combination With Radiotherapy in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Sun Yat-sen University

Monotherapy • New P1 trial • Oncology • Solid Tumor

Effect of erythrocyte-antibody conjugates on cancers resistant to checkpoint blockade immunotherapy: A phase I trial. (ASCO 2025) - P1 | "Our study suggests that PD-1 blockade in the spleen using erythrocyte-antibody conjugates triggers systemic anti-tumor responses while maintaining a favorable safety profile. Erythrocyte-drug conjugates represent a novel approach for targeting immune cells in the spleen, with broad implications for cancer treatment and drug development."

Checkpoint block • Checkpoint inhibition • P1 data • Oncology • Solid Tumor

A Dose Escalation and Dose Expansion Trial of WTX212A in the Treatment of Patients with Advanced Malignant Tumors (clinicaltrials.gov) - P1 | N=44 | Recruiting | Sponsor: Zhejiang University | Trial completion date: May 2025 ➔ Aug 2026 | Trial primary completion date: Aug 2024 ➔ Aug 2026

IO biomarker • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • PD-L1

Erythrocyte-αPD-1 conjugates suppress cancers with resistance to checkpoint blockade immunotherapy (SITC 2024) - P1 | "Additionally, αPD-1-Ery treatment rapidly reduced the number of immunosuppressive myeloid cells and stimulated T cell responses in the peripheral blood of all patients, consistent with preclinical findings. Conclusions These findings suggested that erythrocyte-antibody conjugates effectively target the spleen and reprogram the TME to overcome immunotherapy resistance."

Checkpoint block • Checkpoint inhibition • Breast Cancer • Lung Cancer • Oncology • Solid Tumor • KRAS

Erythrocyte-αPD-1 conjugates suppress cancers with resistance to checkpoint blockade immunotherapy (SITC 2024) - P1 | "Additionally, αPD-1-Ery treatment rapidly reduced the number of immunosuppressive myeloid cells and stimulated T cell responses in the peripheral blood of all patients, consistent with preclinical findings. Conclusions These findings suggested that erythrocyte-antibody conjugates effectively target the spleen and reprogram the TME to overcome immunotherapy resistance."

Checkpoint block • Checkpoint inhibition • Breast Cancer • Lung Cancer • Oncology • Solid Tumor • KRAS

Safety, Tolerability and Preliminary Efficacy of Erythrocyte-αPD-1 Conjugate in Patients With Advanced Malignancies (clinicaltrials.gov) - P1 | N=39 | Not yet recruiting | Sponsor: Zhejiang Provincial People's Hospital

Metastases • New P1 trial • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor

FIH: Safety, Tolerability and Preliminary Efficacy of Engineered Red Blood Cell in Patients With Advanced Malignancies (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Westlake Therapeutics | Trial completion date: Jul 2024 ➔ Jul 2026 | Trial primary completion date: Dec 2023 ➔ Dec 2025

Metastases • Trial completion date • Trial primary completion date • Hematological Disorders • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

Erythrocyte-αPD-1 conjugates overcome resistance to checkpoint blockade immunotherapy: A first-in-human study. (ASCO 2024) - P1 | "WTX-212 treatment is safe and tolerable and shows promising clinical signs in cancer patients resistant to anti-PD-1 immunotherapy, supporting further investigation and exploration of WTX-212 monotherapy and combination therapy."

Checkpoint block • Checkpoint inhibition • P1 data • Cervical Cancer • Esophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD8

A Dose Escalation and Dose Expansion Trial of WTX212A in the Treatment of Patients With Advanced Malignant Tumors (clinicaltrials.gov) - P1 | N=44 | Recruiting | Sponsor: Zhejiang University | Not yet recruiting ➔ Recruiting

Enrollment open • IO biomarker • Metastases • Oncology • Solid Tumor • PD-L1

An Erythrocyte-αPD-1 conjugate suppresses cancers resistant to checkpoint blockade immunotherapy: A first-in-human study (AACR 2024) - P1 | "The initial promising data support further investigation and exploration of the combination therapy strategies to expand the therapeutic potential of WTX-212 in cancer patients. Erythrocyte-drug conjugation may serve as a unique strategy for targeting the peripheral immune system to treat cancers."

Checkpoint block • Checkpoint inhibition • P1 data • Cervical Cancer • Esophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Reboot-105: WTX212A Monotherapy and in Combination With PD -1/PD-L1 Monoclonal Antibody (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Monotherapy • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • PD-1 • PD-L1

A Exploratory Trial of WTX212A Injection in the Treatment of Patients With Advanced Lung Cancer (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Metastases • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Reboot-101: Safety, Tolerability and Preliminary Efficacy of Engineered Red Blood Cell in Patients With Advanced Malignancies (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Westlake Therapeutics | Trial completion date: Dec 2023 ➔ Jul 2024

Metastases • Trial completion date • Hematological Disorders • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

WTX212, an erythrocyte-anti-PD1 antibody conjugate, to demonstrate anti-tumor activities in tumor models and patients with cancer with acquired resistance to immunotherapy. (ASCO 2023) - P1 | "WTX212 demonstrated anti-tumor activities by activating the peripheral immune system to overcome resistance to immunotherapy in both preclinical models and human patients. WTX212 is well-tolerated supporting the future clinical trials."

Preclinical • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Immune Modulation • Lung Cancer • Oncology • Solid Tumor • CD8 • PD-L1