igermetostat (XNW5004) / Evopoint - LARVOL DELTA

A phase 1b/2 study to evaluate the safety and efficacy of igermetostat (XNW5004) in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer. (ASCO-GU 2026) - P1/2 | "Clinical Trial Registry Number: NCT06702995. The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

Clinical • Combination therapy • Metastases • P1/2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

To Evaluate a Phase I/II Clinical Study of XNW5004 Tablets in Patients With Relapsed/Refractory Advanced Tumors (clinicaltrials.gov) - P1/2 | N=120 | Completed | Sponsor: Evopoint Biosciences Inc. | Recruiting ➔ Completed | N=176 ➔ 120 | Trial completion date: Dec 2024 ➔ Aug 2025 | Trial primary completion date: Dec 2024 ➔ Aug 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology • TNFRSF8

A Randomized, Double-blind, Multicenter Phase III Study of XNW5004 Tablets in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (clinicaltrials.gov) - P3 | N=120 | Recruiting | Sponsor: Evopoint Biosciences Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • TNFRSF8

A PHASE 1/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF XNW5004, A SELECTIVE EZH2 INHIBITOR, IN SUBJECTS WITH RELAPSED/ REFRACTORY NON-HODGKIN LYMPHOMA (ICML 2025) - "XNW5004 has shown a well-tolerated safety profile and promising efficacy in different types of NHL. Pivotal studies of XNW5004 monotherapy in PTCL are ongoing."

Clinical • IO biomarker • P1/2 data • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • EZH2

A phase 1/2 study to evaluate the safety and efficacy of XNW5004, a selective EZH2 inhibitor, in subjects with relapsed/refractory non-Hodgkin lymphoma. (ASCO 2025) - P1/2 | "XNW5004 has shown a well-tolerated safety profile and promising efficacy in different types of NHL. Pivotal studies of XNW5004 monotherapy in PTCL are ongoing."

Clinical • IO biomarker • P1/2 data • Anemia • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • EZH2

Study of XNW5004 Tablet in Combination With Enzalutamide in Subjects With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1/2 | N=307 | Recruiting | Sponsor: Evopoint Biosciences Inc. | Enrolling by invitation ➔ Recruiting

Enrollment status • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Targeting first-line therapy! XNW5004 approved for important clinical study in PTCL [Google translation] (bydrug.pharmcube.com) - "On February 12, 2025, Sinovent Pharmaceuticals Inc...independently developed an innovative drug, EZH2 inhibitor, XNW5004, which was approved and issued by the National Medical Products Administration (NMPA). The Company will soon conduct a Phase Ib/II clinical study of XNW5004 combined with CHOP/CHOEP for the treatment of newly diagnosed peripheral T-cell lymphoma (PTCL)...The approved Phase Ib/II study combines XNW5004 with first-line chemotherapy to explore its potential as a first-line treatment for patients with newly diagnosed PTCL."

New P1/2 trial • Peripheral T-cell Lymphoma

A Randomized, Double-blind, Multicenter Phase III Study of XNW5004 Tablets in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (clinicaltrials.gov) - P3 | N=120 | Not yet recruiting | Sponsor: Evopoint Biosciences Inc.

New P3 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Study of XNW5004 Tablet in Combination With Enzalutamide in Subjects With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1/2 | N=307 | Enrolling by invitation | Sponsor: Evopoint Biosciences Inc.

Combination therapy • Metastases • New P1/2 trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

To Evaluate XNW5004 Tablets in Patients with Relapsed or Refractory Peripheral T Cell Lymphoma (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Evopoint Biosciences Inc.

New P2 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

The XNW5004 of Sinovi EZH2 inhibitor was granted Breakthrough Therapy Designation [Google translation] (bydrug.pharmcube.com) - "On September 10, Sinovi, a portfolio company of Oceanpine Capital, learned from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China that the company's self-developed innovative drug EZH2 inhibitor, XNW5004, has been officially recognized as a breakthrough therapy for the treatment of relapsed or refractory peripheral T Cellular lymphoma (PTCL)....The Breakthrough Therapy Designation for Sinovi XNW5004 is based on the excellent results of its Phase II clinical trials, which XNW5004 is expected to bring important new treatment options to more patients in China."

Breakthrough therapy • Hematological Malignancies • Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

To Evaluate a Phase I/II Clinical Study of XNW5004 Tablets in Patients With Relapsed/Refractory Advanced Tumors (clinicaltrials.gov) - P1/2 | N=176 | Recruiting | Sponsor: Evopoint Biosciences Inc.

Metastases • New P1/2 trial • Hematological Malignancies • Lymphoma • Oncology

Study of XNW5004 Tablet in Combination With KEYTRUDA® (Pembrolizumab) in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19) (clinicaltrials.gov) - P1/2 | N=204 | Recruiting | Sponsor: Evopoint Biosciences Inc. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Cervical Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Study of XNW5004 Tablet in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19) (clinicaltrials.gov) - P1/2 | N=204 | Not yet recruiting | Sponsor: Evopoint Biosciences Inc.

Combination therapy • Metastases • Trial completion date • Trial initiation date • Trial primary completion date • Cervical Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Study of XNW5004 Tablet in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19) (clinicaltrials.gov) - P1/2 | N=204 | Not yet recruiting | Sponsor: Evopoint Biosciences Inc.

Combination therapy • Metastases • New P1/2 trial • Cervical Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Small Cell Lung Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

XNW5004: a novel EZH2 inhibitor efficacious in multiple cancer xenograft models as a single agent and in combination studies (AACR 2023) - "In summary, XNW5004 is a potent EZH2 inhibitor with promising efficacy, pharmacokinetic and safety properties. XNW5004 is expected to be a potent therapeutic candidate in cancer treatment and is now in Phase II clinical trial for both liquid and solid tumors."

IO biomarker • Preclinical • Genito-urinary Cancer • Hematological Malignancies • Lymphoma • Oncology • Prostate Cancer • Solid Tumor • AR • EZH2 • SMARCA2 • SMARCA4 • SMARCB1

Evopoint Announces Clinical Trial Collaboration Agreement with MSD for the Study of XNW5004 in Combination with KEYTRUDA (pembrolizumab) in Advanced Solid Tumors (Businesswire) - "Evopoint Biosciences Co., Ltd...announced today a collaboration with MSD (Merck & Co., Inc., Rahway, NJ, USA) to evaluate Evopoint’s XNW5004, a selective EZH2 inhibitor, in combination with KEYTRUDA®(pembrolizumab), MSD’s anti-PD-1 therapy, in a Phase Ib/II study in Chinese patients with advanced solid tumors....The combination trial is an open label, single-arm Phase Ib/II study designed to establish the RP2D dose of XNW5004 in combination with KEYTRUDA® and to evaluate the safety and efficacy of XNW5004 in combination with KEYTRUDA® for patients with advanced solid tumors....Under the terms of the agreement, Evopoint will sponsor the Phase Ib/II trial and MSD will supply KEYTRUDA®. Evopoint maintains the global rights to XNW5004."

Licensing / partnership • Oncology • Solid Tumor