emfizatamab (GNC-038) / Biokin Pharma - LARVOL DELTA

A Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of GNC-038, a Tetra-specific Antibody, in Participants With R/R Diffuse Large B-cell Lymphoma (DLBCL) (clinicaltrials.gov) - P1/2 | N=12 | Active, not recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting | N=20 ➔ 12

Enrollment change • Enrollment closed • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Phase I Clinical Study of GNC-038 in Patients With Non-Hodgkin's Lymphoma or Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1 | N=47 | Active, not recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

A Study of GNC-038, a Tetra-specific Antibody, in Patients With Central Nervous System Lymphoma (PCNSL) and Relapsed or Refractory Secondary Central Nervous System Lymphoma (SCNSL) (clinicaltrials.gov) - P1/2 | N=7 | Active, not recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting | N=33 ➔ 7

Enrollment change • Enrollment closed • CNS Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma • Secondary Central Nervous System Lymphoma

A Study of GNC-038 Injection in Patients With Relapsed or Refractory NK/ T-cell Lymphoma, AITL, and Other NHL (clinicaltrials.gov) - P1/2 | N=4 | Active, not recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting | N=40 ➔ 4

Enrollment change • Enrollment closed • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

A Study of GNC-038, a Tetra-specific Antibody, in Participants With R/R Diffuse Large B-cell Lymphoma (DLBCL) (clinicaltrials.gov) - P1/2 | N=20 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial primary completion date: Jun 2025 ➔ Dec 2025

Trial primary completion date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of GNC-038 Injection in Patients With Relapsed or Refractory NK/ T-cell Lymphoma, AITL, and Other NHL (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial primary completion date: Jun 2025 ➔ Dec 2025

Trial primary completion date • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Phase I Clinical Study of GNC-038 in Patients With Non-Hodgkin's Lymphoma or Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1 | N=41 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial primary completion date: Jun 2025 ➔ Dec 2025

Trial primary completion date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

A Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial primary completion date: Jun 2025 ➔ Dec 2025

Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of GNC-038 Tetra-specific Antibody Injection in Patients With Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=54 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2025 ➔ Jun 2025

Enrollment open • Trial initiation date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Study of GNC-038, a Tetra-specific Antibody, in Patients With Central Nervous System Lymphoma (PCNSL) and Relapsed or Refractory Secondary Central Nervous System Lymphoma (SCNSL) (clinicaltrials.gov) - P1/2 | N=33 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: May 2025 ➔ Dec 2025 | Trial primary completion date: May 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • CNS Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma • Secondary Central Nervous System Lymphoma

A Study of GNC-038 Tetra-specific Antibody Injection in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=54 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Study of GNC-038 Tetra-specific Antibody Injection in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=54 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P1 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Study of GNC-038 Tetra-specific Antibody Injection in Patients With Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=54 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Phase I Clinical Study of GNC-038 in Patients With Non-Hodgkin's Lymphoma or Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1 | N=41 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Nov 2024 ➔ Nov 2025 | Trial primary completion date: Nov 2024 ➔ Jun 2025

Metastases • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

A Study of GNC-038 Injection in Patients With Relapsed or Refractory NK/ T-cell Lymphoma, AITL, and Other NHL (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Feb 2025 ➔ Dec 2025 | Trial primary completion date: Feb 2025 ➔ Jun 2025

Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

A Study of GNC-038, a Tetra-specific Antibody, in Participants With R/R Diffuse Large B-cell Lymphoma (DLBCL) (clinicaltrials.gov) - P1/2 | N=20 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Phase Ib/II Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of GNC-038, a Tetra-specific Antibody, in Participants With R/R Diffuse Large B-cell Lymphoma (DLBCL) (clinicaltrials.gov) - P1/2 | N=20 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Aug 2024 ➔ Dec 2024 | Trial primary completion date: Aug 2024 ➔ Dec 2024

Trial completion date • Trial primary completion date • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Phase Ib/II Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Aug 2024 ➔ Dec 2024 | Trial primary completion date: Aug 2024 ➔ Dec 2024

Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

GNC-038, a tetra-specific antibody, in patients with R/R non-Hodgkin lymphoma or acute lymphoblastic leukemia: A phase 1 study design and rationale. (ASCO 2023) - P1 | "The dose expansion phase (Ib) has been initiated. Clinical trial information: NCT04606433."

Clinical • IO biomarker • P1 data • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19

SystImmune, Inc. to Present New Data from Oncology Programs at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2023 (PRNewswire) - "Systimmune, Inc. (SystImmune) announced today that it will present clinical data from its lead programs at the ASCO Annual Meeting 2023 in Chicago in June. The clinical results to be presented will be from trials involving patients with several solid tumor types."

Clinical protocol • P1 data • P2 data • B Acute Lymphoblastic Leukemia • Head and Neck Cancer • Hematological Malignancies • Leukemia • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Tetra-specific antibody GNC-038: guidance and navigation control (GNC) molecule development for treatment of CD19+ malignancies (AACR 2023) - "Based on these results, the primary indicator of CRS, IL-6, does not suggest increased risk compared to Blinatumomab, while the type of T cell activity induced by GNC-038 in PBMC with leukemia cells is distinct.Collectively, the GNC-038 represents a class of multi-specific and multi-modal immune cell engagers with potential to mediate CD19+ cancer killing, while also increasing the T cell compartment’s therapeutic potential to respond to T cell redirection upon subsequent cycles of therapy. The clinical phase I-b study of GNC-038 is under way and the available data exhibit strong signals of efficacy with acceptable tolerability."

IO biomarker • Hematological Malignancies • Leukemia • Lymphoma • Oncology • CD19 • IFNG • IL2 • IL6 • PD-1 • PD-L1 • TNFA

SystImmune to Present Data from Seven Preclinical Programs at the American Association of Cancer Research (AACR) Annual Meeting 2023 (PRNewswire) - "SystImmune...has announced that it will present data from seven preclinical programs in poster presentations at the American Association of Cancer Research (AACR) meeting....SystImmune will present its findings in several poster sessions at the AACR meeting, including 'Antibody Technologies', 'Therapeutic Antibodies, Including Engineered Antibodies', and 'Growth Factor Receptors as Therapeutic Targets'."

Preclinical • Oncology • Solid Tumor

Baili Tianheng (688506.SH): 5 clinical research results were selected for the 2023 American Society of Clinical Oncology (ASCO) annual meeting [Google translation] (Zhitong Finance) - "Zhitong Finance APP News, Baili Tianheng (688506.SH) announced that a total of 5 important clinical research results of the company's independent research projects were selected for the 2023 American Society of Clinical Oncology (ASCO) annual meeting...GNC-038: GNC-038 is independently developed by the company....SI-B003: SI-B003 is a PD-1×CTLA-4 bispecific antibody, which can simultaneously target PD-1 and CTLA-4, and has the potential to achieve breakthrough therapeutic effects."

Clinical data • Oncology • Solid Tumor