CND261 / Walvax, Candid Therapeutics - LARVOL DELTA

GB261, an Fc-Function Enabled and CD3 Affinity De-Tuned CD20/CD3 Bispecific Antibody, Demonstrated a Highly Advantageous Safety/Efficacy Balance in an Ongoing First-in-Human Dose-Escalation Study in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma (ASH 2023) - P1/2 | "At 100mg dose, there were 5 evaluable patients, with ORR 100% (5/5), CRR 80% (4/5) and PR (20%, 1/5; mosunetuzumab-refractory rrDLBCL patient)...All cases of CRS were grade 1 (8.5%, 4/47) or 2 (4.3%, 2/47), no grade 3 (Lee et al., ASTCT criteria), no interruptions of treatment, and no administration of Tocilizumab... GB261, a novel and highly differentiated CD20/CD3 bispecific antibody, is the first clinical stage Fc+ CD20/CD3 T cell engager. In heavily pretreated B-NHL patients, GB261 showed a highly advantageous safety/efficacy balance, consistent with the MOA. The safety profile is excellent especially for the CRS which is very mild, transient and less frequent compare with other CD20/CD3 bispecific antibodies."

Clinical • First-in-human • P1 data • B Cell Non-Hodgkin Lymphoma • Chronic Lymphocytic Leukemia • CNS Disorders • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Respiratory Diseases • CD20

A Study of GB261 in Systemic Sclerosis (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Ruijin Hospital

New P1 trial • Immunology • Scleroderma • Systemic Sclerosis

GB261 (CND261), A NOVEL CD20/CD3 T-CELL ENGAGER, HAS A DIFFERENTIATED SAFETY PROFILE AND POTENTIAL FOR DEVELOPMENT IN AUTOIMMUNE DISEASES (EULAR 2025) - "GB261 (CND261), a CD20/CD3 TCE, is capable of potent and specific killing of CD20+ B cells through multiple mechanisms (T cell dependent cellular cytotoxicity, ADCC and CDC) and is optimized to induce lower levels of cytokine production relative to other TCEs. Clinical data with GB261 (CND261) in R/R B-NHL patients showed a favorable safety profile with predominantly low-grade, transient CRS and no incidents of ICANs. GB261 (CND261) demonstrated clinical activity comparable to other CD20/CD3 TCEs."

Clinical • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Immunology • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

An Open-label Study of GB261 in Refractory Seropositive Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=19 | Not yet recruiting | Sponsor: Wuhan Union Hospital, China

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

Genor Biopharma : GB261 Phase I/II Clinical Trial is officially launched in China (Market Screener) - "Genor Biopharma...announced today that the first patient has been successfully dosed in a Phase I/II clinical trial of GB261(CD20/CD3, bispecific antibody) in China. The clinical trial application was approved by the National Medical Products Administration (NMPA) on 23 May for the treatment of patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (B-NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The trial was then achieved first China patient dosed on September 8."

Trial status • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

A Safety, Tolerability, Pharmacokinetics and Efficacy Study of GB261 in B-Cell NHL and CLL. (clinicaltrials.gov) - P1/2; N=460; Recruiting; Sponsor: Genor Biopharma Co., Ltd.; Not yet recruiting ➔ Recruiting; Initiation date: Jun 2022 ➔ Aug 2021

Clinical • Enrollment open • Trial initiation date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

Biological activity validation of a computationally designed Rituximab/CD3 T cell engager targeting CD20+ cancers with multiple mechanisms of action. (PubMed, Antib Ther) - "Bispecific T cell engaging antibodies (TEAs) with one arm targeting a cancer antigen and another arm binding to CD3 have demonstrated impressive efficacy in multiple clinical studies. It exhibited better RRCL cell killing than the BM in a PBMC-engrafted, therapeutic treatment mouse model and good safety in cynomolgus monkeys. Thus, GB261 is a promising novel TEA against CD20+ cancers."

Journal • Oncology • CD20

A Safety, Tolerability, Pharmacokinetics and Efficacy Study of GB261 in B-Cell NHL and CLL. (clinicaltrials.gov) - P1/2; N=460; Not yet recruiting; Sponsor: Genor Biopharma Co., Ltd.; Initiation date: Jun 2021 ➔ Jun 2022

Clinical • Trial initiation date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

A Safety, Tolerability, Pharmacokinetics and Efficacy Study of GB261 in B-Cell NHL and CLL. (clinicaltrials.gov) - P1/2; N=460; Not yet recruiting; Sponsor: Genor Biopharma Co., Ltd.

Clinical • New P1/2 trial • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

[VIRTUAL] A novel CD20/CD3 T cell engager designed from Rituximab targeting CD20+ cancer with multiple mechanisms (AACR 2021) - "Background Bispecific T cell engaging antibodies (TEAs) with one arm targeting a cancer antigen and another arm binding to CD3 have demonstrated impressive efficacy in multiple clinical studies. Finally, GB261 also demonstrated excellent manufacturability based on expression level and bio-analytic data.Conclusions GB261 exhibits enhanced efficacy and safety, and great manufacturability, presenting several advantages over the BM antibody. Thus, GB261 is a promising bispecific therapeutic antibody against CD20+ cancers."

IO biomarker • Late-breaking abstract • Oncology • CD2 • CD20 • CD69 • PD-L1

Genor Biopharma Releases Its Annual Results for 2020 (Taiwan News) - “Upcoming Milestones; GB261 (CD20/CD3) – First Patient Enrollment in Australia in Q321, and initial POC Data in 1H22. GB491 (Lerociclib) (cyclin-dependent kinase, CDK4/6) – First Patient Enrollment for Phase 3 trial for 1L /2L HR+/HER2- mBC in Q421, and Interim Analysis for 2L HR+/HER2- mBC in 2Q23. GB226 (Geptanolimab) – NDA approval for r/r PTCL, Q321…Genor Biopharma expects to launch Geptanolimab (GB226) at Q3 this year…we plan to file NDA to NMPA for Coprelotamab (GB221) in HER2+ breast cancer at Q4 of 2021.”

Enrollment status • IND • Launch non-US • Non-US regulatory • P1 data • P3 data • Breast Cancer • Hematological Malignancies • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Solid Tumor • T Cell Non-Hodgkin Lymphoma

Genor Bio to put CD20/CD3 BsAb into FIH trials in Oz (GBI Health) - "China’s Genor Biopharma Co., Ltd (6998.HK) made an IND filing for pipeline candidate GB261, a bispecific antibody (BsAb) targeting cluster of differentiation (CD) 20 and CD3, to enter first-in-human (FIH) trials in Australia. Genor is seeking approval from the Bellberry Human Research Ethics Committee, targeting the indication of B-cell non-Hodgkin's lymphoma (nHL)."

Non-US regulatory • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology