GB221 (coprelotamab) / Walvax - LARVOL DELTA

A Phase I Clinical Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of GB221 Injection and Trastuzumab (Herceptin®) in Healthy Chinese Adults. (PubMed, Eur J Drug Metab Pharmacokinet) - "GB221 demonstrated similar pharmacokinetics to trastuzumab and comparable safety and immunogenicity in healthy Chinese adults."

Clinical • Journal • P1 data • PK/PD data

Single Dose Pharmacokinetic Study of GB221 in Comparison With Herceptin ® (clinicaltrials.gov) - P1; N=87; Completed; Sponsor: Genor Biopharma Co., Ltd.

Clinical • New P1 trial • Breast Cancer • Oncology • Solid Tumor

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

Immunotherapy for Breast Cancer (Breast Cancer) - "'We know that not all tumor types are the same, and also that every patient's tumor is going to be unique,' said Leisha Emens, MD...'We still need to learn a lot to be able to predict which patients may respond to immunotherapy,' Dr. Emens continued. 'For some breast tumors, the mutational load may be important, and for others that may not be the case. Also, the presence of PD-L1 [a checkpoint protein that helps the immune system recognize cells as part of the body...Small numbers of patients without PD-L1 in their tumors can also respond to immunotherapy, so we need to know more about what is driving their tumor immunity.'"

Media quote

Clinical Study of Recombinant Anti-HER2 Humanized Monoclonal Antibody for Injection (clinicaltrials.gov) - P1/2; N=132; Recruiting; Sponsor: Genor Biopharma Co., Ltd.; Trial completion date: Dec 2020 ➔ Dec 2022; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Clinical Study of Recombinant Anti-HER2 Humanized Monoclonal Antibody for Injection (clinicaltrials.gov) - P1/2; N=132; Recruiting; Sponsor: Genor Biopharma Co., Ltd.; Trial completion date: Apr 2020 ➔ Dec 2020; Trial primary completion date: Dec 2019 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Dr. Brufsky on trastuzumab biosimilars in breast cancer (YouTube) - "Adam M. Brufsky, MD, PhD, discusses the utility of trastuzumab biosimilars in breast cancer."

Video

Newly added product (clinicaltrials.gov) - P3, Breast Cancer

Pipeline update