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- GB261 / Walvax
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 ... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_2139;
P1/2
Median age was 60.0 years (range: 28, 81), 55.3% of patients were male. Median prior lines of therapy were 3 (range: 1, 10).
- | Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal: Biological activity validation of a computationally designed Rituximab/CD3 T cell engager targeting CD20+ cancers with multiple mechanisms of action. (Pubmed Central) - Nov 24, 2021
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.
- |||| GB261 / Walvax
Enrollment open, Trial initiation date: GB261-001: A Safety, Tolerability, Pharmacokinetics and Efficacy Study of GB261 in B-Cell NHL and CLL. (clinicaltrials.gov) - Nov 22, 2021
P1/2, N=460, Recruiting, Sponsor: Genor Biopharma Co., Ltd.
Thus, GB261 is a promising novel TEA against CD20+ cancers. Not yet recruiting --> Recruiting | Initiation date: Jun 2022 --> Aug 2021
- ||| GB261 / Walvax
Trial initiation date: GB261-001: A Safety, Tolerability, Pharmacokinetics and Efficacy Study of GB261 in B-Cell NHL and CLL. (clinicaltrials.gov) - Aug 18, 2021
P1/2, N=460, Not yet recruiting, Sponsor: Genor Biopharma Co., Ltd.
Not yet recruiting --> Recruiting | Initiation date: Jun 2022 --> Aug 2021 Initiation date: Jun 2021 --> Jun 2022
- ||||| GB261 / Walvax
New P1/2 trial: GB261-001: A Safety, Tolerability, Pharmacokinetics and Efficacy Study of GB261 in B-Cell NHL and CLL. (clinicaltrials.gov) - Jun 11, 2021
P1/2, N=460, Not yet recruiting, Sponsor: Genor Biopharma Co., Ltd.
- Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
[VIRTUAL] A novel CD20/CD3 T cell engager designed from Rituximab targeting CD20+ cancer with multiple mechanisms () - Mar 11, 2021 - Abstract #AACR2021AACR_1625;
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.