Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 661 |
| INN | Gulgafafusp alfa |
| Status | Clinical |
| Drug code(s) | GMA-102 (diabetes indication), GMA-105 (obesity indication), Glutazumab (not WHO assigned INN) |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Immunoconjugate |
| Format, general category | Full length Ab fusion |
| Format details | None |
| Isotype (Fc) | IgG2 |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | GLP-1 peptide |
| Discovery method/technology | None |
| Target(s) | GLP-1R |
| Indications of clinical studies | Diabetes |
| Primary therapeutic area | Metabolic disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 01, 2015 |
| Start of Phase 2 | November 15, 2017 |
| Start of Phase 3 | September 15, 2021 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Gmax Biopharm Australia Pty Ltd |
| Licensee/Partner | None |
| Comments about company or candidate | CTR20222558 Phase 3 studY for Type 2 diabetess "in progress, recruiting" In November 2024 Phase 3 CTR20211661 study completed. Gmax announced https://www.gmaxbiopharm.com/news_detail_zh/125.html Sep 2021: On September 27th, the Phase III clinical trial (CTR20211661) of the type 2 diabetes treatment drug GMA102 injection independently developed by Hongyun Huaning completed the first subject enrollment. The trial is a randomized, double-blind, placebo-controlled, multi-center phase III clinical trial designed to evaluate the effectiveness and safety of GMA102 injection in patients with type 2 diabetes. Glutazumab - Gmax Biopharm is available for licensing for phase III development in World (excluding China) as of 20 Jan 2021. http://www.gmaxbiopharm.com/pipeline/id/7.html Aug 2019 Gmax Biopharm LLC press release indicates assett is still at Phase 2. Dec 2018: multi-center, randomized, double-blinded, placebo controlled study started in China. Gmax is planning to initiate a multi-region, multi-center phase II/III clinical trial in China, US and Australia. The trial will be the pivotal study for BLA application. Aug 2018: IND approved in China. The ongoing phase Ib/IIa clinical trial of GMA102 in Australia and New Zealand has finished dosing of the 2nd cohort and the recruitment of the 3rd cohort. From the preliminary results of the finished two dosing cohorts, GMA102 has demonstrated expected efficacy, is safe and well tolerated. The phase Ib/IIa trial is expected to finish in Q3, 2019. ACTRN12617000811303p Phase 2 study "A Randomised, Placebo-controlled, Double-blind, Semi-sequential Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeated Escalating Subcutaneous Doses of Glutazumab in Subjects with Type 2 Diabetes" listed on Australian New Zealand Clinical Trials Registry; recruiting as of when record was accessed on Aug 18, 2019. |
| Full address of company | Suite 12.03, Level 12, 50 Margaret Street, Sydney NSW 2000, Australia Australia Australia https://www.gmaxbiopharm.com/contact.html |
GPCR target. "About GMA102 and GMA105: the world's only Mab GLP-1R agonist for T2D/Obesity, GMA102 and GMA105 is the same humanized anti-GLP-1R Mab (IgG2) carrying a GLP-1 fragment. GMAX completed phase 1b/2a trial in 2020 and plan to start phase III trial in China in 2021. Superb clinical data in earlier stage trials show that in T2D, GMA102 is a candidate of super long acting (2QW) and solution with robust efficacy standing head-to-head with the leading competitors. In Obesity, it offers outstanding weight reduction when dosed 1QW. Both GMA102 and GMA105 exhibited excellent tolerability throughout the early clinical studies." https://www.gmaxbiopharm.com/news_detail/30.html Glucagon like peptide 1 receptor agonist. Glutazumab is a novel antibody fusion protein engineered by linking the human GLP-1 derivative to a humanized GLP-1 receptor (GLP-1R) antibody via a peptide linker. Biochem Pharmacol. 2018 Apr;150:46-53. doi: 10.1016/j.bcp.2018.01.029. The glucagon-like peptide-1 receptor (GLP1R) is a receptor protein found on beta cells of the pancreas and on neurons of the brain. It is involved in the control of blood sugar level by enhancing insulin secretion. ... It is a member of the glucagon receptor family of G protein-coupled receptors.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |