Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1014 |
| INN | Quavonlimab |
| Status | Clinical |
| Drug code(s) | MK-1308, AK107 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | CTLA-4 |
| Indications of clinical studies | Renal cell carcinoma, Melanoma, solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 02, 2017 |
| Start of Phase 2 | June 26, 2020 |
| Start of Phase 3 | April 14, 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 | Akeso Inc. |
| Licensee/Partner | Merck |
| Comments about company or candidate | Listed as Phase 3 in Merck pipeline dated Nov 1, 2024. Phase 3 studies for Renal cell carcinoma (NCT04736706, NCT05899049) are active not recruiting as of Nov 2024. On June 16, 2021, Akeso, Inc. revealed that the CTLA-4 monoclonal antibody, which the company licensed out to MSD for a total consideration of US$200 million, has entered Phase III clinical trial. This is a Phase III Study to evaluate efficacy and safety of this CTLA-4 monoclonal antibody as co-formulation with pembrolizumab（MK-1308A）in Combination with lenvatinib, versus pembrolizumab and lenvatinib, as First-Line treatment in participants with advanced Clear Cell Renal Cell Carcinoma (ccRCC). NCT04736706 Phase 3 in renal cell carcinoma started in April 2021 has primary completion date in Oct 2026. NCT04305041 Phase 1/2 in melanoma started in June 2020. NCT03179436 Phase 1 study still recruiting as of March 2019. Phase 1 study results published in 2019: MK-1308 plus pembro was generally well tolerated with no unexpected toxicity and conferred encouraging antitumor activity in 1L advanced NSCLC pts. Efficacy, safety, and PK data suggest that 25 mg given Q6W is the recommended phase 2 dose for MK-1308 in combination with pembro. (https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.2558) Phase 1 results published in Annals of Oncology, Volume 29, Issue suppl_8, 1 October 2018, mdy279.402, https://doi.org/10.1093/annonc/mdy279.402. Preliminary results suggest that the combination of MK-1308 and pembrolizumab shows promising responses in a 1L advanced NSCLC population and manageable toxicity in most tumor types evaluated. Enrollment is ongoing. Outlicensed from Akeso to Merck in Nov 2015 (http://pdf.dfcfw.com/pdf/H3_AP202007081390358126_1.pdf) |
| Full address of company | Address : No. 6 Shennong Road, Torch Development Zone, Zhongshan City, Guangdong Province, China Asia China https://www.akesobio.com/en/about-us/contact-us/ |
Immune checkpoint target. MK-1308 is a novel humanized monoclonal antibody that binds CTLA-4 and blocks interaction with its ligands.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |