Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1732 |
| INN | Iparomlimab, Tuvonralimab |
| Status | Approved |
| Drug code(s) | PSB-103, PSB205, QL1706, QL1706H, 艾帕洛利单抗托沃瑞利单抗注射液 |
| Brand name | (Pending) |
| mAb sequence source | mAb - source TBD |
| General Molecular Category | Mixture of 2 |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | PD-1, CTLA-4 |
| Indications of clinical studies | Hepatocellular carcinoma, Nasopharyngeal Carcinoma, Non-small cell lung cancer, small cell lung cancer, renal cell carcinoma, cervical cancer, solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | March 10, 2019 |
| Start of Phase 2 | March 11, 2022 |
| Start of Phase 3 | May 01, 2022 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2024 |
| Date of first US approval | |
| INN, US product name | Iparomlimab, Tuvonralimab |
| US or EU approved indications | None |
| Company | Qilu Puget Sound Biotherapeutics Corp. |
| Licensee/Partner | None |
| Comments about company or candidate | Conditional marketing approval for cervical cancer in China 25 Sep 2024. https://www.einpresswire.com/article/751512407/sound-biologics-announces-breakthrough-approval-of-psb205-by-the-national-medical-products-administration-in-china?n=2 China marketing application acceptance date is Aug 12, 2023 according to NMPA's CDE database. NCT05976568 Phase 2/3 in hepatocellular carcinoma due to start in Sep 2023. As of Aug 2023, Phase 3 study for PD-L1 negative, locally advanced or metastatic non-small cell lung cancer (CTR20223309) status is "In progress, Recruiting" (this study has the same protocol id as NCT05690945 study); Phase 3 study for non-small cell lung cancer (CTR20222281) status is "In progress, recruiting" (this study has the same protocol id as the NCT05487391 study). Phase 2/3 study for Nasopharyngeal carcinoma (NCT05576272) is recruiting as of Octover 24, 2022; phase 3 studies: for Non-small cell lung cancer (NCT05487391 is not yet recruiting as of August 4, 2022, NCT05690945 is not yet recruiting as of January 19, 2023), Cervical cancer (NCT05446883) is recruiting as of November 30, 2022. NCT05690945 Phase 3 in lung cancer due to start in Feb 2023 NCT05446883 Phase 3 in cervical cancer started in Nov 2022. NCT05576272 Phase 2/3 in Nasopharyngeal Carcinoma started in May 2022. NCT05179317 is a Phase 2 in cervical cancer. April 13, 2021: Qilu Puget Sound Biotherapeutic Corp. (Sound Biologics), an emerging biotechnology company focused on developing a novel MabPair™ platform for antibody-based combination therapies for the treatment of cancer, inflammation and autoimmune disease, announced a clinical update on its first MabPair product PSB205 at the American Association for Cancer Research (AACR) Annual Meeting. Dr Li Zhang of Sun Yat-Sen University Cancer Centre (SYSUCC), Guangzhou, China presented a poster on Phase 1 Clinical Trial results of PSB205, a combination of anti-PD1 and anti-CTLA-4 antibodies that are manufactured together as a single product, in patients with advanced malignant tumors. The study is sponsored by Qilu Pharma in China. NCT04296994 in solid tumors not yet recruiting when first posted on March 5, 2020. NCT03986606 Phase 1 in solid tumors not yet recruiting as of last update in June 2019. April 10, 2019: Qilu Puget Sound Biotherapeutic Corp. (Sound Biologics), an emerging biotechnology company dedicated to developing next generation antibody combination therapies, today announced that U.S. Food and Drug Administration (FDA) has accepted the Company's Investigational New Drug (IND) application and issued authorization to commence a Phase I First-in-Human Clinical Trial of PSB205 for the treatment of patients with relapsed/refractory solid tumors. PSB205 is an immuno-oncology biotherapeutic that represents the first of a new class of therapeutic modality. |
| Full address of company | 21720 23rd Dr SE Bothell, WA 98021 North America United States of America https://www.soundbiologics.com/news/ |
Immune checkpoint targets PSB205 is a novel bifunctional product that contains a mixture of unique anti-PD-1 and anti-CTLA4 monoclonal antibodies produced by a single cell line via the company's proprietary MabPair technology. MabPair products offer many advantages over bispecific antibodies. The relative ratio of the two antibodies in the MabPair can be well-controlled and each antibody is individually engineered for optimal target coverage, effector function, pharmacokinetics and exposure. PSB205 represents a potentially best-in-class immuno-oncology product that promises to exhibit robust combination activity while being significantly more tolerable to patients than currently approved anti-PD-1/anti-CTLA-4 combinations. Iparomlimab is humanized heavy chain and chimeric light chain; tuvonralimab is humanized https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.16_suppl.5535. Iparomlimab (anti-PD-1), Tuvonralimab (anti-CTLA-4) QL1706H is the subcutaneously administered formulation of QL1706. (anti-PD-1; hinge-stabilized (S228P)); IgG1 kappa (anti-CTLA4; K147D F170C V173C C220G R255K D399R K409E mutations for heterodimerization)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |