Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2578 |
| INN | Oportuzumab monatox |
| Status | Terminated |
| Drug code(s) | VB4-845 |
| Brand name | Vysyneum™, Vicineum |
| mAb sequence source | mAb humanized |
| General Molecular Category | Immunoconjugate, Immunotoxin |
| Format, general category | Fragment-Fc fusion |
| Format details | TBD |
| Isotype (Fc) | None |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | Pseudomonas exotoxin A |
| Discovery method/technology | None |
| Target(s) | EpCAM |
| Indications of clinical studies | Bladder cancer, head and neck cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Terminated at regulatory review |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | May 15, 2003 |
| Start of Phase 2 | December 15, 2005 |
| Start of Phase 3 | August 15, 2015 |
| 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 | Sesen Bio |
| Licensee/Partner | Qilu Pharmaceutical Co. Ltd. |
| Comments about company or candidate | July 2023: No evidence of further development. Sep 2022: Sesen Bio, Inc. and Carisma Therapeutics announced that they have entered into a definitive merger agreement to combine the companies in an all-stock transaction. The combined company will focus on the advancement of Carisma’s proprietary cell therapy platform that utilizes engineered macrophages and monocytes to potentially transform the treatment of cancer and other serious disorders. Jul. 18, 2022-- Sesen Bio announced that it has made the strategic decision to voluntarily pause further development in the US of its lead asset, Vicineum. The decision was based on a thorough reassessment of Vicineum, which included the incremental development timeline and associated costs for an additional Phase 3 clinical trial for the treatment of non-muscle invasive bladder cancer (NMIBC), following recent discussions with the US Food & Drug Administration (FDA). This decision enables Sesen Bio to conserve cash while it continues to assess potential strategic alternatives with the goal of maximizing shareholder value. Additionally, the Company intends to seek a partner for the further development of Vicineum. On August 20, 2021, Sesen Bio, Inc. (the “Company”) withdrew its marketing authorization application (“MAA”) to the European Medicines Agency (“EMA”) for Vysyneum™ for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (“NMIBC”). https://ir.sesenbio.com/static-files/4b10acb3-3750-4995-b9ce-48a820549f0b On August 13, 2021, Sesen Bio announced that it received a Complete Response Letter from the FDA) regarding the BLA for Vicineum™ (oportuzumab monatox-qqrs) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The FDA provided recommendations specific to additional clinical/statistical data and analyses in addition to Chemistry, Manufacturing and Controls (CMC) issues pertaining to a recent pre-approval inspection and product quality. Feb 2021: Sesen Bio announced that the U.S. Food and Drug Administration (FDA) accepted for filing the Company’s Biologics License Application (BLA) for Vicineum for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), and granted the application Priority Review. In addition, the FDA stated that it is not currently planning to hold an advisory committee meeting to discuss the BLA for Vicineum. PDUFA date for a decision on the BLA is August 18, 2021. On July 30, 2020, Sesen Bio, Inc. (the “Sesen”) and Viventia Bio, Inc., a wholly-owned subsidiary of Sesen (“Viventia” and collectively with Sesen, the “Company”) entered into an Exclusive License Agreement (the “License Agreement”) with Qilu Pharmaceutical Co., Ltd. (“Qilu”), pursuant to which the Company granted Qilu an exclusive, sublicensable, royalty-bearing license, under certain intellectual property owned or exclusively licensed by the Company, to develop, manufacture and commercialize the Company’s product candidate VB4-845, also known as Vicineum™ (the “Licensed Product”), for the treatment of non-muscle invasive bladder cancer and other types of cancer (the “Field”) in China, Hong Kong, Macau and Taiwan (the “Territory”). The Company also granted Qilu a non-exclusive, sublicensable, royalty-bearing sublicense, under certain other intellectual property licensed by the Company to develop, manufacture and commercialize the Licensed Product in the Territory. The Company retains development, manufacturing and commercialization rights with respect to Vicineum in the rest of the world. On June 17, 2020, the U.S. Food and Drug Administration (FDA) informed Sesen Bio that the FDA has conditionally accepted the proprietary brand name Vicineum for the Company’s product candidate, oportuzumab monatox. Dec 6, 2019: Rolling BLA for BCG-unresponsive non-muscle invasive bladder cancer started. May 2019: announced that the Company has completed its Type C CMC meeting and has reached agreement with the U.S. Food and Drug Administration on the Analytical Comparability Plan, and that, subject to final comparability data to be provided in the BLA submission, no additional clinical trials to establish comparability are deemed necessary at this time. Aug. 9, 2018-- Sesen Bio, Inc., a late-stage clinical company developing next-generation antibody-drug conjugate (ADC) therapies for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Vicinium™ for the treatment of BCG-unresponsive high-grade non-muscle invasive bladder cancer (NMIBC). Vicinium, Sesen Bio’s lead product candidate, is currently being evaluated in a Phase 3 registration trial, the VISTA Trial, for the treatment of patients with high-grade NMIBC who have previously received two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Sesen Bio was formally Eleven Biotherapeutics; Eleven Therapeutics acquired Viventia Bio in Sep 2016. Phase 3 NCT02449239 study in bladder cancer still recruiting as of Oct 2017. Vicinium contains the active pharmaceutical ingredient VB4-845, which is produced in Escherichia coli (E. coli) expressing a humanized single-chain antibody fragment specific for the epithelial cell adhesion molecule (EpCAM) antigen linked to ETA(252-608) Pseudomonas exotoxin. Once bound to the EpCAM antigen on the surface of carcinoma cells, Vicinium is internalized through an endocytic pathway. The ETA(252-608) is cleaved off and induces cell death by irreversibly blocking protein synthesis. Orphan desginations in EU and US. |
| Full address of company | 245 First Street Suite 1800 Cambridge, MA 02142 United States North America United States of America https://pitchbook.com/profiles/company/52624-72#overview |
Humanized single-chain antibody fragment specific for the epithelial cell adhesion molecule (EpCAM) antigen linked to ETA(252-608) Pseudomonas exotoxin. ETA252-608 is a truncated form lacking cell-binding domain
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |