Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1324 |
| INN | Luveltamab tazevibulin |
| Status | Clinical |
| Drug code(s) | STRO-002 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | ADC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | Valine citrulline p-aminobenzyl carbamate linker functionalized with dibenzocyclooctyne (DBCO) (Cleavable linker) |
| Ave. DAR | 4; Site-specific (Y180F) |
| Conjugated/fused moiety | Tubulin inhibitor, SC209 (Hemiasterlin) |
| Discovery method/technology | None |
| Target(s) | FR alpha |
| Indications of clinical studies | Acute Myeloid Leukemia, Lung cancer, Ovarian cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 2/3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | October 15, 2018 |
| Start of Phase 2 | May 15, 2023 |
| Start of Phase 3 | |
| 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 | Sutro Biopharma |
| Licensee/Partner | Tasly Biopharmaceuticals Co. Ltd. |
| Comments about company or candidate | August 22, 2024 I Sutro Biopharma, Inc. announced that REFRαME-L1, the global Phase 2 study of luveltamab tazevibulin (luvelta) for patients with non-small cell lung cancer whose tumor expresses Folate Receptor-α (FRα), has been initiated and is open for enrollment. NCT06555263 Phase 2 in lung cancer due to start in Aug 2024. The U.S. Food and Drug Administration (FDA) has granted luvelta a Fast Track designation for Ovarian Cancer, as well as Orphan and Rare Pediatric Disease designations for CBF/GLIS2 Pediatric AML. Pivotal phase 2 (/3?) study REFRaME-O1 (NCT05870748) is recruiting as of June 1, 2023. On clinicaltrials.gov is listed as phase 2. In the pipeline updated in June 2023 is listed as phase 2/3. On the press release of June 3, 2023is listed as "Sutro Biopharma Announces Oral Presentation at ASCO 2023 Featuring Data for Luveltamab Tazevibulin from the Phase 1 Dose-Expansion Study in Ovarian Cancer and the Initiation of the Phase 2/3 Pivotal Study REFRaME-O1" https://www.sutrobio.com/sutro-biopharma-announces-oral-presentation-at-asco-2023-featuring-data-for-luveltamab-tazevibulin-from-the-phase-1-dose-expansion-study-in-ovarian-cancer-and-the-initiation-of-the-phase-2-3-pivotal-s/ . Mar 2023: Sutro plans to initiate REFRaME, a Phase 2/3 registration-directed study for patients with platinum-resistant ovarian cancer, in the second quarter of 2023 May 2022: Regulatory discussions on a potential registrational study for patients with advanced ovarian cancer are planned for mid-year 2022. Dec. 27, 2021 – Sutro Biopharma, Inc. announced an exclusive license agreement with Tasly Biopharmaceuticals Co., Ltd. (hereinafter referred to as “Tasly”), a holding subsidiary of Tasly Pharmaceutical Group Co., Ltd. (SHA:600535) for the development and commercialization of STRO-002 in Greater China, consisting of mainland China, Hong Kong, Macau and Taiwan. August 18, 2021 – Sutro Biopharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for STRO-002, a folate receptor alpha (FolRα)-targeting antibody-drug conjugate (ADC), for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior lines of systemic therapy. Through April 20, 2020, the Phase 1 trial of STRO-002 has enrolled 30 patients with recurrent platinum resistant or refractory ovarian cancer, without regard to FolRα expression levels. A dose expansion phase of this trial is planned to commence in the second half of 2020. Although maximum tolerated dose (MTD) has not been reached, Sutro is continuing to actively explore the 5.2 mpk to 6.0 mpk dose levels as it seeks to determine the recommended Phase 2 dose. NCT03748186 Phase 1 in ovarian cancer started Feb 1 2019. Nov 2018: Sutro announced that the U.S. Food and Drug Administration (FDA) has concluded their 30-day review of the Investigational New Drug (IND) application for STRO-002 to be evaluated in a Phase I clinical study as a potential treatment for ovarian and endometrial cancer. The antibody-drug conjugate STRO-002 targets folate receptor-α, a cell-surface protein expressed in 80% of ovarian and endometrial cancers. The Phase I clinical trial of STRO-002 is expected to begin in early 2019. Sutro plans to file an investigational new drug application for STRO-002 in the second half of 2018 and to begin a Phase I clinical trial by year’s end. Sutro Biopharma announced data from its first antibody drug conjugate (ADC) to treat solid tumors. Results were presented in an abstract entitled "Preclinical activity and safety of STRO-002, a novel ADC targeting folate receptor alpha for ovarian cancer" at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer on March 25, 2018 and in an abstract entitled "Discovery and activity of STRO-002, a novel ADC targeting folate receptor alpha for ovarian and endometrial cancer" at the annual meeting of the American Association for Cancer Research on April 16, 2018. |
| Full address of company | 111 Oyster Point Blvd , South San Francisco, CA 94080 North America United States of America https://www.sutrobio.com/contact-us/ |
STRO-002 contains the anti-FolRa human IgG1 antibody (SP8166) conjugated to a proprietary cleavable drug-linker (SC239). SC239 contains a tubulin-targeting 3-aminophenyl hemiasterlin warhead, SC209, which has potent cytotoxic activity and is a weak substrate for efflux pumps. SP8166 was discovered and optimized using a Fab ribosome display selection and screening platform based on Sutro's Xpress CF+TM system. Four non-natural amino acid p-azidomethyl phenylalanine (pAMF) residues are incorporated into SP8166 at two defined sites on each heavy chain. These sites were selected based on optimal stability and activity in vitro and in vivo. The SC239 drug-linker is conjugated via a cleavable valine citrulline p-aminobenzyl carbamate linker functionalized with dibenzocyclooctyne (DBCO). Mutations for site specific conjugation are the following: Y180 amber, F404 amber, on each heavy chain for the incorporation of a total of 4 non-natural amino acid pAMF for site specific conjugation (https://www.sutrobio.com/wp-content/uploads/2019/02/STRO-002-AACR-2018-Poster-FInal.pdf) Aglycosylated (?) because it is produced in a cell free system
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |