Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2572 |
| INN | Zilovertamab |
| Status | Terminated |
| Drug code(s) | UC-961 |
| 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) | ROR1 |
| Indications of clinical studies | Urothelial Carcinoma, Diffuse large B cell lymphoma, Mantle cell lymphoma, Chronic Lymphocytic Leukemia |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | August 15, 2014 |
| Start of Phase 2 | August 06, 2020 |
| Start of Phase 3 | January 15, 2022 |
| 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 | Oncternal Therapeutics |
| Licensee/Partner | None |
| Comments about company or candidate | Sep 2024: Octernal will discontinue all product development activities and will take other steps to reduce costs, including a reduction in its workforce to preserve cash resources; the company intend to explore strategic options with the hope of advancing and realizing value from their pipeline including ONCT-534, ONCT-808, zilovertamab and ONCT-216. Press release: In April 2023 we announced a strategic reprioritization based on the rapidly changing commercial landscape for Bruton’s tyrosine kinase inhibitors (BTK inhibitors), under which Phase 3 study ZILO-301 and Phase 1/2 study CIRM-001* of zilovertamab in combination with ibrutinib will be closed, in order to extend the company’s cash runway into 2025 and focus efforts upon the clinical development of ONCT-808 and ONCT-534. The decision was not based on any concerns about the safety or efficacy of zilovertamab. We plan to continue exploring the potential value of zilovertamab in areas of high unmet medical need. The robust response rates and prolonged PFS seen for MCL and CLL patients expressing TP53 aberrations will be further investigated preclinically and extended into other tumor types, such as lung cancer and prostate cancer. We expect partnerships and collaborations to be essential for executing future late-stage clinical trials of zilovertamab." https://www.oncternal.com/pipeline/zilovertamab/ NCT05431179 Phase 3 study due to start in Sep 2022. Sep 28, 2022: Oncternal Therapeutics, Inc. announced the initiation of its Phase 3 global registrational study of zilovertamab, ZILO-301 (NCT05431179), for the treatment of patients with relapsed/refractory mantle cell lymphoma NCT05139017 Phase 2/3 in DLBCL started in January 2022. Jan 2022: The company is planning a Phase 3 superiority clinical trial ZILO-301 entitled, “Randomized, Double-blind, Placebo-controlled, Multi-center Phase 3 Study of Zilovertamab (A ROR1 Antibody) Plus Ibrutinib Versus Ibrutinib Plus Placebo in Patients with Relapsed or Refractory Mantle Cell Lymphoma.” Michael Wang MD, Endowed Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, will serve as the U.S. Principal Investigator and Chairman of the steering committee for this study. The study will randomize patients with relapsed or refractory MCL who have experienced stable disease or a partial response after receiving four months of oral ibrutinib therapy to receive either blinded zilovertamab or placebo, and all patients will continue receiving oral ibrutinib. The primary endpoint, intended to support submission of a Biologics License Application (BLA) seeking regular FDA approval, will be progression-free survival (PFS). an 2022: NCT04501939 Phase 2 study of Cirmtuzumab Consolidation for Treatment of Patients With Detectable CLL on Venetoclax (Venetoclax) not yet recruiting when first posted on Aug 6, 2020. In June 2019, the company presented data at the American Society of Clinical Oncology (ASCO) annual meeting, reporting that results from the first 12 patients with CLL treated in Part 1 of the Phase I portion of the study showed an observed interim objective response rate (ORR) of 91.7% for the combination of cirmtuzumab plus ibrutinib, including three patients with clinical or confirmed complete responses, and a well-tolerated safety profile consistent with that seen for ibrutinib treatment alone. June 2020: The FDA has granted an Orphan Drug designation to the ROR1 antibody cirmtuzumab (UC-961) for the treatment of patients with mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL). June 2019: Oncternal Therapeutics announced that the reverse merger with GTx closed on June 7, 2019. The combined company will operate under the name Oncternal Therapeutics and its shares will commence trading on the Nasdaq stock exchange on June 10, 2019. NCT02776917 Phase 1 study in breast cancer recruiting as of Aug 15, 2018; Oncternal is listed as collaborator. Phase 1/2 NCT03088878 and NCT03420183 studies in lymphoid malignancies recruiting as of Sep 2018. Phase I Trial: Cirmtuzumab Inhibits ROR1 Signaling and Stemness Signatures in Patients with Chronic Lymphocytic Leukemia (Cell Stem Cell. 2018 Jun 1;22(6):951-959.e3. doi: 10.1016/j.stem.2018.05.018). April 12, 2016 – Oncternal Therapeutics, Inc, a new oncology-focused biotechnology company, today announced that it has received an exclusive worldwide license to develop and commercialize antibodies and antibody-related binding agents recognizing Receptor-tyrosine kinase-like orphan receptor 1 (ROR1) from University of California San Diego. The licensing agreement also encompasses rights for all therapeutic indications to cirmtuzumab, an anti-ROR1 monoclonal antibody that is currently in a clinical trial for patients with chronic lymphocytic leukemia (CLL), as well as rights to develop antibody-drug conjugates (ADCs), genetically modified effector immune cells, such as chimeric antigen receptor T-cells (CAR-T), and bispecific antibodies |
| Full address of company | 12230 El Camino Real, Suite 230, San Diego, CA 92130 North America United States of America https://www.oncternal.com/contact/ |
Cirmtuzumab is a humanized IgG1 monoclonal antibody designed and developed to bind with high affinity to a biologically important epitope on the extracellular domain of Receptor-tyrosine kinase-like Orphan Receptor 1 (ROR1). http://www.oncternal.com/Pipeline/Cirmtuzumab Zilovertamab formerly named Cirmtuzumab
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |