Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1720 |
| INN | Cosibelimab |
| Status | Regulatory review |
| Drug code(s) | CK-301, TG-1501 |
| Brand name | (Pending) |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | PD-L1 |
| Indications of clinical studies | Non-small cell lung cancer, cutaneous squamous cell carcinoma, advanced cancer, lymphoma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Regulatory review US |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | March 18, 2015 |
| Start of Phase 2 | |
| Start of Phase 3 | December 08, 2021 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | Cosibelimab |
| US or EU approved indications | None |
| Company | Checkpoint Therapeutics Inc. |
| Licensee/Partner | Novotech (Australia) Pty Limited, TG Therapeutics |
| Comments about company or candidate | July 2, 2024: Checkpoint Therapeutics announces completion of the BLA re-submission of cosibelimab for potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma (“cSCC”) who are not candidates for curative surgery or curative radiation. (https://ir.checkpointtx.com/news-events/press-releases/detail/119/checkpoint-therapeutics-announces-biologics-license) June 2024: Checkpoint Therapeutics Inc announced it has reached alignment with the Food and Drug Administration on its biologics license application (BLA) resubmission strategy for cosibelimab. Accordingly, Checkpoint plans to move forward with a mid-year BLA resubmission seeking the U.S. marketing approval for cosibelimab as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. Dec. 18, 2023 Checkpoint Therapeutics, Inc. announced that the U.S. Food and Drug Administration (“FDA”) has issued a complete response letter (“CRL”) for the cosibelimab biologic license application (“BLA”) for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma (“cSCC”) who are not candidates for curative surgery or radiation. The FDA has set a Prescription Drug User Fee Act (“PDUFA”) goal date of January 3, 2024. Jan 4 2023: Checkpoint Therapeutics, Inc. announced the submission of a Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for the approval of cosibelimab, its investigational anti-PD-L1 antibody, as a treatment for patients with metastatic cutaneous squamous cell carcinoma (“cSCC”) or locally advanced cSCC who are not candidates for curative surgery or radiation. June 2022: Checkpoint intends to continue discussions with the FDA on the potential addition of locally advanced cSCC as a second indication in the planned Biologics License Application (BLA) targeted for submission later this year. Checkpoint previously reported positive top-line data from a cohort of 78 patients with metastatic cSCC in its pivotal trial of cosibelimab. NCT04786964 Phase 3 in NSCLC started in Dec 2021. May 2021: Enrollment in our registration-enabling study for cosibelimab in metastatic cutaneous squamous cell carcinoma (“mCSCC”) is nearly complete and the study remains on track to report top-line results by year-end. With a successful study, we anticipate submitting our first application for marketing approval for cosibelimab next year. May 2019: Positive interim clinical results announced for cosibelimab (formerly CK-301) showing anti-tumor activity across multiple advanced cancers. The initial data are encouraging and potentially differentiate cosibelimab from other drugs in this class as a result of its dual mechanism of action through engaging both T-cells and NK cells. January 07, 2019: Checkpoint Therapeutics, Inc., a clinical-stage immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, today announced that the ongoing multi-center clinical trial of CK-301 has been expanded to enroll patients in three cohorts intended to support requests for accelerated approval and Biologics License Application (BLA) submissions to the U.S. Food and Drug Administration (FDA). March 2018: Checkpoint Therapeutics announced the completion of the dose escalation portion of the ongoing Phase I clinical trial of CK-301, a fully human anti-PD-L1 antibody, in selected recurrent or metastatic cancers, and the initiation of the first dose expansion cohort, which is evaluating an 800 mg dose of CK-301 administered every two weeks. NCT03212404 Phase 1 study recruiting as of Sep 20 2017. Licensed from Dana-Farber Cancer Institute. NCT03778073 Phase 1 study in lymphoma started in April, 2019 Terminated (Strategic/Business Decision). As per March 8, 2018 press release, TG Therapeutics advanced its anti-PD-L1 mAb into clinical development, with the first patient being dosed in a Phase 1 study in 2017. NCT02535286 Phase 1/2 in CLL started in March 2015 March 4, 2015 TG Therapeutics, Inc. announced today an agreement with Checkpoint Therapeutics, Inc., a newly formed subsidiary of Coronado Biosciences, Inc. (Nasdaq:CNDO) to develop and commercialize Checkpoint's fully human anti-PD-L1 and anti-GITR antibody research programs in the field of hematological malignancies. Checkpoint will develop and commercialize these antibodies in solid tumors. The antibodies were generated in the laboratory of Dr. Wayne Marasco, MD, PhD, a Professor in the Department of Cancer Immunology and AIDs at Dana-Farber Cancer Institute (Dana-Farber). |
| Full address of company | 95 Sawyer Road, Suite 110, Waltham, MA 02453 North America United States of America https://checkpointtx.com/contact/ |
Immune checkpoint inhibitor. CK-301 is a fully human monoclonal antibody of IgG1 subtype that directly binds to Programmed Death-Ligand 1 (PD-L1) and blocks its interactions with the Programmed Death-1 (PD-1) and B7.1 receptors
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |