Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 464 |
| INN | Gotistobart |
| Status | Clinical |
| Drug code(s) | BNT316, ONC-392 |
| 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) | CTLA-4 |
| Indications of clinical studies | Metastatic Castration-Resistant Prostate Cancer, Ovarian cancer, Solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | November 30, 2019 |
| Start of Phase 2 | December 15, 2022 |
| Start of Phase 3 | May 26, 2023 |
| 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 | OncoC4 Inc. |
| Licensee/Partner | BioNTech SE |
| Comments about company or candidate | NCT05671510 Phase 3 in NSCLC started in May 2023 still recruiting as of last update in Nov 2024. June 2023: Initiation of a pivotal Phase 3 trial with BNT316/ONC-392 as monotherapy in immunotherapy-resistant NSCLC patients is planned in Q3 2023, following FDA’s Fast Track designation in 2022 March 20, 2023 – BioNTech SE and OncoC4, Inc. announced that they have entered into an exclusive worldwide license and collaboration agreement to develop and commercialize OncoC4’s next-generation anti-CTLA-4 monoclonal antibody candidate, ONC-392, as monotherapy or combination therapy in various cancer indications. NCT05671510 Phase 3 in NSCLC started in May 2023. NCT05446298 Phase 2 in ovarian cancer started in Dec 2022. Sep 2020: OncoImmune, Inc. announced that it has dosed the first patient in the first-in-human clinical trial of ONC-392, its novel, next generation anti-CTLA-4 antibody, at the University of California (UC) Davis Comprehensive Cancer Center on September 16, 2020. This is a Phase 1A/1B clinical trial designed to assess the safety, pharmacokinetics, and clinical activity of ONC-392 as a single agent in advanced solid tumors and in combination with anti-PD(L)1 standard of care therapy in Non-Small Cell Lung Cancer. NCT04140526 Phase 1 in solid tumors not yet recruiting; due to start in Feb 2020. Pfizer has option to exclusively license ONC-392--as well as any other OncoImmune anti-CTLA4 antibodies. Dec 30 2019: OncoImmune, Inc. announced today that its Investigational New Drug (“IND”) application for ONC-392, its novel, next generation anti-CTLA-4 antibody, has been approved by the U.S. Food and Drug Administration (“FDA”). The IND approval enables OncoImmune to begin a Phase 1A/1B clinical trial of ONC-392 that is designed to assess the safety, pharmacokinetics, and efficacy of ONC-392 as a single agent in advanced solid tumors and in combination with anti-PD(L)1 standard of care in Non- Small Cell Lung Cancer. This open label trial is expected to begin in early 2020. |
| Full address of company | 9640 Medical Center Dr, Rockville, MD 20850, United States North America United States of America https://www.oncoc4.com/ |
Immune checkpoint target. ONC-392 is the first known acid pH-sensitive anti-CTLA-4 mAb that interacts strongly with CTLA-4 at a pH typical of normal tissues/organs and the tumor microenvironment. When the pH drops below 6.0, ONC-392 rapidly disassociates from its target, thus allowing CTLA-4 to preserve its normal life cycle and avoid antibody-induced lysosomal degradation
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |