Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1094 |
| INN | Bentracimab |
| Status | Regulatory review |
| Drug code(s) | PB2452, MEDI2452 |
| Brand name | (Pending) |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Fragment |
| Format details | Fab |
| Isotype (Fc) | None |
| Light chain isotype | lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | Ticagrelor |
| Indications of clinical studies | Reversal of the antiplatelet effects of ticagrelor. |
| Primary therapeutic area | Cardiovascular / hemostasis disorders |
| Most advanced stage of development (global) | Regulatory review US |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | April 05, 2018 |
| Start of Phase 2 | April 16, 2019 |
| Start of Phase 3 | March 27, 2020 |
| 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 | AstraZeneca |
| Licensee/Partner | PhaseBio Pharmaceuticals Inc, Alfasigma, SFJ Pharmaceuticals, SERB Pharmaceuticals |
| Comments about company or candidate | August 2 2024: SFJ Pharmaceuticals, (SFJ), Sponsor of the bentracimab Biologics License Application (BLA), and SERB Pharmaceuticals (SERB), who acquired exclusive US rights to bentracimab from SFJ and will commercialize bentracimab in the United States, announced today that the US Food and Drug Administration (FDA) has accepted the bentracimab BLA for filing and priority review with a target action date in Q1 of 2025. https://serb.com/news/fda-has-accepted-a-bla-for-bentracimab-the-first-and-only-ticagrelor-reversal-agent-for-filing-and-priority-review/ May 2023: SERB Pharmaceuticals and SFJ Pharmaceuticals, Inc. announced that SERB has acquired exclusive US rights to bentracimab from SFJ. SFJ will remain responsible for the ongoing clinical trials of bentracimab and will work in collaboration with SERB to submit the Biologics License Application to the US Food and Drug Administration, which they expect to file later this year. Oct. 24, 2022-- PhaseBio Pharmaceuticals, Inc. announced that it has elected to file a voluntary petition under Chapter 11 of the Bankruptcy Code in the U.S. Bankruptcy Court for the District of Delaware. As part of the case, PhaseBio also intends to file a motion seeking authorization to pursue an auction and sale process under Section 363 of the U.S. Bankruptcy Code. The proposed bidding procedures, if approved by the court, would require interested parties to submit binding offers to acquire PhaseBio’s bentracimab program assets, which would be purchased free and clear of liens and interests. June 2021: Alfasigma has acquired European rights for PhaseBio's monoclonal antibody bentracimab to treat uncontrolled bleeding in patients taking ticagrelor and will commercialize the drug in 49 European countries and other markets. The Company expects to complete enrollment of the first 100 patients in the REVERSE-IT trial in mid-2021 and is targeting to submit its Biologics License Application (BLA) for bentracimab in mid-2022 NCT04286438 Phase 3 Multicenter, Open-Label, Single-Arm Study of PB2452 in Ticagrelor-Treated Patients With Uncontrolled Major or Life-Threatening Bleeding or Requiring Urgent Surgery or Invasive Procedure recruiting as of Oct 2020. Feb 2020: PhaseBio Pharmaceuticals announced that PB2452 has been granted PRIority MEdicines (PRIME) designation by the European Medicines Agency (EMA) for reversal of the antiplatelet effects of ticagrelor in patients with uncontrolled major or life-threatening bleeding or requiring urgent surgery or an invasive procedure. Based on the written guidance, CHMP appears aligned with PhaseBio’s plan to conduct a non-randomized, open-label Phase 3 trial of major bleeding and urgent surgical populations to support a Marketing Authorization Application (MAA) for PB2452. NCT03928353 Phase 2 study in healthy volunteers started in April 2019. September 24, 2018 I PhaseBio Pharmaceuticals, Inc. announced positive preliminary results from a Phase 1 clinical trial of PB2452, a novel reversal agent for the antiplatelet drug ticagrelor. April 5, 2018 — PhaseBio Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing therapies for the treatment of orphan diseases, today announced that it has completed dosing in the first cohort of subjects in its Phase 1 clinical trial of PB2452, which was in-licensed from MedImmune. Nov 2018: PhaseBio Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing therapies for the treatment of orphan diseases, announced that the Company has entered an exclusive, worldwide license agreement with MedImmune, the global biologics research and development arm of AstraZeneca, for PB2452 (formerly MEDI2452), a Phase 1-ready reversal agent for ticagrelor. |
| Full address of company | Cambridge, United Kingdom Europe United Kingdom https://www.astrazeneca.com/our-company/contact-us.html |
PB2452 is a neutralising Fab antibody fragment that binds to ticagrelor and its active metabolite AR-C124910XX, and is intended to reverse the antiplatelet effects of ticagrelor. Immunoglobulin Fab G1-lambda
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |