Entry ID | 2341 |
INN | None |
Status | Terminated |
Drug code(s) | MW33, 9MW3311, ABP-300 |
Brand name | None |
mAb sequence source | mAb human |
General Molecular Category | TBD |
Format, general category | TBD |
Format details | TBD |
Isotype (Fc) | TBD |
Light chain isotype | TBD |
Linker | None |
Ave. DAR | None |
Conjugated/fused moiety | None |
Discovery method/technology | None |
Target(s) | SARS-CoV-2 (spike protein) |
Indications of clinical studies | COVID-19 |
Primary therapeutic area | Infectious diseases |
Most advanced stage of development (global) | Terminated at Phase 2/3 |
Status | Inactive |
Start of clinical phase (IND filing or first Phase 1) | August 07, 2020 |
Start of Phase 2 | |
Start of Phase 3 | December 15, 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 | Mabwell (Shanghai) Bioscience Co. Ltd. |
Licensee/Partner | Abpro Corporation |
Comments about company or candidate | Not in Maxwell pipeline; Abpro focused on ABP 310, an anti-SARS-CoV-2 antibody that neutralizes Omicron variant. Dec 16, 2020: Abpro Corporation announced the initiation of global Phase 2/3 registrational studies evaluating the safety, tolerability, efficacy, and pharmacokinetics of ABP 300, a human neutralizing antibody for the treatment of COVID-19 derived from patients who have recovered from the SARS-CoV2 infection. The first trial site has been opened with the remainder to follow in 2021. The Phase 1 clinical trial, which included 42 subjects, study results are expected in Q1 2021. NCT04627584 is a Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of MW33 Injection to Evaluate the Efficacy and Safety in Patients With Mild or Moderate COVID-19. NCT04533048 is Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Immunogenicity of a Single Dose of MW33 Injection in Healthy Subjects |
Full address of company | BLDG 3, No 576, Libing Rd, Pudong New District, Shanghai, PRC Asia China https://www.mabwell.com/en/about.html?ab=l#mwView |
Nov. 16, 2020-- Abpro Corporation today announced the publication of a peer-reviewed article in the scientific journal Nature Communications titled, “Characterization of neutralizing antibody with prophylactic and therapeutic efficacy against SARS-CoV-2 in rhesus monkeys.” The publication is available online here. ABP 300, referred to as MW05 in the publication, neutralizes COVID-19 by binding to the receptor binding domain (RBD) of the SARS-CoV-2 spike protein, blocking the viral interaction with the angiotensin-converting enzyme 2 (ACE2) receptors of host which are critical for viral entry and infection. Through this mechanism of action, ABP 300 not only completely and safely neutralizes COVID-19 in animal models but could potentially do so with superior safety and efficacy than other monoclonal antibodies in development. “We are highly encouraged by this preclinical best-in-class proof-of-concept data showing the potential of our monoclonal antibodies to neutralize multiple SARS-CoV-2 strains. The data supports further development of antibody-based therapies for prophylactic and therapeutic treatment of COVID-19,” said Ian Chan, chief executive officer and co-founder of Abpro Corporation. “As the SARS-CoV-2 mutates, which could undermine the effectiveness of vaccines and therapies, there is an urgent need for treatments that can address a broad range of strains.” Numberous authors are affiliated with Mabwell (Shanghai) Bioscience Co., Ltd, 201210, Shanghai, China Study highlights: Potent prophylactic and therapeutic effects against SARS-CoV-2 were observed in rhesus monkeys – a widely used model to assess efficacy of therapeutics and vaccines of SARS-CoV-2 because it closely mirrors human infection and disease. A single dose of ABP 300 blocked infection of SARS-CoV-2 in prophylactic treatment and cleared SARS-CoV-2 in three days in a therapeutic treatment setting. ABP-300 was shown to have a protective effect by alleviating the lung lesions caused by SARS-CoV-2 in the monkeys whether the antibody was injected before or after the virus challenge. ABP 300 showed high RBD binding abilities and strong ability to disrupt RBD/ACE2 binding, and effectively neutralized both SARS-CoV-2 pseudo virus and authentic live virus. Additional antibodies from Abpro’s program, ABP-300, as known as MW05, and an additional antibody, MW07, exhibited strong binding abilities to eight high frequency mutant RBD proteins, blocking viral interactions with host cells. These results suggest both monoclonal antibodies may neutralize a broad range of SARS-CoV-2 strains. https://www.nature.com/articles/s41467-020-19568-1
Anticipated events | None |
Factor(s) contributing to discontinuation | None |