ABP-300 / Abpro, BIO invest, Mabwell (Shanghai) Biosci - LARVOL DELTA

No new local confirmed cases of new coronary pneumonia in Shanghai have new results [Google translation] (Sina Pharmaceutical News) - P1, N=42; NCT04533048; Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.; "A clinical trial of 'MW33' injection...has shown that its safety, tolerability, pharmacokinetic characteristics, etc. have a stable antibody structure and more Low immunogenicity, after binding to the new coronavirus S protein, it can effectively block the virus...He pointed out that by formulating the appropriate dosage and time of administration, the drug concentration and total absorption of the drug can be maintained at a reasonable level...The study will enroll healthy volunteers in 5 dose groups for a climbing test, that is, a single injection of MW33 injection at a dose of 4, 10, 20, 40, and 60 mg per kilogram of body weight."

New P2 trial • P1 data • Infectious Disease • Novel Coronavirus Disease

Safety, tolerability, pharmacokinetic characteristics, and immunogenicity of MW33: A Phase 1 clinical study of the SARS-CoV-2 RBD-targeting monoclonal antibody. (PubMed, Emerg Microbes Infect) - P1, P2, P2/3 | "The positive rates of serum ADAs and antibody titers were low with no evidence of an impact on safety or PK. In conclusion, MW33 was well-tolerated, demonstrated linear PK, with a lower positive rate of serum ADAs and antibody titers in healthy subjects.Trial registration: ClinicalTrials.gov identifier: NCT04427501..Trial registration: ClinicalTrials.gov identifier: NCT04533048..Trial registration: ClinicalTrials.gov identifier: NCT04627584.."

Clinical • Journal • P1 data • PK/PD data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Abpro Announces Positive Phase 1 Results Demonstrating A Favorable Safety and Pharmacokinetic Profile of ABP 300, A Neutralizing Antibody Therapeutic for the Treatment of COVID-19 (GlobeNewswire) - P1, N=42; "Abpro Corporation today announced the results of a Phase 1 study demonstrating a favorable safety and pharmacokinetic profile of ABP 300...The Phase 1 clinical trial was conducted in 42 healthy subjects and showed safety and pharmacokinetic data at doses from 4 mg/kg to 60 mg/kg."

P1 data • PK/PD data • Infectious Disease • Novel Coronavirus Disease

Abpro Announces Initiation of Phase 2/3 Registrational Studies of its Neutralizing Antibody Therapeutic ABP 300 for the Treatment of COVID-19 (GlobeNewswire) - "Pivotal/Registrational studies will assess safety, tolerability, efficacy, and pharmacokinetics of ABP300 in approximately 2,000 subjects; Abpro Corporation today announced the initiation of global Phase 2/3 registrational studies evaluating the safety, tolerability, efficacy, and pharmacokinetics of ABP 300...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....ABP 300 not only completely neutralizes COVID-19 in animal models but could potentially do so more safely and more effectively..."

P1 data • Preclinical • Trial status • Infectious Disease • Novel Coronavirus Disease

Abpro Announces Completion of Dosing in Phase 1 Study of its Neutralizing Antibody Therapeutic, ABP 300 for Treatment of COVID-19 (GlobeNewswire) - "Abpro Corporation today announced it has completed dosing all subjects in a Phase 1 clinical trial evaluating the safety of ABP 300....The Company expects final data readout in the first quarter of 2021....ABP 300 not only completely neutralizes COVID-19 in animal models but could potentially do so more safely and more effectively than other monoclonal antibodies in development....'We look forward to presenting data from this trial in the first quarter of 2021'. The Phase 1 clinical trial is a randomized safety study and has enrolled 42 healthy subjects. ABP 300 is being co-developed with Mabwell, a biotechnology company based in Shanghai, where Abpro’s Phase 1 trial is being conducted."

Licensing / partnership • P1 data • Trial status • Infectious Disease • Novel Coronavirus Disease

Newly added product (Abpro Press Release) - Preclinical, Non-Hodgkin’s Lymphoma, Hematological Malignancies

Pipeline update • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology