NEWARK, U.S.A. and NANJING, China — Dec 12, 2023, CTTQ Pharma, partner of Biosion today announced abstracts have been accepted for poster presentation at the 2023 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference. The presentation will highlight new Phase 1 study results evaluating the safety, tolerability, pharmacokinetic characteristics, and immunogenicity of TQC2722/BSI-045A, a novel anti-IL4R monoclonal antibody. TQH2722/BSI-045A was discovered by Biosion H³ antibody discovery platform.
About TQH2722 / BSI-045A
TQH2722 is a humanized monoclonal antibody targeting interleukin 4 receptor alpha (IL4Rα) independently developed by Biosion and CTTQ, which leads to the dual-blockade of interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling, inhibiting the T-helper cell type 2 immune pathway, and thereby could achieve the goal of controlling Th2 disease, such as atopic dermatitis, asthma, and chronic sinusitis.
A study with single dose escalation and multiple dose escalation in healthy adult subjects was conducted (TQH2722-I-01). The published data in this RAD meeting is the blinding data of safety and PK. The phase II study investigating the effect of TQH2722 in patients with atopic dermatitis (TQH2722-II-02) had finished the enrollment as planned, and the study results will be published in 2024. At the meantime, the phase II study (TQH2722-II-02) in patients with chronic sinusitis is ongoing.
Study method
This dose escalation study in healthy adult subject is to evaluate the safety, tolerability, PK characteristics, and immunogenetics of TQH2722. The dose levels for the SAD study were from 50 mg to 1200 mg, and150 mg and 600 mg were applied (Q2W, a total of 4 doses) for MAD study. 66 subjects were enrolled as planned, of whom 52 (78.8%) received TQH2722 treatment and 14 (21.2%) received placebo. The safety was evaluated as long as 8 weeks after last dose.
Study results
TQH2722 showed well tolerated safety profile, no SAE or TEAEs (AEs occurred during study treatment) leading to treatment discontinuation occurred. Injection site reactions and lab abnormalities are the most common TEAEs, and most of the TEAEs spontaneously regressed. TQH2722 showed a nonlinear target-mediated PK characteristics, with the exposure increased in a manner greater than the dose increases. The half-life of a single sc. administration of TQH2722 ranged between 4 and 18 days. These data support further clinical development of TQH2722 as a therapeutic treatment for patients with Atopic Dermatitis and other related diseases mediated by Th2 inflammation.
Website for RAD meeting abstract and e-posters
https://revolutionizingad.com/education-resources/december-2023-abstracts-and-posters
About Biosion
Biosion is a global, clinical-stage biotechnology company committed to developing antibody-based therapies to improve patient outcomes for the treatment of immune and oncologic diseases. Established in 2017, Biosion has built a pipeline of innovative biologics through its internally derived proprietary technologies including the H³ antibody discovery platform, SynTracer® high-throughput endocytosis platform, and Flexibody™ bispecific platform. Biosion's lead asset, BSI-045B (anti-TSLP mAb), is currently in phase-II for severe asthma and phase-I for atopic dermatitis. Biosion and partners have plans to progress the immune-oncology and antibody drug conjugate-based portfolio into clinical trials for oncology indications over the next year. Biosion has operations in the US, Australia, and China.
BIOSION ALL RIGHTS RESERVED.
NEWARK, U.S.A. and NANJING, China — Dec 12, 2023, CTTQ Pharma, partner of Biosion today announced abstracts have been accepted for poster presentation at the 2023 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference. The presentation will highlight new Phase 1 study results evaluating the safety, tolerability, pharmacokinetic characteristics, and immunogenicity of TQC2722/BSI-045A, a novel anti-IL4R monoclonal antibody. TQH2722/BSI-045A was discovered by Biosion H³ antibody discovery platform.
About TQH2722 / BSI-045A
TQH2722 is a humanized monoclonal antibody targeting interleukin 4 receptor alpha (IL4Rα) independently developed by Biosion and CTTQ, which leads to the dual-blockade of interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling, inhibiting the T-helper cell type 2 immune pathway, and thereby could achieve the goal of controlling Th2 disease, such as atopic dermatitis, asthma, and chronic sinusitis.
A study with single dose escalation and multiple dose escalation in healthy adult subjects was conducted (TQH2722-I-01). The published data in this RAD meeting is the blinding data of safety and PK. The phase II study investigating the effect of TQH2722 in patients with atopic dermatitis (TQH2722-II-02) had finished the enrollment as planned, and the study results will be published in 2024. At the meantime, the phase II study (TQH2722-II-02) in patients with chronic sinusitis is ongoing.
Study method
This dose escalation study in healthy adult subject is to evaluate the safety, tolerability, PK characteristics, and immunogenetics of TQH2722. The dose levels for the SAD study were from 50 mg to 1200 mg, and150 mg and 600 mg were applied (Q2W, a total of 4 doses) for MAD study. 66 subjects were enrolled as planned, of whom 52 (78.8%) received TQH2722 treatment and 14 (21.2%) received placebo. The safety was evaluated as long as 8 weeks after last dose.
Study results
TQH2722 showed well tolerated safety profile, no SAE or TEAEs (AEs occurred during study treatment) leading to treatment discontinuation occurred. Injection site reactions and lab abnormalities are the most common TEAEs, and most of the TEAEs spontaneously regressed. TQH2722 showed a nonlinear target-mediated PK characteristics, with the exposure increased in a manner greater than the dose increases. The half-life of a single sc. administration of TQH2722 ranged between 4 and 18 days. These data support further clinical development of TQH2722 as a therapeutic treatment for patients with Atopic Dermatitis and other related diseases mediated by Th2 inflammation.
Website for RAD meeting abstract and e-posters
https://revolutionizingad.com/education-resources/december-2023-abstracts-and-posters
About Biosion
Biosion is a global, clinical-stage biotechnology company committed to developing antibody-based therapies to improve patient outcomes for the treatment of immune and oncologic diseases. Established in 2017, Biosion has built a pipeline of innovative biologics through its internally derived proprietary technologies including the H³ antibody discovery platform, SynTracer® high-throughput endocytosis platform, and Flexibody™ bispecific platform. Biosion's lead asset, BSI-045B (anti-TSLP mAb), is currently in phase-II for severe asthma and phase-I for atopic dermatitis. Biosion and partners have plans to progress the immune-oncology and antibody drug conjugate-based portfolio into clinical trials for oncology indications over the next year. Biosion has operations in the US, Australia, and China.
BIOSION ALL RIGHTS RESERVED.