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Integrated Platform
The innovative, platform-oriented and integrated platform with innovative drug R&D, preclinical research, clinical development, regulatory, and CMC development, Genor Biopharma has successfully built encompasses all the key biologic drug development functionalities, and enables us to identify and address potential clinical, manufacturing and commercial and clinical barriers in the development process so we can direct our efforts towards molecules with the best potential to become clinically active, cost-effective and commercially viable drugs.
Discovery and Research

Genor Biopharma has successfully set up an early discovery platform with first in class (FIC)/differentiated T-cell Engager (T-cell Engager) bi-specific/multi-specific antibodies in immune-oncology / bispecific antibody-drug conjugates (BsADC). The focus is to conduct molecular research that have the potential to become global best-in-class (BIC) products and have the greatest potential to produce clinical and commercially viable drugs.

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Our R&D process starts with strategic target identification and selection, focusing on targets with proven or high potential clinical benefits. Once the targets have been identified, we fully leverage our research hubs in Shanghai and San Francisco to advance our synergized discovery and research efforts.

Discovery and Research

Genor Biopharma Co. Ltd participated at the 38th Annual Meeting of The Society for Immunotherapy of Cancer, 2023, in San Diego, shared two posters for two programs:

  • Generation of an innovative BsAb targeting CCR8/CTLA-4,
  • Development of a tri-specific antibody targeting PD-1/CTLA-4/TIGIT.

BACKGROUD: CTLA-4-expressing regulatory T cells (Tregs) are abundantly present in tumor tissues and suppress anti-tumor responses. Currently approved CTLA-4 inhibitors, such as ipilimumab, induce severe irAEs, which limited their use. Therefore, next-generation of CTLA-4 inhibitors with reduced toxicity and increased efficacy is highly demanded, given the fact that CTLA-4 inhibition has showed unique advantages in inducing immune memory response and prolonging anti-tumor activity.

SIGNIFICANCE: CCR8 is recently found to be predominantly expressed on intra-tumor Tregs but little on peripheral Tregs or activated Tconv. Anti-CCR8 antibodies have been shown significant anti-tumor activity in pre-clinical studies. We have hypothesized that a strong anti-CCR8 arm may provide preferential inhibition of CTLA-4 on CCR8+CTLA-4+ intra-tumor Tregs and have synergistic effects on Tregs in TME. Therefore, we have developed a novel BsAb, GBD201, targeting CCR8/CTLA-4. The innovative bsAb exhibited potent depletion of intra-tumor Tregs but spared peripheral Tregs and Tconv. In hCCR8/hCTLA-4 mice, GBD201 showed better efficacy and safety profile compared to ipilimumab.

GBD201 (CCR8/CTLA-4): SITC2023 Abstract#491

BACKGROUD: Immune checkpoint inhibitors (ICIs) such as anti-PD-1/PD-L1 and anti-CTLA-4 antibodies have achieved enormous success in cancer treatment. However, only a subset of patients shows clinical responses. The combination of CTLA-4 and PD-1 blockers have increased response rates in patients, but severe immune related adverse events (irAEs) have limited their use. TIGIT is another inhibitory receptor, and often co-expressed with PD-1 on tumor-infiltrating CD8+ cytotoxic T cells, which may also provide important negative signals. Several anti-TIGIT blocking antibodies have shown encouraging anti-tumor activity in clinical studies when combined with PD-1/PD-L1 blockers. We have recently generated a tri-specific antibody, GBD209, targeting PD-1/CTLA-4/TIGIT and by fine tuning and balancing the potency of each arm.

SIGNIFICANCE: GBD209 has excellent anti-tumor efficacy by synergistically blocking PD-1, TIGIT, and CTLA4 pathways on T cells. To reduce the potential toxicity caused by CTLA4 inhibition, GBD209 was designed to only partially block the interactions of CTLA4 with it’s ligands CD80/CD86, and the blockade was highly dependent on the expression PD-1, reducing peripheral toxicity. GBD209 exhibited better efficacy than PD-1/CTLA-4 bsAb as well as the combination therapy of anti-PD-1, CTLA-4, and TIGIT antibodies in animal model. In vivo arthritis model in hPD-1/hPD-L1/hCTLA-4/hTIGIT KI mice showed GBD209 had at least 15-fold better tolerance compared to Ipilimumab. Thus, GBD209 may represent a next generation of check point inhibitor with good safety profile for cancer treatment.

GBD209 (PD-1/CTLA-4/TIGIT): SITC2023 Abstract#492
Clinical Development

We strategically design the clinical trials of our drug candidates, critically select the registration pathways, diligently conduct our clinical trials to ensure speed of execution and data quality, maintain constructive dialogues with the regulatory authorities to achieve optimal clinical development efficiency, and accelerate the approval process of our drug candidates.

At present, the Company has achieved rapid application, approval and promotion of clinical trials of product pipelines in China and Australia.

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  • Based on in-depth perception of product science, mechanisms and features, developed the registration and clinical development strategies, and continuously enhanced communication with industry leaders in relevant treatment fields, drug regulatory authorities, drug review agencies, and clinical research centers.
  • Relying on plentiful experience and extensive resources, efficient, quality and speedy accomplishment was made in the layout and establishment of the research center, project initiating and management, selection and recruitment of, and the entering of agreements with patients and subjects.
Chemistry, Manufacturing and Controls (CMC)

Genor Biopharma’s strong Chemistry, Manufacturing and Controls (CMC) capabilities resulted from approximately one decade of relentless development efforts. It is capable of developing comprehensive bioprocesses and formulations, and manufacturing preclinical and clinical materials with advanced analytical, quality control, and quality assurance systems for compliance, and have supported our and our collaborators’ IND applications for more than 20 antibodies with the NMPA and/or planned IND applications with the FDA.

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The Company continued to promote efficient innovation and development in technology, research and development, processes, management and other areas. In addition to solving the industry pain points such as low heterologous pairing rate, high polymer content, removal of homodimer impurities, unstable intermediates, difficulty in activity analysis methods and difficulty in the development of formulations, especially high-concentration formulations, the Company’s CMC team demonstrated industry-leading strength and rapid execution in the process technology development of GB261 (CD20/CD3, BsAb), GB263T (EGFR/cMET/cMET, TsAb) and other products.

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