Bayer's Anti-CCR8 Monoclonal Antibody BAY 3375968 Receives IND Approval in China for Advanced Solid Tumors
Bayer
Pharmaceutical Product R&D Developer
On July 23, according to the announcement on the CDE official website,Bayer's Class 1 new drug BAY 3375968 has been approved for clinical trials, intended for the treatment of advanced solid tumors.
BAY 3375968 is a humanized monoclonal antibody targeting CCR8, developed by Bayer, which relies on ADCC and ADCP. In vivo efficacy studies using mouse surrogate antibodies have shown that monotherapy has strong efficacy in various mouse tumor models, significantly associated with the depletion of intratumoral CCR8+ Tregs and an increase in CD8+ T cells. The monotherapy effect of the CCR8-depleting antibody is further enhanced when combined with ICIs. BAY 3375968 also demonstrated good safety in cynomolgus monkeys.
According to the trial results published at the 2022 AACR,BAY 3375968Demonstrates the ability to specifically bind to the CCR8 protein on the surface of regulatory T cells (Tregs). This binding can reduce the number of Tregs and weaken their immunosuppressive effects, potentially enhancing the body's immune response to cancer. Through this mechanism, the product has the potential to become a new strategy for promoting anti-tumor immune responses.
Results announced at the 2022 AACR
CurrentlyA Phase 1 first-in-human clinical study is underway to evaluate the safety of BAY 3375968 when used alone or in combination with the PD-1 inhibitor pembrolizumab, and to explore the optimal dosage of this product in patients with advanced solid tumors.
Ongoing Phase 1 Clinical Trial
CCR8 is a chemokine receptor that is specifically highly expressed on tumor-infiltrating regulatory T cells (Treg), and is also expressed in Th2 cells and tumor cells; however, it is basically not expressed on peripheral blood Treg or normal tissues.
CCR8 is involved in the recruitment of Treg and Th2 cells to inflammatory and tumor sites. Its high expression is associated with various cancers, including colorectal cancer, breast cancer, gastric cancer, metastatic brain cancer, and metastatic liver cancer, and is considered a potential specific marker for Treg in tumor sites, making it a highly promising target for cancer immunotherapy.
Currently, no CCR8-targeted drugs have been approved for marketing globally. However, multiple pharmaceutical companies, both in China and internationally, have already made strategic investments, primarily focusing on monoclonal antibodies targeting CCR8.
Global CCR8 Target Drug Research and Development Status
Source:
1. CDE Official Website
2.AACR Official Website
3.Emerging Immune Target CCR8 Atlas.Pharmacodia Daily.January 31, 2023
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