EOC202 (eftilagimod-alpha, efti for short) is a first-in-class soluble human lymphocyte-activation gene 3 (LAG-3) IgG Fc fusion protein which functions as an activator of antigen-presenting cells (APCs). It modulates the activation of the adaptive immune system by regulating the balance between CD4+/Th1 and T-reg cells, and by boosting APC's interactions with T cells to drive adaptive immune responses (CD8+ cytotoxic lymphocytes) against tumor cells. Based on the ability of EOC202 to activate APCs, administration in combination with chemotherapy can amplify the immune response by promoting recognition of antigens released by dying tumor cells.
A Phase IIb AIPAC study sponsored by Immutep has shown positive interim OS (Overall survival) in subgroups of the less than 65 years-old and the low monocyte (< 0.25/nl) in patients with metastatic breast cancer treated by EOC202 in combination with paclitaxel. EOC has licensed in the Greater China rights of efti from Immutep and sponsored the Phase I bridging study in Mainland China which has been completed in mid of 2021. EOC will initiate a Phase II study of EOC202 in combination with chemotherapy in metastatic breast cancer in the second half of 2021.
Additionally, the immunotherapy combination research of efti has recently demonstrated improved clinical benefits in OS and good safety profile from Immutep's on-going TACTI-002 study, which is a Phase II combination trial with pembrolizumab at first and second- line in patients with NSCLC and at second- line in patients with HNSCC. This regimen has synergistic effect with anti-PD-1 because the activation of APC and subsequent T cell recruitment with efti may lead to amplification of anti-tumor responses. EOC is also preparing such a combination therapy study and expects to kick off in the first half of 2022.
EOC and Chime started collaborating in 2018 with technical transfer project for EOC202 ahead of scale-up and process optimization for clinical batch manufacture. EOC and Chime set up a project team to collaborate closely to develop, implement and manage a comprehensive development program including comparability studies. In Aug 2020, EOC got positive feedback from CDE on the CMC comparability study results. This is a significant milestone for EOC and Chime demonstrating the success of the CMC development and manufacturing collaboration. EOC202 is now undergoing the next stage of clinical development, and EOC will continue to use Chimes technical, quality and manufacturing expertise to supply this program.
"Encouraged by our partner Immutep's exciting clinical performance, we are ready to further exploit the clinical benefits of this promising drug in the IO realm,” said Xiaoming Zou, CEO, EOC Pharma. “At such an important moment of our expansion in clinical development, we're very excited to continue our partnership with Chime Biologics as a highly qualified CDMO expertise. We look forward to working more closely with Chime Biologics and to bring safe and high-quality products to the Chinese patients."
John Zeng, CEO, Chime Biologics, said, "We're pleased to extend the agreement and strengthen our collaboration with EOC. This agreement validates Chime's track record, compliance and expertise as a leading CDMO for biologics development and manufacture. It demonstrates that collaborating with a reliable CDMO partner is a viable and cost-effective model to develop and manufacture biopharmaceuticals for global supply. We are expanding our capacity to further support EOC and biopharma industry.”