ProBio Congratulates Selecxine on FDA Clearance of IND Application for Innovative Antibody Drug Program
Recently, Selecxine, a partner of ProBio, announces FDA clearance of its IND application for innovative antibody drug program (SLC-3010). ProBio was responsible for the CMC development and supporting IND filing in this project. ProBio extends congratulations on this.
In December 2019, ProBio announced the strategic collaboration with Selecxine for an innovative antibody drug program. The project (SLC-3010) is an antibody-cytokine conjugate based on Selecxine’s proprietary non-covalent conjugation technology to implement triple immune reaction for cancer treatment. Different from conventional ADC product, SLC-3010 shows the following advantages: mild conjugation condition, excellent yield and product purity. There was no similar drug on the market by then for the reference, which presented a great challenge to ProBio's process development and analytical development. Based upon ProBio’s extensive experience in protein CMC, ProBio provided customized solutions and developed the upstream cell culture, downstream purification, and the conjugation processes, which resulted in a robust and flexible overall bioprocess characterized with excellent product yield and low level of host cell protein and host cell DNA residuals. In addition, ProBio developed multiple customized assays to support the quality control and release of the product.
Junyoung Lee, CEO of Selecxine,"With the approval of this innovative antibody drug project in the United States and the successful development of several sub-projects of SLC-3010 in the past few years, ProBio demonstrated strong process development and clinical application strength. The project will enter the clinical trial stage, we are very grateful to ProBio for providing fast and high-quality services for the project, and it has played an important role in the rapid promotion to clinical trial stage with its rich experience."
Dr. Brian Min, CEO of ProBio said, "We congratulate Selecxine on FDA clearance of its IND application for this innovative antibody drug program. The approval of this program demonstrates our superior process development capabilities. Compared with classic monoclonal antibody and protein drug, this project also provides a new insight into new drug development. We hope to empower more innovative companies like Selecxine to jointly accelerate development of innovative therapies and launch of new drugs."
About Selecxine
Selecxine was founded in Dec 2018 in Pohang, Korea and opened brand office at Seoul, Korea in August 2019. Selecxine is a newly established bio start-up with expertise in developing monoclonal antibodies using platform technology. Based on the understanding of cancer immunology and protein structural information, Selecxine develops antibodies that bind to specific epitope on target protein for modification and amplification of the desired signal from bifunctional biomolecules such as cytokines and cytokine receptors. One of the novel candidates being developed in Selecxine is immune mediated anti-cancer therapeutics named SLC-3010 which is a conjugate of IL-2 and anti-human IL-2 antibody (TCB2). SLC-3010 selectively stimulates anti-tumor immune response and the efficacy of SLC-3010 in eradication of various types of tumor was thoroughly demonstrated through various in vitro and in vivo experiments. Furthermore, not only SLC-3010, Selecxine is also actively developing subsequent pipelines based on the well-established in-house platform.
About ProBio
ProBio is the subsidiary of GenScript Biotech Corporation, proactively providing end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. ProBio has established GMP capacity which meets FDA, EMA and NMPA regulatory requirements and has established companies in the United States, the Netherlands, South Korea, Shanghai, Hong Kong, Nanjing and other places to serve global customers, and supported customers in the United States, Europe, Asia Pacific and other regions to obtain more than 30 IND approvals. https://www.probiocdmo.com/
