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Jan 14, 2010

Rentschler to Manufacture Kenta’s Human mAb against MRSA for Clinical Trials

  • Rentschler Biotechnologie is collaborating with Kenta Biotech on the development of the latter’s fully human mAb against MRSA called KBSA301. Rentschler will use Kenta’s hybridoma cell line to develop a manufacturing process for KBSA301 using single-use bioreactor technology. KBSA301 is progressing toward Phase I development.

    Founded in 2006, Kenta is leveraging a technology called MabIgX® for the generation and selection of fully human mAbs, primarily against hospital-acquired infections. The technology combines classical hybridoma technology with a unique, specific heteromyeloma fusion cell line.

    Kenta Biotech has developed a method of selecting B cells isolated either from healthy individuals who have been actively immunized with a vaccine against the target organism or from individuals who have successfully defeated an infection caused by the target pathogen. After isolation these highly antigen-specific human B cells are immortalized employing a specific heteromyeloma cell line as fusion partner, which generates stable hybridomas for large-scale manufacturing of fully human mAbs.

    The ability to generate human hybridomas from human blood lymphocytes allows the isolation of all isotypes including gM, IgG, IgA, and IgE isotypes, according to Kenta. The company claims this approach effectively allows the rapid generation and testing of a variety of therapeutically promising antibodies against a number of new targets within a short period of time.

    Lead clinical-stage product, KBPA101, is a fully human IgM mAb targeting Pseudomonas aeruginosa bacteria. In September Kenta reported positive Phase IIa results, demonstrating the antibody to be safe and well-tolerated in patients with hospital-acquired pneumonia caused by Pseudomonas aeruginosa.

     



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