Date: 2014-06-19
Type of information: Production agreement
Compound: CAB102 antibody
Company: Cellmid (Australia) Biotecnol (UK) Rodon Biologics (Portugal)
Therapeutic area: Cancer - Oncology
Type agreement: production manufacturing
Action mechanism: CAB102 is a humanised monoclonal antibody targeting the growth factor midkine (MK) for use in solid tumours. In vivo pre-clinical studies have shown that anti-MK antibodies inhibit tumour growth, tumour spread (metastasis) and tumour blood vessel growth (angiogenesis) in a variety of xenograft models. IND-enabling studies are expected to be completed during 4Q 2014 with the aim of CAB102 to become ready for phase I/IIa clinical testing in early 2015.
Disease:
Details: * On June 19, 2014, Cellmid Limited announced that it has selected Rodon Biologics, a subsidiary of Biotecnol SA, to manufacture its humanised anti-midkine (MK) antibody CAB102 for clinical trials in multiple oncology indications. Under the agreement, Rodon will engineer a high yielding CHO cell line expressing CAB102, along with the processes necessary to manufacture and formulate the drug for first in human trials. Biotecnol Ltd, the biopharmaceutical development subsidiary of Biotecnol SA, has been responsible for the humanisation of the antibody. Rodon produced the humanised candidates for initial screening and has already tested CAB102’s manufacturability and stability in small-scale production runs as part of the humanisation program. In addition, and following a successful humanisation project, Cellmid and Biotecnol Ltd have recently entered into a co-development agreement to engineer novel anti-cancer Tribodies™. This manufacturing collaboration will be the third project between the parties and aligns well with the ongoing anti-MK Tribody program. It allows for seamless transition by Rodon from manufacturability studies to actual cell line development and manufacture, which is expected to save up to six months in the Company’s product development program. With the appointment of Rodon Biologics Cellmid’s clinical program for CAB102 is progressing as planned with first-in-human studies expected to commence in early 2015.
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