Cellmid (ASX:CDY) has selected Biotecnol SA subsidiary Rodon Biologics as the manufacturing partner for its humanised anti-midkine (MK) antibody CAB102 for clinical trials in multiple oncology indications.
Biotecnol has successfully completed numerous drug product and process development projects for 14 years.
This will save six months in 'time to clinic' for CAB102 with the clinical program on track for first in human studies in early 2015.
Rodon has already completed manufacturability studies of the drug.
It 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.
CAB102 is Cellmid's lead oncology drug following antibody humanisation and pre-clinical testing.
It has been shown to significantly reduce chemotherapy resistance in a preclinical model of lung cancer in combination with carboplatin.
"Contracting Rodon Biologics to manufacture CAB102 makes sense for many reasons. Cellmid and Rodon/Biotecnol have collaborated closely during the humanisation of CAB102 establishing a very productive working relationship," Cellmid chief executive officer Maria Halasz said.
"Also critical in our decision was their deep understanding of the specific manufacturing requirements for our planned CTN (Clinical Trial Notification) scheme based clinical studies."
This manufacturing collaboration will be the third project between the parties and aligns well with the ongoing anti-MK Tribody program.
CAB102 anti-midkine antibody
CAB102, has been shown to significantly reduce chemotherapy resistance in a preclinical model of lung cancer in combination with carboplatin.
In addition to its functional activity in vivo, it has produced strong in vitro functionality in specifically designed MK migration assays.
Its selection is the result of a pre-clinical program in which dozens of Cellmid's proprietary and patent-protected murine anti-midkine antibodies were assessed for efficacy and mechanism of action both in vivo and in vitro.
A preliminary assessment showed that the six most promising candidates were secreted at commercially viable concentrations during cell culture.
All six were readily purified and have been confirmed as structurally stable and aggregate free.
The candidates were then tested for functional activity using an in vitro cell migration inhibition assay and an in vivo tumor xenograft model in combination with carboplatin.
Carboplatin was selected as the chemotherapy of choice as it is standard therapy in lung cancer.
As expected, and consistent with clinical experience, carboplatin did not significantly reduce tumor volume or mass when used alone compared to untreated controls in the NCI-H460 model.
However, three candidates significantly reduced tumour growth when combined with carboplatin.
Rodon/Biotecnol was one of the early biologics manufacturers in Europe with a 14-year record of accomplishment and with many successful projects at various stages of the drug development spectrum.
The new 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.
This is expected to save up to six months in the Company's product development program.
The appointment of experienced biologics manufacturer Rodon/Biotecnol is a significant step ahead for Cellmid as it progresses towards a clinical trial for its humanised anti-midkine antibody CAB102.
That Rodon's ongoing collaboration with Cellmid will save up to six months in the product development program adds to the value of the agreement.
Share price catalysts ahead include the start of the clinical program in early 2015 and ongoing progress on the development of the novel MK Tribodies with Biotecnol.
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