In a recent press release, Cellmid Ltd. has announced Rodon Biologics will be Cellmid's manufacturing partner for its latest "antibody" project. This will be the third project between the two firms as this partnership is set to save six months in "time for clinic" for CAB102 antibody.
Manufacturability studies of the drug has been completed by Rodon. Having Rodon in the team was seen as a huge step for Cellmid toward the success of the clinical trial of its humanized anti-midkine antibody, CAB102.
Maria Halasz, chief executive officer of Cellmid, said, "Contracting Rodon Biologics to manufacture CAB102 makes sense for many reasons. Cellmid and Rodon/ Biotecnol have collaborated closely during the humanization of CAB102 and establishing a very productive working relationship. Also critical was their deep understanding of the specific manufacturing requirements for our planned clinical trial notification scheme based on clinical studies."
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 the first in-human trials.
CAB102 is Cellmid's lead oncology drug, following antibody humanization and antibody testing. It is shown to significantly reduce chemotherpay resistance in a preclinical model of lung cancer in combination with carboplatin. It has produced strong in vitro functionality in specifically designed MK migration assays.
Based on the analysis by Proactive Investors on CAB102, an assessment showed six promising candidates that were secreted at commercially viable concentrations during cell culture. The candidates were readily purified and confirmed as structurally stable and aggregate free. The candidates, later, were 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 seen 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.