MilliporeSigma, the US-based life science business of Merck KGaA, Darmstadt, Germany, has agreed to support Cambridge, Massachusetts-based Angiex ability to speed-up the development of the company’s its lead oncology antibody-drug candidate, getting it ready for clinical use.

Angiex is developing an antibody-drug conjugate or ADC therapy for cancer against a vascular target, TM4SF1

This target, also known as transmembrane 4 L6 family member 1, a member of the transmembrane 4 superfamily, also known as the tetraspanin family, plays a role in the regulation of cell development, activation, growth and motility. The encoded protein is a cell surface antigen and is highly expressed on many human cancer cells and also on the endothelial cells lining tumor blood vessels.[1]

The potential of an anti-TM4SF1 ADCs was tested in a preclinical collaboration between Pfizer and Angiex founders at Beth Israel Deaconess Medical Center. As part of their preclinical work, the researchers involved in this project, generated humanized anti-human TM4SF1 monoclonal antibody, v1.10.  they conjugated it with an auristatin cytotoxic agent LP2 (chemical name mc-3377). The preclinical agent, v1.10-LP2, selectively killed cultured human tumor cell lines and human endothelial cells that express TM4SF1, providing proof-of-concept that TM4SF1-targeting ADCs have potential as anticancer agents with dual action against tumor cells and the tumor vasculature.[2]

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Biodevelopment center
The collaboration between MilliporeSigma an Angiex is the first project to be undertaken at MilliporeSigma’s new biodevelopment center in Massachusetts. Based on the agreement, MilliporeSigma gives Angiex access to end-to-end process development tools, education programs and training to support its success.

“Companies benefit from our expertise and experience in developing GMP manufacturing processes for early clinical development programs,” explained Udit Batra, CEO, MilliporeSigma.

“With an end-to-end approach, MilliporeSigma can facilitate and accelerate scaling and technical transfer for companies like Angiex,” Batra added.

“Through this collaboration, [we] hopes to accelerate our path to the clinic. We appreciate MilliporeSigma’s expertise in bringing to cancer patients an innovative treatment capable of addressing the most dangerous solid tumors,” noted Angiex CEO Dr. Paul Jaminet. He applauded MilliporeSigma’s broad range of process development capabilities and services for customers at all stages of molecule development and commercialization.

MilliporeSigma’s BioReliance® End-to-End Solutions, which is part of the Process Solutions business area within the company’s Life Science business, delivers products and services allowing biopharmaceutical companies to accelerate the progression of potential new therapies from the laboratory into clinical trial and on toward commercialization. The turnkey package includes process development, cGMP manufacturing, facility design, equipment for pilot-plant production, process and equipment training, technology transfer, equipment qualification and set-up for commercialization.

To further support its global BioReliance® End-to-End Solutions, MilliporeSigma is expected to inaugurate its new biodevelopment center in Burlington, Massachusetts, in October 2017.

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