The CDMO's expertise and capabilities a "perfect fit" for overcoming the challenges of manufacturing this complex molecule

Contract development and manufacturing organisation (CDMO) Sterling Pharma Solutions has signed a clinical development agreement with biotech OncoTex to manufacture its oncology drug candidate, OxaliTEX.

Sterling will produce clinical material in its cGMP facility in Germantown, Wisconsin, which can handle highly potent active pharmaceutical ingredients (HPAPIs) in fully contained manufacturing suites.

“The challenges involved in the manufacture of this complex molecule was a perfect fit for the expertise and capabilities that our team in Germantown have,” said Dr Andrew Henderson, Chief Commercial Officer at Sterling Pharma Solutions.

OxaliTEX, a conjugate of oxaliplatin -- a platinum-basd chemotherapy drug -- and a tumour-localising metallotexaphyrin, is the first candidate to emerge in a new class of oncology drugs that are tumour localising, well-tolerated, and overcome platinum-resistance. It is also MRI-detectable, allowing clinicians and patients to easily monitor tumour regression during treatment.

The drug candidate has been developed by OncoTEX using its proprietary oncology drug platform, TEX Core, to address the unmet clinical need in ovarian cancer diagnosis and treatment.

According to Dr Jonathan Arambula, Vice President of Research at OncoTEX, working with Sterling will enable them to produce OxaliTEX that meets the FDA regulatory requirements necessary for clinical use.

OncoTex is a member of The iQ Group Global, a consortium of companies which finds, funds and develops bioscience discoveries.