OncoTEX Inc, an oncology company, and member of the iQ Group Global bioscience investment enterprise The iQ Group Global and Sterling Pharma Solutions, a global contract development and manufacturing organisation, have signed a clinical development agreement for the manufacture of OncoTex’s novel platinum-resistant oncology drug candidate, OxaliTEX, for use in clinical trials.
Under the terms of the agreement, Sterling will produce clinical material in its cGMP facility in Germantown, Wisconsin, which has the capabilities to handle highly potent active pharmaceutical ingredients (HPAPIs) in fully contained manufacturing suites.
OxaliTEX is the first candidate to emerge in a new class of oncology drugs that are tumour localising, well-tolerated, and overcome platinum-resistance, as well as being MRI-detectable, allowing clinicians and patients to easily monitor tumour regression during treatment. It has been developed by OncoTEX using its proprietary oncology drug platform, TEX Core, to address the urgent, unmet clinical need in ovarian cancer diagnosis and treatment.
“The current prognosis for patients with platinum-resistant ovarian cancer is very poor, so the development of OxaliTEX is an important step in advancing the way ovarian cancer is treated,” commented Dr Jonathan F. Arambula, Vice President of Research at OncoTEX. “The partnership with Sterling will allow us to make OxaliTEX that meets the FDA regulatory requirements necessary for clinical use.”
“Our mission is to find, fund and develop bioscience discoveries into life-changing medical innovations, and deliver them to the people who need them the most. Today’s announcement marks a momentous milestone for The iQ Group Global and our novel cancer-fighting drug, OxaliTEX. It brings us closer to our goal of giving the hundreds of thousands of women who are diagnosed with ovarian cancer each year access to a powerful new weapon,” added Dr George Syrmalis, CEO and Chairman of The iQ Group Global.
“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. “We have worked closely with the OncoTEX team to identify a suitable development and manufacturing strategy, and we look forward to continuing our partnership with them throughout the process to ensure the greatest chance of advancing this new therapy through clinical development.”