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Sterling Pharma Solutions and OncoTEX have entered into a clinical development agreement for the manufacturing of OncoTex’s novel platinum-resistant oncology drug candidate, OxaliTEX, for use in clinical trials.
Sterling Pharma Solutions and OncoTEX, an oncology company and member of the iQ Group Global bioscience investment enterprise, The iQ Group Global, announced on May 10, 2021 that they have entered into a clinical development agreement for the manufacturing of OncoTex’s novel platinum-resistant oncology drug candidate, OxaliTEX, for use in clinical trials.
Through the agreement, Sterling will produce clinical trial material at its current good manufacturing practice (CGMP) facility in Germantown, Wis., which can accommodate highly potent active pharmaceutical ingredients in fully contained manufacturing suites, Sterling said in a company press release. OxaliTEX has been developed using OncoTEX’s oncology drug platform, TEX Core, to address the clinical need for 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,” said Jonathan F. Arambula, vice-president of Research at OncoTEX, in the press release. “The partnership with Sterling will allow us to make OxaliTEX that meets [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,” said George Syrmalis, CEO and chairman of The iQ Group Global, in the press release.
“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,” added Andrew Henderson, chief commercial officer at Sterling Pharma Solutions, in the press release. “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.”