OncoTEX & Sterling Pharma Solutions Sign Clinical Manufacturing Agreement 

OncoTEX Inc and Sterling Pharma Solutions recently announced that they had 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 localizing, 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.”

OxaliTEX is a conjugate of oxaliplatin – a well-established platinum-based chemotherapy drug – and a tumour-localising metallotexaphyrin for targeted drug delivery to cancerous tumours. Preclinical studies show OxaliTEX targets solid tumour cells, activates within tumours, and overcomes multi-factorial drug resistance mechanisms with minimal adverse effects and so is shown to be superior to traditional platinum-based chemotherapy drugs. Read more

OncoTEX Inc is an oncology company and member of the iQ Group Global bioscience investment enterprise The iQ Group Global. OncoTEX Inc owns TEX Core, a novel oncology drug platform that enables the development of well-tolerated, MRI-detectable cancer therapeutics that target drug-sensitive and drug-resistant solid tumours. Find out more.

The iQ Group Global is a consortium of companies that finds, funds and develops bioscience discoveries to create life-changing medical innovations. Find out more.

Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years’ experience in providing small molecule API development and manufacturing services to the pharmaceutical industry, specialising in handling challenging chemistries. Sterling manages the most complex API and API intermediate challenges from proof-of-concept to commercial manufacture. Sterling has four facilities employing more than 750 people: its HQ in Dudley, Northumberland, UK; a dedicated bioconjugation and ADCs facility in Deeside, North Wales, UK; and two sites in the US, in Cary, North Carolina and Germantown, Wisconsin. Find out more.