With one woman in Australia dying every eight hours from ovarian cancer, the urgency to address the unmet clinical need in cancer therapeutics has never been more paramount.
A significant manufacturing agreement between OncoTEX Inc. (OncoTEX) and Sterling Pharma Solutions will see the production of novel platinum-resistant cancer-fighting drug, OxaliTEX, scaled up for preclinical and clinical testing.
Sterling Pharma Solutions, with more than 50 years of experience and state-of-the-art global facilities, will oversee the production of OxaliTEX that meets the FDA regulatory requirements necessary for clinical use. Manufacturing is the first development step in the multiphase process that will culminate with an Investigative New Drug (IND) application for submission to the FDA and will play a vital role in addressing an urgent, unmet clinical need in ovarian cancer diagnosis and treatment.
OxaliTEX is the first candidate from a new class of oncology drugs and is being developed in Texas by US oncology company, OncoTEX, a member of Australian bioscience enterprise The iQ Group Global, from their oncology drug platform, TEX Core.
OxaliTEX’s development is being led by OncoTEX Vice President of Research, Dr. Jonathan F. Arambula, guided by an advisory board consisting of leaders from the University of Texas at Austin, MD Anderson Cancer Center and UT Dell Medical School.
Each year almost 240,000 women are diagnosed with ovarian cancer, and only approximately 49 percent survive beyond five years.
In Australia, more than 1400 women are diagnosed with ovarian cancer each year with one woman in the country dying every eight hours, making it one of the leading causes of cancer-related death in women. This is largely because it is rarely symptomatic in its early stages and often untreatable and fatal by the time of detection.
At present, there is no effective early screening test for ovarian cancer and during the first few months of growth, it is extremely difficult to detect.
Chloe Spitalnic, 22, told Ovarian Cancer Australia the only warning sign before her ovarian cancer diagnosis was a mild pain in her abdomen.
“My first symptoms started on August 6, just another day uni. I just felt a bit of pain in my abdomen, like you get all these random pains in your body, you never know what it is,” Ms Spitalnic said.
“Six days after seeing the GP (general practitioner), I’m in surgery, and then five days later, I’m given the stage three ovarian cancer diagnosis. I’m worried to think too much about the future, or to get my hopes up, because I don’t know what the future holds. Even before surgery, I was already thinking who do I tell? Like how close of friends do I tell? I wanted everything to be on my terms. I just want my life to kind of continue and for this to be a little bump in the road.”
Dr. Arambula said the agreement with Sterling Pharma Solutions is an important step in advancing the way ovarian cancer is treated.
“We believe our work is significant as the prognosis for patients with platinum-resistant ovarian cancer is very poor,” Dr. Arambula said.
“As OxaliTEX was designed to treat platinum resistance, we are hopeful that its addition to ovarian cancer treatment algorithms will give clinicians and patients a solution that they have long been searching for. The partnership with Sterling will allow us to make OxaliTEX that meets the FDA regulatory requirements necessary for clinical use.”
CEO and Chairman of The iQ Group Global, Dr. George Syrmalis, said the partnership with Sterling Pharma Solutions will help The Group continue its mission 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,” Dr. Syrmalis said.
“It brings us closer to our goal of giving hundreds of thousands of women diagnosed with ovarian cancer each year, access to a powerful new weapon. Working with Sterling will reinforce the reasons why we do the work that we do. It’s of course, the patients.”
Chief Commercial Officer at Sterling Pharma Solutions, Dr Andrew Henderson said the partnership will facilitate OncoTEX’s goal of developing a new means to combat ovarian cancer.
“We are delighted to be working with OncoTEX on the development and manufacture of this drug in support of their novel approach to oncology therapy,” Dr Henderson said.
“The challenges associated with this complex molecule at scale were a perfect fit for our Germantown facility; as a complex program consisting of more than 16 steps of chemistry, as well as being highly potent, choosing the right partner was crucial. Working as a collaborative team early on to identify a development and manufacturing strategy was critical and we look forward to continuing our partnership with the OncoTEX team throughout the process to ensure that they achieve their goals to address this critical and unmet therapeutic need.”
The patent for OxaliTEX is now issued in Australia, USA, Singapore and Mexico, and has a notice of allowance in Israel, and is patent pending in multiple other countries.
Unlike current platinum-based SOC oncology therapeutics, OxaliTEX is tumor localizing, well-tolerated, overcomes platinum-resistance, and is MRI-detectable, allowing clinicians and patients to easily monitor tumor regression during treatment.
The early discovery and proof of concept efforts are ongoing through a Sponsored Research Agreement with the Jonathan Sessler lab at the University of Texas at Austin. Through this collaboration, researchers will be able to identify additional clinical candidates for bladder, pancreatic, prostate, breast and other cancers.
OxaliTEX is currently in preclinical development. As OxaliTEX addresses an unmet medical need in patients with ovarian cancer, OncoTEX intends to carry out regulatory submission via orphan drug designation following an IND submission with the FDA.
OxaliTEX is a conjugate of oxaliplatin – a well-established platinum-based chemotherapy drug – and a tumor localizing metallotexaphyrin for targeted drug delivery to cancerous tumors. Preclinical studies show OxaliTEX targets solid tumor cells, activates within tumors 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
About OncoTEX Inc.
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 tumors. Find out more
About The iQ Group Global
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
About Sterling Pharma Solutions
Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with over 50 years’ experience in providing small molecule API development and manufacturing services to the pharmaceutical industry, specializing 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