Oncolix: Pole position for cancer therapy on the prolactin pathway
The CEO of Oncolix, Michael Redman, arrives at Biotech Showcase™ in San Francisco sitting in the pole position for what promises to be a race to develop a novel cancer therapy targeting the prolactin pathway.
A clinical trial set to begin in 2010 for the first-in-class drug Prolanta, will provide the first test of a therapy for cancers that are prolactin receptor positive. Approximately 90 percent and 60 percent of breast and ovarian cancer patients respectively are prolactin receptor positive. “With successful patient outcomes, Prolanta would be positioned to capture a significant share of the breast cancer therapy market,” said Redman.
Dr Wen Chen, who developed Prolanta (G129R), also developed Somavert (G120R). Somavert is marketed by Pfizer for the treatment of acromegaly, or gigantism, a condition caused by excessive growth hormone. Somavert sales in 2008 to treat this rare disease were reported at USD 135 million. Both Prolanta and Somavert feature a single amino acid mutation (glycine to arginine) in human prolactin and growth hormone. “There are 250 times more patients with breast cancer than gigantism,” said Redman, adding that the need is that much greater, and so is the opportunity.
His presentation to potential investors at Biotech Showcase shows that a market share of even 1 to 2 percent of the breast cancer market could equate to blockbuster status. The market leading Herceptin from Hoffmann-LaRoche-Genentech in five years grew to a 7 percent share valued at USD 4.7 billion in 2008.
A significant preclinical finding for Prolanta, he said, is that the prolactin therapy may prove to be synergistic, meaning that Prolanta in combination therapy may work better than either product alone.
“We believe pharmaceuticals with existing therapies will want to position their treatment with ours,” he said. “And that is a good position to be in.”
Oncolix was founded in 2006 as a spin-out from a collaborative effort between Greenville Hospital System in Greenville, South Carolina, and Clemson University to support the development work of Dr Chen.
The company’s strategy is to develop Prolanta through Phase IIb results and then seek an exit through licensing, an IPO or a trade sale.
Redman is currently seeking USD 10 million in Oncolix’s first institutional financing round.
The company has been underwritten to this point by USD 6.5 million from the Greenville Hospital, USD 1.5 million of in-kind contract manufacturing services from BioVectra, and a USD 2.4 million Emerging Technology Grant from the state of Texas (pending governor signature), where Oncolix relocated this past summer.
In 2009 Oncolix licensed a bacterial cell expression system for Prolanta from Monsanto and contracted BioVectra, which had acquired the Monsanto technology, to manufacture Prolanta suitable for use in clinical trials and then scale up the production process to the kilogram level.
Early production of Prolanta proved prohibitive with a cost exceeding USD 8,000 per gram. Using the expression system developed by Monsanto the drug is now being produced at under USD 50 per gram.
“Often a drug development company does not know, even as they finish clinical trials, whether they can actually manufacture the drug,” said Redman. “Before we even begin our trials, Oncolix not only knows how and where to manufacture Prolanta, but we have taken steps to assure reduced costs of manufacturing.”
The 40-patient clinical trial planned for the third quarter of 2010 will run for two years and progress in a continual study design from Phase Ia into Phase Ib and then through Phase IIa.
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