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Lipoxen and Baxter confident that PolyXen-based haemophilia treatments will move into clinical development

Lipoxen (LON:LPX) told investors that the lead programme in its partnership with Baxter International Inc (NYSE:BAX) has achieved positive results in preclinical models and the partners are confident in the programme’s potential to transition into clinical development. Through the partnership Lipoxen could receive up to US$73m in development milestones.

"Baxter is one of Lipoxen's most important partners and the company's third largest shareholder.  We are extremely encouraged by the results seen to date,” Lipoxen chief executive Scott Maguire commented. “In light of the strong scientific progress that has been made over the last three years, there is clear potential for both the lead program PSA-Factor VIII but also for broadening this collaboration for other haemophilia drug therapies.”

The ‘PSA-Factor VIII’ project is being developed alongside Baxter, to develop treatments of haemophilia, with improved longer-acting forms of blood-clotting factors. The partner agreed the exclusive world-wide development and licence agreement back in 2006. Lipoxen and Baxter continue to move forward on preclinical work using Lipoxen's PSA technology focused on linking Lipoxen's PolyXen drug delivery technology with Baxter's proprietary proteins.

The PolyXen platform is a versatile protein drug delivery technology. The technology is essentially based on a polymer of sialic acid which is naturally found in the body.  The polymer is attached to a drug, which generates several positive attributes.

Firstly, as the polymer is a natural substance, it effectively hides the drug from the body’s immune system.  Second, the polymer acts like a tail on the drug, substantially increasing its life once administered. This means the drug dose frequency required is greatly reduced as the drug is released over a longer time frame. PolyXen polymers also improve the stability and water solubility.

Under the terms of the development deal, Lipoxen has the potential to receive up to US$73m in milestone payments, plus royalties as the first development candidate progresses through clinical development and commercialisation. “Importantly, progressing this PSA-Factor-VIII programme alone through the clinic will trigger additional cash payments to the company which would significantly advance our objective of reaching the pivotal cash inflection point in our company's development to convert Lipoxen into a cash-generative enterprise”, Maguire added.

Baxter is also investigating the Lipoxen PSA technology for other potential factor replacement therapies in the treatment of haemophilia A, B and for patients with inhibitors. According to Lipoxen, the Factor VIII global market size is approximately US$5bn whilst the Inhibitor and Factor IX markets were US$1.2bn and US$600m respectively.

Back in April, Lipoxen announced it secured the necessary funding to move forward with its development programme, for its proprietary product pipeline, after conducting a successful placing to raise £1.2 million. The shares were placed at 7 pence per share compared to the stock’s yesterday’s closing price of 7.13 pence.

The company also told investors that it expects its project base to return significant license fee income going forward.

Lipoxen has three proprietary patented technology platforms - PolyXen, ImuXen, and SiRNAblate.

The proprietary ImuXen technology uses lipids, natural substances found in the human body, to entrap active ingredients - like antigens - to ensure direct delivery into the appropriate cells of the immune system.

According to Lipoxen, the use of the technology results in enhanced immune responses, which could potentially lead to single dose immunity being achieved, while reducing the side effects associated with traditional vaccines.

SiRNAblate is a delivery platform for gene silencing technology, siRNA, which stands for small interfering RNA, sometimes known as short interfering RNA or silencing RNA.