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Almac, Queen’s Univ. Belfast Cancer Alliance Expanding

By Nuala Moran
Staff Writer

LONDON – Almac Discovery sealed a £13 million (US$20.4 million) collaboration with Queen’s University Belfast, which will see 17 Almac scientists seconded for three years to work at the Centre for Cancer Research and Cell Biology at the university.

The agreement, which builds on a previous £4.4 million grant-funded pilot project, will have two arms. One involves a joint program in oncology drug discovery; in the second a cancer drug discovered at Queen’s and put through preclinical development by Almac Discovery, will be advanced into Phase I/IIa development.

“The first is an industrial/academic partnership formalizing what has been a less-formal collaboration, in which we will set up a drug discovery [facility] in Queen’s said Tim Harrison, VP of Discovery chemistry at Almac Discovery. “What is significant in what we are trying to do is that we are taking a personalized medicine approach, with the aim of getting better validated products,” he told BioWorld International.

This will involve making early clinical inputs – in the form of biomarkers – into a select number of targets. “Both [Almac] and Queen’s have got strong backgrounds in biomarker development. Now we are going to take an integrated approach, applying biomarkers from the earliest stages of discovery,” Harrison said.

In parallel with applying biomarkers to validate targets, the researchers will investigate how they can be applied to select patients for clinical trials and to demonstrate that drug candidates are acting on the target. The collaboration with clinicians and researchers at Queen’s will provide access to biobanks and patient data to support this work.

“Of course we could be doing all these things at a distance, but it is a multidisciplinary process, and it is only by getting everyone on the same room that you can do this work efficiently,” Harrison said. As part the agreement Harrison has been appointed to a chair in medicinal chemistry at Queen’s and will be dividing his time between professorial duties and his corporate role.

Harrison noted that many other companies are striking up academic alliances of this kind. For him, this underlines an increasing appreciation of the central role of target biology in drug discovery. “Getting the right, validated target is the most important thing you can do,” he said.

This is illustrated in the second part of the agreement with Queen’s, for the Phase I/IIa development of ALK201 in the treatment of ovarian cancer. The product is a novel anti-angiogenic discovered by Queen’s researcher Tracy Robson and advanced through pre-clinical development by Almac Discovery.

As the biotech arm of Almac Group, a 3,300-strong contract research organization, Almac Discovery has access to the full range of expertise needed to advance ALM201 and other products, through to commercialization.

The three-year 60-patient study of ALM201 will be led by Richard Wilson, director of the Northern Ireland clinical trials unit, and managed by Almac Discovery.

Unlike other marketed and development-stage anti-angiogenesis drugs, ALM201 is not a vascular endothelial growth factor (VEGF) inhibitor. Rather it acts via the cell surface receptor CD-44, to inhibit cell migration, tubule formation and microvessel formation. In preclinical development it was shown to inhibit tumor growth in human xenograft models.

The preclinical work and published mechanism of action indicate ALM201 could be effective in a range of solid tumors. It is also relevant to other indications where anti-VEGF drugs are used, such as macular degeneration, according to Harrison. In addition, the mechanism of action gives hope that ALM201 may have a better resistance profile than anti-VEGF drugs.

If successful in Phase I/IIa, it is likely that ALM201 will be outlicensed. Harrison would not comment on how any returns from ALM201, or other compounds discovered in the collaboration, will be divided between Almac and the university, other than to say an agreement is in place.

After joining the Almac Group in 2006, Harrison spearheaded the formation of Almac Discovery in 2008. While operating as biotech, Almac Discovery is entirely funded by the parent company. As a result, Harrison “has to make a pitch to management” to get funding for particular programs. “The advantage we have is that it was recognized this would be a long-term venture and take time to turn a profit,” he said.

Almac Discovery has had early success with its lead program ALM101, a nasally administered formulation of the 5HT-3 antagonist granisetron for the treatment of chemotherapy-induced nausea and vomiting. After taking the product through Phase I, it was outlicensed to an undisclosed partner and is now in Phase II development.

A third program, ALM301, is an inhibitor of Akt, a kinase that plays a key role in multiple cellular processes including apoptosis and cell proliferation. The lead candidate is now ready for out-licensing.

Harrison said Alma discovery also is interested in in-licensing programs that have been parked by pharma companies, to take them to the next phase of development. The company is currently pursuing some possibilities, but Harrison said it can be difficult to identify projects. “It’s an approach we would like to expand because we think it is win-win model,” he said.