Sexual HealthCelleron Therapeutics And Astrazeneca Announce Personalised Medicine Collaboration In Cancer For The Development Of AZ's Leading HDAC Inhibitor
Celleron Therapeutics Ltd, the Oxford UK based specialist in the development of individually targeted cancer medicines, has secured exclusive rights to AstraZeneca plc"s lead histone deacetylase (HDAC) inhibitor (AZD 9468), for global development in conjunction with its proprietary "CancerNav" predictive biomarker platform. "CancerNav" specifically identifies those tumours which are most likely to respond to an individual cancer drug, thereby enabling a highly focussed clinical development and commercialisation programme, based on a closely linked diagnostic and therapeutic "personalised medicine" approach.
Celleron will lead the clinical trial programme and plans to use "CancerNav" to identify tumours that undergo a favourable response to the drug. This strategy of targeting the drug to responsive tumours potentially allows for much more rapid clinical development and subsequent market entry.
HDAC"s are a family of enzymes that control a wide variety of mechanisms involved with tumour cell growth and division, and HDAC inhibitors represent a new group of anti-cancer agents. However, because HDAC"s are ubiquitously expressed targets, the clinical utility of HDAC inhibitors has been historically difficult to determine. Celleron"s "CancerNav" platform has already identified a specific biomarker for HDAC responsive tumours. This will now be applied to AZD 9468 (now to be
known as CXD101), enabling a rapid move to Phase I clinical study, using the biomarker to select patients that respond well to the drug. After extensive due diligence and based upon its world-leading cancer biology expertise, Celleron believe that CXD101 is an HDAC inhibitor with multiple points of positive differentiation from competing products. The combined benefit of a predictive biomarker applied to a drug with potentially class-leading properties means that CXD101 is more likely to demonstrate greater clinical value than other HDAC inhibitor based therapies.
"Today"s announcement provides early and strong endorsement of our predictive biomarker platform, "CancerNav" and secures an immediate and strong partner to share in the future value of the product. It is the ideal partnership to leverage our clinical and biomarker expertise", commented Professor Nick La Thangue, founder of Celleron. "The clinical potential of CXD101, as mono and combination therapy, encompasses a range of different tumour types, which can now be identified through a biomarker analysis program which Celleron will conduct. We will apply learning from our biomarker platform to build a focussed clinical development program and are actively seek partnerships at later stages of development to ensure the thorough and timely development of promising products. Our extensive HDAC inhibitor know-how and clinical development expertise, coupled with our unique biomarker capability, "CancerNav", gives us singular competitive advantage".
Under the terms of the agreement, full development and commercialisation rights to CXD101 pass to Celleron, including the right to sublicense. AstraZeneca will receive significant milestones, royalties and additional share of financial proceeds in the event of successful commercialisation by a third party. Celleron has furthermore granted to
AstraZeneca the right to discuss the reacquisition of commercialisation rights at an appropriate future juncture.
John Goddard, SVP of Strategic Planning and Business Development at AstraZeneca commented that; "We are very pleased to enter into this innovative and flexible agreement with Celleron Therapeutics. We have strong respect for Celleron and Oxford University"s unique skills in this specific field. AstraZeneca will benefit from the potential success of this drug in several ways and through partnership can do so without the need to commit internal R&D res".
Professor David Kerr, Chief Medical Officer and Founder of Celleron, and Professor of Cancer Therapeutics at Oxford University added; "I am delighted that a company of AstraZeneca"s global stature in oncology has recognised the value and potential of our novel biomarker and clinical development expertise. Cancer is a large unmet medical need but there remain significant deficiencies in the traditional clinical trial paradigm. Celleron"s biomarker-driven clinical development and patient stratification capability overcomes many of the existing bottlenecks. Furthermore, this innovative transaction structure gives AZ and Celleron a very attractive combination of partnership and flexibility".
AstraZeneca