On January 15, 2011 Bayer reported that an eagerly-anticipated initial public offering by the Swiss-Italian biotech Philogen has been cancelled at the last minute after partner Bayer pulled out of their oncology collaboration (Press release, Bayer, JAN 15, 2011, View Source [SID1234564248]).

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Philogen planned to list on the Milan Stock Exchange this Friday (February 18) and was looking to sell a 23% stake. This would have raised between 50.9-65.3 million euros, valuing the group at 170.9-219.5 million euros.

However the Siena-based firm, whose Philochem R&D unit is headquartered in Zurich, has withdrawn the tender offer. This is directly as a result of the "unexpected" decision by Bayer to terminate licence agreements and product development pacts for the cancer treatments radretumab and darleukin, which are in Phase II.

Bayer has not given any details for its withdrawal and told PharmaTimes World News simply that "we have sent a letter to Philogen informing them about our decision to terminate our licence agreement". The latter firm said that such a "material change" to its position had left bookrunners "unwilling to continue with the listing". Philogen also pulled a proposed IPO in 2008 due to market conditions.

Observers were watching with interest to see how the offering would go as it would have been Europe’s first biotechnology IPO in 2011. It would have provided an interesting guide to sentiment among the investment community for a sector that has been struggling to raise funds of late.

On January 14, 2011 Cancer Research UK and its commercial arm Cancer Research Technology (CRT), reported to have established a team of scientists with expertise in cancer stem cell research to identify new targets to detect, monitor and treat cancer (Press release, Cancer Research Technology, JAN 14, 2011, View Source [SID1234523328]).

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The charity has hand-picked four world class research groups to collaborate on an initial two-year research project to unravel the role of cancer stem cells in the development, growth and spread of tumours in breast, prostate and head and neck cancers. The research groups* are led by: Professor Fiona Watt, Cancer Research UK’s Cambridge Research Institute; Dr Robert Clarke, The University of Manchester and Paterson Institute for Cancer Research; Professor Norman Maitland, University of York and Professor Alan Clarke Cardiff University.

It was previously thought that all the cells within a tumour are the same, but it is now known a small number of slow-growing cells do not respond to standard treatments. These ‘cancer stem cells’ are thought to be a cause of resistance to common therapies and the spread of tumour cells to other parts of the body.

Scientists do not yet know how cancer stem cells can be identified and killed. The Cancer Stem Cell Consortium will develop tests and models to refine a common set of known proteins – or biomarkers – present on cancer stem cells across three different tumour types for future drug discovery programmes. The team will also identify new biomarkers as potential targets for the development of new cancer drugs.

Professor Fiona Watt, deputy director of Cancer Research UK’s Cambridge Research Institute and leader of the consortium, said: "Conventional treatments – which do not target cancer stem cells – may shrink a tumour initially but they don’t prevent regrowth or spread of the tumour.

"At the moment there is limited information on the ways scientists could target cancer stem cells. But I hope that knowledge generated by our team of experts will help in the development of potential new therapies to treat difficult to beat cancers."

Initially the project will receive £500,000 from Cancer Research UK for two years. It is hoped each research team will attract an industry partner to bring in additional skills know-how and more funding for longer term research. In return industry partners will benefit through access to the consortium’s latest discoveries and intellectual property and share Cancer Research UK’s expertise in translating scientific discoveries into new cancer treatments.

Once the early development phase is complete, the industrial partner can choose to develop any joint discoveries into compounds with potential to be taken into early clinical trials.

Dr Phil L’Huillier, Cancer Research Technology’s business development director, said: "We’ve selected the world’s leading experts in cancer stem cell research to push the frontiers of knowledge in this important field.

"Targeting cancer stem cells is an important strategy in the fight against cancer. By bringing together industry partners and using our commercial expertise alongside the critical mass of the best brains in science we hope to identify important new leads for the development of new therapies to increase survival from a range of cancers."

Any profits from the success of the projects will be shared between the charity and the research partners involved, with Cancer Research UK re-investing any proceeds in its future research work. The business relationships will be managed by CRT, which has more than 20 years experience in licensing patents and developing opportunities for new cancer drugs and diagnostics, working closely with licensees and the pharmaceutical industry.

This is the second of CRT’s consortia, the first called Senectus Therapeutics Ltd** formed in 2008 to further research into the triggers of cellular senescence – cell aging – a process by which cells irreversibly halt their cell cycle of growth and division.

Harpal Kumar, Cancer Research UK’s chief executive, said: "Cancer stem cells represent an exciting new frontier in our efforts to beat cancer. We urgently need to find new and effective ways to target these cells. This early research will pave the way for our scientists to develop more treatments and help more people survive a diagnosis of cancer – especially people who have aggressive cancers or for whom conventional treatments do not prevent the cancer returning.

"We’re investing in this exciting collaboration made up of world-leading scientists to combine our research expertise with support from industry partners to crack the codes behind the causes and development of cancer."

On January 13, 2011 Cancer Research UK’s drug development office (DDO) reported it has signed a Strategic Combinations Alliance with AstraZeneca to take combinations of experimental cancer drugs into early phase clinical trials (Press release, Cancer Research Technology, JAN 13, 2011, View Source [SID1234523329]).

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The move will increase patient access to trials of potential new cancer treatments that combine molecularly targeted experimental drugs developed and owned by AstraZeneca. The trials will also test these combinations alongside conventional chemotherapy radiotherapy and other novel agents.

It is hoped that combination therapy using a number of molecularly targeted drugs may decrease the chance of patients developing resistance to any individual drug. This is because different types of drugs attack the faults in cancer cells at different points.

The trials will be managed and run through the Cancer Research UK/ UK Health Departments Experimental Cancer Medicine Centre (ECMC) Network* at hospitals across the UK with support from Cancer Research UK’s Drug Development Office. AZ will provide access to its drugs to be trialled through the alliance as well as additional financial support. The charity will also hold workshops with the ECMC Network and AZ to identify promising combinations of experimental treatments to trial.

Kate Miller, head of the combinations alliance at Cancer Research UK’s DDO, said: "We are delighted to be collaborating with AstraZeneca through the combinations alliance. This initiative will provide a huge boost to the UK research community in developing exciting new combination therapies and will mean that more UK patients will be able to take part in important clinical trials of potential new treatments".

"We are actively looking for additional partners who are interested in collaborating with us.

"Our plan is to take the model we’ve established with AstraZeneca forward by developing cross company agreements and providing access to a larger number of potential combinations to help us beat cancer."

Cancer Research UK’s Drug Development Office is adding value by mediating between the cross company partners and across the ECMCs.
Professor Andrew Hughes, vice president, Oncology Clinical Innovative Medicines, said: "As we further understand the heterogeneity of cancer, we not only need to redefine the disease but also our solutions to it with the ultimate aim of restoring patients’ lives. The collaboration with Cancer Research UK and the ECMCs provides a key opportunity to redefining our solutions to cancer through combination treatments."

Cancer Research UK and the ECMC Network have established clear processes to run early phase combination clinical trials through the ECMC Network. This includes peer-review of the scientific data and trial endorsement through Cancer Research UK’s New Agent’s Committee**.

Kate Miller added: "This partnership with AstraZenenca has enabled us to create a standardised way of evaluating and delivering combination studies through the ECMC network."

Dr Sally Burtles, director of the Experimental Cancer Medicine Network, said: "It is incredibly exciting to have the opportunity to run trials of these promising new drugs which could potentially be used to treat a range of different cancers.

"The ECMC network brings together cancer doctors, nurses and scientists to make it easier to run clinical trials of powerful new tailored treatments – and it is thanks to the generosity and time of patients that it is possible to develop these new approaches which could benefit thousands of people in the future."

On January 10, 2011 Epizyme reported a worldwide strategic alliance with GlaxoSmithKline (GSK) to discover, develop, and market novel small molecule therapeutics targeting histone methyltransferases (HMTs), an important class of epigenetic enzymes, for the treatment of cancer and other diseases (Press release, Epizyme, JAN 10, 2011, View Source [SID:SID1234515218]).

This alliance leverages Epizyme’s unique HMT discovery platform, including its proprietary chemical library, expertise, and intellectual property, to discover and develop HMT therapeutics against the set of targets to be included in the collaboration. Under the terms of the agreement, Epizyme will receive an upfront payment of $20 million, as well as research funding. Epizyme is eligible to receive more than $630 million in total milestone payments if medicines are commercialized for all targets in the collaboration. Additionally, Epizyme is eligible to receive up to double-­-digit royalties on net sales of products resulting from the alliance. For each target in the collaboration, Epizyme will be primarily responsible for research up to development candidate selection, and GSK will be solely responsible for development and commercialization.

Epigenetic enzymes are an important class of proteins that regulate whether genes are turned off or on. The HMT family of epigenetic enzymes contains as many as 96 members, many of which have been associated genetically with cancer and other diseases. Targeting specific HMTs with potent and selective small molecule therapeutics offers the possibility of controlling pathways of gene expression that contribute to diseases.

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Robert Gould, Ph.D., CEO and President of Epizyme, said: "Epizyme’s mission is to develop personalized therapeutics for genetically-­-defined patients based on our understanding of the driving role played by many HMTs in human disease. We are excited to be working with GSK. This collaboration validates our unique discovery platform and the targeted approach we bring to HMT therapeutics."

On January 6, 2011 Cell Medica, a leading cellular therapeutics company which develops, manufactures and markets cellular immunotherapy products for the treatment of infectious disease and cancer, reported an exclusive license agreement and research collaboration with the Center for Cell and Gene Therapy (CAGT), Baylor College of Medicine (Houston, Texas), for the commercialization of an innovative cell-based treatment for cancers associated with the oncogenic Epstein Barr virus (EBV) (Press release, Cell Medica, JAN 6, 2011, View Source [SID:1234513475]). Financial terms were not disclosed.

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Cell Medica’s expertise and experience in the development and manufacturing of cellular immunotherapy products in combination with the CAGT’s leading position in the research and development of cell therapies targeting EBV-related disease will accelerate the development of this potentially curative treatment for EBV-associated lymphoma and nasopharyngeal carcinoma (NPC). Cell Medica has already introduced its first cell therapy product in the UK which is based on antigen-specific T cells and is pioneering the manufacturing strategy for high volume production of patient-specific cell therapies.

EBV is present in 90% of the human population and the virus resides in a latent state in B cells and epithelial cells in the nasopharynx. EBV was one of the first viruses to be associated with malignancies. The expression of EBV antigens by cancerous cells provides the opportunity to use EBV antigen-specific cytotoxic T lymphocytes (EBV CTLs) for therapy. EBV CTLs can be recovered from the patient and activated through an ex vivo procedure to enhance their ability to target and kill tumor cells. Re-infusion of these activated T cells into the patient has been shown to be safe and effective as a curative treatment for EBV associated malignancies.

The CAGT has treated more than 250 patients over the past 15 years and has collected an impressive body of clinical data which indicate that EBV-CTLs can induce long-term cancer remission and prevent cancer relapse. An improved product design is currently being tested in an ongoing clinical trial[1] involving the treatment of EBV-associated Hodgkin lymphomas and non-Hodgkin lymphoma. A total of 33 evaluable patients in two treatment groups have received the cell therapy to date and no immediate toxicity was observed following infusion. Of 17 patients in remission but at high risk of relapse at the time of treatment, 16 remain in remission for a median of 2.5 years (ranging six months to more than five years). Of 16 patients with active disease refractory to standard treatment, 11 had clinical responses, including 8 complete responses, with a median duration of the clinical responses at 1.5 years.

In the NPC application, the CAGT recently reported indications of positive clinical results in patients with locoregional disease and further investigation is ongoing.[2]

Based on the positive clinical results Cell Medica and CAGT will collaborate to establish a commercially viable and fully GMP compliant manufacturing process as part of a plan to launch a confirmatory multicenter Phase II/III trial by 2012. Cell Medica believes the potential market size for successful treatment of EBV associated Hodgkin lymphoma, non-Hodgkin lymphoma and nasopharyngeal carcinoma could exceed $1.0 billion based on the application of the cellular therapy in first or second line treatment for these diseases.

Professor Malcolm Brenner, Director of the Center for Cell and Gene Therapy, said: "The results from our ongoing lymphoma clinical trial demonstrate that cellular immunotherapy can be used very effectively to target cancerous cells which co-express viral antigens. Based upon our recent success with an improved product design, we are looking forward to working with Cell Medica to take this therapy into advanced clinical trials and regulatory approval."

Gregg Sando, CEO of Cell Medica, commented: "We are very excited to be signing this exclusive license agreement and further strengthening our relationship with the CAGT who we believe is the clear leader in the use of research and development of cell therapies targeting EBV-related disease. Clinical results arising from the current trials indicate that this cell product is an excellent candidate for commercialization. Different types of cancer can be targeted in different ways, and EBV CTLs provide an effective approach to treat EBV associated malignancies. We will use our experience in the manufacturing scale-up, regulatory approval and reimbursement of cell therapies to bring this cell therapy into routine clinical practice as rapidly as possible."

[1] Bollard CM et al. Complete responses of relapsed lymphoma following genetic modification of tumor-antigen presenting cells and T-lymphocyte transfer. Blood; 110:2838-2845 (2007).

[2] Louis CU et al. Adoptive Transfer of EBV-specific T Cells Results in Sustained Clinical Responses in Patients With Locoregional Nasopharyngeal Carcinoma. Journal of Immunotherapy; 33:983-990 (2010).