On February 6, 2007 Sareum Holdings plc (Sareum) the specialist structure-based drug discovery business, The Institute of Cancer Research (The Institute), Europe’s leading cancer research centre, and Cancer Research Technology Limited (CRT), the oncology focused development and commercialisation company, reported that novel small molecule compounds, the subject of a series of patent filings, show activity in targeting Checkpoint Kinase 1 (CHK1) (Press release, Cancer Research Technology, FEB 6, 2007, View Source [SID1234523392]).

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CHK1 is a key component of a biochemical pathway responsible for preventing the effectiveness of traditional cancer therapeutics such as chemotherapy and is the primary target of the joint collaboration. The aim of the programme, first announced in July 2005, is to develop potential cancer treatments with valuable benefits for cancer patients including lower doses of existing therapies, fewer adverse side-effects and efficacy where tumours currently do not respond to chemotherapy. In August 2006 Sareum announced that the collaboration had discovered a novel compound series which showed activity in cancer cell models.

The patent filings are part of an ongoing strategy to secure the intellectual property rights relating to the novel compound series developed from this collaboration, their effectiveness in inhibiting CHK1 function and their use in the treatment of cancer.

Sareum has used its expertise in fragment and structure-based drug discovery to identify novel chemical compounds effective against CHK1. These compound series have been rapidly progressed towards drug candidates utilising Sareum’s high throughput medicinal chemistry and structure determination platforms combined with the drug screening, specialist cancer biology and medicinal chemistry expertise at The Cancer Research UK Centre for Cancer Therapeutics at The Institute.

Under the terms of the collaboration agreement, CRT will commercialise the drug candidates developed by the collaboration to secure future clinical development. Payments, milestones and royalties received by CRT will be shared with Sareum and The Institute.

Commenting on the announcement, Sareum’s Chief Executive Officer, Dr Tim Mitchell, said: "The progress of these compounds represents an important milestone in Sareum’s strategy to generate value through our in-house drug discovery. We are now looking forward to advancing our novel chemical series through to clinical candidate nomination."

Professor Paul Workman, Director of The Cancer Research UK Centre for Cancer Therapeutics at The Institute of Cancer Research, said: "We are very pleased with the progress that has been made so far with this project. By utilising the complementary expertise of each organisation we can speed up the drug development process and bring new treatments to patients as soon as possible."

On January 11, 2007 Cancer Research Technology Limited (CRT), the oncology-focused development and commercialisation company, reported that a milestone has been reached following entry of Stimuvax into a global phase 3 trial in patients with unresectable stage 3 Non Small Cell Lung Cancer (NSCLC) (Press release, Cancer Research Technology, JAN 11, 2007, View Source [SID1234523393]).

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Stimuvax is a liposomal peptide vaccine against the tumour-associated protein MUC1. The vaccine was developed by Biomira under a portfolio of patents licensed by CRT, following Cancer Research UK-funded investigations led by Prof Joyce Taylor-Papadimitriou at Guy’s Hospital, London. Under the terms of the agreement with Biomira, CRT receives development-related milestones and royalties on sales, including a milestone following entry into phase 3 clinical trials. The large multinational phase 3 trial is being undertaken by Biomira’s co-development partner, Merck KGaA, who is also responsible for the regulatory approval and commercialisation of Stimuvax in all territories apart from Canada. Merck KGaA additionally plans to investigate the use of Stimuvax to treat other types of cancer.

Lung cancer is the most common cancer worldwide with 1.2 million new cases occurring annually. It remains the leading cancer killer. Survival times for patients diagnosed with the disease are extremely poor. In the US, 80% of patients presenting with advanced disease will not survive 5 years and survival rates are considerably lower than this in many other parts of the world. NSCLC accounts for 80% of total lung cancer cases and current standard treatments for lung cancer patients are surgery, platinum-based combination chemotherapy and radiotherapy.

Compared with traditional treatment approaches, anti-cancer vaccines have the advantage that they are likely to be associated with relatively high tumour specificity and low patient toxicity together with prolonged activity. Furthermore, vaccines could potentially be used as a supplementary treatment and be administered in combination with existing cancer therapies.

Keith Blundy, COO of CRT, commented: "We are extremely pleased that Stimuvax, one of CRT’s portfolio of more than 20 partnered agents in clinical development, has entered late-stage clinical trials. Development of targeted vaccines for therapeutic use is an exciting approach that could potentially offer new treatment options in some major cancer indications."

On January 6, 2006 Cancer Research Technology Limited (CRT), the oncology-focused development and commercialisation company, today announce that Phil L’Huillier, the Director of Business Management, reported that it will present at the BioEurope 2006 Annual International Partnering Conference (Press release, Cancer Research Technology, NOV 6, 2006, View Source [SID1234523394]). Dr L’Huillier will introduce two of CRT’s collaborative discovery programmes: Protein Kinase D (PKD) and Migration Stimulating Factor (MSF). The presentation will take place on Wednesday 8th November at 10.45 CET in Düsseldorf.

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MSF is an exciting new anti-angiogenic therapeutic antibody programme that CRT has undertaken in collaboration with the University of Dundee. Within the collaboration, a panel of highly specific MSF function-neutralising monoclonal antibodies have been generated. These antibodies block growth of blood vessels ex vivo and invasion in vitro. Initial progress in this programme is extremely encouraging and CRT expects to have further data within the next three months. In addition, the University of Dundee is investigating the potential of MSF as a prognostic biomarker by correlating MSF expression with patient survival in a large cohort of breast cancer tissues.

PKD is a promising novel anti-cancer and anti-angiogenic target that is involved in the regulation of cell proliferation, apoptosis and invasion in a variety of cancers. To date, several series of compounds have been identified and developed from a screen of CRT’s compound library. Two lead series have been the subject of an intense hit-to-lead and lead optimisation programme. These series include compounds with IC50s of <1 nM, that show good selectivity, solubility, cell permeability and have encouraging CYP450 inhibition and microsomal stability profiles. Cell based studies have shown initial proof of concept and the lead compounds are currently undergoing pharmacokinetic studies in advance of proof of efficacy studies.

CRT’s Development Laboratories collaborate with research institutes worldwide to build on exploratory academic research and create attractive commercial opportunities. Both small molecule and biological therapeutic projects are taken from the discovery stage through to in vivo proof of concept studies. Currently, CRT are working on more than 15 ‘in-house’ small molecule and biotherapeutic discovery projects. Such R&D programmes are pivotal for the progression of discoveries originating from academic cancer research and have previously resulted in the completion of licenses with major biotechnology and pharmaceutical companies.

On November 2, 2006 XOMA Ltd. (Nasdaq:XOMA) and Takeda Pharmaceutical Company Limited (TSE4502:Takeda) reported that they have entered into an agreement for therapeutic monoclonal antibody discovery and development (Press release, Xoma, NOV 2, 2006, View Source [SID1234537390]). The collaboration is intended to capitalize on XOMA’s comprehensive antibody discovery, development and production technologies and expertise.

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The agreement calls for Takeda to make up-front and milestone payments to XOMA, fund XOMA’s R&D activities including manufacturing of the antibodies for preclinical and early clinical supplies, and pay royalties to XOMA on sales of products resulting from the collaboration. Payments to XOMA could exceed $100 million before royalties over the life of the collaboration.

Using its extensive collection of phage display libraries and antibody optimization technologies, XOMA will discover therapeutic antibodies against multiple targets selected by Takeda. Other XOMA activities will include preclinical studies to support regulatory filings, cell line and process development, and production of antibodies for initial clinical trials. Takeda will be responsible for clinical trials and commercialization of drugs after IND submission, and is granted the right to manufacture once the product enters into phase 2 clinical trials.

"XOMA’s extensive antibody discovery and development expertise and technologies fit well with Takeda’s objective of building a strategic presence and pipeline in therapeutic antibodies. We look forward to working with our new partner," said John L. Castello, chairman of the board, president, and chief executive officer of XOMA.

"We are pleased with the conclusion of the agreement with XOMA, which has state-of-the-art technology in the antibody field," said Shigenori Ohkawa, PhD, General Manager of Pharmaceutical Research Division of Takeda. "We believe that the collaboration with XOMA will accelerate our drug discovery and development activities in therapeutic antibodies, a field that continues to grow as an important source of new medicines."

On October 11, 2006 Bellicum Pharmaceuticals reported an non-exclusive, royalty-bearing licensing agreement with ARIAD Pharmaceuticals for its ARGENT cell-signaling regulation technology. ARIAD will have an equity stake in Bellicum and will receive additional payments (Press release Bellicum Pharmaceuticals, OCT 11, 2006, View Source [SID:1234500803]). Bellicum also may be granted exclusive licenses in certain product applications based on its achievement of development, regulatory and commercial milestones. The Bellicum product candidates will use ARIAD’s small molecule dimerizer drug, AP1903, which already has successfully completed a Phase 1 clinical trial.

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Bellicum Pharmaceuticals, Inc. is focused on the development of next generation therapeutic vaccines and other immunotherapeutic approaches for the treatment of cancer. Bellicum’s BP-GMAX-CD1 lead product candidate is a novel dendritic cell vaccine to treat prostate cancer. This vaccine incorporates an AP1903-activated CD40 gene, which acts as a pharmacologically regulated switch to boost the potency and enhance the durability of the anti-cancer immune response (see, Hanks, et al, Nature Medicine2005, 11:130). "We are delighted that ARIAD has selected Bellicum to advance the dimerizer technology", stated Bellicum CEO Tom Farrell. "We have assembled a compelling set of preclinical data, and completion of this license now allows us to move rapidly to clinical development of our first cancer vaccine."

In a widely reported study (Morgan, et al, Science 10.1126/science.1129003, published online 31 August 2006), researchers at the National Cancer Institute reported the cure of two advanced melanoma patients using a genetically modified autologous vaccine. According to Bellicum Founder and Baylor Prostate Center Director Kevin Slawin, M.D., "Dr. Rosenberg’s work has demonstrated proof of principle that genetically modified autologous vaccines, such as those being developed by Bellicum, can lead to the complete eradication of even advanced cancers, an achievement rarely seen with more conventional therapies, whose benefits are often more incremental".

David M. Spencer, Ph.D., Bellicum’s Co-Founder and Chief Scientific Officer, and Associate Professor of Immunology, Baylor College of Medicine, co-invented the dimerizer technology while a student in Professor Gerald R. Crabtree’s lab at Stanford University. He is also the lead author of the seminal dimerizer paper (Spencer, et al, Science 1993, 262, 1019). "It is especially gratifying to see my earlier work at Stanford come full-circle with the opportunity to apply the dimerizer technology to our work here at Bellicum," stated Spencer.