On July 22, 2009 REGiMMUNE Corporation reported that Astellas Pharma Inc. and REGiMMUNE have entered into a collaboration agreement to jointly research and develop a novel vaccine-platform technology (Press release, REGimmune, JUL 22, 2009, View Source [SID1234642238]). The partnership will combine Astellas’ broad range of capabilities in screening and developing natural source-derived compounds with REGiMMUNE’s immune liposome technology. Terms of the agreement have not been disclosed.

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"Our goal is to develop a potent vaccine-platform technology that enables effective vaccination with novel adjuvant and immune liposome technologies, increasing the efficiency of delivery to immune cells. Our approach will eliminate many of the current limitations for vaccine development," explained Haru Morita, CEO of REGiMMUNE. "This is particularly important for responding to new or changing virus strains. Astellas has a strong presence in immunology and is one of the largest vaccine distributors in Japan," Mr. Morita continued. "We believe this collaboration can produce a technology that will allow a rapid response to various viral outbreaks spreading around the world."

"We are pleased to initiate our first partnership with REGiMMUNE," stated Masafumi Nogimori, President and Chief Executive Officer of Astellas. "Disease prevention through timely and adequate vaccination is a key to maintaining human health. Astellas is committed to developing a new vaccine platform and this collaboration with REGiMMUNE will strengthen our position in this important area of disease prevention."

About Vaccines
Prophylactic vaccines need to elicit sufficient immune responses to protect individuals from the challenge by infectious agents. Most commonly, attenuated live viral particles are used to develop effective vaccines; however, development of live viral particles requires significant lead time and lengthy, costly manufacturing processes. While efforts have been made to develop improved adjuvants to enhance the potency of non-viral vaccines, Alum remains the only adjuvant approved by the U.S. FDA for use in humans. The Astellas-REGiMMUNE collaboration is expected to address these obstacles and provide a number of benefits over currently marketed products.

On July 13, 2009 Cancer Research Technology (CRT), Merck Serono, a division of Merck KGaA, Darmstadt, Germany, Cancer Research UK, Cardiff University and The Institute of Cancer Research (ICR) reported new research collaboration for the first time (Press release, Cancer Research Technology, JUL 13, 2009, View Source [SID1234523348]). This will provide substantial investment in research on the WNT signalling pathway in the hope of finding new drug targets.

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This cross-disciplinary, multicentre effort, spanning up to three years, will focus on the discovery of inhibitors of the WNT pathway. This pathway is involved in the physiological tissue development in embryos, as well as in tissue maintenance in adults.

Mutations in this pathway alter the molecular switches that regulate the WNT pathway and leave it permanently switched on. Such continuous activation can result in the development of cancer. Deregulation of this pathway is a frequent activating event in human cancers and is known to be linked to bowel, skin, breast and other cancers. The aim of this collaboration is to identify and develop small molecule inhibitors of the WNT pathway that could eventually become novel treatments for cancer patients.

This collaboration was established by CRT, Cancer Research UK’s commercialisation and development company, following work funded by the charity’s Discovery Committee which set the translational foundations for the programme.

Merck Serono will contribute substantial funding which will augment existing investment by Cancer Research UK and allow more rapid translation of insights into drugs that may benefit cancer patients. The work will take place at Cardiff University, the ICR and Merck Serono. Financial details were not disclosed.

Professor Trevor Dale, lead scientist on the programme at Cardiff University said: "Normal cells communicate with each other by exchanging WNT protein signals. A WNT signal will instruct a cell to grow, divide and behave like a stem cell. Cancer mutations break the molecular switches that connect WNT proteins to cell growth. This in effect leaves the pathway permanently switched on. This collaboration will allow us to convert these biological insights into therapies which one day may help us treat cancer patients."

Professor Julian Blagg, the lead scientist at The Institute of Cancer Research continued: "This collaboration brings together Cardiff’s expertise in the fundamental biology of the pathway along with the drug discovery and development expertise at the ICR and Merck Serono. This will enable us to make real progress in targeting this exciting area and harness the enormous potential in WNT pathway therapy."

Dr Phil L’Huillier, CRT’s director of business management, said: "Today’s deal represents a significant endorsement for investment in the development of early scientific research. It is testament to the promise of the lab-based research that we are now in a position to take it forward with such a large-scale project and begin to think about new treatments for cancer patients. We hope by pooling expertise we will be able to progress WNT pathway inhibitors in the fastest possible time."

On July 6, 2009 Cancer Research Technology (CRT) and The Institute of Cancer Research (ICR) reported a major research collaboration with AstraZeneca (Press release, Cancer Research Technology, JUL 6, 2009, View Source [SID1234523353]). The three partners will combine their expertise to discover and develop potential new anti-cancer drugs to target molecular "chaperones" which support the growth of cancer cells.

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As part of the deal, AstraZeneca will contribute over £4 million to the three-year project. The ICR will lead the scientific work utilising £1.6 million in funding from Cancer Research UK, who supported the original lab-based discovery on which this work will now build.

Molecular chaperones play an essential ‘escort role’ by ensuring that newly made proteins adopt the correct shape to function correctly and also help normal cells to respond to stress. However, new research suggests that these same chaperones also contribute substantially to the activity of cancer-causing proteins and actually help cancer cells to survive and become more aggressive.

Professor Paul Workman, director of the Cancer Research UK Centre for Cancer Therapeutics at The Institute for Cancer Research, Sutton, said: "We are very pleased to work with AstraZeneca, who bring great expertise in cancer drug discovery and development. By working together in this collaboration, we hope to exploit an ‘Achilles heel’ in the chaperone and stress pathways of cancer cells that will lead to the discovery of new powerful drugs to fight cancer."

Under the terms of the agreement, AstraZeneca has obtained an exclusive worldwide licence to commercialise the compounds developed during the collaboration. CRT and the ICR will receive up-front payments as well as milestone payments and royalties on any future sales resulting from the work.

Dr Les Hughes, AstraZeneca Vice President, Discovery for the Oncology and Infection Research Area, said: "We are impressed by the potential in these targets and are delighted to be joining forces with this world-renowned research team to progress this work. Drawing on our long history of discovering and developing cancer therapeutics, we aim to convert this early scientific promise into treatments that could make a real impact on the lives of cancer patients."

Dr Phil L’Huillier, director of business management at CRT, added: "We’re delighted to be involved in this collaboration between the charity sector, industry and academia so that we can help create a comprehensive approach to finding new treatments to help to beat cancer. This deal signifies a shared commitment to ensuring that the understanding gained from Cancer Research UK’s early laboratory-based research work is given the investment necessary to ensure it reaches its full potential. Only time will tell if these potential targets will become workable treatments for cancer patients in the future, but this work shows great promise."

On June 30, 2009 BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) and Cell Genesys (NASDAQ:CEGE), reported that they have entered into a definitive merger agreement by which the companies will merge in an all-stock transaction, with BioSante as the surviving company (Press release, BioSante, JUN 30, 2009, View Source [SID1234531733]).

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Under the terms of the merger agreement, Cell Genesys stockholders will receive 0.1615 of a share of BioSante common stock for each share of Cell Genesys common stock they own. Based on the companies’ closing stock prices on June 29, 2009, this represents $0.347 per share of consideration to be received by the Cell Genesys stockholders, or a total consideration of approximately $38 million, and a premium of 12 percent to the closing sale price of Cell Genesys’ common stock on that date. Upon completion of the transaction, BioSante stockholders prior to the merger are expected to own approximately 60.4 percent of the outstanding shares of the combined company and the former Cell Genesys stockholders are expected to own 39.6 percent.

Stephen M. Simes, president and CEO of BioSante, and Phillip B. Donenberg, CFO of BioSante, will continue to serve in those positions in the merged company. Dr. Louis W. Sullivan, chairman of the board of BioSante, will continue in that position. It is anticipated that Stephen A. Sherwin, M.D., chairman and CEO of Cell Genesys, and John T. Potts, Jr., M.D., a current member of the Cell Genesys board, will join the board of the merged company upon completion of the merger.

The merged company will focus primarily on LibiGel, BioSante’s testosterone gel in Phase III clinical development under a U.S. Food and Drug Administration (FDA) agreed Special Protocol Assessment (SPA) for the treatment of female sexual dysfunction (FSD). The merged company also will seek future development opportunities for GVAX Immunotherapies including potential combination with BioVant, BioSante’s vaccine adjuvant, as well as possible external collaborations, and also will seek to outlicense other Cell Genesys technologies. In addition, the merged company will acquire a 16 percent equity ownership position in Ceregene, Inc., a former subsidiary of Cell Genesys which is developing gene therapies for neurodegenerative disorders.

"This merger allows BioSante to secure additional funding required for the continued Phase III development of LibiGel for FSD and offers the potential to expand our product development portfolio with the addition of GVAX Immunotherapies," said Stephen M. Simes, BioSante’s president and CEO. "LibiGel remains the only pharmaceutical product in the U.S. in active development for the treatment of hypoactive sexual desire disorder (HSDD) in menopausal women. We continue to believe that LibiGel can be the first product approved by the FDA for the common and unmet medical need of FSD with the completion of Phase III studies targeted for mid-to-late 2010. In addition, our company has had a long-standing interest in immunotherapy based on our proprietary vaccine adjuvant, BioVant, and we look forward to future value-creating opportunities for our stockholders based on Cell Genesys’ technologies and other assets."

"Over the past several months, we have had the opportunity to evaluate a wide range of strategic alternatives for our company including several merger opportunities. After reviewing various strategic alternatives, engaging in discussions with a number of other potential merger candidates and conducting extensive due diligence on BioSante’s product development and business activities, our board of directors has voted to recommend a merger with BioSante," stated Stephen A. Sherwin, M.D., chairman and CEO of Cell Genesys. "We believe that BioSante’s lead product, LibiGel, represents a compelling near term product opportunity with significant upside potential. We also are impressed with BioSante’s record of achievement including the recent launch of Elestrin (estradiol gel) as well as their CaP nanotechnology platform which includes BioVant, a novel vaccine adjuvant with potential in immunotherapy."

The merger agreement has been approved unanimously by the boards of directors of both BioSante and Cell Genesys and will need to be approved by both BioSante’s and Cell Genesys’ stockholders. The merger is subject to customary closing conditions as well as a condition requiring Cell Genesys’ net cash, less certain expenses and liabilities, to be a specified minimum amount as of 10 calendar days prior to the anticipated closing date of the merger.

As of June 23, 2009, Cell Genesys’ cash balance was approximately $36 million and BioSante’s cash and cash equivalents balance was approximately $6.2 million. As a result of Cell Genesys’ recently completed exchange offer, Cell Genesys has outstanding approximately $20.8 million of new 3.125% Convertible Senior Notes due in 2013 and $1 million of the original 3.125% Convertible Senior Notes due in 2011.

The transaction is expected to be completed in the late third quarter or early fourth quarter of 2009. BioSante was advised in this transaction by Oppenheimer & Co. Inc. and Cell Genesys was advised by Lazard.

About BioVant

An adjuvant is a substance that, when added to a vaccine, enhances the vaccine’s effectiveness by enhancing the body’s immune response. In multiple studies, BioVant has been shown to be safe and cause minimal dose-dependent inflammation at the injection site, and has been shown both to prevent the manifestation of allergic response, and, to effectively ‘switch off’ established Th2-T-cell-associated allergic reactions. BioVant also may permit a reduction in the needed dosage of vaccine, thereby potentially improving the safety profile of the vaccine.

About GVAX Immunotherapies

GVAX cancer immunotherapies are non patient-specific therapies comprised of whole tumor cells that have been modified to secrete GM-CSF (granulocyte-macrophage colony-stimulating factor), an immune stimulatory cytokine, and then irradiated for safety. GVAX is administered via intradermal injections on an outpatient basis. To date, over 1000 patients have been treated in clinical trials with different GVAX cancer immunotherapies for various types of cancer. Although phase III trials in prostate cancer were discontinued in 2008, phase II trials under physician investigator sponsored-INDs are ongoing at the Sidney Kimmel Cancer Center at Johns Hopkins Hospital in pancreatic cancer, leukemia and breast cancer.

On June 22, 2009 Cancer Research Technology Limited (CRT), the oncology-focused development and commercialisation company, reported initiation of global Phase III clinical study by Merck KGaA of the therapeutic cancer vaccine Stimuvax (BLP25 liposome vaccine, L-BLP25) in patients with advanced, inoperable breast cancer (Press release, Cancer Research Technology, JUN 22, 2009, View Source [SID1234523352]). The STRIDE(a) study will determine if Stimuvax can extend progression-free survival in patients treated with hormonal therapy who have hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer.

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Stimuvax is a liposomal peptide vaccine against the tumour-associated protein MUC1. The vaccine was developed by Oncothyreon (formerly 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. Stimuvax was the first investigational cancer vaccine to enter Phase III clinical testing in NSCLC with the February 2007 launch of the STARTb study, which will involve more than 1,300 patients with unresectable stage III NSCLC, who were stable or responding after chemoradiotherapy.

You can find out more about this new study by reading Merck KGaA announcement here.