On October 29, 2012 Del Mar Pharmaceuticals (BC) Ltd. ("DelMar") reported a strategic collaboration with Guangxi Wuzhou Pharmaceutical Company, a subsidiary of publicly traded Guangxi Wuzhou Zhongheng Group Co., Ltd (SHG 600252) for the development of VAL-083, known as "DAG for Injection" in China (Press release, DelMar Pharmaceuticals, OCT 29, 2012, View Source [SID1234556371]).

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DAG for Injection in China, is approved by the Chinese State Food and Drug Administration (SFDA) as a cancer chemotherapy for the treatment of Chronic Myelogenous Leukemia (CML) and lung cancer. Guangxi Wuzhou Pharmaceuticals is licensed by SFDA to manufacture and sell VAL-083 in China for these indications.

DelMar is conducting clinical studies using the Guangxi Wuzhou Pharmaceutical’s drug product in the United States as a potential treatment for refractory glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer.

In addition, DelMar is conducting research aimed at demonstrating the utility of DAG for Injection in cancers refractory to current therapies. Recently published data elucidated sub-types of CML and lung cancer that are uniquely prevalent in persons of East Asian decent and highly resistant to treatment by tyrosine kinase inhibitors (TKIs). DelMar’s research demonstrates activity against cancer cell lines resistant to TKI therapy.

The Companies plan to use new data being generated through DelMar’s clinical programs to expand the market in China and to seek regulatory approval for the drug in multiple indications on a global basis.

The collaboration expands the exclusive supply relationship between DelMar and Guangxi Wuzhou Pharmaceuticals to include the Chinese market and all markets outside China. The companies will work together to insure the product specifications meet global standards in order to accelerate international development and regulatory approval. Wuzhou Pharmaceuticals will be the exclusive supplier of DAG for Injection and DelMar will be responsible for development and commercialization.

"This expanded collaboration positions DelMar to unlock the value of our research by benefiting patients in China where our VAL-083 is already approved as a cancer chemotherapy," said Jeffrey Bacha, President & CEO of DelMar.

The expanded collaboration, was announced at a joint press conference and signing ceremony in Wuzhou China on October 24, 2012. During the ceremony, Chen Ming, Vice Chairman of Zhongheng Group, outlined six key areas of focus for the collaboration:

Seek approval from regulatory authorities outside China, including the FDA, EMEA and other international jurisdictions to commercialize DAG for Injection for the treatment of GBM and other indications;
DelMar will support Wuzhou Pharmaceuticals by developing and providing new clinical and non-clinical data for the approved indications in China in order to support marketing and sales of DAG for Injection in China;
Wuzhou Pharmaceutical will assist and provide financial support for DelMar to initiate development work in one or more Clinical Centers in China as part of an international multi-center clinical development strategy;
DelMar will provide clinical and non-clinical data to support Wuzhou Pharmaceuticals to obtain approval of DAG for Injection from SFDA for new indications, including GBM;
DelMar and Wuzhou Pharmaceuticals will work together to enable Wuzhou Pharmaceuticals to obtain FDA certification as a cGMP manufacturer of DAG for Injection; and
Through co-development of DAG for injection, the collaboration will seek to maximize the value of Wuzhou Pharmaceuticals business in China and create a foundation for sales in international markets.
Xu Shuqin, Chairman of Zhongheng Group said, "It is understood that, through this collaboration, we will seek to establish approval of DAG for Injection through international authorities including FDA and EMEA and other international jurisdictions outside China for multiple indications including brain cancer. DelMar will assist Wuzhou Pharmaceuticals within China to support sales and marketing of the product and promote the optimization of production and quality assurance to meet international standards. Wuzhou Pharmaceuticals will assist DelMar by supporting international multi-center clinical trials. We will work together to jointly develop and promote Wuzhou Pharmaceuticals business in China, to maximize the value of products sold in the international market, and to lay the foundation for more extensive collaboration opportunities."

On October 29, 2012 Astex Pharmaceuticals, Inc. (Nasdaq: ASTX), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, Cancer Research Technology Limited (CRT) and Newcastle University reported they have signed a major five-year strategic drug discovery alliance (Press release, Cancer Research Technology, OCT 29, 2012, View Source [SID1234523268]). The partners will discover and develop new cancer drugs in collaboration with researchers at the Cancer Research UK Drug Discovery Program at the Northern Institute for Cancer Research (NICR, Newcastle University).

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During the five-year alliance, Astex will provide £1M funding annually to Newcastle University to support research across biology, chemistry, pharmacology and imaging at the NICR to identify and develop new cancer drugs and associated biomarkers to develop tests to determine which patients to treat and if new drugs are working.

Harren Jhoti, PhD, director and president of Astex Pharmaceuticals, said: "We are delighted to enter into this broad strategic drug discovery alliance with one of Cancer Research UK’s leading drug discovery centers as it allows Astex to access world-leading translational research in oncology.

"This new alliance builds on a previous collaboration between Astex, Newcastle and CRT on FGFr, a key cancer target, which led to the development of a clinical candidate that our partners at Janssen have recently taken into a Phase I clinical trial, and we look forward to discovering more new potential therapies for cancer patients."

Astex will retain an option to an exclusive worldwide license to develop and commercialize pharmaceutical products from each alliance project. CRT and Newcastle are eligible to receive development and regulatory milestone payments on exercise of the options, and on products that Astex takes into development (and royalties on sales of products). Financial terms of the milestone payments and royalties were not disclosed.

Professor Herbie Newell, co-director of the Cancer Research UK Drug Discovery Program at the NICR, Newcastle University, said: "This exciting alliance represents an innovative route to the development of more effective cancer drugs by combining the partners’ expertise and experience.

"The research will bring together pre-clinical drug and biomarker discovery approaches using molecular, genetic and clinical data to identify new targets in cancer cells that can be treated with drugs, and ultimately medicines to take into clinical trials that will provide new ways to treat the disease and increase survival."

Dr Keith Blundy, Cancer Research Technology’s chief executive, said: "This major collaboration, which builds on the successes and impressive track record of all partners, will further develop Cancer Research UK’s world-class research into cancer treatments.

"Risk-sharing partnerships like this enable us to maximise the development of our basic research portfolio into new treatments for patients.

"The success of our existing network of partnerships is seen in our drug development pipeline which is the largest and most diverse of any academic partner worldwide with more than 30 cancer therapies in clinical development, and a further 175 discovery/pre-clinical projects in our portfolio, of which 55 are partnered with industry."

On October 29, 2012 Menarini and Oxford BioTherapeutics (OBT) reported a major strategic alliance to develop a portfolio of antibody-based drugs in the field of cancer (Press release Oxford BioTherapeutics, OCT 29, 2012, View Source [SID:1234500496]). The agreement covers five of OBT’s antibody and antibody drug conjugate (ADC) programs, each of which addresses a different cancer indication via a different novel oncology target. The deal brings together OBT’s discovery expertise with Menarini’s clinical knowledge, and expanding capabilities in the manufacture and development of biologics, to build value for both companies as they work to bring this exciting portfolio of next generation antibody-based cancer drugs to market.

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Under the collaboration, Menarini will lead the efforts in the manufacture and clinical development of each program, supported by OBT, while OBT will provide the proprietary cancer target, antibody and arming technologies. Once clinical proof of concept has been achieved, OBT will complete the clinical development and commercialize these novel antibody-based products in North America and Japan, whilst Menarini will develop and commercialize the products in Europe, CIS, Asia and Latin America.

On October 28, 2012 REGiMMUNE Corporation reported that RGI-2001, the company’s liposomal formulation of alpha-GalCer, has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for the treatment of Graft-versus-Host Disease (GvHD) associated with hematopoietic stem cell transplantation (Press release, REGimmune, OCT 28, 2012, View Source [SID1234642237]).

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Orphan Drug Designation is a special status granted by FDA to a novel product to treat a rare disease or condition on the basis of Orphan Drug Act (ODA) In order to give incentive to biotech companies to tackle treatments for race diseases, the company of the product is qualified for some benefits such as tax credit or waiver of a prescription drug user fee.

About RGI-2001
RGI-2001 is a liposomal formulation of alpha-GalCer (a CD1d ligand), which induces regulatory T cells (Treg), a key player in immune tolerance. Because the compound promotes transplantation tolerance, Treg has been shown to have significant potential for treating Graft-versus-Host Disease (GvHD). In studies by independent researchers, Treg has proven to produce longer patient survival because it reduces rejection without reducing an anti-tumor graft versus leukemia (GvL) effect. Unlike immunosuppressents that destroy entire T cell subsets, RGI-2001 induces Treg while maintaining normal immune cell functions and has the potential to reduce GvHD and improve survival for patients.

About Graft-versus-Host Disease (GvHD)
GvHD is a serious complication that results from rejection of the donor Human Stem Cell Transplantation (HSCT). GvHD is caused by the donor’s immune system recognizing the cells/organs derived from the patient (recipient) as pathogens (foreign body). A low grade of GvHD is regarded as positive, because it reflects a normal immune reaction while trying to eliminate residual cancer cells. However, a more severe grade of GvHD can be life threatening as it may significantly damage skin cells, fast growing cells in the gastrointestinal (GI) tract and liver cells.

On October 23, 2012 DNAtrix, Inc., the Houston-based biotechnology company developing targeted adenovirus-based oncolytic virus products for brain cancer, reported a merger with VectorLogics, Inc. (VLI), a company with a complementary intellectual property portfolio developing products for ovarian cancer (Press release, DNAtrix, OCT 23, 2012, View Source [SID1234572158]). The merged company will retain the name DNAtrix and continue to develop its lead cancer product, DNX-2401, which is in clinical testing at the University of Texas M.D. Anderson Cancer Center for treating high grade brain tumors.

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Dr. Imre Kovesdi, Ph.D., chief executive officer of VLI, and Dr. David T. Curiel, M.D., Ph.D., chief scientific officer and founder of VLI, will join the merged company as chief scientific officer and member of the Scientific Advisory Board, respectively. "We are extremely pleased to join forces with Dr. Curiel and Dr. Kovesdi in this important effort," stated Frank Tufaro, Ph.D., chief executive officer of the merged company. "The merger makes strategic sense, and we are now a much stronger company in all respects."

"As an inventor of VLI’s adenoviral technology," stated Dr. Curiel. "I am very pleased to be able to work with the DNAtrix team in turning these discoveries into new cancer therapies. This is a win-win for both companies."

About Frank Tufaro, Ph.D., Chief Executive Officer
Dr. Tufaro serves as the chief executive officer of DNAtrix, Inc., where he has been since 2010 and has extensive experience in biotechnology. He was CEO and co-founder of Neurovir, Inc., a Vancouver-based biotech company developing viral-based oncolytic vectors for treating cancer. Dr. Tufaro was instrumental in raising venture financing that established NeuroVir as the major player in the field of viral oncology and also helped negotiate and execute the successful merger of NeuroVir with MediGene AG. Prior to Neurovir, Dr. Tufaro was a University of British Columbia virology professor and holds a Ph.D. in molecular and development biology from McGill University.

About Imre Kovesdi, Ph.D., Chief Scientific Officer
Dr. Kovesdi joins DNAtrix as chief scientific officer (CSO) and previously served as chief executive officer of VLI. Prior to joining VLI, he served as CSO with GenVec Inc. He joined GenVec in 1993 as one of its first employees and held several senior positions directing research, development and manufacturing before being appointed as CSO. Dr. Kovesdi was also a major contributor to GenVec’s intellectual property portfolio. Prior to joining GenVec, he led projects in the development of gene expression systems and therapeutic gene design at the Medical Research Division of the New York-based American Cyanamid Company. He holds a PhD in molecular biology from Simon Fraser University and a degree in electrical engineering from University of British Columbia. Dr. Kovesdi is the holder of over 100 US and foreign patents and has authored over 130 scientific articles in the areas of virology, gene delivery and molecular biology. Dr. Kovesdi has served on the boards of a number of biotechnology and information technology companies.

About David T. Curiel, M.D., Ph.D., Scientific Advisory Board member
Dr. Curiel joins DNAtrix as an advisor and previously served as chief scientific officer and founder of VLI. Dr. Curiel is also presently the Director of Cancer Biology and the Biologic Therapy Center at Washington University School of Medicine in St. Louis. Previously he directed the Gene Therapy Center (GTC) of the University of Alabama at Birmingham (UAB) for 18 years. He holds an M.D. from Emory University where he also completed his internship and residency in Internal Medicine. Dr. Curiel’s scientific training includes tenureship at the National Institutes of Health in Bethesda, Maryland, at the Pulmonary Branch of the Heart and Lung, and Blood Institute (NHLBI), a fellowship in Biotechnology at the National Cancer Institute, Navy Medical Oncology Branch. He received his PhD from the University of Groningen, in the Netherlands. He is a recognized leader in the field of vector development and in bench-to-bed translation of gene therapy and virotherapy interventions.

About DNX-2401
The company’s first product, DNX-2401, represents the culmination of over a decade of work and is the first oncolytic virus capable of killing cells with defects at any point in the retinoblastoma (Rb) pathway. DNX-2401 functions by replicating in, and killing tumor cells lacking growth control caused by any defect in the Rb pathway, without targeting a specific point in the pathway itself. This property greatly lowers the risk of drug resistance and toxicity. DNX-2401 is in clinical testing at University of Texas M.D. Anderson Cancer Center for treating glioblastoma multiforme, a type of stage IV brain tumor. For more information about current clinical trials, please visit www.clinicaltrials.gov.

Glioblastoma multiforme (GB) is a fatal primary brain tumor resistant to conventional therapies. It is the second most common cause of death from intracranial disease, after stroke. The current standard of care – surgery, radiotherapy and chemotherapy-has extended the overall median survival to 14.6 months. GB is an unmet medical need with a clear need for new therapeutic modalities that can impact the course of the disease.