On March 29, 2014 Ono Pharmaceutical and OncoTherapy Science reported that the companies entered into a license agreement for new therapeutic peptide vaccines for all types of cancer, including hepatocellular carcinoma (Press release Ono, MAR 29, 2011, www.ono.co.jp/eng/news/pdf/sm_cn110329.pdf [SID:1234500749]). Under this agreement, Ono is granted the exclusive rights (including sublicense rights) in Japan, South Korea and Taiwan to develop, manufacture and commercialize OncoTherapy’s therapeutic peptide vaccines derived from three kinds of oncoantigens. Ono will pay to OncoTherapy an upfront payment at closing of this agreement, followed by milestone payments based on development stages and achievement of projected sales as well as royalties on sales of the vaccines. In addition, Ono retains an option to expand the licensed territory based on the future development status.

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OncoTherapy is a company in the development of novel therapeutic agents for cancer. It has collaborated with Human Genome Center, the Institute of Medical Science, the University of Tokyo to identify and analyze functions of genes playing an important role for development and progression of cancer using comprehensive analysis of gene expressions, and to select proteins for drug discovery. OncoTherapy has already identified various peptide vaccines through its research and development on oncoantigens enhancing specific immune function for target protein.

Meanwhile, since we have already estimated the upfront payment under this license agreement in research and development expenditures of the current fiscal period ending March 2011, there is no financial impact on the projected business performance of this fiscal period.

Advanced Life Sciences has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

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On March 23, 2011 Senectus Therapeutics* reported it has signed a deal to screen a selection of AstraZeneca’s chemical compound library to identify those which trigger a key element of cancer cell ageing – called senescence (Press release, Cancer Research Technology, MAR 23, 2011, View Source [SID1234523325]).

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Senescent cells are those which after many rounds of cell growth and division enter a ‘sleep’ phase where the normal cell cycle is stopped. This blocks the uncontrolled growth and division of cells. It is a natural mechanism to prevent cancer. But cancer cells find ways to trick their way past this block and continue to grow and divide.

Understanding the triggers to cell ageing may reveal molecular targets for completely new ways to treat cancer.

The Senectus consortium,** a group of Cancer Research UK experts in senescence, has developed a screening platform to identify compounds which trigger this cancer cell ageing process and also find potential new drug targets.

The deal will allow the consortium to screen a well characterised sub-set of AstraZeneca’s compound library to identify those which potentially trigger senescence. Thereafter the parties will decide how or if they want to progress individual compounds.

Dr Phil L’Huillier, Cancer Research Technology’s director of business development and chairman of Senectus Therapeutics, said: "The collaboration with Senectus is one of a number of initiatives that AstraZeneca has put in place to use its compound library in early stage research, to explore novel mechanisms that may lead to new therapeutics. The collaboration recognises the value and potential AstraZeneca attributes to the Senectus screening platform.

"Before now, there hasn’t been a reliable and robust process to identify compounds which trigger senescence. The Senectus consortium has addressed these hurdles and developed the relevant tools and approaches to identify the ways by which cancer cells escape cell ageing. This opens up an exciting and valuable area for scientists to discover new routes to treat cancer."

Through this collaboration AstraZeneca has the opportunity to extend the agreement with Senectus to investigate any compounds with properties that may lead to future cancer treatments.

Dr. Paul Elvin, principal scientist, AstraZeneca, said: "Collaboration with Senectus complements their knowledge-base and experimental platform with well characterised molecules that will provide insight into the nature of some key drivers of senescence."

Nicol Keith, Cancer Research UK’s Professor of Molecular Oncology at the University of Glasgow, and co-ordinator of the Senectus team, said: "The joint work programme with AstraZeneca emphasises the importance of senescence as an exciting, untapped pool of new therapeutic targets which could provide potential new routes to treat cancer.

"To date there has been very little progress in translating laboratory findings into therapeutic targets. By bringing together these expert groups from industry and academia we have the best group of people to speed up development in this area."

On March 21, 2011 Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, reported a positive outcome from a pivotal Phase II clinical trial conducted by Roche and Genentech, Curis’ collaborator and a wholly owned member of the Roche Group, of GDC-0449, a first-in-class hedgehog pathway inhibitor, in patients with advanced basal cell carcinoma (BCC) (Press release, Cancer Research Technology, MAR 21, 2011, View Source [SID1234523524]). Genentech informed Curis that the study met its primary endpoint of achieving a target overall response rate, showing that GDC-0449 shrank advanced BCC tumors in a pre-defined percentage of people in the study. A preliminary safety assessment showed the most common adverse events were consistent with previous experience with vismodegib. A detailed safety assessment is ongoing. Roche has indicated that it anticipates making at least one regulatory submission in 2011 to seek approval to commercialize GDC-0449.

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Hedgehog was initially identified as a developmentally related gene in drosophila at the London Research Institute (Phil Ingham in collaboration with Harvard scientists). CRT subsequently licensed Hedgehog IP to Curis in 1995.

View the Curis press announcement for more information.

On March 11, 2011 Apexigen reported that its partner, Simcere Pharmaceutical Group filed an Investigational New Drug (IND) application with the State Food and Drug Administration (SFDA) of China to evaluate APX003 (also known as BD0801) as a potential cancer therapy (Press release Apexigen, MAR 11, 2011, View Source [SID:1234500905]). APX003 is a humanized monoclonal antibody directed against VEGF, and is intended for the treatment of multiple malignancies. Upon review and approval of the IND application by the SFDA, Simcere plans to initiate Phase 1 safety and tolerability studies in cancer patients.

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Simcere will develop and commercialize APX003 in China under a license agreement with Apexigen. In 2008, Simcere acquired rights to APX003 from Epitomics, Inc. Then in July of 2010, Epitomics created Apexigen as an independent therapeutic antibody company, licensed to Apexigen exclusive rights to the use of its antibody technologies for the development and commercialization of antibody therapeutics, and assigned to Apexigen the license and collaboration agreement with Simcere. Apexigen and Simcere collaborated on the IND enabling studies and on the completion of the IND for APX003.

The initiation of this Phase 1 clinical study will mark a significant milestone for Apexigen. APX003 will be the first humanized antibody generated through the use of its technology to be administered to humans.

"This is an exciting time for Apexigen. We are eager to see the first of our antibodies demonstrate safety, tolerability and efficacy in man as a first step toward the development of best-in-class therapeutics", said Dr. Xiaodong Yang, President & CEO of Apexigen. "The collaboration with Simcere has been very productive. We look forward to continuing to collaborate with Simcere on the clinical development program which will provide the first clinical validation of our technology."

"This IND filing is the outcome of dedicated effort and collaboration between Apexigen and Simcere," said Mr. Jinsheng Ren, chairman and chief executive officer of Simcere.