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(Press release, Biotecnol, OCT 23, 2012, View Source [SID:1234505947])

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(Press release, TNI BioTech, OCT 18, 2012, View Source [SID:1234502813])

TNI BioTech, Inc., and Hubei Qianjiang Pharmaceuticals CO., LTD., Announce Venture Partnership for the Development of New Drug for Cancer Therapies

On October 18, 2012 TNI BioTech and Hubei Qianjiang Pharmaceutical reported an agreement to co- develop new cancer drugs based on TNI BioTech’s patents involving Methionine Enkephalin which when approved will be marketed in China under the band name IRT-101 and IRT-102 (Press release TNI BioTech, OCT 18, 2012, View Source [SID:1234501361]).

Under the Supervision of Dr. Ronald Herberman, Chief Medial Officer, and Professor Fengping Shan, Chief Science Officer, TNI BioTech, Inc. will maintain oversight responsibility for pre-clinical and clinical trials in China complying with both FDA and SFDA standards. The companies believe this joint development will fast track the drugs for the Chinese pharmaceutical markets.

Hubei Qianjiang Pharmaceutical Co., Ltd., has committed a minimum of 10 million yuan, approximately $1,600,000 dollars, for pre-clinical work. The pre-clinical trials, designed to assess safety, tolerability and antitumor activity of Methionine Enkephalin, are required in China as Methionine Enkephalin is a new drug.

Once the companies complete pre-clinical studies, TNI BioTech, Inc. will apply for clinical trials with SFDA. Hubei Qianjiang Pharmaceutical Co., Ltd.will provide the funding for clinical trials in China to have Methionine Enkephalin approved as a new drug for the treatment of cancer. Methionine Enkephalin potential in fighting cancer was identified in completed Phase I and early phase II trials in the United States. During Phase I and Phase II trials, Methionine Enkephalin exhibited encouraging antitumor efficacy and a favorable toxicity profile.

"This alliance with TNI BioTech validates Hubei Qianjiang Pharmaceutical Co., Ltd.’s business model of co-developing novel compounds as therapies for Chinese markets," in conjunction with a U.S. biotech company" said Mr. Ye Jige, President of Hubei Qianjiang Pharmaceutical Co., Ltd. "The initiation of the pre-clinical trials for IRT-101 and IRT-102 in China is a significant achievement for the development of Hubei Qianjiang Pharmaceutical Co., Ltd. and It represents both an important development milestone for this promising cancer drug and illustrates the benefits of Chinese and Western biopharmaceutical companies working together to efficiently carry out drug development. This important step will expedite the clinical development process of IRT-101 and IRT-102 in China".

Noreen Griffin, CEO of TNI BioTech, at the signing ceremony in Qianjiang China said,"This agreement illustrates TNI BioTech’s’ ability to draw upon its patents to build alliances that help biopharmaceutical companies navigate the approval process of new therapies and further illustrates our strategy to maximize the potential of biopharmaceutical development and innovation for the benefit of patients and our shareholders."

On October 17, 2012 Tanabe Research Laboratories U.S.A. Inc. (TRL) and its parent company Mitsubishi Tanabe Pharma Corporation (Osaka, Japan) reported that they have entered into a strategic research collaboration and license agreement with Covagen of Zurich Switzerland (Press release Mitsubishi Tanabe Pharma, OCT 17, 2012, View Source [SID:1234501610]).

Under the agreement, Covagen will use Covagen’s proprietary Fynomer-antibody platform to generate bispecific proteins (FynomAbs) against two target pairs selected by TRL and Mitsubishi Tanabe. Fynomers are small binding proteins that can be engineered to bind to any antigen of interest. Because of their excellent biophysical properties, Fynomers can be readily fused to therapeutic proteins such as antibodies to create bispecific FynomAbs.

Under the agreement, Mitsubishi Tanabe will fund all research activities and be solely responsible for the development, manufacturing and global commercialization activities. "Bispecific therapeutic compounds have enormous potential in the treatment of many types of diseases and this collaboration is an important validation of our pioneering work in this field." said Julian Bertschinger, Ph.D., chief executive officer of Covagen.

Dragan Grabulovski, Ph.D., chief scientific officer of Covagen, added: "This agreement underlines the value of our FynomAb platform as a source of innovative bispecific biologics with excellent biophysical properties and positions our company as a highly attractive partner for the development of next generation biotherapeutics."

Roland Newman, Ph.D. chief scientific officer of TRL, said: "This collaboration with Covagen will allow TRL and Mitsubishi Tanabe to bring a new generation of biologics with novel mechanisms to physicians and their patients. We anticipate an exciting and fruitful relationship with Covagen utilizing their bispecific FynomAb technology and their extensive expertise in this area."

Kite Pharma Partners with the National Cancer Institute to Develop Novel Cellular Immunotherapy Clinical Products

On October 16, 2012 Kite Pharma reported that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) for the development and commercialization of novel engineered peripheral blood autologous T cell therapeutics (eACT) for the treatment of multiple cancer indications (Press release Kite Pharma, OCT 16, 2012, View Source [SID:1234501824]). The collaboration with the Surgery Branch at NCI, led by Steven A. Rosenberg M.D., Ph.D., provides Kite with exclusive access to the current and future clinical product pipeline of autologous peripheral blood T cells, engineered with the NCI’s proprietary tumor-specific T Cell Receptors (TCRs) and Chimeric Antigen Receptors (CARs), directed to multiple hematological and solid tumor types.

Clinical evidence has demonstrated that patients’ peripheral blood T cells engineered with TCRs or CARs that recognize tumor specific molecules can traffic directly to the tumor, become activated upon engagement with the tumor antigen, and selectively eradicate tumors. Clinical studies using these types of engineered peripheral blood T cells, performed at NCI, have been associated with highly significant and durable objective clinical responses in cancer patients with advanced metastatic disease, including those with refractory melanoma, sarcoma, lymphoma and leukemia. These encouraging results highlight eACT/TCR/CARs as an emerging therapeutic modality that could provide new personalized targeted therapy options for cancer patients spanning the spectrum of disease from its early stages to the salvage setting.

"We are very pleased to partner with Dr. Rosenberg and his team, whose vision, innovation, and groundbreaking work in the field of cancer immunotherapy was instrumental in the development of autologous cell therapy and realization of its potential for cancer treatment," said Dr. Aya Jakobovits, President and CEO of Kite. "We regard eACT/TCR/CAR as a potential game-changing therapeutic approach to treat cancer patients. Kite will focus its efforts and resources to advance the NCI clinical product pipeline into multi-center studies aimed at successful registration and commercialization."

The CRADA will focus on:

(1) evaluation of the clinical safety and efficacy of current and future NCI proprietary eACT/TCR/CAR products in relevant cancer indications and the development of optimized clinical protocols;

(2) optimization of eACT/TCR/CAR product manufacturing and characterization in compliance with cGMP, suitable for large multi-center trials and commercialization to broad patient populations; and

(3) generation and advancement to clinical trials of additional eACT/TCR/CAR products and the development of technologies to enhance eACT/TCR/CAR product potency and durability of clinical response.

"I am excited to again join forces with Dr. Rosenberg whose pioneering and lifelong work in adoptive T cell therapy has demonstrated its potential for the treatment of incurable cancers" said Arie Belldegrun, M.D., Founder and Executive Chairman of Kite. "Combining the basic and translational research expertise at the Surgery Branch with Kite’s development expertise and capabilities positions us well to accomplish our goal of becoming a leader for innovative cancer immunotherapy products."