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]).

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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."

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.

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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."

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. 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.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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."

Burzynski Research Institute has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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(Filing 10-K , Cancer Therapeutics CRC, OCT 11, 2012, View Source [SID:1234501663])

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