(Press release, Kolltan Pharmaceuticals, OCT 31, 2011, View Source [SID:1234504455])

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On October 26, 2011 ATLAB Pharma and BZL Biologics entered into a sublicense agreement to develop 177Lu-J591 for cancer treatment (Press release ATLAB Pharma, OCT 28, 2011, View Source [SID:1234500930]). The agreement includes exclusive rights to manufacture, develop and commercialize this radiopharmaceutical product worldwide as well as a joint Phase IIB/III clinical validation program.

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177Lu-J591 has shown a highly attractive efficacy and tolerability profile in phase I and Phase II trials involving 108 patients with metastatic castrate-resistant prostate cancer (M+ CRPC). A large randomized multicenter Phase IIB study is ongoing in CRPC patients with rising PSA but no detectable metastasis (M0 CRPC), a clinical condition affecting more than a million men worldwide, for whom there is no approved therapy.

According to the agreement, ATLAB Pharma will fund certain product development and clinical trials.

Dr. Jean-Marc Le Doussal, President of ATLAB Pharma, stated that "177Lu-J591 has a very good therapeutic profile in metastatic prostate cancer patients, validated by several clinical trials and an exceptional scientific rationale. 177Lu-J591 has a large market potential in CRPC patients and beyond. We are very happy to join forces with BZL to hasten the development of this unique drug."

"Our partner BZL shares our vision that targeted radiotherapy drugs have the unique ability to eradicate micro-metastatic disease at an early stage of cancer progression. We believe that current trials will confirm the 177Lu-J591 survival benefit at the micro-metastatic stage of castrate resistant prostate cancer progression" added Dr. Jean-Francois Chatal, Emeritus Professor of Nuclear Medicine and Chief Medical Director at ATLAB Pharma.

On October 28, 2011 Topotarget and Multimeric Biotherapeutics reported the signature of an exclusive license agreement granting Multimeric rights to the further development of the multimeric TNF superfamily ligands (TNFSFs) for all therapeutic uses (Press release TopoTarget, OCT 28, 2011, View Source;messageId=580641 [SID:1234500429]). TNFSFs are not a core activity of Topotarget IP assets. Topotarget continue to focus efforts on its lead compound the HDACi belinostat.
Under the agreement, Multimeric will license the rights to all multimeric fusion proteins containing TNFSFs which are covered by Topotarget’s issued and pending patents in Europe, US, Canada, Japan, Australia, South Korea, and other territories. The agreement also grants Multimeric the rights to sub-license.
No details on the terms of the agreement were disclosed

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On October 25, 2011 Takara Bio reported that it has entered into an agreement with Memorial Sloan-Kettering Cancer Center (MSKCC; New York, US) as of October 25, 2011, under which the company conducts in Japan a clinical research for gene therapy targeting non-Hodgkin lymphoma, in which Chimeric Antigen Receptor (CAR) technology is applied (Press release Takara Bio, OCT 25, 2011, View Source [SID:1234501097]). Based on the agreement, MSKCC’s data and materials relevant to CAR gene therapy will be provided to the company to be used for its planned clinical research in Japan.

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Since 2007, MSKCC has been conducting in the United States clinical trials of CAR gene therapy for leukemia, in which a CAR targeting CD19, which is a protein expressed on the surface of cancerous B cells, are utilized ("CD19-CAR gene therapy"). In August this year, MSKCC team published in Blood journal an article about encouraging results from the clinical trials, where certain efficacies of the CD19-CAR gene therapy were suggested in three out of eight evaluable patients who received the treatment.

Takara Bio will move forward clinical development of CD19-CAR gene therapy targeting non-Hodgkin lymphoma jointly with its endowed chair Division of Immuno- Gene & Cell Therapy (Takara Bio) of Jichi Medical University. The parties will prepare for an application for gene therapy clinical research in Japan by leveraging MSKCC’s data and materials such as the clinical protocol for CD19-CAR trial. Furthermore, the company will manufactures itself a GMP-grade CD19-CAR retrovirus vector for the planned clinical research in by utilizing virus producer cells provided by MSKCC.

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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