Inhibrx announces an Option & License Agreement with Celgene Corporation for Inhibrx Antibody Program

On June 27, 2012 Inhibrx LLC reported a worldwide Option and License Agreement with Celgene for an Inhibrx Antibody Program (Press release, Inhibrx, JUN 27, 2012, View Source [SID1234527493]). The target of this Antibody Program was not disclosed.

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"Inhibrx has developed an antibody with strong pre-clinical study results on a highly validated target with very promising therapeutic potential," said Tom Daniel, M.D., President of Research and Early Development for Celgene Corporation.

"We are pleased to have a company of Celgene’s caliber as the licensee of this program. On a global basis, Celgene has the science, clinical, regulatory and commercial expertise as well as the commitment to patients that continue to deliver disease-altering solutions to patients in need as quickly as possible," stated Mark Lappe, CEO of Inhibrx.

The total deal potential is in excess of $500M. This includes upfront, clinical and regulatory milestone payments. Additionally, Inhibrx is eligible to receive royalties on commercial sales.

Cancer Research Technology and BioInvent enter Oncology collaboration

On June 12, 2012 Cancer Research Technology Ltd (CRT), the commercial arm of Cancer Research UK, and BioInvent International AB (OMXS: BINV) reported that they have entered a collaboration with Queen Mary, University of London, to identify new therapeutic antibodies in oncology (Press release, Cancer Research Technology, JUN 12, 2012, View Source [SID1234523272]).

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BioInvent and scientists funded by Cancer Research UK at Queen Mary, under the leadership of Dr Thorsten Hagemann, Senior Cancer Research UK Fellow, will jointly be looking for new therapeutic targets by applying BioInvent’s F.I.R.S.T. technology, a functional approach to therapeutic antibody discovery. Dr Hagemann and his team will in return provide the collaboration with biological pathways for the development of new oncology therapies.

The F.I.R.S.T. platform, through its ground-breaking proprietary biopanning technology, enables identification of functionally superior antibodies across multiple targets overexpressed by target cells. This combined target and drug discovery platform utilizes primary cancer patient cells, rather than recombinant proteins, as an antigen source allowing for discovery of novel specificities (receptors and epitopes) and target receptor functions.

The agreement gives BioInvent the option to enter into licenses to bring forward drug candidates beyond lead candidate identification in exchange for milestones and royalties to CRT.

Cancer Research UK’s scientist Dr Thorsten Hagemann said: "By combining the preclinical expertise in animal models within my laboratory and our access to patient samples with BioInvent’s F.I.R.S.T. technology we hope to speed up the discovery and development of new possible treatments. We will focus primarily on targets which affect the pro-tumour role of myeloid cells in solid malignancies, an area in which my lab has developed significant experience. We would anticipate such therapies to be applicable across a range of tumour types."

Björn Frendéus, Vice President Preclinical Development at BioInvent, comments: "It is of major importance for BioInvent to tap into the vast knowledge base of a multi-pronged organisation such as Cancer Research Technology. One of our first areas of interest will be in the biology of myeloid cells in cancer, which has been an area of focus for us for many years."

Dr Phil L’Huillier, CRT’s director of business development, said: "CRT has a strong interest in exploring the exciting area of the tumour microenvironment to create innovative new cancer therapies. Tumour associated macrophages are increasingly recognised as important players in cancer, and bringing together BioInvent’s unique antibody discovery platform with Dr Hagemann’s expertise in the macrophage field provides this collaboration with a unique blend of skills to develop multiple therapeutic projects with the potential to benefit cancer patients".

(Press release, Cannabis Science, JUN 5, 2012, View Source [SID:1234506795])

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Launch of POTELIGEO® (Mogamulizumab) Injection in Japan,
a Therapeutic Antibody for Adult T-cell Leukemia-Lymphoma (ATL)

On May 29, 2012 Kyowa Hakko Kirin Co., Ltd. ("Kyowa Hakko Kirin") announced today that it has launched POTELIGEO (Mogamulizumab) Injection ("POTELIGEO") that is a therapeutic antibody for patients with relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma (ATL) (Press release, Kyowa Hakko Kirin, MAY 29, 2012, View Source [SID1234527222]).

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POTELIGEO is a humanized monoclonal antibody produced by applying POTELLIGENT technology which was developed exclusively by Kyowa Hakko Kirin. This product is the first antibody for which Kyowa Hakko Kirin has an NDA approved, and is also the world’s first POTELLIGENT antibody approved for marketing approval. POTELIGEO binds to CCR4 that is expressed on the surface of ATL cells. POTELIGEO was also granted an orphan drug designation for the treatment of CCR4-positive ATL by the Ministry of Health, Labour and Welfare.

Kyowa Hakko Kirin is working to provide treatment for a wide range of diseases with an unmet medical need including orphan diseases such as ATL. Kyowa Hakko Kirin will strive to contribute to the improvement of patients’ QOL through the development of therapeutic antibodies using its unique antibody technologies.

Overview of POTELIGEO
Product Name POTELIGEO Injection
Generic Name USAN, INN: Mogamulizumab
Indication Relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma
Dosage and Administration Once-weekly doses (eight administrations) of 1.0 mg/kg POTELIGEO Injection.
Date of marketing business license March 30, 2012
Drug tariff(including tax) 155,999 yen (per 5ml vial)

About Adult T-cell leukemia-lymphoma (ATL)
HTLV-1 (retrovirus)-induced peripheral T-cell lymphoma. Currently, about 1150 people a year develop ATL in Japan. Generally, combination chemotherapy such as mLSG15 is used, but no curative treatment has been established for ATL, except transplantation, which is actively being studied at present. For recurrent/relapsed ATL, different types of chemotherapies are used based on the treatment of malignant lymphoma, but no effective treatment has been established.

About POTELLIGENT
Kyowa Hakko Kirin’s unique technology to produce antibodies with enhanced ADCC activity. This technique allows production of antibodies that reduces the amount of fucose in the carbohydrate structure of an antibody. Non-clinical studies have confirmed that antibodies produced by this technology killed the target cells much more efficiently than existing antibodies and exhibited stronger antitumor effects.

About CCR4 (chemokine [C-C motif] receptor 4)
CCR4 is one of chemokine receptors involved in leukocyte migration. It is known that in normal cells, CCR4 is selectively expressed in type 2 helper T (Th2) cells that produce cytokines such as IL-4 and IL-5 (CD4-positive). It is also known that CCR4 is highly expressed in certain hematological malignancies.

About ADCC (antibody-dependent cellular cytotoxicity)
When an antibody binds to an antigen, effector cells such as macrophages and NK cells subsequently bind to the antibody. Antigen-bearing target cells are killed by these effector cells.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Burzynski Research Institute 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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