Advanced Cancer Therapeutics to Acquire Antisoma Drug

On May 3, 2011 Advanced Cancer Therapeutics (ACT), a privately held company dedicated to bringing new anti-cancer therapies to market, reported that it has signed an agreement to acquire 100% rights to AS1411 from Antisoma plc, a biotechnology company specializing in the development of novel drugs for the treatment of cancer (Press release, Antisoma, MAY 3, 2011, View Source [SID1234532622]).

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AS1411, now to be renamed ACT-GRO-777, is the first DNA aptamer developed as an anti-cancer agent that has shown activity against a range of solid and blood cancer lines; positive results were obtained in acute myeloid leukemia and renal carcinoma Phase I and II clinical trials combined with an excellent safety profile.

"Based on the positive results seen in early stage clinical trials both in terms of anti-cancer activity and demonstrated safety in more than 150 patients, we are excited to acquire this drug from Antisoma and believe it could have utility in a variety of cancers types," said Randall Riggs, President & CEO of ACT. "We intend to work closely with Dr. Don Miller at the Brown Cancer Center, Louisville, KY, to evaluate new potential indications or uses for ACT-GRO-777, including neuroblastoma in children, and believe it will be a strong addition to our preclinical pipeline."

ACT-GRO-777 is believed to bind specifically to a protein called nucleolin, which is found on the surface of many cancer cells. Once bound, the AS1411 aptamer is taken into the cancer cell, where it leads to cancer cell death. Louisville-based Aptamera, co-founded by Dr. Miller, originally sold this novel aptamer drug to Antisoma in 2005.

(Press release, Cancer Research Technology, MAY 2, 2011, View Source [SID:1234503926])

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Cancer Research Technology and Affitech A/S sign exclusive antibody development deal

On April 27, 2011 CANCER RESEARCH TECHNOLOGY, the commercial arm of Cancer Research UK, reported it has signed a license agreement to grant antibody medicines company, Affitech A/S, (NASDAQ OMX: AFFI), exclusive rights to a CRT patent application and relevant know how to develop and use therapeutic antibodies that recognise and block the function of CCR4, a protein found on certain tumours – including early and late stage cervical cancer and oesophageal cancer (Press release, Cancer Research Technology, APR 27, 2011, View Source [SID1234523324]).

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Under the license, Affitech will continue to develop its existing anti-CCR4 antibody program AT008, which is currently in pre-clinical development, and will be able to use any candidate identified in that program in the future for the licensed diagnostic and therapeutic applications.

Cancer Research UK-funded scientist, Professor Frances Balkwill, based at Queen Mary University of London was first to discover that CCR4 is present on cancer cells in various solid tumours, and was a promising target for new drugs to treat a range of cancer types. Cancer Research Technology holds a patent application based on this research and Cancer Research UK has funded further research to prove that CCR4 is a valuable therapeutic target.

Coinciding with the license deal, Cancer Research Technology, Affitech and Queen Mary University of London have also signed a collaborative agreement to provide pre-clinical validation for Affitech’s AT008 programme – with the aim of proving its potential as a new drug programme to treat cancer – using techniques developed in Professor Balkwill’s laboratory. This programme will be fully funded by Affitech.

CCR4 is one of 18 known chemokine receptors – proteins which bind molecules called chemokines to trigger various cellular responses. Chemokine receptors are generally present on the surface of immune cells. But a few – now known to include CCR4 – are also found on the surface of tumour cells, while not present on healthy cells. One of the roles of chemokine receptors in tumor progression is thought to be to evade immune responses, increase the ability of cancer cells to move from the original tumour and to spread to other parts of the body.

Developing antibodies to interfere with CCR4-expressing cells, such as under the AT008 programme, could provide a new highly targeted treatment to block cancer growth and spread for a range of solid tumour types.

Dr Phil L’Huillier, Cancer Research Technology’s director of business development, said: "This important license deal combines Cancer Research UK’s world-class research expertise in the exciting area of chemokine research with the development of Affitech’s existing AT008 antibody programme. This opens new avenues of research and development for potential therapies which could increase survival for patients with a range of cancer types."

Alexander Duncan, Affitech’s chief scientific officer, said: "We are delighted to have attracted the interest and participation of an outstanding investigator at the forefront of cancer research. Professor Balkwill is at the leading edge of understanding cancer biology and will be a huge asset to our anti-cancer programme.

"She is a world leader in understanding the role of immunology in cancer, particularly the chemokine system. We have embarked on an ambitious programme to understand potential mechanisms of action of the anti-CCR4 antibody, AT008, and its application in solid tumours.

"This agreement and research collaboration will extend our capabilities to advance our lead therapeutic program GPCR targeted AT008/CCR4 significantly."

Under the license, Cancer Research Technology will receive an initial signature payment, as well as pre-clinical and clinical development milestone payments, and royalties on sales of CCR4 antibodies developed by Affitech.

Cancer Research Technology retains rights to the therapeutic use in solid tumours of antibodies against CCL17 and CCL22 – the chemokine molecules which bind to CCR4 receptor to trigger cellular responses.

Dr. Reddy’s to release Q4 & Full Year FY11 results on May 13, 2011 Earnings call slated for May 13, 6.30 PM IST / 9.00 AM EST

On April 26, 2011 Dr. Reddy’s Laboratories (NYSE: RDY) reported that results for the Fourth Quarter & Full Year ended March 31, 2011 on Friday, May 13, 2011 after the Board Meeting (Press release, Dr Reddy’s, APR 26, 2011, View Source [SID1234571044]). The results will be available on the Company’s website www.drreddys.com

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Earnings Call
Following the release, the management of the Company will host an earnings call to discuss the Company’s financial performance.

No password/pin number is necessary to dial in to any of the other calls. As participation in the call is limited, early registration is encouraged. The operator will provide instructions on asking questions before and during the call.

Audio Webcast
The audio webcast of the earnings call will be available to all interested parties at www.drreddys.com. Please visit the web site at least fifteen minutes ahead of the scheduled start time to register and to download and install any necessary audio software. Participants in the webcast can listen to the proceedings, but will not be able to ask questions. The replay will be available 2 hours after the earnings call, through May 18, 2011. For play back dial in phone No: 022 3065 1212 and ID: 375#.

Transcript
The transcript of the earnings call will also be available on the Company’s website.

Kyowa Hakko Kirin submitted New Drug Application in Japan for KW-0761,
a Therapeutic Antibody for Adult T-cell Leukemia-Lymphoma (ATL)

On April 26 2011 Kyowa Hakko Kirin reported that it has submitted a new drug application (NDA) to the Ministry of Health, Labour and Welfare for KW-0761 under development for the treatment of adult T-cell leukemia-lymphoma (ATL) (Press release Kyowa Hakko Kirin, APR 26, 2011, View Source [SID:1234500291]).
KW-0761 is a humanized monoclonal antibody produced by applying POTELLIGENT, a technology to produce antibodies with enhanced ADCC activity which was developed exclusively by Kyowa Hakko Kirin. This product is the first antibody for which Kyowa Hakko Kirin has submitted a NDA, and is also the world’s first POTELLIGENT antibody to be submitted for marketing approval. KW-0761 binds to CCR4 that is expressed on the surface of ATL cells. Clinical studies of KW-0761 in patients with relapsed CCR4-positive ATL in Japan met their primary endpoint, which allowed Kyowa Hakko Kirin to submit an NDA. KW-0761 was also granted an orphan drug designation for the treatment of CCR4-positive ATL by the Ministry of Health, Labour and Welfare.

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