On July 19, 2013 Kyowa Hakko Kirin reported that it has been filed an application to Japan’s Ministry of Health, Labour and Welfare (MHLW) seeking approval for additional indication for untreated CCR4-positive adult T-cell leukemia-lymphoma (ATL), relapsed CCR4-positive peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) of Mogamulizumab (brand name: POTELIGEO Injection 20 mg) (Press release , JUL 19, 2013, View Source [SID:1234500288]).

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Mogamulizumab is a novel, humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4), which is over-expressed on various malignant T cells, including ATL, PTCL and CTCL cells. Engineered by Kyowa Hakko Kirin’s unique POTELLIGENT Technology, the antibody is designed to kill its target cells through potent antibody-dependent cellular cytotoxicity (ADCC). Clinical studies of Mogamulizumab in patients with untreated CCR4-positive ATL, relapsed CCR4-positive PTCL and CTCL in Japan met their primary endpoint, which allowed Kyowa Hakko Kirin to file an application. Mogamulizumab was also granted orphan drug designations for the treatment of CCR4-positive ATL in August 2010, PTCL and CTCL in March 2013 by the MHLW.
Mogamulizumab was launched in Japan with the brand name "POTELIGIO Injection 20 mg" on May 29, 2012 for the treatment of patients with relapsed or refractory CCR4-positive ATL and is being investigated world-wide in a number of clinical studies for other potential indications.

On July 15, 2013 Ipsen (Euronext: IPN; ADR: IPSEY) reported the closing of the acquisition of Syntaxin, a UK-based private life sciences company specialized in botulinum toxin engineering (Press release, Ipsen, JUL 15, 2013, View Source [SID1234517245]). Under the terms of the agreement, Ipsen will pay €28 million upfront, as well as further contingent payments that could reach €130 million or more depending on the achievement of development and commercial milestones. Furthermore, Syntaxin’s shareholders will receive the greater part of additional downstream payments related to the company’s most advanced asset, currently in Phase II clinical trials.

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The transaction fits into Ipsen’s strategy to reinforce its core technological platforms, peptides and toxins. Syntaxin has a wealth of experience in botulinum toxin biology, supported by an extensive patent portfolio – with 75 granted patents and over 130 patents pending.

Syntaxin and Ipsen started collaborating in 2010. A year later, they signed a global strategic partnership to explore the discovery and development of new compounds in the field of recombinant botulinum toxins. Syntaxin’s team has used its extensive expertise in the discovery of new therapeutic candidates while Ipsen applied its skills to pharmacological, preclinical and clinical assessment of the compounds. Prior to the transaction, Ipsen owned c.10% of Syntaxin’s capital on a fully diluted basis.

Marc de Garidel, Chairman and CEO of Ipsen stated: "We are very pleased to see Syntaxin become part of Ipsen. This is an important step in our ambition to become a global leader in targeted debilitating diseases. The acquisition of Syntaxin is a considerable addition to our neurology franchise and is fully aligned with our strategy of focus."

Syntaxin has a strong R&D portfolio which exploits the diversity of botulinum toxins, including recombinant botulinum toxins with improved designs and properties. The Company’s technology has been validated by the Phase II clinical trials of Syntaxin’s lead candidate. Dr Keith Foster and Dr John Chaddock, the co-founders of Syntaxin, will join Ipsen to help the Group build a highly differentiated and innovative toxin platform. Syntaxin’s recombinant toxin expertise and Ipsen’s know-how will be a powerful combination to release the full potential of the Targeted Secretion Inhibitors platform across Ipsen’s therapeutic areas of neurology, endocrinology and uro-oncology.

Ipsen expects to achieve full integration by the end of the year.

Ipsen has been supported on this transaction by Lazard Ltd, Freshfields Bruckhaus Deringer LLP, and Bristows LLP (for IP matters).

On July 15th, 2013 Affimed Therapeutics AG, the TandAb antibody company reported that its subsidiary Amphivena Therapeutics Inc., a drug discovery company developing bispecific TandAb antibodies to treat hematological tumors, has successfully completed a $14 million Series A equity financing.

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The Series A financing was led by MPM Capital, with participation from Aeris Capital and Affimed AG. Amphivena will use the proceeds for the pre-clinical development of a novel therapy for a hematological disorder based on Affimed’s proprietary TandAb antibody technology.

Separately, in addition to the Series A financing, working with the London Innovation Centre of Johnson & Johnson Innovation and the Oncology Therapeutic Area within Janssen Research & Development, LLC, Amphivena has entered into an agreement with Janssen Biotech, Inc. (Janssen) that grants Janssen the exclusive right, at Janssen’s discretion, to acquire Amphivena following IND approval upon pre-negotiated terms and conditions set forth in the agreement. Janssen will provide Amphivena with an initial upfront payment plus additional contingent payments based on reaching predetermined milestones in return for its rights under the agreement.

Affimed AG has entered into a license and development agreement with Amphivena to support the discovery and pre-clinical development of the novel TandAb based therapy.

Dr. Luke Evnin, Managing Director of MPM Capital; Phil Gutry, Principal at MPM Capital; Dr. Frank Mühlenbeck, Partner at Aeris Capital; and Dr. Adi Hoess, CEO of Affimed AG; will each join Amphivena’s Board of Directors.

"Affimed’s TandAb platform shows significant promise in addressing this critical patient need," said Dr. Luke Evnin of MPM Capital. "We are excited to partner with antibody cancer experts of such caliber."

"Amphivena in collaboration with Affimed AG will develop novel bi-specific TandAb antibodies to improve the existing therapy for a specific hematological malignancy," said Adi Hoess, CEO of Affimed AG. "We are excited that MPM and Aeris Capital have partnered with us to support the development of a novel agent and are pleased to enter into this relationship with Janssen."

On July 10, 2013 Patrys reported that scientific collaborators at Macquarie University (Macquarie), Sydney, have been awarded a $427,510 Australian Government grant to support the development of new highly sensitive, non-invasive cancer diagnostic kits using Patrys’ lead candidate PAT-SM6 (Press release Patrys, JUL 10, 2013, View Source [SID:1234500546]).
PAT-SM6 is an IgM antibody that has successfully completed a Phase I trial in melanoma and is currently in a Phase I/IIa trial for patients with relapsed or refractory multiple myeloma.
The grant, which has been awarded by the Australian Research Council ("ARC"), will bring together experts from Macquarie led by Dr. Dayong Jin, Professor Nicolle Packer, Professor James Piper, Associate Professor Robert Willows and Professor Simon Foote with industry partners Minomic International Limited and Patrys.
The project will combine Macquarie’s new Super Dot nanocrystal technology with Minomic’s and Patrys’ antibodies directed against prostate and multiple myeloma cancer biomarkers, respectively.
Patrys’ previous collaboration with Professor Packer showed that PAT-SM6 detects specific changes in the proteins present on the surface of multiple myeloma cells, but not on normal cells. These cancer-modified cells in the patients’ blood and urine are very rare in early stages of disease and their detection poses a "needle-in-a-haystack" challenge at both the research and clinical levels. Current diagnostic tests are not sensitive enough to detect these rare-event cells, resulting in an inefficient early detection and diagnosis of cancer and consequently poor prognosis.
Dr. Jin and colleagues from Macquarie University have developed highly sensitive technologies using super-bright nanocrystals that will enable the detection of single abnormal cells in body fluids, and will provide the basis for new, sensitive and non-invasive, early-stage screening of multiple myeloma, prostate cancer and other malignancies.

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On July 9, 2013 Immunocore Limited, the Oxford-based biotechnology companydeveloping novel biological drugs called ImmTACs to treat cancer and viral disease, reported it has entered into a partnership with GlaxoSmithKline (GSK) for multiple novel targetsnot addressable using antibody-based technologies (Press release, Immunocore, JUL 9, 2013, View Source [SID1234529018]). This is Immunocore’s second major partnershipthis year.

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Under the terms of the agreement, Immunocore will receive up to a total of £142 million in pre-clinical milestone payments across the targets. In addition, for each product that reaches the market,up to £200 million is due to Immunocore in development and commercial milestone payments, plusup to double digit royalties. Immunocore will be responsible for all of the pre-clinical development and for the initial clinical trials in patients and GSK will be responsible for the remaining development and commercialisation of the products.

Immunocore has created a world-leading platform of bi-specific biological drugs, called ImmTACs (Immune mobilising mTCR Against Cancer), which exploit the power of T Cell Receptors (TCRs) torecognise intracellular changes that occur during cancer or viral infection. This unique recognitionability of TCRs sets them apart from traditional antibody-based therapies that can only recognise changes on the surface of cells, and provides, for the first time, the ability to develop extreme lypotent targeted therapies for cancers that are currently poorly served. The most advanced ImmTACdrug, IMCgp100 for the treatment of melanoma, is currently in Phase I/II clinical trials in the UK and USA.

James Noble, Chief Executive Officer of Immunocore, commented: "We are delighted to collaboratewith GSK, our second major partnership signed this year. GSK is a leading pharmaceutical companywith a proven track record in the development of biotherapeutics and this is an important partnership for Immunocore."

Laurent Jespers, VP and Head of Innovation BDU, Biopharm R&D of GSK, said: "We are very excitedabout the opportunity to work together with Immunocore to develop ImmTACs. We believe ImmTACs offer a tremendous opportunity in treating cancer and in other areas where there is a large unmet medical need."