Amphivena, a Subsidiary of Affimed AG, Completes $14 Million Equity Financing and Signs Agreement with Janssen

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."

Ipsen strengthens its neurology R&D capabilities with the acquisition of Syntaxin, a leader in recombinant botulinum toxin technology

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).

ARC Linkage Grant to Support PAT-SM6 Diagnostics Development

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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FORMA Therapeutics and CRT to discover cancer drugs targeting deubiquitinating enzymes (DUBs)

On July 9, 2013 FORMA Therapeutics and Cancer Research Technology, Ltd. (CRT), the commercialisation company of Cancer Research UK, reported a bold research initiative to discover innovative tools, technologies and therapeutic drug candidates against a variety of protein homeostasis regulators called, deubiquitinating enzymes (DUBs) (Press release, Cancer Research Technology, SEP 9, 2013, View Source [SID1234523253]).

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Under this agreement, FORMA will pair its ultra-efficient drug discovery capabilities with CRT’s expertise in translating academic discoveries through its Discovery Laboratories (CRT-DL) and the exclusive world-class academic network of Cancer Research UK Principal Investigators.

"This initiative with CRT and Cancer Research UK has the potential to significantly accelerate our understanding of the relevant biological applications of DUBs, a key class of enzymes involved in regulating protein homeostasis," said Steven Tregay, Ph.D., President and CEO, FORMA Therapeutics. "We are particularly looking forward to working closely in this initiative with CRT’s Discovery Laboratories and a group of preeminent investigators, who bring critical insights in this area of important biology and have proven track records in basic and translational research."

Keith Blundy, CEO of Cancer Research Technology stated, "Cancer Research UK’s breadth of research combined with CRT-DL’s drug discovery capabilities are a unique platform that has secured the FORMA relationship and will contribute to bringing breakthrough cancer therapeutics to patients."

Protein ubiquitination is involved in many cellular processes and its regulation is controlled in part by DUBs. Ubiquitin "tags" proteins for degradation, and DUBs remove this tag, providing a tool for manipulating protein levels (protein homeostasis) in a cell. Ubiquitin biology is therefore complex and important to a broad range of human diseases. FORMA and CRT-DL will leverage their combined strengths to explore the protease enzymes that regulate ubiquitin-dependent pathways implicated in cancer.

"DUBs represent an attractive area for drug discovery exploration. As key regulators of ubiquitin recycling, processing, proofreading and disassembly, there is a tremendous opportunity to build a franchise of complementary therapeutics targeting the diverse collections of protein complexes," stated Kenneth W. Bair, Ph.D., Chief Scientific Officer and Head of Research and Development for FORMA Therapeutics. Dr. Bair further noted that a tremendous investment is being made by several groups to propel protein homeostasis research and discoveries into the practice of medicine.

As part of this agreement, a collaborative consortium will be formed consisting of FORMATherapeutics Inc. and up to ten FORMA ADDCos (Asset Discovery and Development Company) subsidiaries, Cancer Research Technology – Discovery Laboratories (CRT-DL) and initially five Principal Investigators including:

Professors Michael Clague and Sylvie Urbé – University of Liverpool, Liverpool, UK
Dr. Benedikt Kessler – The University of Oxford, UK
Dr. David Komander – Medical Research Council, Laboratory of Molecular Biology, Cambridge, UK
Dr. Huib Ovaa – Chemical Biology Laboratory, Netherlands Cancer Institute, The Netherlands.
These investigators will focus on furthering the consortium’s understanding of biological and structural insights of DUBs, and assist the discovery teams to ensure the most relevant screening technologies and secondary characterisation assays are deployed for selection of lead candidates. FORMA will provide research funding support and defined compensation payments for DUB-specific ADDCo programs that achieve specified milestones.

Rob Sarisky, Chief Business Officer, FORMA Therapeutics, stated, "We are pleased to have CRT participate as a cornerstone partner in FORMA’s launch of the ADDCo framework. This vehicle allows our not-for-profit collaborators to access a capital efficient engine operating at scale, attain financial returns mirroring their contributions and collectively advance medical science within the framework of a unified team."

Harpal Kumar, Chief Executive of Cancer Research UK, added, "Our research is saving lives. We are making great progress in uncovering the causes of cancer to find better ways to tackle the disease. But there is much still to do and highly collaborative partnerships focused on novel biological pathways to deliver new treatments are urgently needed. This alliance with FORMA allows us to explore a very exciting emerging area of biology to identify and develop potential new cancer drugs that will hopefully benefit patients in the future."

Immunocore signs research and licensing agreement with GlaxoSmithKline to discover ImmTACs against novel targets

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."